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Lupus Clinical Trials

New Medical Therapies™

Psoriasis and Psoriatic Disorders

Patient Medical Areas

April 7, 2014

Idera Pharmaceuticals issued results from its randomized, double-blind, placebo-controlled phase II trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis. All patients were withdrawn from prior therapies with an appropriate wash-out period and were randomized equally to receive subcutaneous IMO-8400 monotherapy at dose levels of 0.075mg/kg, 0.15mg/kg and 0.3mg/kg or placebo, weekly for 12 weeks, with a six-week follow-up period. The trial met its primary objective as all treatments were well-tolerated with no treatment-related discontinuation, serious adverse events or dose reductions. The trial also met a secondary objective of demonstrating clinical activity based on Psoriasis Area and Severity Index (PASI) scores. Among patients who completed 12 weeks of treatment per protocol, PASI 50 was achieved in nine (45%) of 20 who received IMO-8400 at any dose level, and in one (14%) of seven who received placebo. PASI 75 was achieved in four (20%) of IMO- 8400 treated patients at any dose level, and in zero placebo patients. PASI 50 and PASI 75 are defined as 50% and 75% improvement, respectively, compared to baseline PASI.

March 31, 2014

Novartis released results of two ongoing phase III studies (FEATURE/JUNCTURE) of secukinumab (AIN457) for the treatment of moderate-to-severe plaque psoriasis. The randomized, double-blind, placebo-controlled, multicenter studies enrolled a total of 352 subjects. FEATURE results showed the efficacy of secukinumab 300mg and 150mg based on a statistically significant higher proportion of patients who achieved a PASI 75 response at week 12 compared with placebo patients: 75.9% (300mg) and 69.5% (150mg), v. 0% for placebo (p<0.0001). On the co-primary endpoint, the efficacy of secukinumab 300mg and 150mg was shown based on a statistically significant higher proportion of patients who achieved an IGA mod 2011 0/1 response at week 12 compared with placebo: 69.0% (300mg) and 52.5% (150mg), v. 0% for placebo (p<0.0001). Results from JUNCTURE also showed the efficacy of secukinumab 300mg and 150mg based on a statistically significant higher proportion of patients who achieved a PASI 75 response at week 12 compared with placebo: 86.7% (300mg) and 71.7% (150mg), v. 3.3% for placebo (p<0.0001). On the co-primary endpoint, the efficacy of secukinumab 300mg and 150mg was shown based on a statistically significant higher proportion of patients who achieved an IGA mod 2011 0/1 response at week 12 compared with placebo: 73.3% (300mg) and 53.3% (150mg), v. 0% placebo (p<0.0001).

Pfizer issued results of a phase III study of tofacitinib for the treatment of moderate-tosevere chronic plaque psoriasis. The 12-week, non-inferiority study compared tofacitinib 5mg and 10mg to high-dose ENBREL (etanercept) 50mg. Results showed tofacitinib 10mg was non-inferior to high-dose ENBREL 50mg as measured by Psoriasis Area and Severity Index (PASI) 75 response and Physician’s Global Assessment (PGA) response. The proportion of patients that achieved a PASI75 response at week 12 was: tofacitinib 10mg: 63.6%; ENBREL 50mg: 58.8%; tofacitinib 5mg: 39.5%; placebo: 5.6%. The proportion of patients that achieved “clear” or “almost clear” in PGA at week 12 were: tofacitinib 10mg: 68.2%; ENBREL 50mg: 66.3%; tofacitinib 5mg: 47.1%; placebo: 15%. Tofacitinib 5mg did not meet the non-inferiority criterion of 15% difference compared to high-dose ENBREL as measured by PASI75. Top-line results from two of the three remaining trials in the phase III Oral treatment Psoriasis Trial (OPT) Program, the OPT Pivotal 1 and OPT Pivotal 2 trials (A3921078 and A3921079), are anticipated in the second quarter of 2014, and these four studies, in addition to a long-term extension study, will form the planned psoriasis submission package to regulatory authorities.

May 20, 2013

Creabilis released results from a phase IIb trial of CT327 for the treatment of chronic pruritus in psoriasis. This randomized, double-blind, placebo-controlled study enrolled 160 patients with chronic pruritus in psoriasis. Subjects received CT327 ointment at 0.05%, 0.1% and 0.5% administered twice daily for eight weeks. Data demonstrated patients receiving CT327 showed a statistically significant and clinically meaningful reduction in pruritus compared to blinded placebo vehicle. Pruritus was measured using a visual analogue scale (VAS), the accepted regulatory endpoint. The reduction from baseline in pruritus VAS reached 60% for CT327 compared to 20% for vehicle alone (p<0.05). A clinically meaningful reduction in pruritus (VAS=20mm) was seen in up to 79% of patients for CT327 compared to 36% for vehicle alone (p<0.05). At baseline, 69% of patients reported at least moderate pruritus (VAS>40mm). An improvement was also seen in the CT327 treated groups versus vehicle in mPASI (modified Psoriasis Area and Severity Index) in all subjects. The drug was safe and well tolerated. Subjects receiving CT327 reported fewer adverse events and withdrawals due to pruritus than the vehicle treated patients.

Idera Pharmaceuticals reported results from a phase II trial of IMO-3100 for the treatment of plaque psoriasis. This randomized, double-blind, placebo-controlled study enrolled 44 patients with moderate to severe plaque psoriasis. Subjects received 0.16mg/kg or 0.32mg/kg or IMO-3100, or placebo, by subcutaneous injection once weekly for four weeks, with a follow-up period through day 57. Results showed on day 57, 48% of patients treated with either dose of IMO-3100 demonstrated statistically significant improvements of 35% to 90% from baseline Psoriasis Area Severity Index (PASI) scores compared with 0 in the placebo cohort (p<0.005). Additionally, analysis of biopsy samples collected from patients during the trial indicated PASI score improvements were associated with significant improvement of psoriasis disease-associated gene profile, including down regulation of activated genes in the IL-17 pathway,which is central to the pathogenesis of psoriasis. IMO-3100 was well tolerated at both dose levels. Based on these data, Idera Pharmaceuticals is planning a 12-week phase II trial of IMO-8400 in psoriasis to initiate in the second half of 2013.

January 14, 2013

Celgene International released results from two phase III trials of apremilast for the treatment of chronic plaque psoriasis. These randomized, placebo-controlled studies, ESTEEM 1 and 2, enrolled 1,250 patients with moderate to severe chronic plaque psoria sis who are also candidates for phototherapy and/or systemic therapy. Subjects received either apremilast 30mg twice weekly (BID) or placebo for the first 16 weeks, followed by a maintenance phase from weeks 16-32 in which placebo subjects were switched to apremilast 3mg BID through week 32. Subjects also had a randomized withdrawal phase from week 32-52 based on their initial randomization and PASI response. Data showed patients receiving apremilast 30mg BID monotherapy in both the ESTEEM 1 and 2 studies achieved Psoriasis Area and Severity Index (PASI) 75. Patients receiving apremilast also achieved a statistically significant benefit over placebo in the major secondary endpoint, Static Physician Global Assessment (sPGA). Apremilast was well tolerated. Subjects are being evaluated for safety and efficacy in long-term extension studies for up to an additional four years. Celgene will be submitting an NDA to the FDA in 2013.

January 7, 2013

Idera Pharmaceuticals (IDRA) released results from a phase II trial of IMO-3100 for the treatment of plaque psoriasis. This randomized, double-blind, placebo-controlled study enrolled 44 patients with moderate-to-severe plaque psoriasis. Subjects received a subcutaneous injection of 0.1632mg/kg or 0.32mg/kg of IMO-3100 once weekly, or placebo, for four weeks. Results showed 48% of patients treated with IMO-3100 demonstrated improvements in Psoriasis Area Severity Index (PASI) scores of 35% to 90% from baseline. None of the 12 placebo-treated patients had improvement in this range; this difference was statistically significant (p<0.005). At the end of the four-week follow-up period, 25% of patients treated with 0.16mg/kg dose and 31% of those with 0.32mg/kg dose achieved PASI 50 or greater. The 0.16mg/kg cohort also achieved, with statistical significance (p<0.02), the pre-specified clinical endpoint of improvement in induration, a measure of plaque thickness. IMO-3100 was well tolerated. No adverse events were noted.

October 8, 2012

Novartis reported results from a phase II trial of AIN457 (secukinumab) for the treatment of plaque psoriasis. This double-blind, parallel group, placebo-controlled study enrolled 404 patients with moderate to severe psoriasis on the hands, feet and nails. Subjects received AIN457 or placebo once-weekly for four weeks, with an analysic period at 12 weeks. Data showed AIN457 was nearly three times more effective than placebo at reducing plaque psoriasis (54.3% of patients versus 19.2% respectively, p=0.005), as measured by the Investigator’s Global Assessment (IGA). Patients also benefited if they received AIN457 once every four weeks, with 39.0% experiencing either “clear” or “minimal” psoriasis after 12 weeks of treatment. In this same treatment group, significantly more patients experienced improvements in pain and discomfort compared to placebo (36.2% versus -1.5%) from baseline; and in anxiety and depression versus placebo (16.3% versus 6.2%), as measured by EuroQol (EQ-5D). AIN457 was well tolerated. The most frequent adverse events were infections. Novartis will await the results of a large-scale and longer-term phase III study, expected in 2013, before submitting an NDA.

April 2, 2012

Eli Lilly reported results from a phase II trial of ixekizumab for the treatment of psoriasis. This randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study enrolled 142 subjects with moderate to severe plaque psoriasis. The subjects received subcutaneous injections of placebo or 10, 25, 75 or 150 mg of ixekizumab at weeks 0, 2, 4, 8, 12 and 16. The primary endpoint was at least a 75 percent improvement in Psoriasis Area and Severity Index scores from baseline (PASI 75) compared with placebo at week 12. Significantly more subjects achieved a PASI 75 response in the 150 mg (82%), 75 mg (83%) and 25 mg (77%) ixekizumab groups compared with placebo (8%; p<0.001) at week 12. Secondary endpoints included the percentage of subjects achieving at least 90 percent and 100 percent improvement in PASI (PASI 90 or PASI 100) at week 12. In subjects treated with ixekizumab, the percentages achieving a PASI 90 response were 71% (150 mg), 59% (75 mg) and 50% (25 mg), which were significantly higher than with placebo (0%). PASI 100 responses were significantly better at the 150 mg dose (39%) and 75 mg dose (38%) when compared with placebo (0%). Improvements were also observed in static Physician Global Assessments, the Nail Psoriasis Severity Index and the Psoriasis Scalp Severity Index.

March 26, 2012

Provectus reported results from a phase IIc trial of PH-10 (Rose Bengal) for psoriasis. This multicenter, randomized controlled study (PH-10-PS-23) enrolled 99 subjects with mild to moderate plaque psoriasis who received placebo or PH-10 (0.01%, 0.005% or 0.002%) applied once daily to affected skin areas for 28 days. The primary efficacy endpoint was treatment success, assessed at day 29 after initial PH-10 treatment. Success was defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale. The Pruritus (itching) Self Assessment scale was also measured. Results for all three efficacy parameters showed improvement, with the low dose of PH-10 (0.002%) providing uniformly consistent improvement, while reduced therapeutic activity was observed at the two higher doses. After 28 days of treatment with PH-10 (all strengths), 23-29% of subjects achieved complete or nearly complete resolution of all PSI components, compared to no subjects in the placebo arm. In the low dose PH-10 arm, 38% of subjects reported no itching after 28 days compared with 14% of those receiving placebo. PH-10 at 0.002% and 0.005% exhibited maximum improvement in Plaque Response Assessment, with the improvements for 0.002% achieving high significance (p<0.001) after two weeks of treatment; all strengths were superior to placebo after 28 days, with the highest strength exhibiting the least activity.

March 14, 2011

Creabilis issued results from a phase IIa trial of CT327 cream for psoriasis vulgaris (PV).This randomized, double blind, placebo controlled trial enrolled 48 subjects with mild to moderate PV. The subjects received CT327 0.1%w/w cream applied to one target lesion twice daily, placebo cream applied to the remaining target lesion twice daily or placebo cream applied to both target lesions twice daily for an eight week treatment period. CT327 produced a good efficacy response across multiple endpoints including PGA (Physician Global Assessment) and mPASI (modified Psoriasis Area and Severity Index). In the PGA analysis, 33% of subjects had 'controlled disease' at the end of the eight week period compared to 8% at baseline and the number of subjects rated 'severe or very severe' was reduced by 50% over the same period. In the placebo arm 7% of subjects had 'controlled disease' at the end of the study compared to 6% at baseline. CT327 was well tolerated with no reported application site irritation.

October 18, 2010

Pfizer issued positive results from four phase III trial of briakinumab for the treatment of psoriasis. These results are from the largest study, M06-890. This 52-week, randomized, study enrolled 1,465 subjects with moderate to severe chronic plaque psoriasis. In an induction phase, subjects were randomized at baseline to briakinumab 200 mg at weeks zero and four, followed by 100 mg at week eight or placebo injections. The subjects who had a clinical response (PGA 0 or 1) were randomized at week 12 to receive briakinumab 100 mg every four weeks, 100 mg every 12 weeks or placebo injections. The co-primary endpoints were proportion of subjects achieving PGA 0 or 1 at week 12; the proportion achieving PASI 75 at week 12 and proportion achieving PGA 0 or 1 at week 52. Briakinumab was statistically superior to placebo by the primary endpoint measures at week 12: 76% of subjects achieved PGA 0 or 1 at week 12 compared to 4.3% with placebo and 80.7% achieved PASI 75 at week 12 compared to 4.5% with placebo. At 52 weeks, 79.2% of subjects treated every four weeks with briakinumab achieved PGA 0 or 1 compared to 41.6% treated every 12 weeks with briakinumab and 6% treated with placebo. All results were statistically significant (P<0.001) versus placebo. The treatment was generally well tolerated.

June 21, 2010

Anacor issued positive results from a phase IIb trial of AN2728 for the treatment of psoriasis. This multicenter, randomized, double-blind, dose-ranging, bilateral trial enrolled 145 subjects with mild-to-moderate plaque-type psoriasis. The subjects were randomly assigned to apply AN2728 ointment, 0.5% or 2.0%, once or twice daily to one target plaque and the placebo ointment to a similar target plaque on the opposite side of the body. The treatment duration was 12 weeks. The psoriasis plaques treated with AN2728 2.0% twice daily achieved greater improvement in the Overall Target Plaque Severity Score in a significantly higher proportion of patients after six weeks compared to placebo (P<0.001). In addition, of those plaques treated for 12 weeks with 2.0% AN2728 twice daily, 54% achieved complete or near complete clearance with at least a two-grade improvement from their baseline severity score. Treatments were generally well tolerated with no serious adverse events reported.

September 14, 2009

Can-Fite released positive results from a phase II trial of CF-101 for the treatment of psoriasis. This trial enrolled 75 subjects with moderate to severe psoriasis across Israel and Europe. The subjects were randomized to twice daily oral treatment with 1, 2 and 4 mg of CF101 or placebo for 12 weeks. The 2 mg dose of CF-101 twice daily was determined to be the most efficacious. This dose resulted in significant improvement in the mean Psoriasis Activity and Severity Index (PASI) score, relative to baseline, after 12 weeks of treatment (p<0.0001). This improvement was statistically significantly superior to the placebo group (p≡0.03). In addition, 83% of the subjects in the 2 mg treatment arm demonstrated improvement in disease parameters upon CF101 treatment and 35% demonstrated an improvement of over 50% (PASI 50). CF101 was well tolerated.

May 4, 2009

Isotechnika issued positive results from a phase III trial of voclosporin for the treatment of psoriasis. This randomized trial, dubbed ESSENCE, enrolled 642 subjects with moderate to severe psoriasis, across sites in Canada, Germany and Poland. The subjects received voclosporin (0.4 mg/kg twice daily), cyclosporine (1.5 mg/kg twice daily) or placebo, for a 24-week treatment duration. At the end of 12 weeks of treatment subjects in the placebo arm were converted to the voclosporin treatment arm. The primary endpoint was superiority in the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment (SPGA) score. In the voclosporin arm, 35% of subjects achieved this endpoint at 12 weeks compared to 6% of subjects receiving placebo (p<0.001). In addition, in the voclosporin arm 43% of subjects at 12 weeks and 46% of subjects at 60 weeks achieved a 75% reduction in the Psoriasis Area and Severity Index (PASI-75) and 67% of subjects at 12 weeks and 68% of subjects at 60 weeks achieved a 50% reduction in PASI (PASI-50). A key secondary endpoint, non-inferiority of voclosporin compared to cyclosporine in the proportion of subjects achieving a "clear" or "almost clear" in SPGA, was not reached. In the cyclosporine arm, 53% of subjects met this endpoint compared to 35% in the voclosporin arm.

March 2, 2009

Anacor released positive results from a phase II trial of AN2728 for the treatment of psoriasis. This randomized, double-blind, placebo-controlled trial enrolled 30 subjects with plaque-type psoriasis. AN2728 (5%) ointment was applied to one target plaque and the placebo ointment alone to a similar matching plaque on the other side of the body. AN2728 ointment was applied twice daily for 12 weeks and the plaques were scored every two weeks. Statistically significant reductions were observed in the overall target plaque severity score (OTPSS), as well as in the individual signs of psoriasis, including erythema, scale and plaque thickness. A significantly higher number of subjects treated with AN2728 showed a lower OTPSS after as few as two weeks of treatment compared to placebo; optimal responses were seen at six and eight weeks (P<0.001 and <0.01, respectively). In addition, 13% of the treated plaques cleared completely and 43% of the plaques achieved clear or almost clear with a two-grade improvement from baseline. Treatments were generally well tolerated with the most common side effect being irritation at the application site.

September 22, 2008

Centocor reported positive results from a phase III trial of ustekinumab for the treatment of psoriasis. This multi-center, randomized head-to-head study, dubbed ACCEPT, enrolled 903 subjects with chronic plaque psoriasis. The subjects received subcutaneous doses of either ustekinumab 45 mg or 90 mg at weeks 0 and 4 or standard of care, Enbrel (etanercept), 50 mg twice weekly for 12 weeks. The primary endpoint of the study was the proportion of subjects who achieved at least a 75 percent reduction in psoriasis at week 12, as measured by the Psoriasis Area and Severity Index (PASI 75). At week 12, PASI 75 was observed in 68% and 74% of subjects receiving ustekinumab 45 mg or 90 mg, respectively, compared with 57% of subjects receiving Enbrel (p = 0.012 for ustekinumab 45 mg; p < 0.001 for ustekinumab 90 mg, versus Enbrel). Secondary endpoints, PASI 90 and Physician Global Assessment (PGA) scores were also achieved. At week 12, PASI 90 was observed in 36% and 45% of subjects receiving ustekinumab 45 mg and 90 mg, respectively, compared with 23% of subjects receiving Enbrel (p < 0.001 for both arms versus Enbrel). In addition, a PGA score of "cleared" or "minimal" was achieved by a larger proportion of subjects in the ustekinumab 45 mg and 90 mg treatment groups (65% and 71%, respectively) compared with those in the Enbrel treatment group (49%; p< 0.001 for both arms versus Enbrel). Treatment was generally well tolerated. A BLA and an MAA are currently under review by the FDA and EMEA, respectively

Incyte released positive results from two phase IIa trials of INCB18424 for the treatment of psoriasis. Study 201 was a 28-day dose-escalation study and enrolled 28 subjects with limited plaque psoriasis. The subjects received 0.5%, 1.0% and 1.5% once or twice-daily topical formulations of INCB18424, placebo or active comparators (Dovenex and Diprolene) applied to paired lesions. Each subject served as their own control. The 1% once-daily dose and the 1.5% twice-daily dose decreased mean total lesion scores by 53% and 54%, respectively, compared with 32% and 27% reduction with placebo treatment on day 28 (p = to 0.05). Mean total lesion scores for the 1.5% twice-daily dose of INCB18424 decreased on day 28 by 46% as compared to 40 % for Dovenex and decreased by 58% as compared to 44% for Diprolene. INCB18424 was well tolerated at all doses. Study 202 is an ongoing 28-day open-label study designed to evaluate the safety and pharmacokinetics of INCB18424 at increasing coverage levels of total body surface area (BSA). To date, the study has enrolled and treated the first cohort of five subjects who applied a 1.5% twice-daily dose of INCB18424 to not less than 2% or more than 7% of their BSA. INCB18424 improved lesion thickness, erythema and scaling and also reduced the overall treated lesion area as compared to the overall untreated lesions. Transcriptional profiling data in these subjects demonstrated that topical INCB18424 inhibits two key pathways, Th1 and Th17. INCB18424 was well tolerated. Based on the results, Incyte plans to initiate a phase IIb trial in October of 2008.

August 11, 2008

YM Biosciences released positive preliminary results from a phase II trial of nimotuzumab for the treatment of colorectal cancer. This open label, single arm trial, dubbed YMB1000-015, has enrolled 61 subjects with irinotecan-refractory, metastatic colorectal cancer, in Canada. The subjects received 400 mg of nimotuzumab weekly plus irinotecan in subjects refractory to irinotecan alone. The subjects remained on nimotuzumab until disease progression. The primary endpoint was objective tumor response rate (RR), secondary endpoints included overall survival, the rate and duration of stable disease, and progression free survival (PFS). In 58 evaluable subjects, the RR was 3.4% and the disease control rate was 50%, consisting of 27 subjects with stable disease and two subjects with partial response, determined using RECIST criteria. Median PFS was 12 weeks and overall survival was 9.3 months. Treatment was determined to be safe and well tolerated. Based on the results YM Biosciences plans to move forward with the development of nimotuzumab.

August 4, 2008

Welichem issued positive results from a phase I trial of WBI-1001 for the treatment of psoriasis. This randomized, double-blinded study enrolled 36 subjects with mild to moderate psoriasis in Montreal, Canada. The subjects were placed in one of six treatment groups. All subjects within a given treatment group received the same dosage of WBI-1001 on one side of the body and a placebo on the other side. Each group received a unique dosage of WBI-1001 (0.5%, 1.0% or 2.0%) applied topically on the affected areas either once or twice a day, for 28 days. The primary endpoints were safety, tolerability and pharmacokinetics. The secondary endpoint was initial efficacy, as assessed by physician's global assessment (PGA), induration, erythema, scaling and body surface area (BSA). The 0.5% and 1.0% doses of WBI-1001 exhibited very good skin tolerance while those treated with the 2.0% WBI-1001 dose experienced mild skin related adverse events. No serious adverse events were reported. The pharmacokinetic profile showed extremely low concentration of WBI-1001 in the blood. There was no evidence that WBI-1001 accumulated systemically upon once or twice daily application over the 28 day treatment period. After 28 days of treatment with WBI-1001, the mean scores for PGA, induration, erythema and scaling for all subjects were reduced from that of the baseline considerably more for the WBI-1001-treated side than for the placebo-treated side. Improvement in the mean scores for PGAs, induration, erythema and scaling started around Day 14, and was maintained or further increased up to Day 35 (7 days post-dose) in the majority of the treatment groups. Based on these results, Welichem plans to initiate phase II studies in 2009.

March 31, 2008

Anacor released positive results from a phase IIa trial of AN2728 for the treatment of psoriasis. This randomized, double-blind, placebo-controlled trial enrolled thirty five subjects with bilateral areas of psoriasis. The subjects were treated on one of their areas of psoriasis with AN2728 ointment 5%, and a matching area on the opposite side with placebo, twice a day for four weeks. The primary and secondary endpoints were reached. In 69% of the subjects, the area treated with AN2728 scored better at the end of therapy than the area treated with placebo, compared with 6% of subjects in whom placebo was superior, a statistically significant difference (p<0.001). In addition, plaques treated with AN2728 continued to improve over the course of the twenty eight days of therapy. No drug-related safety issues were reported. Based on the results, Anacor plans to move forward with the development of AN2728.

March 17, 2008

CombinatoRx issued positive results from a phase IIa trial of CRx-191 for the treatment of psoriasis. This twelve day, single-center, randomized, double-blind, placebo-controlled study enrolled twenty one subjects with chronic, stable plaque psoriasis in an area sufficient for six treatment fields within an occlusive dressing. The subjects received CRx-191 low dose (0.1% mometasone furoate + 0.05% nortriptyline), CRx-191 high dose (0.1% mometasone furoate + 0.1% nortiptyline), 0.1% mometasone alone, 0.05% nortriptyline alone, 0.1% nortriptyline alone and placebo. The primary endpoint was the reduction from baseline in psoriatic infiltrate band thickness as measured by ultrasound at Day twelve. The high dose of CRx-191 demonstrated an 81% reduction in psoriatic infiltrate from baseline to day twelve, compared to 11% for placebo (p<0.0001). CRx-191 also led to a 58% reduction in erythema compared to a 6% reduction with placebo (p<0.0001). In clinical assessments of skin condition, CRx-191 demonstrated clinically significant improvements from baseline to day twelve in 100% of all test fields, as compared to 0% for placebo. CRx-191 also produced greater improvements on multiple measures, including psoriatic infiltrate thickness, erythema and clinical skin conditions, when compared to mometasone and nortriptyline alone. The mean reduction in erythema for CRx-191 compared to mometasone was statistically significant (p=0.017) and numerically greater on infiltrate thickness reduction and clinical skin assessment scores. CRx-191 induced statistically significant reductions compared with nortriptyline on infiltrate thickness (p<0.0001) and erythema (p<0.0001), and improved clinical skin assessment scores. Treatment was well tolerated, with no reported adverse events. Based on the results, CombinatoRx plans to move forward with the development of CRx-191.

February 11, 2008

Centocor reported one year data from a phase III trial of ustekinumab for the treatment of moderate to severe plaque psoriasis. This randomized, double- blind, placebo-controlled trial, dubbed PHOENIX-1, enrolled seven hundred and sixty six subjects. The subjects received subcutaneously administered ustekinumab (45 mg or 90 mg) at weeks zero and four followed by the same dose every twelve weeks, or placebo. Following the double-blind phase, the subjects in the placebo group crossed over to receive either 45 mg or 90 mg doses of ustekinumab at weeks twelve and sixteen and every twelve weeks thereafter. The primary endpoint was the proportion of subjects achieving at least a 75% improvement on the Psoriasis Area and Severity Index (PASI 75) at week twelve. The endpoint was reached; after two doses of ustekinumab 67% of subjects receiving the 45 mg dose and 66% of subjects receiving the 90 mg dose achieved PASI 75 compared with 3% of subjects receiving placebo (p<0.001). In addition, 42% of subjects in the 45 mg ustekinumab dosing group and 37% of subjects in the 90 mg ustekinumab dosing group achieved PASI 90, compared with 2% of subjects receiving placebo (p<0.001). The subjects who received 45 mg or 90 mg of ustekinumab and consistently achieved a 75 percent improvement from baseline were randomized at week forty to either continue treatment or switch to placebo, with levels of response to maintenance therapy measured at week fifty two. Of those subjects who continued treatment with ustekinumab 45 mg and 90 mg, 87% and 91%, respectively, had a sustained PASI 75 response compared with 64% and 62% of subjects switched to placebo (p less than or equal to 0.001 for 45 mg comparison; p<0.001 for 90 mg comparison). Also at week forty, 66% and 73% of subjects achieved PASI 90 after receiving either 45 mg ustekinumab or 90 mg ustekinumab, respectively, and response rates remained stable through week fifty two with continued treatment, compared with 37% and 38% of subjects switched to placebo. The adverse events profile was comparable between the treatment arms. A BLA is currently under review by the FDA.

January 21, 2008

Amgen and Wyeth issued positive results from a phase III trial of Enbrel for the treatment of moderate to severe plaque psoriasis in children and adolescents. This trial enrolled two hundred and eleven pediatric subjects with psoriasis who were initially randomized to receive twelve once-weekly weight-based doses of Enbrel (0.8 mg/kg up to the intended dose of 50 mg) or placebo. After this double-blind portion, two hundred and eight subjects entered a twenty four-week period of open-label Enbrel treatment once-weekly. At week thirty six, one hundred and thirty eight subjects were re-randomized to receive either Enbrel or placebo, to investigate withdrawal and re-treatment. The primary endpoint was at least a 75% improvement on the Psoriasis Area and Severity Index (PASI 75) at week twelve. After twelve weeks, the conclusion of the double-blind, placebo-controlled portion of the study, 57% of the subjects treated with Enbrel achieved PASI 75, compared with 11% of those treated with placebo (p less than 0.001). After twenty four weeks of open-label treatment, during which all subjects received Enbrel, PASI 75 was achieved by 68% of the subjects initially treated with Enbrel from the start of the study and 65% of those who initially received placebo. At the conclusion of the open-label treatment period (week thirty six), one hundred and thirty eight subjects were re-randomized to receive either Enbrel or placebo. During this period, the subjects who lost PASI 75 were re-treated. No rebounds or changes in the type of psoriasis were reported. Based on the results, Amgen filed a sBLA with the FDA for the use of Enbrel in this population.

October 22, 2007

Cutanea Life Sciences issued positive results from a phase II trial of omiganon for the treatment of rosacea. This randomized, placebo-controlled, double-blind, multi-center trial enrolled 240 subjects with papulopustular rosacea in the US. The subjects received omiganan 1% once daily (QD), omiganan 2.5% QD, omiganan 2.5% twice-daily (BID), placebo QD, or placebo BID, all for a duration of nine weeks. Safety and efficacy assessments were performed at weeks one, three, six, and nine. The primary efficacy endpoint was mean percent reduction in the number of inflammatory lesions from Baseline to Week 9. The subjects receiving omiganan 2.5% QD, showed a mean 31% reduction in the number of inflammatory facial lesions compared to a 14% reduction in those receiving placebo QD. Among subjects with 18 or more lesions at Baseline, the mean reduction for once-daily omiganan 2.5% was 40%, compared to an 11% lesion increase in the once-daily placebo group. Treatment was well tolerated at all doses tested. Based on the results phase III trials are expected to commence shortly.

Johnson & Johnson announced positive results from a phase III trial of CNTO1275 for the treatment of psoriasis. This randomized, double-blind, placebo-controlled study, dubbed PHOENIX 2, enrolled 1,230 subjects with chronic psoriasis. The subjects received CNTO1275 administered subcutaneously or placebo. In the CNTO1275 arm, the subjects received 45 mg or 90 mg doses at weeks 0 and 4 followed by the same dose every 12 weeks. Those in the placebo arm crossed over to receive either 45 mg or 90 mg doses of CNTO1275 at weeks 12 and 16 and every subsequent 12 weeks. The primary endpoint was the proportion of subjects who achieved a Psoriasis Area and Severity Index (PASI) score of 75 at week 12. By week 12, 67% of the subjects treated with 45 mg of CNTO1275 and 76% of those treated with 90 mg of CNTO1275 achieved PASI75 compared with 4% of those treated with placebo (p < 0.001). In addition, 42% of the subjects in the 45 mg arm and 51% in the 90 mg arm achieved a PASI 90, or almost complete clearance of psoriasis, compared to 1% in the placebo arm (p < 0.001). Comparable results were seen in the placebo group 12 weeks after crossover to CNTO1275. Following an additional dose at week 16, responses were maintained through week 28. Treatment was well tolerated, with adverse events comparable between the CNTO1275 and placebo groups. Additional phase III trials are currently underway.

July 23, 2007

Barrier Therapeutics announced positive results from a phase II trial of oral Rambazole for the treatment of psoriasis. This European trial enrolled 176 subjects with plaque psoriasis and a Psoriasis Area and Severity Index (PASI) score of greater than or equal to 10. Subjects were randomized to receive oral Rambazole at doses of 0.5 mg, 1 mg or 2 mg or placebo once daily for 12 weeks. The primary endpoint was to evaluate response based on PASI 75, an assessment to indicate an improvement of at least 75% in psoriasis as measured by the Psoriasis Area Severity Index. The trial was also designed to determine the maximum tolerated dose for future trials. Increased responses were associated with increasing doses of Rambazole and reached significance at week 20 for PASI 75 when compared to placebo (p=0.030). Based on the Investigators Global Assessment, the 2.0 mg dose of Rambazole was determined to be the most effective, with 49% of the subjects having a score of "cleared or almost cleared" at week 20 compared to 20% of those in the placebo group. Barrier plans to meet with the FDA to discuss initiating future trials of Rambazole in the US.

June 4, 2007

Cytos announced positive results from a phase I/IIa trial of CYT007-TNFQb for the treatment of psoriasis. This randomized, placebo-controlled and double-blind trial enrolled 48 subjects with moderate to severe plaque psoriasis. In the phase I portion of the study, 24 subjects received ascending doses of the vaccine (100 ?g, 300 ?g) to evaluate the safety and tolerability. This was followed by phase IIa whereby 24 subjects received 5 subcutaneous injections of CYT007-TNFQb (300 ?g) or placebo at weeks 0, 2, 4, 8 and 12. Disease severity was determined by the Psoriasis Area and Severity Index (PASI) score at baseline and then every two weeks up to week 16. All doses of CYT007-TNFQb were safe and well tolerated. All subjects who were vaccinated mounted an antibody response against TNF-alpha. PASI scores reached the lowest point at week 8 compared to placebo. Based on the results, Cytos plans to move forward with the development of CYT007-TNFQb.

May 28, 2007

Celgene announced positive results from a phase II trial of CC-10004 for the treatment of plaque-type psoriasis. This randomized, double blind, placebo- controlled, parallel-group, dose comparison trial enrolled 260 subjects who received CC-10004 twice daily or placebo. The primary endpoint was Psoriasis Area and Severity Index (PASI) 75 after 12 weeks of treatment. This was accomplished, with 24% of the subjects on CC-10004 therapy achieving PASI 75 versus 10% of those on placebo. PASI 50 was reached by 57% of the subjects receiving CC-10004 compared to 23% of those receiving placebo. Treatment was well tolerated, with adverse events mild to moderate in nature. Based on the results, Celgene plans to accelerate the development of CC-10004.

May 14, 2007

Abbott announced positive results from a phase II trial of ABT874 for the treatment of psoriasis. This 12-week, double-blind, placebo-controlled trial enrolled 180 subjects with moderate to severe psoriasis. Subjects were randomized to six treatment groups: a single, subcutaneous 200-mg injection of ABT-874 at week zero; 100 mg every other week for 12 weeks; 200 mg weekly for four weeks; 200 mg every other week for 12 weeks; 200 mg weekly for 12 weeks; or placebo. The primary endpoint was the proportion of subjects reaching a 75% improvement in degree and severity of skin lesions at week 12 as measured by the Psoriasis Area and Severity Index (PASI). All dose groups reached PASI75. Respective results were 63%, 93%, 90%, 93%, and 90%, versus 3% for placebo (p<0.001). In addition, significant improvement in skin clearance was observed in four of the treatment groups. The single-dose, 200-mg injection at week zero arm did not reach significance. Respective results were 17%, 53%, 63%, 77% and 53% versus 0% for placebo; p<0.001 for all groups except the 200 mg arm. Based on these results Abbott plans to move the development of ABT874 into phase III trials later in 2007.

February 19, 2007

Centocor announced positive results from a phase II trial of CNTO 1275 for the treatment of psoriasis. This double-blind, placebo-controlled trial enrolled 320 subjects with psoriasis who were randomized to receive one of four dose regimens of CNTO 1275 (a single dose of 45 mg or 90 mg or four weekly doses of 45 mg or 90 mg) or placebo for 52 weeks. Subjects on placebo crossed over to 90 mg of CNTO 1275 at week 20. Treatment was generally well tolerated with serious adverse events occurring in 4% of the subjects. At week 12, 81% of the subjects receiving four weekly 90-mg doses, 67% receiving four weekly 45-mg doses, 59% receiving a single 90-mg dose and 52% receiving a single 45-mg dose achieved a Psoriasis Area Severity Index score of 75 (PASI 75) indicating a 75% or greater improvement in symptoms, versus 2% of those on placebo (p < 0.001 for each comparison). In addition, 20% of the subjects receiving four weekly 90-mg doses, 16% receiving four weekly 45-mg doses, 16% receiving a single 90-mg dose and 5% receiving a single 45-mg dose achieved total skin clearance (PASI 100). Efficacy in placebo-treated patients who crossed over at week 20 to receive a single 90-mg injection of CNTO 1275 mirrored the improvements observed in patients randomized to receive a single 90-mg dose of the monoclonal antibody at baseline, as measured by improvements in PASI and PGA scores. Efficacy in placebo-treated subjects who crossed over at week mirrored the improvements observed in the subjects randomized to receive a single 90-mg dose of the monoclonal antibody at baseline, as measured by improvements in PASI and PGA scores. CNTO 1275 is currently undergoing phase III trials.

October 16, 2006

Abbott released positive results from a phase III trial of Humira for the treatment of psoriasis. This trial, dubbed CHAMPION (Comparative Study of HUMIRA vs. Methotrexate vs. Placebo In PsOriasis PatieNts), enrolled 271 subjects in Europe and Canada. Subjects were randomized into one of three arms to receive subcutaneous injections of either Humira, in an initial dose of 80 mg, than one week later in its standard dose of 40 mg, Methotrexate or placebo. Treatment duration was 16 weeks. Safety and tolerability profiles were positive with the most commonly reported adverse events including injection site reaction, hepatic events and nasopharyngitis. The primary efficacy endpoint, the percentage of patients achieving at least a 75% reduction in disease activity at week 16, as measured by the Psoriasis Area and Severity Index score (PASI 75), was achieved. Results at week 16 revealed that 80% of the subjects receiving Humira reached this, compared to 35.5% receiving MTX (p<0.001) and 18.9% receiving placebo (p<0.001). Results from the secondary endpoint, Physician's Global Assessment (PGA), showed that at the trial’s end, 73% of those taking HUMIRA had physician assessments of their psoriasis of "clear" or "minimal" compared to 30% of those taking MTX (p<0.001) and 11% of those taking placebo (p<0.001). Based on these results, Abbott plans to submit a NDA to the FDA for this indication in the first half of 2007.

July 31, 2006

Foamix reported positive results of a phase I/II trial of their betamethasone valerate 0.12% topical foam, under investigation for the treatment of psoriasis. This randomized, investigator-blinded, controlled study enrolled 30 subjects with bilateral plaque psoriasis. Each patient applied the betamethasone foam to an affected area on one side or their body, and a control cream preparation to a similar area on the other, twice daily for 6 weeks. Trial data yielded a significant improvement in efficacy parameters for more than 84% of subjects after 3 weeks of treatment. Further, subjects reported higher usability for the foam preparation, noting faster absorption and reduced residue after application, compared to the control cream.

Intercytex announced positive results of a phase I trial of ICX-RHY, their investigational cell therapy product for facial rejuvenation. Trial data yielded a positive safety profile, with no serious adverse events reported and an overall tolerability profile including only transient adverse events. This placebo-controlled study enrolled 10 healthy volunteers at the Cranley Clinic in London, under the direction of Dr. Nick Lowe. Subjects received three injections of the drug or placebo into the skin of the upper arm. Based on these results, the company announced plans to initiate a phase II trial of the drug, for the treatment of facial wrinkles, in the second half of 2006.

July 24, 2006

UCB announced positive results of a phase II trial of Cimzia for the treatment of psoriasis. This randomized, double-blind, placebo-controlled dose-ranging study enrolled 176 subjects with moderate to severe chronic plaque psoriasis. Subjects received one of two regimens of the drug (400mg every other week, or an initial dose of 400mg followed by 200mg every other week) or placebo via subcutaneous injection. Trial data indicated that both doses produced a significant increase in the number of subjects achieving a 75% decrease from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 12 (200 mg: 74.6%, p<0.001; 400 mg: 82.8%, p<0.001; vs. placebo: 6.8%). The drug was generally well tolerated. A 24 week follow-up study was ongoing.

November 21, 2005

Biogen Idec issued positive results of a phase II trial of Amevive (alefacept) for the treatment of psoriatic arthritis (PA). Amevive is currently approved to treat psoriasis. Trial results indicated that 54% of subjects receiving the drug achieved ACR20 response, vs. 23% of subjects receiving placebo (p<0.001). 17% achieved ACR50 and 7% achieved ACR70 with Amevive, vs. 10% and 2% respectively for placebo. Improvements in tender-joint (31% vs. 18%) and swollen-joint count (46% vs. 34%) were also noted. This randomized, double-blind, placebo- controlled study enrolled 185 PA patients, who received standard therapy with methotrexate plus Amevive (n=123) or placebo (n=62).

Jazz Pharmaceuticals announced positive results of a phase II trial of Xyrem (sodium oxybate) for the treatment of fibromyalgia. Xyrem is currently approved for the treatment of narcolepsy. Results from the study indicated that both the low and high dose regimens of the drug produced significant reductions in composite primary outcome variable (including Pain Visual Analog Scale, Fibromyalgia Impact Questionnaire, and Patient Global Impression of Change) compared to placebo: 34.5% in the low dose group (p=0.005) and 27.3% (p=0.048) achieved significant improvement in this measure, vs. 12.5% for placebo. Treatment was generally well tolerated. This randomized, double-blind, placebo-controlled study enrolled 188 patients, who received one of two daily doses of Xyrem (4.5g or 6g) or placebo for 8 weeks, taken in two divided doses (first at bedtime, second 2.5 to 4 hours later).

Savient issued positive results of a phase II trial of Puricase (PEG-uricase) for the treatment of refractory gout. This randomized, open label, multicenter, parallel group study enrolled 41 patients, who received one of 4 regimens of the drug (4 mg every 2 weeks, n=7; 8 mg every 2 weeks, n=8; 8 mg every 4 weeks, n=13; 12 mg every 4 weeks, n=13). The drug was shown to reduce plasma urate levels at all trial doses (from 7.56 mg/dL to 4.20; from 9.09 to 1.42; from 9.08 to 2.57; and from 8.47 to 2.60, respectively). The doses also maintained urate levels below 6 mg/dL for 73%, 92% 86% and 84% of the time. There were 5 serious adverse events reported, including gout flare (n=3), hypersensitivity reaction (n=1), and anemia (n=1).

November 14, 2005

AlgoRx Pharmaceuticals and Corgentech issued positive results of their second phase III trial, dubbed Trial 004, of ALGRX 3268 for use as a local anesthetic for the prevention of pain related to venipuncture procedures (IV line placements and injections). Trial data met their primary efficacy endpoint, significantly reducing needle-insertion pain score on the FACES scale (p=0.002). No serious safety or tolerability concerns were raised. This randomized, placebo-controlled study enrolled 535 pediatric patients across 9 US sites, who received ALGRX 3268 (n=269) or placebo (n=266) 1 to 3 minutes prior to procedures which required either venipuncture or intravenous line placement. Based on the combined results of trial 003 and 004, the companies announced plans to file an NDA for the drug in 2006, with projected approval in 2007.

Isotechnika announced preliminary results from the phase III SPIRIT trial of their investigational immunosuppressive ISA247, for the treatment of psoriasis. Trial data met primary efficacy endpoints at 24 weeks: overall decreases in PASI symptom severity scores were 41%, 55% and 70% for the low, middle and high dosing groups respectively. Subjects transferring from placebo to the middle dosing group experienced a 62% reduction at 24 weeks. Further, at 24 weeks, the portion of patients achieving PASI 50 and PASI 75 score targets for the middle and high dosing groups was statistically significant (56% and 70% for PASI 50; 26% and 49% for PASI 75, respectively; p<0.05). No clinically significant changes were noted in rates of hypertension, cholesterol levels, triglyceride levels, renal function measures or rates of infectious complications. This double-blind, placebo-controlled study enrolled 451 psoriasis patients across 32 Canadian sites, who were randomized 1:1:1:1 to receive one of three doses of the drug (0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg) or placebo twice daily compared for 24 weeks.

October 24, 2005

Chelsea Therapeutics reported positive results of a phase Ia trial of their investigational anti- inflammatory drug CH-1504. Primary safety data were considered positive, with no serious adverse events reported and no clinically significant alterations in laboratory values for any dose, including levels higher than those predicted to be therapeutically relevant. Pharmacokinetic data yielded an elimination half-life suitable for once-daily dosing. This randomized, double-blind, placebo-controlled study enrolled 30 healthy volunteers at Guy's Hospital in London, who received single ascending doses in sequential cohorts. Based on these results, the company announced the initiation of a 24-subject phase Ib multiple-dose study of the drug.

October 10, 2005

AlgoRx and Corgentech reported positive interim results of a phase III trial, dubbed 003, of ALGRX 3268, their fast acting local anesthetic designed to reduce pain associated with venipuncture procedures (including blood draws and intravenous cannulation). Trial data met their primary efficacy endpoint, producing a significant reduction in patient reported pain scores on needle insertion on the FACES pain scale, compared to placebo (p=0.007). The drug was generally well tolerated, and no serious adverse events were reported. This ongoing randomized, placebo- controlled study enrolled 574 patients, who received treatment with ALGRX 3268 (n=289) or placebo (n=285) via the Powderject needleless injection system 1-3 minutes prior to venipuncture. The company announced that they expected to report preliminary data from their second phase III study, dubbed 004, within 2 months.

Antisense Therapeutics has reported positive results of a proof- of-concept trial of ATL1101, for the treatment of psoriasis. Trial data met their primary efficacy in reducing Local Plaque Severity Index (LPSI) score, with the low-concentration cream producing a significant improvement 13% greater than placebo (p= 0.03). The high-concentration cream yielded a non-significant but positive-trending 11% improvement (p=0.09). These improvements were less significant than those achieved with a pair of approved psoriasis treatments (calcipotriol, 36% improvement, p<0.001; and betamethasone, 44% improvement, p<0.001). This double-blind, placebo-controlled, within-patient randomized study enrolled 11 psoriasis patients with mild-to- moderate disease in Adelaide, Australia, who received treatment with one of two concentrations of the drug (1% and 10%), the two approved agents, and placebo at multiple small application sites. Based on these results, the ATL1101 program was to undergo review to maximize efficacy, including potential formula optimization, prior to additional studies.

September 26, 2005

Barrier Therapeutics issued positive results of a phase IIa trial of their investigational retinoic acid metabolism-blocking agent Rambazole, for the treatment of acne. The drug reduced total lesion count by 50% or more in 94% of subjects (n=16/17), relative to baseline; 35% of subjects (n=6/17) experienced reductions of 90% or greater. The drug was equally efficacious in treating both inflammatory and non-inflammatory lesions, and no serious adverse events were reported. This open-label study enrolled 17 moderate-to-severe acne patients, who received 1 mg oral Rambazole once daily for 12 weeks.

Isotechnika has announced positive interim results of a phase III trial of ISA247 for the treatment of psoriasis. 12-week data met primary efficacy endpoints, with the drug producing improvements on the Psoriasis Area and Severity Index (PASI) scale: 48% of high-dose subjects and 24% of mid-dose subjects achieved a PASI 75 (a reduction in disease severity of 75% or better), and 72% and 47% (respectively) achieved a PASI 50 score (p<0.05 compared to placebo for all values). Mean PASI score reduction was 62.5% for the high dose group and 44.0% for the mid dose group. This randomized, double-blind study enrolled 453 moderate-to-severe psoriasis patients across 32 site in Canada, who received one of three doses of ISA247 (0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg) or placebo twice daily for 24 weeks.

August 8, 2005

CollaGenex issued positive results of a phase II trial of COL-3, for the treatment of rosacea, at the summer meeting of the North Carolina Dermatology Association. The drug met its primary efficacy endpoint, reducing mean lesion count at day 42 by 12.8 per patient, compared to a mean increase of 2.3 lesions per patient receiving placebo (p=0.0213). Furthermore onset of action was observed to be rapid, with 80% of the total endpoint reduction observed by day 14. 75% of patients receiving COL-3 achieved complete or near complete disappearance of symptoms, as measure by Investigators Global Assessment. Finally, incidence of erythema was slightly improved in the COL-3 group (2.5 point reduction in severity) compared to placebo (1.7 point reduction). This double-blinded, placebo- controlled proof-of-principle study enrolled 14 patients, who received 10 mg of the drug (n=8) or placebo (n=6) once daily for 42 days.

Cytochroma has issued positive results of a phase Ib trial of CTA018, their vitamin D analog and CYP24 inhibitor for the treatment of psoriasis. Trial data met their primary safety endpoint, with no serious adverse events reported and positive local and systemic adverse event profiles. Pharmacokinetic data did not indicate systemic exposure 48 hours post treatment in the highest dosing group. This multicenter, 4-arm, randomized, open-label, parallel- group comparison study enrolled 28 patients with plaque psoriasis; subjects received one of three dose concentrations of CTA018 (1, 3, or 10 mcg/g) or vehicle cream, applied to 5% of the body surface daily for 13 days, with a observational follow-up 7 days after treatment. Based on these results, the company announced plans to initiate a phase II trial of the drug in Q4 2005.

Isolagen announced positive results of a phase III trial of their autologous fibroblast transplant therapy, dubbed the Isolagen Process, for the treatment of dermal contour deformities. Results from the parallel-arm study met three of four primary endpoints, producing significant improvements in appearance of contour deformities on both patient and physician visual assessment scales in one arm, but only statistical improvement in patient assessment in the second arm. Significant efficacy variance was noted between investigative sites (range of improvement: 7.6%-73.3%), based primarily on differences in injection technique. This randomized, double blind, placebo-controlled parallel arm study enrolled two study cohorts of 100 patients each across 5 US sites. Based on these results, Isolagen announced that they planned to initiate an additional 100 patient study of the drug with expended training regarding injection technique. This additional trial delays the projected BLA filing date until 2006.

Isotechnika reported positive interim results of their phase III SPIRIT trial of ISA247 for the treatment of psoriasis. Blinded, combined data from all treatment groups from the first 12 weeks of the trial (n=369 patients) yielded a mean reduction in Psoriasis Area and Severity Index (PASI) score of 38%, indicating potential efficacy. The data also indicated a positive safety profile, with the highest variance in serum creatinine levels in any treatment group being 5.6%, a value considered within the normal physiogical range. Less than 2% of subjects in any dosing group withdrew from the study after 12 weeks due to changes in kidney function. This randomized, double-blind study enrolled 453 patients with severe plaque psoriasis across 32 sites in Canada. Subjects received one of 3 doses of ISA247 (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg) or placebo twice daily, with subjects receiving placebo switching to the middle dosing regimen after the first 12 weeks of the 24 week study. Full 24 week data was expected during the first half of 2006.

July 11, 2005

Advitech announced positive results of a clinical trial of XP-828L, for the treatment of psoriasis. Trial data indicated that the drug achieved its primary endpoint, producing a significant improvement on the Physician's Global Assessment (PGA) after 56 days in both Student's t- test (p=0.0395) and covariance analysis (p=0.0167), vs. placebo; 21.4% of subjects achieved reduction in symptom severity of at least one PGA level. Additional results from an open-label extension indicated that a higher dose of the drug did not yield improved efficacy over the initial dose. No serious adverse events were reported. This randomized multicenter, double-blind, placebo-controlled crossover study enrolled 84 psoriasis patients at 2 sites in Canada. Subjects received daily treatment with either 5 mg XP-828L or placebo for 56 days, followed by a 56 open-label extension study with either 5 mg or 10 mg daily XP-828L.

June 20, 2005

QUATRx Pharmaceuticals has reported positive results of a phase IIb study of their investigational topical vitamin D analog becocalcidiol, for the treatment of mild to moderate psoriasis. Trial results indicated that both low and high dose regimens of the drug produced a statistically significant difference in the primary efficacy endpoint, the physician's global assessment showing psoriatic lesions clear or almost clear, compared to vehicle gel. Greater than five times the number of patients reached this endpoint at the high dose of becocalcidiol. Patients treated at the high dose level also showed improvement in secondary measures, including a statistically significant reduction in psoriasis symptom severity and affected body surface area, compared to vehicle. The drug was observed to be safe and well tolerated. This vehicle-controlled multi- center study enrolled 185 patients with mild to moderate chronic psoriasis across 12 US sites, who received one of two doses of becocalcidiol or vehicle gel for 8 weeks. Based on these results, the company announced plans to initiate design of phase III studies of the drug.

June 6, 2005

Cytochroma announced positive results of a phase Ia trial of CTA018, their vitamin D analog under investigation for the treatment of psoriasis. Safety results yielded positive preliminary tolerability, with no treatment related localized adverse events. Initial efficacy data showed reductions in overall disease severity with all trial doses; symptom severity remained suppressed up to one week following treatment. This randomized, double-blind, within- subject comparison study enrolled 17 otherwise- healthy subjects with mild to moderate plaque psoriasis, who each received treatment with three doses of the drug (3 mcg/g, 10 mcg/g, and 20 mcg/g), vehicle cream control, and active control (0.1% betamethasone) applied topically via microplaque assay every 24 hours for 13 days, with a 7 day follow-up. The company announced that these results supported the initiation of phase II trials of the drug in Q4 2005.

May 2, 2005

Isotechnika issued positive preliminary data from a phase III study of their investigational immunosuppressive ISA247 for the treatment of psoriasis. Trial data from the first 200 subjects indicated efficacy in the primary endpoint, producing a reduction in Psoriasis Area and Severity Index (PASI) symptom severity score at 12 weeks, and the degree of score reduction was comparable to those observed in previous studies. Further, preliminary efficacy was noted as early as 4 weeks after beginning treatment. This randomized, double-blind trial enrolled 453 patients with stable moderate to severe plaque psoriasis across 32 sites in Canada. Subjects received one of three oral doses of the drug (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg) or placebo twice daily for 12 weeks, followed by an open-label extension through 24 weeks which re-randomized the placebo and low-dose groups to receive therapeutic doses of the drug. The company announced plans to extend the trial through 36 weeks with the 0.3 mg/kg dose to gather long-term safety data.

April 11, 2005

Biogen Idec and Fumapharm reported positive results of a phase III trial of BG-12, an oral fumarate for the treatment of psoriasis. Trial data met their primary efficacy endpoint, with a statistically significant improvement in Psoriasis Area and Severity Index (PASI) score at 16 weeks compared to placebo: subjects receiving BG-12 had a median score of 5.8, a 68% reduction from baseline, vs. a median score of 14.2 (10% reduction) for placebo. This multicenter, double-blind, placebo-controlled study enrolled 175 patients with moderate to severe psoriasis, who were randomized to receive 720 mg BG-12 (n=105) or placebo (n=70) daily for 16 weeks.

March 21, 2005

Astralis has reported preliminary results of a phase II trial of its immuno-stimulatory drug Psoraxine, for the treatment of psoriasis. Results from the study failed to meet their primary efficacy endpoint, with no significant improvement in symptom severity score compared to subjects receiving placebo on the Psoriasis Area and Severity Index (PASI), a standardized diagnostic scale. The drug was safe and well-tolerated, with no serious adverse events reported. This randomized, double-blind, placebo-controlled study enrolled 120 patients with moderate to severe psoriasis, who received 6 intra-muscular injections of Psoraxine or placebo over 12 weeks. Following these results, the company announced plans to continue development of the drug, and data analysis of this trial is ongoing.

Biocryst Pharmaceuticals issued positive results of a phase I trial of BCX-4208, their investigational oral purine nucleoside phosphorylase inhibitor, for the treatment of psoriasis. Trial results indicated that the drug met primary safety and tolerability endpoints, with no serious adverse events reported and renal and liver function tests, hematologic parameters, immunological markers, and cardiac function tests yielding results deemed acceptable to merit further development. In addition, the drug yielded a dose- related inhibition of purine nucleoside Phosphorylase. This placebo-controlled, single ascending dose study enrolled 84 healthy volunteers, who received single doses ranging from 0.5 mg/kg to 3 mg/kg. Based on these results, the company announced plans to initiate a randomized, double-blind, escalating multi-dose phase I trial of the drug in 60 healthy volunteers in the second quarter of 2005.

February 28, 2005

Biogen Idec reported positive interim results of a phase II study of Amevive (alefacept) in combination with methotrexate for the treatment of psoriatic arthritis. Amevive is currently approved to treat moderate-to-severe chronic plaque psoriasis. Data from the ongoing study indicated that 54% of subjects receiving the drug experienced a reduction in arthritic symptom severity of at least 20% (an ACR20 response), vs. only 23% for patients receiving methotrexate alone at 24 weeks. Furthermore, 17% of Amevive-plus-methotrexate patients achieved ACR50 and 7% achieved ACR70 responses, vs. 10% and 2%, respectively, for methotrexate alone. Adverse events were generally manageable, and no serious infections or malignancies were noted. This double-blind, placebo-controlled study randomized 185 patients with active psoriatic arthritis to receive either once weekly Amevive-plus-methotrexate (n=123) or methotrexate alone (n=62) for 12 weeks, followed by a 12-week observation period.

January 24, 2005

ALK-Abello has reported positive preliminary results of their “GT-07” trial of their sublingual grass-pollen immunotherapy tablet, for the prevention of rhinoconjunctivitis (hay-fever). Trial data met their primary efficacy endpoint, producing a 37% reduction in symptoms of rhinoconjunctivitis and a 41% reduction in the need for additional medication, vs. placebo. The drug was also found to be safe and well tolerated. This double-blind, placebo-controlled, multi-centre study enrolled 114 patients with moderate-to-severe rhinoconjunctivitis and grass pollen induced mild-to-moderate asthma in Sweden and Denmark. Subjects were randomized to receive either the tablet or placebo once daily for at least 10 weeks.

Genentech has reported positive final results of a phase III extension study of their approved humanized monoclonal antibody Raptiva (efalizumab), for the treatment of moderate to severe plaque psoriasis. Results indicated that the drug produced demonstrated improved efficacy at 24 weeks vs. 12 in a number of clinical outcomes, including improvements in the portion of subjects achieving PASI-75 severity score improvement levels (43.8% vs. 26.6%), PASI-50 (66.6% vs. 58.5%). Furthermore, the percentage of patients who achieved a sPGA rating of minimal or clear increased from 25.7% at 12 weeks to 35.9% at 24, and the mean percentage of improvement in all patient-reported outcomes was maintained at week 24. Overall reported adverse events also declined during the extension (from 80.4% to 63.2%). This 12-week, 516-patient open-label extension followed a 12-week, 556-patient, double-blind, placebo-controlled parallel-group study, which investigated once-weekly subcutaneous dosing of 1 mg/kg Raptiva or placebo.

Valeant Pharmaceuticals has issued positive results of a phase II trial of its oral guanosine analog Viramidine, for the treatment of Hepatitis C. Preliminary analysis of trial data has indicated that the trial met its primary efficacy endpoint, demonstrating non-inferiority of Sustained Viral Response (SVR) for the 600 mg. BID dose of Viramidine, compared with ribavirin (an approved treatment), at both the end of treatment (24 or 48 weeks) and after an additional 24 week follow-up. Furthermore, the drug produced a significantly lower rate of anemia than the approved therapy (4% vs. 27%; p<0.001), and incidence of all other adverse events was similar between drugs. This active-controlled proof of concept study enrolled a total of 180 treatment-naïve patients with chronic HCV, who were randomized to receive one of three BID regimens of Viramidine (400 mg, 600 mg, or 800 mg) or standard therapy with ribavirin (1,000/1,200mg daily). Subjects were treated for 24 or 48 weeks, based on viral genotype analysis, and then enrolled in a 24 week extension study. Based on these results, Valeant has announced plans to use the 600 mg BID regimen of the drug in phase III trials.

January 18, 2005

Barrier Therapeutics also reported preliminary results of a phase IIa trial of Rambazole, for the treatment of psoriasis. Data from the first 10 patients completing treatment indicated that drug was efficacious in treating psoriasis, producing a mean reduction of 50% in PSAI score (a standardized symptom-severity scale) after 8 weeks of treatment, compared to baseline. The drug was safe and well tolerated in these patients, with mild dryness of the skin and lips reported most often. This ongoing, open-label study has a projected total enrollment of 17 subjects. Assuming final data confirm these interim results, Barrier announced plans to initiate a phase IIb trial of Rambazole by the end of Q2, 2005.

Barrier Therapeutics reported positive data from a phase IIa study of Azoline, for the treatment of superficial dermal fungal infections. Results from the trial demonstrated preliminary evidence of efficacy, with 60% response rates for subjects receiving 1 day of treatment and 78-100% response for subjects receiving either 3 or 5 days of treatment, depending of the nature of the skin condition. In addition, the drug demonstrated a positive safety and tolerability profile, with no serious treatment-related adverse events noted. This open-label study enrolled a total of 67 subjects, who were randomized to receive 200 mg. Azoline once daily for 1,3, or 5 days. Based on these results, Barrier announced plans to initiate phase IIb trials of Azoline in the second half of 2005.

November 8, 2004

Isotechnika reported positive results of a dose ranging safety study of their immunosuppressive drug candidate ISA247, under investigation for the treatment of psoriasis. Assembled data indicated that the drug met all safety endpoints, with no clinically significant impact on renal function (as measured by serum creatinine or 24-hour creatinine clearance) and no incidence of serious adverse events associated with clinically relevant doses of the drug. This multiple ascending dose trial enrolled a total of 43 healthy subjects, who received a fixed oral dose twice daily for 10 days, followed by one of three dose levels twice daily for an additional 10 days. The company announced that these results would pave the way for the initiation of a phase III trial of the drug before the end of 2004.

August 16, 2004

Astralis reported positive results from a phase I trial investigating Psoraxine, an injectable treatment for moderate psoriasis. Results showed that treatment with Psoraxine was generally well tolerated with a similar safety profile to that of placebo. In addition, more subjects in the Psoraxine groups exhibited improvements in the total and partial PASI scores at Day 14 than in the placebo group. The score for itching also showed an improvement in the Psoraxine groups as compared to the placebo group. No subjects evaluated developed skin anergy, a state of immune unresponsiveness, to standard recall antigens. The randomized, double-blind, placebo-controlled, parallel group, dose-ranging study enrolled 21 subjects with moderate and clinically stable plaque psoriasis. Subjects were given a single intramuscular injection of Psoraxine (50 mg, 150 mg, or 300 mg).

August 9, 2004

Astralis has announced the results of its phase I study of Psoraxine, a protein immunotherapy product being investigated for the treatment of psoriasis. Trial data have indicated that the drug is safe and well tolerated, with similar adverse event profiles observed among all three trial doses of the drug and placebo. In addition, despite the fact that doses used in the trial were considered sub-optimal for producing therapeutic response, evidence of efficacy was observed, with a greater number of patients showing improvement in each of the trial groups than the placebo group. The double-blind, placebo-controlled, parallel group, dose-ranging study randomized a total of 21 subjects, who received one of three doses of Psoraxine or placebo via single intramuscular injection, followed by a 14 day observation period.

August 2, 2004

Abbott has announced positive results of a phase II study in their supplemental development of Humira (adalimumab) for the treatment of chronic plaque psoriasis. Study data indicated that the drug is efficacious in both mitigating disease symptoms and improving quality of life of psoriasis sufferers. The double-blind study enrolled a total of 148 subjects into weekly or bi-weekly regimens of Humira or placebo. Weekly Humira treatments resulted in 72% of subjects achieving a 75% improvement in disease state, and 62% achieving 90% improvement, and all Humira regimens produced significant improvements over placebo on the DLQI index, a standardized measurement of the impact of psoriasis on quality of life. No new safety concerns were raised, and the drug was generally well tolerated. Humira is currently approved for the treatment of rheumatoid arthritis.

May 3, 2004

Biogen Idec and Fumapharm AG reported results from a phase II trial investigating BG-12, an oral fumarate for the treatment of severe psoriasis. Results demonstrated that subjects administered BG-12 showed greater improvement compared with subjects given placebo. Data showed that 42% of subjects receiving the highest dose of BG-12 achieved at least a 75% improvement in their Psoriasis Area and Severity Index (PASI) after 12 weeks, as compared to 11% of subjects receiving placebo. The multicenter, double-blind, placebo-controlled, dose-ranging study enrolled44 subjects with severe forms of psoriasis. Subjects received BG-12 or placebo at 120 mg, 360 mg, or 720 mg per day for 12 weeks. The results were reported at the spring symposium of the European Academy of Dermatology and Venereology in Budapest.

April 5, 2004

Celltech Group reported positive preliminary results from a phase III trial investigating CDP870 for the treatment of rheumatoid arthritis (RA). Results showed the study met its primary endpoint, determined by the number of subjects achieving a 20% reduction in the American College of Rheumatology score ACR20 at 24 weeks. A significant ACR20 response was seen at week 1 and was maintained for the duration of the study. The six-month study (Study 014) was designed to test the safety and efficacy of CDP870 in combination with methotrexate on signs and symptoms of disease over a six month period. They trial enrolled subjects who had active moderate to severe RA despite treatment with methotrexate and other disease modifying anti-rheumatic drugs. In addition, Celltech announced plans to develop CDP870 for new indications, such as psoriasis, psoriatic arthritis and ankylosing spondylitis.

March 29, 2004

Genentech and XOMA reported preliminary results from a phase II trial investigating Raptiva (efalizumab), a targeted T-cell modulator for the treatment of psoriatic arthritis. Results showed the study did not reach statistical significance at 12 weeks (84 days) for the primary endpoint, ACR 20 response (20% improvement). Data demonstrated that 28% of Raptiva subjects achieved an ACR 20 response compared with 19% receiving placebo. Statistically significant Psoriasis Area and Severity Index results were found among a subgroup of subjects with moderate-to-severe plaque psoriasis. The randomized, placebo-controlled study enrolled 107 subjects with psoriatic arthritis.

February 16, 2004

Centocor reported positive results from a retrospective analysis of a phase II trial investigating Remicade (infliximab), a monoclonal antibody for the treatment of psoriasis from psoriatic arthritis. Results showed that subjects treated with Remicade showed a greater than or equal to 75% improvement from baseline to week 10 in the Psoriasis Area and Severity Index score (PASI 75 response) compared to placebo-treated subjects. At week 10, 75% and 86% of subjects treated with Remicade 3mg/kg and 5 mg/kg, respectively, achieved a PASI 75 response compared to 0% in the placebo group. The data presented were from a retrospective analysis in a subset of 78 subjects who also had psoriatic arthritis (PsA). Results were presented at the annual meeting of the American Academy of Dermatology (AAD) in Washington, DC.

Genzyme and Cambridge Antibody Technology reported preliminary results from a phase I/II trial of CAT-192, a human anti-TGFß1 monoclonal antibody for the treatment of scleroderma. Results showed that the primary objective was met and the drug was safe and well tolerated at each dose level. There were no treatment-related serious adverse events observed. Four subject’s deaths occurred during the trial but were unrelated to treatment. The double-blind, placebo-controlled trial enrolled 45 subjects at 12 sites in the U.S. and Europe. The primary objective of the trial was to assess the safety, tolerability and pharmacokinetics of CAT-192 in patients with diffuse systemic sclerosis. Subjects were randomized to receive one of three dose levels of CAT-192 (0.5mg/kg, 5 mg/kg or 10 mg/kg) or matching placebo, as an intravenous infusion every six weeks for four doses.

July 7, 2003

Serono reported positive results from a phase II trial investigating onercept (r-hTBP-1), a type I TNF receptor for the treatment of psoriasis and psoriatic arthritis. Subjects treated with onercept showed significant improvement in their Psoriasis Area and Severity Index (PASI) scores after two weeks of treatment compared with placebo. Data demonstrated that 54% (23/43) of subjects treated with onercept (150 mg) demonstrated a 75% or greater PASI score improvement compared with 12% (5/43) of subjects given placebo. PASI is the globally accepted measure of treatment efficacy in this indication. The multi-center, double blind, placebo-controlled study enrolled 130 subjects with moderate-to-severe psoriasis. Results were presented at the 9th International Psoriasis Symposium in New York.

May 12, 2003

CellGate reported positive results from a phase IIa trial investigating PsorBan (CGC1072), a topical cyclosporine ointment for the treatment of psoriasis. The study lesions were evaluated using the psoriasis severity score (PSS), color photograph and the physician treatment preference. Results showed that high dose PsorBan exhibited benefits over placebo in both PSS and physician preferences scores. Data also demonstrated that blinded investigators preferred the actively treated group versus placebo 80% of the time. In addition, higher concentration of drug resulted in an improvement in PSS as early as day 14. The double blind, placebo controlled study enrolled 24 subjects with mild to moderate plaque psoriasis. Subjects received PsorBan ointment plus an internal control vehicle in self-applied treatments over six weeks.

April 7, 2003

Isotechnika reported positive results from a phase II trial investigating ISA247, a calcineurin inhibitor for the treatment of psoriasis. Results showed the drug met or exceeded all of the primary, secondary and saftey endpoints. Data demonstrated that 54% of subjects in the high dose ISA247 group achieved a 2-point reduction in Static Global Assessment scores, the primary endpoint, compared to 0% in the placebo group. A secondary endpoint, achievement of a 75% reduction in Psoriasis Area and Severity Index (PASI) scores was demonstrated in 74% of subjects in the high dose group compared to 0% in the placebo group. No significant adverse effects on blood pressure and lipid levels were reported. The double-blinded placebo controlled study enrolled 201 subjects at twelve centers in Canada. Subjects received ISA247 high dose (0.75 mg/kg), low dose (0.25 mg/kg) or placebo twice a day for 12 weeks.

March 31, 2003

Centocor reported positive results from a phase III trial investigating Remicade (infliximab), an anti-tumor necrosis factor for the treatment of psoriatic arthritis. Subjects were evaluated using the Psoriasis Area and Severity Index (PASI). The average reduction of the PASI was 81 % with Remicade compared 36 % with placebo. In addition, 67 % of the subjects treated with Remicade achieved a 75 % improvement compared to zero % of the subjects treated with placebo. The randomized, double blind, placebo-controlled study enrolled 101 subjects with active psoriatic arthritis at nine centers in the U.S., Canada and Europe. Subjects received either Remicade (5 mg/kg) or placebo administered at weeks zero, two, six, and 14, followed by an open label treatment with 5 mg/kg every 8 weeks with follow up through week 50.

March 24, 2003

Angiotech reported positive results a phase I trial investigating Paxceed (Cremophor EL-free paclitaxel formulation) for the treatment of psoriasis. Results showed that all subjects had a positive response to the treatment. Subjects in the optimal dose group (75 mg/m2 monthly) achieved an average Psoriasis Area and Severity (PSAI) score increase of 64%. Both the saftey and side effect profiles for Paxceed were excellent. The pilot study enrolled subjects with a PSAI of 20 or greater and who had been treated with at least two other systemic agents. Subjects were treated with either 75 mg/m2 every four weeks with six treatments or 37.5 mg/m2 every two weeks.

September 9, 2002

IDEC Pharmaceuticals announced that data from two phase II trials of IDEC-114 for the treatment of moderate-to-severe psoriasis did not reach a level of clinical efficacy to support further development for this indication. IDEC-114, a primatized anti-CD80 (anti-B7-1) monoclonal antibody, was well-tolerated in clinical trials, and the company plans to continue to evaluate the product for other immunologic disorders.

August 12, 2002

Preliminary data from an open-label, long-term trial with Raptiva (formerly Xanelim) showed that of the 215 subjects who completed a year of therapy, 79.1% of subjects had 50% improvement in Psoriasis Area and Severity Index (PASI) scores (PASI 50), and 61% of the subjects treated for one year had 75% improvement in PASI scores (PASI 75). In total 339 subjects completed at least three-months of treatment with Raptiva. 85% of these subjects achieved PASI 50 or an Overall Leasion Severity (OLS) score of "Mild." Raptiva is being co-developed by Genentech and Xoma.

May 20, 2002

Phase IIb trial results demonstrated that treatment with ABX-IL8 did not produce a significant improvement in PASI scores (the primary endpoint). The double-blind, placebo-controlled trial randomized subjects to receive placebo, 200 mg ABX-IL8 or 300 mg ABX-IL8. Data showed that 3% of placebo-treated subjects experienced greater than 75% improvement in PASI scores, compared to 2% of subjects receiving 200 mg ABX-IL8 and 6% receiving 300 mg ABX-IL8. Abgenix does not plan to conduct any additional studies with ABX-IL8. In addition to discontinuing development for psoriasis, the company will not proceed with a planned trial in melanoma, and they will wind down an ongoing phase IIa trial in chronic obstructive pulmonary disease.

April 15, 2002

According to study data comparing Xoma-produced Xanelim (efalizumab), an investigational psoriasis treatment, and Genentech-produced material, a pre-defined statistical definition for comparability was not achieved. In 2001, the FDA requested that a pharmacokinetic study be conducted to ensure the comparability of Xanelim used in clinical trials (primarily produced at Xoma) with the Genentech material produced for marketing after approval. Study results indicated that the Genentech material achieved a slightly higher serum concentration than the Xoma-produced material. Due to these results, the filing of a BLA for Xanelim may be delayed.

March 25, 2002

Preliminary results of a phase II trial showed that Zenapax (daclizumab) did not prolong time to recurrence of psoriasis (the primary endpoint of the trial). The randomized, double-blind, placebo-controlled trial evaluated Zenapax as maintenance therapy following cyclosporine treatment in subjects with moderate-to-severe psoriasis. Subjects were initially treated with cyclosporine for a period of one to three months; those who responded were randomized to receive placebo or one of two dosing regimens of Zenapax. While the data indicated that Zenapax was well tolerated, remissions of psoriasis were not prolonged with either of the dose regimens. Based on the analysis, Protein Design Labs does not plan to continue development of Zenapax as a maintenance agent in psoriasis following treatment with other therapeutic agents.

March 11, 2002

Positive results were reported from a phase II trial of topical alicaforsen (ISIS 2302) in subjects with mild to moderate plaque psoriasis. The double-masked trial, which included 31 subjects, compared 4% topical alicaforsen cream to placebo. Fifteen subjects in the trial applied treatment once per day, while 16 applied twice per day. Results showed that treatment with alicaforsen resulted in statistically significant improvement in Investigators Global Response Score (IGRS) at week four and a positive trend toward improvement at week eight. Furthermore, alicaforsen produced a 31% improvement from baseline in terms of plaque induration at both four and eight weeks. Alicaforsen is being developed by Isis Pharmaceuticals.

March 5, 2002

Data from a pooled analysis of two phase III trials indicates that Xanelim (efalizumab) produces an early clinical improvement in subjects with moderate-to-severe psoriasis. In the two trials, 1,095 subjects received weekly subcutaneous doses of 1 mg/kg Xanelim, 2 mg/kg Xanelim or placebo. At 12 weeks, mean PASI score improvements were 14% for the 1 mg/kg Xanelim group and 13% for the 2 mg/kg group, compared to 8% for placebo-treated subjects. Furthermore, after 12 weeks, 29% of subjects treated with 1 mg/kg Xanelim and 28% of those treated with 2 mg/kg achieved PASI score improvement of 75% or greater, versus 3.4% of those receiving placebo. Xanelim is being developed by Genentech and Xoma.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.