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DUSA Pharmaceuticals issued results from a phase II trial of Levulan, Kerastick and BLU-U with or without occlusion versus vehicle for the treatment of actinic keratoses (AKs). This multi-center, blinded, randomized, vehicle-controlled study enrolled 70 patients with minimally to moderately thick AKs on the upper extremities. Subjects received Levulan, Kerastick and BLU-U or vehicle, with or without occlusion, for three-hour incubation periods. The study showed a statistically significant lesion reduction and complete clearance of AK of the extremities when compared to treatment with vehicle. At 12 weeks following PDT, the subjects treated with Levulan plus occlusion regimen demonstrated an 89% (p<0.0001) AK lesion clearance rate as compared to a 70% (p<0.0001) clearance rate for those treated without occlusion after up to two PDT treatments; subjects receiving vehicle plus occlusion and vehicle alone demonstrated 17% and 6% lesion clearance rates, respectively. The safety profile was similar to that seen in the current labeling. DUSA will use the data, in combination with anticipated phase II results from another trial, to form the basis for label expansion.
Curis and Genentech released interim results from a phase II trial of vismodegib for basal cell carcinoma. This international, single-arm, two-cohort study (ERIVANCE BCC) enrolled 104 subjects with inoperable metastatic or locally advanced basal cell carcinoma. The subjects received 150 mg once daily until disease progression or toxicity. The primary endpoint was overall response rate as assessed by an independent review facility. The overall response rate was 43% in the locally advanced cohort and 30% in the metastatic cohort. The independent review also showed a clinical benefit rate (response as well as prolonged stable disease for more than 24 weeks) in 75% of the locally advanced cohort and 76% of the metastatic cohort. The median duration of progression free survival and response for both cohorts was 9.5 months and 7.6 months, respectively.
Curis and Genentech reported preliminary results from a phase II trial of vismodegib for basal cell carcinoma (BCC). This international, open label, single-arm, two-cohort study, ERIVANCE BCC, enrolled 104 subjects with inoperable metastatic or locally advanced BCC. The subjects received 150 mg vismodegib once daily until disease progression. Data showed that the study met its primary endpoint of achieving a target overall response rate: vismodegib shrank advanced BCC tumors in a pre-defined percentage of subjects. A preliminary safety assessment showed the most common adverse events were consistent with previous studies.
Peplin issued positive results from a phase IIb trial of PEP-005 for the treatment of actinic keratosis (AK). This eight-arm, multi-center, randomized, double blind, placebo controlled trial, dubbed PEP005-015, enrolled 240 subjects with actinic keratosis lesions on the face and scalp, in the US and Australia. The subjects were randomized into either a two day or three day treatment regimen. Three concentrations (0.005%, 0.010% or 0.015%) or placebo were applied to a 25 cm2 treatment area containing four to eight AK lesions. The primary endpoint was the complete clearance rate of AK lesions. Four out of the six treatment groups achieved statistically significant clearance of AK lesions compared to placebo. The complete clearance rates ranged from 15.6% to 42.3% across the six active treatment groups. In the highest dose group, (0.015% PEP005 Gel for three consecutive days) the complete clearance rate was 42.3% (p≡0.005 versus placebo) and the median reduction in lesion count was 84.5%. At all concentrations, for both treatment regimens, the PEP005 Gel demonstrated a favorable safety profile and was well tolerated. No drug-related serious adverse events were reported. Phase III trials of PEP-005 are currently underway.
Genta reported positive preliminary results from a phase III trial of Genasense for the treatment of melanoma. This international, randomized, double-blind, placebo-controlled study, dubbed AGENDA, enrolled 300 chemotherapy nave subjects that had shown maximal benefit in a previous trial. The subjects received Genasense plus dacarbazine (DTIC) or placebo plus DTIC in 21-day cycles for up to 8 cycles. They were subsequently followed every 2 months for 24 months and evaluated for the primary endpoints of progression free survival (PFS) and overall survival (OS) and the secondary endpoint of response rate (RR). Reported data is from 14 subjects enrolled in the first cohort. Of these 14 subjects, 6 (43%) have achieved major objective responses: one with complete response after 6 cycles of treatment, and 5 subjects with at least a partial response after only one treatment cycle. Three additional subjects have maintained stable disease after at least three treatment cycles, for an overall clinical benefit response of 64%. Treatment was well tolerated and no dose-limiting toxicities were observed. Based on the results Genta plans to continue with the study.
Peplin announced positive results from a phase IIa trial of PEP005 for the treatment of actinic keratosis. This open-label, dose escalation trial, dubbed PEP005-007, enrolled subjects in Australia and New Zealand. Topical PEP005 was applied to a 25 square centimeter infected area on the face or scalp, at strengths from 0.0025% to 0.025%, on either two or three consecutive days. The maximum tolerated dose was determined to be 0.025% applied daily for two consecutive days. Treatment safe and well tolerated. In addition, the two and three day course of PEP005 demonstrated complete and partial clearance of AK lesions in some subjects tested at each formulation strength, with the exception of the lowest strength, which demonstrated partial clearance in some subjects and no complete clearance. Based on the results, Peplin plans to continue with the development of PEP005.
BioFrontera released positive results from a phase IIb/III trial of BF-200 ALA for the treatment of actinic keratosis. This placebo-controlled, randomized, double-blind study enrolled 105 subjects in Germany. The subjects were treated once by photodynamic therapy with one of three different BF-200 ALA concentrations or placebo, for 12 weeks. The primary endpoint was the percentage of the complete remission of actinic lesions. Results showed the 10% dose of BF-200 ALA was superior to the other doses tested, with 60-70% of the treated lesions cleared by week 12. Treatment was well tolerated, with no relevant side effects reported. Based on the results, BioFrontera plans to initiate future trials.
Peplin reported positive results from a phase I trial of PEP005 for thetreatment of squamous cell carcinoma. This open label trial enrolled 25subjects who received 12, 25 or 40 micro litres (depending on tumor size)applied to the tumor once daily on two treatment days. The subjects were thenfollowed for 57 or 85 days. Treatment was well tolerated with no drug relatedserious adverse events. The most commonly reported reaction was skin siteirritation, which was graded mild and resolved spontaneously. PEP005 was foundto be efficacious. Application of the therapy on two consecutive days resultedin an overall histological clearance of 36% of tumors and clinical clearance of64% of tumors. Based on the results, Peplin initiated a dose escalation trialto determine an optimal dose for further trials.
Bayer and Onyx announced negative results from a phase III trial of Nexavar, in combination with carboplatin and paclitaxel, for the treatment of melanoma. This double-blind, randomized, placebo-controlled trial enrolled 270 subjects who received Nexavar or placebo in combination with a standard dosing schedule (21-day cycles) of carboplatin and paclitaxel. The primary endpoint, improvement in progression free survival, was not met with the treatment effect comparable in each arm. Bayer and Onyx plan to continue the development of Nexavar for the potential treatment of various other forms of cancer.
Immunomedics released positive results from a phase II trial of epratuzumab, in combination with rituximab and combined cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP), for the treatment of diffuse large B-cell lymphoma (DLBCL). This trial enrolled 15 subjects with previously untreated DLBCL who received epratuzumab at 360 mg/m2, followed by rituximab at 375 mg/m2, and a standard dose of CHOP every 3 weeks for 6 to 8 cycles. Treatment was generally well tolerated, although grade 3 or 4 neutropenia observed in 93% of the subjects, or in 28 of 92 cycles (30%), only three subjects developed grade 3 or more infection or fever. Efficacy results revealed that 87% of the subjects responded, including 10 complete responses (67%) and 3 partial responses (20%). At a median follow-up of 30 months, 13 of 15 subjects remained alive. The 1-year progression-free survival (PFS) and overall survival (OS) rates were 93% and 100%, respectively, and the 2-year PFS and OS rates were 86% and 86%, respectively. An additional phase II trial using ER-CHOP is currently underway.
Synta reported positive data from a phase IIb trial of STA-4783, a heat shock protein 70 inducer, for the treatment of metastatic melanoma. This double-blind, randomized, controlled trial enrolled 81 subjects with Stage IV metastatic melanoma, at 21 sites in the US. Subjects were randomized in a 2:1 ratio to receive STA-4783 plus paclitaxel or paclitaxel alone. Treatment was administered intravenously once weekly for three weeks, followed by one week off therapy, until disease progression. STA-4783 was well tolerated with adverse effects similar to those seen with palitaxel alone. Efficacy results revealed that the combination treatment reached statistical significance in progression-free survival (PFS), the primary endpoint. The subjects receiving STA-4783 plus paclitaxel reached PFS at a median time of 112 days versus 56 days for those receiving paclitaxel alone (p=0.035). Synta plans to advance STA-4783 into further trials for the treatment of melanoma as well as other cancers.
Provectus issued interim results of a phase I trial of Provecta (PV-10), for the treatment of metastatic melanoma. Results from the first cohort, receiving treatment with a low-dose regimen, indicated that the drug was well tolerated, with no serious adverse events reported. Preliminary efficacy data were also positive, and in line with those observed in preclinical models. This ongoing dose-escalation study enrolled 20 melanoma patients across 2 sites in Australia, who received a single injection of 1 of 2 dose levels of Provecta directly into 1-3 tumor sites, followed by a 12-24 week observational follow-up. The company expected the study to be complete by early 2006, and expected to initiate an additional trial of the drug for the treatment of breast carcinoma before the end of 2005.
Adventrx Pharmaceuticals reported results of a phase II trial of CoFactor (CH2FH4), in combination with 5- fluorouracil (5-FU), for the treatment of colorectal cancer. Toxicity and pharmacodynamic data indicated a positive toxicity profile based on a laboratory measures. Specifically, administration of CoFactor produced an increase producing increases in RBC folate pool expansion (form a mean baseline score of 533 ng/ml to a score of 1295 ng/ml following weekly dosing), urinary folate excretion (an indication of formaldehyde toxicity) showed a small decrease (from a baseline historical baseline of 5 ug/ml to a post-treatment mean of 3.7 ug/ml). These data support the use of CoFactor in combination with 5-FU to improve efficacy and reduce toxicity. This open-label study enrolled subjects with metastatic colorectal cancer, and was designed to investigate several laboratory measures of the toxicity associated with CoFactor administration and metabolism, in the hopes that the drug in combination with 5-FU will provide better efficacy and reduced toxicity, compared to standard therapy of 5-FU and leucovorin. The company announced that these data would serve to support upcoming phase IIb and III trials in the UK and the US.
Agennix reported positive results of a phase II trial of talactoferrin alpha in combination with chemotherapy, for the first line treatment of non-small cell lung cancer (NSCLC). Results from the study found that the addition of talactoferrin significantly improved overall response rate vs. placebo. Specifically, overall response rate in the prospectively defined evaluable patient group was 47%, vs. 29% for placebo (p= 0.05). The addition of talactoferrin was also well tolerated, with no evidence of increased toxicity. This double-blind, placebo- controlled study enrolled 110 treatment-naïve NSCLC patients, who were randomized 1:1 to receive talactoferrin or placebo, in combination with a standard chemotherapeutic regimen of carboplatin/paclitaxel.
Human Genome Sciences reported positive results of an ongoing phase I trial of their investigational TRAIL-1 monoclonal antibody HGS-ETR1, for the treatment of solid tumors. Trial data met their safety endpoints, with the highest dose acceptably tolerated and a generally mild (Grade 1 or 2) adverse event profile. Pharmacokinetics were proportional to dose, and mean elimination half-life was 17 days. Efficacy was also noted, with 10 instances of stable disease, including one subject who had received 16 treatments with the drug. This open-label, multi-center, dose- escalation trial had enrolled 44 heavily pretreated subjects to date (median prior chemotherapeutic regimens: 6), who received one of 7 IV doses of the drug (0.01, 0.03, 0.1, 0.3, 1.0, 3.0, or 10.0 mg/kg), once every 14 or 28 days.
Medarex and Bristol-Myers Squibb reported positive results of a phase II study of their investigational two-drug therapy for metastatic melanoma, which includes the anti-CTLA-4 antibody MDX-010 and the gp100 melanoma vaccine MDX-1379. Both trial dosing regimens yielded evidence of efficacy, with 2 complete responses (ongoing through 30 and 31 months) and 2 partial responses (4 months; ongoing through 34 months) in cohort 1, and 3 partial responses (6 months; ongoing through 25 and 26 months) in cohort 2. Serious Grade III/IV adverse events occurred more often in cohort 1 (n=9) than cohort 2 (n=5). This two- armed open-label study enrolled 56 subjects with metastatic melanoma, who received MDX-1379 plus 3.0 mg/kg MDX-010 every 3 weeks (cohort 1; n=29), or MDX-1379 plus an initial 3.0 mg/kg dose of MDX-010, followed by 1.0 mg/kg every 3 weeks (cohort 2; n=27).