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Benign Prostatic Hyperplasia (Enlarged Prostate)

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April 1, 2013

Eli Lilly released results from a phase III trial of Cialis for the treatment of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostates. This randomized, double-blind, placebo-controlled, 26-week study enrolled 696 males aged 45 and older with lower urinary tract symptoms of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostates. Patients also were required to have an International Prostate Symptom Score (IPSS) of at least 13, a urine flow rate (Qmax) of 4mL/sec to 15mL/sec and a prostate volume at least 30mL. Subjects received Cialis 5mg plus finasteride or placbo plus finasteride. Data demonstrated that Cialis/finasteride met the primary endpoint, significantly improving IPSS total scores through 12 weeks versus placebo/finasteride (-5.2 versus -3.8, p=0.001). Cialis/finasteride also significantly improved IPSS total scores versus placebo/finasteride at four weeks (-3.9 versus -2.3, p<0.001) and 26 weeks (-5.5 versus -4.5, p=0.022). On the key secondary measure, Cialis/finasteride improved IIEF-EF scores in sexually active men with ED versus placebo/finasteride at Week Four (2.7 versus -1.4, p<0.001), Week 12 (4.2 versus 0.5, p<0.001) and Week 26 (3.9 versus -0.3, p<0.001). The drug was well tolerated. The most frequent adverse events were headache, indigestion and back pain. Eli Lilly did not note its plans for Cialis.

March 21, 2011

Nymox issued long-term results from two phase I/II trials of NX-1207 for benign prostatic hyperplasia (BPH). These trials, NX02-0012 and NX02-0013, were initiated in 2003 and enrolled subjects who did not respond to conventional approved BPH treatments. Data are from 63% of the enrolled population, 7 years after a single treatment with NX-1207. Of these subjects, 58% reported no subsequent surgical treatment and no current drug treatment for their BPH and had an ongoing mean improvement of 11.7 points in AUA BPH Symptom Score. In addition, 38% of the subjects reported no prolonged use of any approved treatments at any time for their BPH since their original treatment with NX-1207, with a mean improvement of 13.7 points.

June 7, 2010

Protox reported positive six-month data from a phase IIb trial evaluating PRX302 for benign prostatic hyperplasia (BPH). This double-blind, placebo controlled, randomized study, TRIUMPH, enrolled 92 subjects with moderate-to-severe BPH. The subjects received PRX302 (3 microg/ml) or placebo via a single ultrasound-guided injection at a volume equivalent to 20% of the total prostate volume. The primary endpoint was efficacy according to change in International Prostate Symptom Score (IPSS). Six-month data are from 68 evaluable subjects. The PRX302 arm (baseline IPSS of 23.5 points), maintained the treatment benefit at six months with an average IPSS improvement of 8.9 points versus a 21% worsening of symptoms in the placebo group; IPSS improvement of 4.6 points. Six-month IPSS sub-scores were also positive in the PRX302 arm for both the obstructive and irritative domain, and all seven individual symptom scores improved by 43% to 133% in the PRX302 arm when compared to placebo. In addition, the PRX302 treatment arm demonstrated statistically significant improvement in Qmax of 3.9 mL/sec at six months as compared to 1.3 mL/sec for placebo (p≡0.0258).

January 25, 2010

Protox released positive results from a phase IIb trial of PRX302 for benign prostatic hyperplasia (BPH). This double-blind, randomized study, TRIUMPH, enrolled 90 subjects with moderate-to-severe BPH. The subjects received either PRX302 (3 μg/mL) or placebo at a volume equivalent to 20% of the total prostate volume via a single ultrasound guided injection into each lobe of the prostate. The primary endpoint was efficacy according to change in International Prostate Symptom Score (IPSS) at 90 days post-treatment compared to placebo. Data are from 73 evaluable subjects. The PRX302 arm showed an average IPSS improvement at 90 days of 9.1 points versus an average IPSS improvement of 5.8 points for the placebo arm (p≡0.0238). A sub-group analysis was conducted on 40 subjects with severe BPH (baseline IPSS>22). Subjects treated with PRX302 had an average IPSS improvement at 90 days from baseline of 10.8 points versus an improvement of 5.8 points for those receiving placebo. PRX302 was generally well tolerated.

August 24, 2009

AEterna Zentaris reported results from a phase III trial of cetrorelix for the treatment of benign prostatic hyperplasia (BPH). This open-label, single-armed safety trial enrolled 528 subjects in the US and Canada. The subjects received cetrorelix by intra-muscular injection at weeks 0 and 2, and were followed up to week 26. The primary endpoint was the incidence of possibly drug-related adverse events; secondary endpoints included efficacy parameters. Cetrorelix was generally well tolerated and adverse events were mostly mild and transient in intensity. Serious adverse events occurred in 12 subjects, but none of these was assessed as possibly drug-related. Efficacy, assessed using the International Prostate Symptom Score (IPSS), showed an improvement from a mean score of 21.2 at baseline to 15.6 at Week 26. In subjects who had received previous treatment for BPH, 46% showed an important mean improvement of 5 points. Maximum uroflow improved by 25%, from 10.3 to 12.5 ml/sec.

December 8, 2008

Protox issued positive results from a phase II trial of PRX302 for the treatment of benign prostatic hyperplasia (BPH). This single-arm, open-label, multi-center study enrolled 18 male subjects with moderate to severe BPH. The subjects were placed in three cohorts of six subjects each and received PRX302 at volumes equivalent to 10%, 20% or 30% of prostate volume. The intended volume for each subject was administered via a single injection consisting of three equal deposits into each lobe of the prostate under ultrasound guidance. Efficacy was measured by the change in International Prostate Symptom Score (IPSS) compared to baseline. IPSS results at 90 days post-treatment demonstrated symptomatic relief in all cohorts with an average improvement in IPSS of 2.8 points in Cohort 1 (15.6%), 10.9 points in Cohort 2 (54.0%) and 10.3 points in Cohort 3 (46.2%).The response was dose dependent and was more evident when subjects were stratified by the volume of PRX302 administered per deposit. Subjects who received 1.0mL or greater volume per deposit (n≡13) showed a statistically significant IPSS improvement of 11.2 points at day 90 post-treatment (p<.0001). The mean reduction in prostate volume at day 90 post-treatment was 23.2% (p <0.05). Treatment was well tolerated.

August 25, 2008

Eli Lilly reported positive results from a phase IIb trial of tadalafil for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). This randomized, double-blind, placebo-controlled study enrolled 1,056 male subjects across several international sites. Any of the subjects who had undergone treatment for erectile dysfunction or other BPH treatments underwent a 4-week treatment-free screening period. All subjects then received placebo for four weeks prior to randomization. They were then divided randomly into five groups and received a placebo, or tadalafil doses of 2.5, 5.0, 10.0 or 20.0 mg/day. Efficacy was based on the International Prostate Symptom Score (I-PSS). All doses of tadalafil were superior to placebo for relieving LUTS, with statistically significant effects at 4, 8 and 12 weeks. The treatments decreased I-PSS scores from 3.9 to 5.2 points in the different dosage groups. Of the doses studied, 5 mg per day improved the I-PSS by 4.9 points and provided the best risk-benefit profile. Based on the results Eli Lilly plans to continue with the development of tadalafil for this indication.

April 21, 2008

Protox reported positive long-term results from a phase I trial of PRX302 for the treatment of benign prostatic hyperplasia (BPH). This open-label, dose escalation study enrolled fifteen male subjects who received PRX302 via a single intra-prostatic injection. The PRX302 dose was increased 14-fold between cohort one and cohort four, keeping the dosing volume constant, whereas one additional cohort received cohort one dose at a 4-fold higher volume. Subjects were followed for ninety days plus three additional visits over twelve months. Therapeutic activity of PRX302 was assessed using International Prostate Symptom Score (IPSS) and Quality of Life Scores (QoL). At six months post-treatment the mean IPSS values improved by an average of 6.4 points from 19.1 +/- 4.3 at baseline to 12.7 +/- 5.2 (p= 0.0009), with six of fifteen subjects showing a ten point or greater improvement in IPSS values. In the six subjects for whom nine-month data are available, IPSS values improved by an average of 6.1 points. QoL scores improved by 2.0 points from an average of 4.5 +/- 1.1 at baseline to 2.5 +/- 1.4 at six months (p= 0.0002). In the six subjects for whom nine-month data is available, QoL scores improved by an average of 2.3 points. The mean prostate volume decreased by over 22%, from 46.4 cc at baseline to 35.8 cc at six months post-treatment and by 20% from 49.6 cc at screening to 39.7 cc at nine months post-treatment. Treatment was well tolerated; no safety issues have been identified and the maximum tolerated dose was not reached. A phase II study of PRX302 for BPH is currently underway.

February 18, 2008

Nymox issued positive results from a phase II trial of NX-1207 for the treatment of benign prostatic hyperplasia (BPH). This prospective, randomized trial, dubbed NX02-0016, enrolled eighty five subjects in the United States. The subjects received a therapeutic dose of NX-1207 (2.5 mg), a very low dose of NX-1207 (0.125 mg), or finasteride, an approved BPH therapy. Subjects randomized to finasteride took finasteride daily. Subjects randomized to NX-1207 were given a one-time single dose intraprostatic injection administered by a urologist in an office setting. After ninety days, the intent-to-treat cohort who received the therapeutic dose of NX-1207 had a mean BPH Symptom Score improvement of 9.71 points compared to an improvement of 4.13 points for the finasteride arm (p=0.001). In addition, after ninety days subjects in the per protocol cohort given the therapeutic dose of NX-1207 had a statistically significant mean reduction in prostate volume (6.11 mL or 13.1%; p less than 0.001) and a statistically significant mean increase in peak urine flow (2.61 mL/sec; p less than 0.001) as compared to baseline values before treatment. The data also showed a clear dose-response as measured by symptom improvement, prostate volume reduction and peak flow increase in comparisons between the therapeutic dose (2.5 mg) of NX-1207 and the very low dose (.125 mg) of NX-1207. Based on the results, Nymox plans to move forward with the development of NX-1207.

January 14, 2008

Protox issued positive final results from a phase I trial of PRX302 for the treatment of BPH. This open-label, multi-center, dose escalation study enrolled fifteen subjects. The PRX302 dose was increased 14-fold between cohort one and cohort four, keeping the dosing volume constant, whereas one additional cohort received cohort one dose at a 4-fold higher volume. The primary endpoint was safety and tolerability following a single intra-prostatic administration. Secondary endpoints included therapeutic activity, prostate volume and uroflow parameters. PRX302 was well tolerated with no serious adverse events. The maximum tolerated dose was not reached. Therapeutic activity of PRX302 was evaluated at day-thirty and day-ninety post-treatment using the International Prostate Symptom Score (IPSS) and Quality of Life (QoL). Across all treatment groups, IPSS scores showed a statistically significant improvement from screening to day-thirty (p less than 0.01) and continued to day-ninety post-treatment (p less than 0.001). The mean IPSS values improved by an average of 5.8 points from 19.1 +/- 4.3 at screening to 14.3 +/- 5.7 at day-thirty post treatment. By day-ninety, IPSS improved by an average of 8.5 points (10.6 - 5.9) with eight of fifteen subjects showing a 10 point or greater improvement in IPSS values. Improvement in QoL scores were observed in all five cohorts. QoL scores improved from an average of 4.3 +/- 1.1 at screening to 2.5 +/- 1.6 by day-thirty (p less than 0.01) and continued to show a 50% improvement by day-ninety (QoL = 2.1 - 1.6; p less than 0.01). In addition, prostate volume decreased in all cohorts. The mean prostate volume decreased by over 26% from 41.6 cc at screening to 30.5 cc at day-ninety post-treatment (p less than 0.05). Based on the results, Protox plans to move forward with the development of PRX302.

October 22, 2007

BioXell reported positive results from a phase IIb trial of Elocalcitol for the treatment of Benign Prostatic Hyperplasia (BPH). This double-blind, randomized, placebo-controlled, parallel group design trial enrolled 514 subjects in Italy and Germany. The subjects were to receive Elocalcitol monotherapy (75 or 150 mcg), Elocalcitol (150 mcg) in combination with tamsulosin (0.4 mg) or placebo. The primary endpoint was met with statistical significance, with Elocalcitol effectively arresting prostate growth. The mean change in prostate volume after 24 weeks was +0.41% in the Elocalcitol 150 mcg arm compared with +2.55% in the placebo arm (p<0.0002). In subgroups with larger prostates (60-80 cc), the mean change in prostate volume in those treated with 150 mcg Elocalcitol was reduced by 4.5% compared with placebo. Among the subjects showing a decrease in prostate volume, a significantly higher percentage was found in the group treated with 150 mcg Elocalcitol compared to placebo (32.77% vs. 12.61%, p<0.0008). Secondary endpoints, including the effects on the symptomatic parameters urgency, frequency and nocturia, and the urodynamic parameter maximum urinary flow rate (Qmax) were also reached. In regards to urgency, a significant effect was observed on the number of episodes per day in both the 150 mcg Elocalcitol (-3.12, p<0.0108) and combination (-2.83, p<0.0386) groups, compared to placebo (-1.82), in subgroups of subjects with 3 or more urgency episodes per day at baseline. In addition both the monotherapy and combination therapy Elocalcitol arms showed a mean increase in maximum urinary flow rate (Qmax) of 2 ml/sec compared with only 1 ml/sec with placebo. Based on the results BioXell plans to move the development of Elocalcitol into phase III development.

Exelixis released negative results from a phase II trial of XL784 for the treatment of proteinuria. This randomized, placebo-controlled study enrolled 130 diabetic subjects with clinically significant proteinuria. The subjects received 200 mg XL784 or placebo daily for 3 months. The primary endpoint of the trial was a significant reduction in proteinuria compared with placebo. Secondary endpoints included changes in renal function and cardiovascular events. While the treatment was determined to be safe and well tolerated, the primary endpoint was not accomplished. Exelixis plans to fully analyze the data in order to determine a future course of development for XL784.

October 15, 2007

Protox reported positive interim results from a phase I trial of PRX302 for the treatment of benign prostatic hyperplasia (BPH). This trial enrolled 12 men who were placed into four dose escalating cohorts. The maximum tolerated dose had not been reached at this time. In nine out of 12 subjects for whom 30-day data was available, a desirable trend towards improved International Prostate Symptom Scores (IPSS scores) was observed. The subjects treated at the lowest dose (cohort 1) showed an average one point (5%) decrease in IPSS scores, while those treated at the intermediate doses (cohorts 2 and 3) both averaged seven point decreases of 39% and 35% respectively. At baseline, Quality of Life scores (0 defined as "delighted" and 6 defined as "terrible") ranged from 4 to 6. By the end of treatment these scores were decreased by an average of 54%, 63% and 60% in cohorts 1, 2 and 3, respectively. Data from the fourth and final cohort are expected in early 2008.

September 10, 2007

GlaxoSmithKline reported positive long-term results from a clinical trial of Avodart for the treatment of benign prostatic hyperplasia (BPH). This randomized, double-blind and parallel-group study, dubbed CombAT (Combination therapy with Avodart and Tamsulosin) enrolled 4,800 men. The subjects received placebo for four weeks and were then randomized to receive Avodart (0.5 mg/day) and tamsulosin (0.4 mg/day), Avodart alone (0.5 mg/day) or tamsulosin alone (0.4 mg/day). The primary endpoint, symptom improvement over two years as measured by the International Prostate Symptom Score (IPSS), was achieved. Over 24 months, Avodart and tamsulosin combination therapy provided a significantly greater improvement in symptoms from baseline than either Avodart or tamsulosin treatment alone (p < 0.001). In addition, Avodart resulted in continuous and sustained Qmax (urine flow rate) improvements to month 24. Treatment was well tolerated, with adverse events similar between all the treatment groups.

March 26, 2007

Acadia reported positive results from a phase II trial of ACP-103 for the treatment of schizophrenia. This multi-center, randomized, double-blind, placebo-controlled trial enrolled 423 subjects in the United States and Brazil. Subjects were randomly assigned to one of five study arms: ACP-103 plus low-dose risperidone; low-dose risperidone plus placebo; high-dose risperidone plus placebo; ACP-103 plus haloperidol; or haloperidol plus placebo. The primary endpoint was antipsychotic efficacy as measured after day 42 compared to baseline in each of the two ACP-103 co-therapy arms using the Positive and Negative Syndrome Scale (PANSS). Treatment was safe and well tolerated, with adverse events mild to moderate in nature and comparable across all treatment arms. Three drug-related serious adverse events occurred in the risperidone plus placebo arm. The ACP-103/risperidone arm showed a 23.0 point (27.4%) improvement in the PANSS at day 42 when compared to baseline (p less than 0.0001). Antipsychotic efficacy was also observed in the ACP-103/risperidone arm, reaching statistical significance when compared to the risperidone low dose arm (p=0.01) and showing similar efficacy to the risperidone high dose arm. The ACP-103/haloperidol arm showed a 21.6 point (25.6%) improvement in the PANSS as measured after day 42 compared to baseline (p less than 0.0001). Antipsychotic activity was observed in both the ACP-103/haloperidol arm and the haloperidol plus placebo arm, no statistical significance was seen between the two groups. Based on the results Acadia plans to move the development of ACP-103 co-therapy forward.

Shionogi and AEeterna Zentaris announced positive results from a phase IIa trial of cetrorelix for the treatment of BPH. This placebo controlled, randomized trial enrolled 50 subjects in Japan. Subjects were placed five dosing groups to receive cetrorelix, administered intramuscularly, in a single administration of 30 mg, 60 mg or 90 mg and a multiple administration of 60 mg and 90 mg, 3 times 8 weeks apart. The trial was designed to evaluate the pharmacokinetics and safety of the drug in this population. Treatment was well tolerated locally and systemically at all doses tested. Cetrorelix resulted in a transient reduction of testosterone concentration in blood, which did not reach or remain at the castration level. None of the doses tested led to a suppression of PSA levels. In addition, the bioavailability of cetrorelix after injection was similar to that observed in non-Japanese subjects. Based on the results, Shionogi initiated a phase IIb trial in Japan to assess the efficacy of cetrorelix in this population.

January 22, 2007

MediciNova reported negative results from a phase II/III trial of MN-001 for the treatment of interstitial cystitis (IC). This randomized, double-blind, placebo-controlled trial enrolled 305 subjects with moderate to severe IC. Treatment was well tolerated. Statistical significance over placebo was not seen in the primary endpoint, overall improvement on a patient-rated Global Response Assessment at a dose of 500mg once or twice a day for 8 weeks. Results indicated that after four weeks of treatment, 25% of the subjects were likely to respond versus 12% on placebo (p=0.04). However, after eight weeks of treatment response rates between the groups did not differ due to continued improvement of the placebo group. Due to these results, MediciNova planned to discontinue development of MN-001 for IC and focus on asthma related disorders.

Wastson announced positive results from two phase III trials of silodosin for the treatment of benign prostatic hyperplasia (BPH). These double-blind, placebo-controlled trials enrolled 1,200 subjects in the US who received 8mg silodosin or placebo once daily for 12 weeks. Treatment was well tolerated with adverse events, including cardiovascular and blood pressure related effects, mild to moderate in nature. The primary endpoint, relief of BPH symptoms as measured by a baseline-to-endpoint change in the total score of the International Prostate Symptom Score-1 (IPSS-1) and the secondary endpoint, improvement in maximum urine flow, were achieved with statistically significant improvements observed for both objectives. Based on these results, Watson plans to file a NDA with the FDA in the first half of 2008.

October 9, 2006

Spectrum and AEterna Zentaris announced positive results from a phase II trial of ozarelix for the treatment of Benign Prostatic Hypertrophy (BPH). This double-blinded, randomized, placebo-controlled, multi-center, dose-ranging trial enrolled 144 subjects with moderate to severe BPH, who were randomized to receive various doses of ozarelix or placebo, given intramuscularly at day 1 and day 15. Treatment was well tolerated across all dose levels with no serious adverse events reported. The primary endpoint, improvement in clinical symptoms of BPH as measured using the International Prostate Symptom Score (IPSS), was achieved at all dose levels. The most efficacious dose was 15mg of ozarelix, with a mean decrease in the IPSS score at weeks 12, 20 and 28 of -8.6, -9.4 and -8.7, respectively. The mean was a 47% decrease from baseline. These results represent a statistically significant difference versus baseline (p<0.001) and placebo (p<0.0001). Based on the positive data Spectrum and AEterna Zentaris plan to move ozarelix into phase III trials.

September 25, 2006

Nymox Pharmaceuticals reported positive results from a phase II trial of NX-1207 for the treatment of benign prostatic hyperplasia (BPH). This double-blind, placebo-controlled, randomized, parallel group, 3-dose range study enrolled 175 subjects across 43 sites in the US. All subjects had AUA Symptom Score values of 15 points or more and prostate volumes of at least 40 grams. Efficacy was assessed by medical and symptom evaluation, prostate volume studies, uroflow measurements and laboratory and safety parameters, all evaluated over the course of a three-month treatment period. Treatment was found to be safe and well tolerated with no serious adverse events reported. Efficacy results demonstrated a pooled mean improvement of 9.35 points in the primary outcome endpoint of AUA Symptom Score values, which reached statistical significance when compared with the placebo control (p=.017). An 11.7% (6.84 g) overall reduction in mean prostate volume was observed as well (p=.02). Based on these results Nymox intends to move development of NX-1207 forward.

July 24, 2006

Threshold reported negative results from both a phase II and phase III trial of TH-070 for the treatment of benign prostatic hyperplasia (BPH). The randomized, placebo controlled, double-blind Phase II study enrolled 216 patients, who received one of four doses of the drug (5mg, 25mg, 50mg, or 150mg) daily for 1 month, with a 3 month observational follow-up. Trial data failed to meet their primary efficacy endpoint, producing no clear dose response with respect to symptomatic improvement on the IPSS diagnostic scale. The randomized, placebo controlled, double-blind phase III study enrolled 567 patients, who were randomized to receive one of two doses of the drug (50mg or 150mg) or placebo daily for three months, with a 1 month observational follow-up. Trial data failed to demonstrate a significant reduction in IPSS score vs. placebo at 1 or 3 months. Dosing in this trial was terminated early due to liver enzyme elevations. Based on these results, Threshold announced plans to discontinue development of the drug for BPH.

May 22, 2006

Nymox has announced long-term efficacy results from a phase I/II trial of NX-1207, for the treatment of benign prostatic hyperplasia (BPH). Trial data indicated that at the end of the follow-up period, patients treated with NX-1207 achieved a significantly superior mean improvement of 6.9 points on the AUA Symptom Score evaluation, relative to control treatment (+7.2 points for NX-1207, vs. +0.3 points for control); this superiority exceeded that observed in the initial 30-day study. Further, 57% of subjects treated with the drug needed no additional treatment for BPH symptoms during the follow-up period. No serious safety concerns were noted. This open-label extension study enrolled 75% of the subjects from the initial phase I/II trial, who received NX-1207 or active control and were followed for 29-34 months.

October 17, 2005

Lilly and ICOS have issued positive preliminary results of a phase II trial of tadalafil for the treatment of benign prostatic hyperplasia (BPH). Tadalafil is currently approved for the treatment of erectile dysfunction under the tradename Cialis. Trial data demonstrated significant improvements in symptom severity on the IPSS diagnostic scale, with a 5m dose of the drug producing a 2.8 point improvement in an initial 6 week phase, and a 20 mg. dose producing a 3.8 point improvement over a second six weeks, vs. 1.2 and 1.7 point improvements for placebo, respectively (p<0.05 for both doses). This placebo-controlled proof-of-concept study enrolled 250 subjects. Based on these results, the companies announced plans to initiate phase III trials of the drug in the near future.

July 11, 2005

Antares Pharma reported positive results of their phase III trial of Bio-E-Gel, their transdermal estradiol gel based on their Advanced Transdermal Delivery platform, for the treatment of hot flashes in menopausal women. The drug was seen to produce significant, dose-dependent reductions in both the number and severity of hot flashes, compared to placebo. No significant safety or tolerability concerns were raised for any dose. This randomized, double-blind, placebo-controlled study enrolled 484 symptomatic menopausal women suffering moderate to severe hot flashes, who received one of 3 doses of the drug or placebo for 12 weeks. Antares announced that, based on these data, they planned to submit an NDA to the FDA as soon as possible, hopefully by the end of September 2005.

Nymox issued positive combined results of a phase I and phase II trials of NX-1207, for the treatment of benign prostatic hyperplasia (BPH). The drug reduced mean symptom severity scores by 6.87 points on the American Urological Association BPH symptom severity scale, vs. a reduction of 0.5 points for controls (p<0.05). Statistically significant reductions in mean prostate size were also observed, and 2-year post-treatment follow-up indicated continued, increased superiority to placebo (9.3 points relative symptom improvement). Serious adverse events or tolerability concerns were not noted. These trials investigated NX-1207 as a first line therapy for men with BPH, and these trial data served to support ongoing phase II studies of the drug, expected to be completed later in 2005.

October 11, 2004

AEterna Zentaris, in collaboration with Solvay Pharmaceuticals and Shionogi/Nippon Kayaku, announced positive results of a phase II trial of cetrorelix, their investigational hormonal therapy for the treatment of benign prostatic hyperplasia (BPH). Results indicated that the drug produced a significant, dose-dependent improvement in BPH symptoms and International Prostate Symptom Score (p<0.001), at all trial doses except the lowest, compared with placebo. Furthermore, the drug was observed to be safe and well tolerated. The double-blind, placebo-controlled study randomized 250 men with symptomatic objective BPH at clinical centers in Europe; subjects received two or three injections of one of four dosing regimens of cetrorelix or placebo over four weeks, followed by a 26 week observation and assessment period.

September 13, 2004

Nymox announced positive 1 year follow-up results of their phase II trial of NX-1207, for the treatment of benign prostatic hyperplasia. Data indicated that symptomatic improvement was observed among subjects who had received a regimen of NX-1207. Furthermore, the noted improvement was statistically superior to control groups, and exceeded the benefits observed in Nymox’s most recent 30 day phase I/II study (which, though lower, was also statistically significant compared with controls). No serious adverse events were observed. NX-1207 is currently in ongoing phase II trials.

August 2, 2004

Nymox has announced additional results of their successful phase I/II trials of NX-1207, for the treatment of benign prostatic hyperplasia (BPH). The new data show that men receiving the drug experienced significant improvements in disease severity self-assessments, with a mean improvement of 6.87 points on the American Urological Association’s BPH scale (p=0.0352). This improvement in perceived disease severity, which includes reduction in frequency of urinary urge, improved perception of bladder emptying, weakness of urinary stream or difficulty urinating and incidence of nocturia, matches a significant reduction in prostate size reported previously. The study enrolled a total of 20 moderate-to-severe refractory BPH patients, who received NX-1207 treatment for 30 days. Plans for expanded phase II efficacy studies have been announced.

May 17, 2004

AEterna Laboratories and Zentaris GmbH reported positive results from six phase II trials investigating cetrorelix, a luteinizing hormone releasing hormone antagonist for the treatments of benign prostatic hyperplasia (BPH), uterine myomas and endometriosis. The placebo-controlled endometriosis study demonstrated that cetrorelix was associated with a rapid response and improvement of endometriosis-related symptoms. Placebo-controlled uterine myoma trials demonstrated that subcutaneous administrations of cetrorelix demonstrated a reduction of myoma/uterine volume within one month. Results from two placebo-controlled BPH trials demonstrated a dose-dependent improvement in clinical symptoms, including IPSS (International Prostate Symptom Score) and maximum uroflow in the cetrorelix treatment group compared with the placebo group. Full results will be presented during the 18th World Congress of the International Federation of Fertility Societies in Montreal.

FemmePharma reported positive results from a phase II trial investigating FP1096, an intravaginally delivered drug for the treatment of endometriosis. Results showed that the primary efficacy endpoint, change in the Biberoglu and Behrman Symptom Score from baseline to treatment end, demonstrated a statistically significant decrease in symptoms. The multicenter, prospective, open-label study enrolled 30 subjects with endometriosis at four sites in the U.S. Secondary efficacy endpoints included a pain assessment questionnaire, a quality of life measure and a daily diary assessment. Results were reported at the 52nd Annual Clinical Meeting of The American College of Obstetricians and Gynecologists.

March 15, 2004

Boehringer Ingelheim reported positive results from a phase II pilot study investigating Flomax (tamsulosin hydrochloride), an alpha blocker for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Results showed that Flomax demonstrated superior symptomatic relief of CP/CPPS. Symptom relief was measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), which evaluates pain, urinary symptoms, and quality of life/impact. Data showed that 48.2% of subjects experienced at least a six-point decrease in the chronic prostatitis symptom NIH-CPSI score. In addition, Flomax treatment improved quality of life scores in men with more severe symptoms. The double-blind, placebo-controlled study enrolled 57 men in the U.S. and Canada without bacterial infection or benign prostatic hyperplasia (BPH). Results were reported in the April issue of the Journal of Urology.

July 7, 2003

GTX reported positive results from a phase II trial investigating Acapodene (toremifene), a non-steroidal estrogen modulator for the treatment of neoplasia. Results showed the drug was well tolerated and significantly reduced high grade prostate intraepithelial neoplasia (PIN). Data demonstrated that 72% of men had no PIN and no cancer on subsequent biopsies compared to 17.9% of historical controls. The open-label study enrolled 21 men with evidence of high grade PIN on biopsy within six months of entry to the study. Eighteen men completed treatment with Acapodene (60 mg/day orally for four months) and then underwent follow-up prostate biopsy to determine high-grade PIN status. PINs are premalignant lesions that have the potential to progress to prostrate cancer. Results were presented at the 4th International Symposium on Hormonal Carcinogenesis in Spain.

NeoPharm reported positive results from a phase I trial investigating LErafAON, a liposomal c-raf oligodeoxynucleotide for the treatment of various cancers. Results showed that a 2.0 mg/kg dose given twice weekly appeared to be well tolerated, and detectable rafAON levels were observed in the bloodstream over time. Most drug-related adverse events were infusion-related reactions such as back pain, chills, dyspnea, fatigue, fever, flushing and hypertension. The study enrolled 13 subjects and was designed to determine the maximum tolerated dose and toxicities of intravenous LErafAON in patients with advanced solid tumors receiving palliative radiation therapy. Subjects received treatment followed by radiation daily for 10 days. Results were reported at the American Society of Clinical Oncology (ASCO) 39th Annual Meeting in Chicago.

April 8, 2002

Pivotal phase II trial results indicate that Celsion's Microfocus BPH 800 Microwave Urethroplasty system is effective in the treatment of benign prostatic hyperplasia (BPH). The trial was designed to compare AUA symptom scores of subjects who received one treatment with the Microwave Urethroplasty system to subjects treated a daily 5 mg dose of Merck's Proscar. Results demonstrated that the Microwave Urethroplasty treatment produced statistically significant greater reductions in AUA symptom scores at each follow-up date. Additionally, only 18% of subjects undergoing Microwave Urethroplasty treatment required any post-treatment catheterization.