Men's Health

June 9, 2008

OncoGenex reported positive preliminary results from a phase II trial of OGX-011 for the treatment of hormone refractory prostate cancer. This open-label, randomized, multicenter study evaluated 42 subjects who received mitoxantrone plus OGX-011 or docetaxel plus OGX-011. Subjects received a median of six cycles of mitoxantrone plus OGX-011 or eight cycles of docetaxel plus OGX-011. At median follow-up of 17.2 months following the start of second-line chemotherapy, approximately 38% of subjects were alive, with a median survival of 12.1 months. Median survival was estimated at 11.4 months in the mitoxantrone plus OGX-011 group and 14.7 months in the docetaxel plus OGX-011 group. Post-treatment serum clusterin levels showed significant reduction compared to baseline levels (p < 0.0001) and the average serum clusterin levels were predictive of survival, with low-average levels predicting median survival time of 14.7 months compared to high-average levels predicting median survival time of 5.5 months. Reductions in pain or analgesic use were seen in 46% of evaluable patients treated with mitoxantrone plus OGX-011 with a median duration of 5.8 months and in 61% of evaluable patients retreated with docetaxel plus OGX-011 with a median duration of 6.2 months. Both treatment groups achieved prostate specific antigen (PSA) declines of at least 50%: 27% of subjects treated with mitoxantrone plus OGX-011 and 40% of subjects treated with docetaxel plus OGX-011.

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.

August 8, 2005

Auxilium reported top line results of a phase II trial of their androgen replacement transmucosal film, for the treatment of male hypogonadism. Preliminary data yielded evidence of efficacy, with 3 doses of the film each yielding increases in serum testosterone levels; the efficiency of absorption indicated that the lowest trial dose would be optimal for future studies. The film had a positive overall tolerability profile, and 97% of subjects indicated that the film treatment was "desirable" or "acceptable." This open-label study enrolled 69 hypogonalal men, who received daily applications of the film at one of three dose levels (5 mg, 10 mg or 15 mg).

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.

October 20, 2003

Eli Lilly reported positive new data from a serious of clinical trials investigating Cialis (tadalafil), a PDE5 inhibitor for the treatment of erectile dysfunction. Results demonstrated that 62% of men who underwent bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP) reported improved erections after taking the drug. Data showed that 82% of men attempted intercourse at least once between four hours and up to 36 hours after taking the drug over a 12-week period. The trial was a phase III multi-center enrolling 303 men who had undergone surgery 12-48 months pre-study. The most commonly reported drug related adverse events were headache, upset stomach and muscle ache. Results were presented at the annual meeting of the Sexual Medicine Society in Denver.

March 24, 2003

Milkhaus Laboratory reported positive results from a phase IIa trial investigating ML-04, an oral form of human chorionic gonadotropin (hCG) for the treatment of prostatitis. Results demonstrated the efficacy of ML-04 for the treatment of chronic, non-bacterial prostatitis. Subjects improved rapidly in the first four weeks of treatment, and by week 12 showed an average reduction of more than 11 points from a baseline Chronic Prostatitis Symptom Index (CPSI) value of 24 points, an improvement of approximately 60%. The CPSI is a NIH standard measure of pain, urinary symptoms and quality of life. No drug-related adverse events were reported. The open-label study enrolled 16 subjects and was conducted at the Stanford University School of Medicine.