Product Preview

August 1, 2006

AEterna Zentaris Inc. said it will file an investigational new drug application with the FDA for permission to proceed to phase III clinical trials of cetrorelix, a luteinizing hormone-releasing hormone antagonist product candidate for the treatment of BPH. The decision follows FDA review of safety and efficacy data from an extensive phase II program of the drug.

Trial of LHRH antagonist in BPH receives go-ahead

AEterna Zentaris Inc. said it will file an investigational new drug application with the FDA for permission to proceed to phase III clinical trials of cetrorelix, a luteinizing hormone-releasing hormone antagonist product candidate for the treatment of BPH. The decision follows FDA review of safety and efficacy data from an extensive phase II program of the drug.

Cetrorelix has been shown to adequately suppress the formation of testosterone, according to AEterna Zentaris. To date, all studies performed with cetrorelix in patients with symptomatic BPH revealed an improvement in symptoms as assessed primarily by International Prostate Symptom Score, an increase in urinary peak flow rate, as well as a reduction in prostate volume, the company said.

Lilly ICOS LLC has submitted a regulatory filing to the European Medicines Agency for marketing approval of a once-daily formulation of tadalafil (Cialis), 2.5 and 5 mg, for treatment of erectile dysfunction.

Regulatory filings are planned in the United States and Canada later this year. If approved, the product could launch in late 2007, the company said.

The filing follows on the heels of a phase III clinical study investigating the safety and efficacy of the once-daily 5-mg dose, in which men experienced significant improvement in erectile function compared with placebo. The drug was generally well tolerated, with transient side effects.

According to the manufacturer, the once-daily, low-dose formulations would be less expensive than the current on-demand 10-and 20-mg versions.

Enrollment is completed for two trials of ED agent

Enrollment has closed in two phase IIb dose-ranging trials of the nasal formulation of bremelanotide in men with mild to severe erectile dysfunction. Bremelanotide is a melancortin receptor agonist whose mechanism of action is on the pathway controlling sexual function without directly affecting the vascular system.

Both studies are designed to identify safe and efficacious doses for evaluation in phase III pivotal trials slated to begin in early 2007. The primary endpoint is a change in the erectile function domain of the International Index of Erectile Function from baseline after 3 months of treatment. While one study evaluates the safety and efficacy of the agent in 560 non-diabetic patients, the second will do so in 265 diabetic patients.

Drug maker submits portion of NDA for HRPC agent

Spectrum Pharmaceuticals, Inc., announced that its partner, GPC Biotech AG, has submitted the non-clinical section of the rolling submission of a new drug application to the FDA for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer.

Earlier, the Independent Data Monitoring Board for the phase III registrational trial of Satraplatin and Prednisone Against Refractory Cancer (SPARC) cited no safety concerns and recommended the study proceed to conclusion, per protocol. Final progression-free survival data are expected by third quarter 2006.

HIFU study enrolls patients with recurrent prostate Ca

The London Health Sciences Centre in London, Ontario, is enrolling men with locally recurrent prostate cancer refractory to radiation in a clinical trial of high-intensity focused ultrasound (HIFU) using the Sonablate 500 (Focus Surgery, Inc., Indianapolis, IN). The intent-to-treat-population consists of men who have undergone external beam radiation or brachytherapy for prostate cancer and who have biopsy-confirmed local recurrence; are between the ages of 40 and 80 years; and have PSA between .5 ng/mL and 10.0 ng/mL and a Gleason score ≤8. Treatment for enrollees will be free.

The purpose of the phase II study is to examine the efficacy, tolerability, and complication rates of HIFU. Researchers said they hope to either verify or refute its claim as an effective, minimally invasive salvage option. HIFU uses sound waves to rapidly heat and destroy targeted tissue.