• AEterna Zentaris Inc., of Quebec City, began the first Phase III study of cetrorelix in benign prostatic hyperplasia (BPH). The one-year, placebo-controlled trial will assess an intermittent dosage regimen of the luteinizing hormone-releasing hormone (LHRH) antagonist compound in providing prolonged improvement in BPH-related signs and symptoms. The primary efficacy endpoint is measuring absolute change in the International Prostate Symptom Score (IPSS) between baseline before beginning treatment and the 52nd week, while safety endpoints include changes in sexual function as well as BPH symptom progression equal to or more than four points and/or acute urinary retention and/or need for BPH-related surgery. Other endpoints consist of plasma levels of testosterone and changes in bone mineral density. The study will include about 600 patients, part of a broad Phase III program enrolling a total of about 1,500 patients.

• Antares Pharma Inc., of Ewing, N.J., said study results showed that its oxybutynin ATD transdermal gel Anturol was absorbed on a bioequivalent basis after a single-dose was applied to three different skin site locations. Additionally, the ratio of plasma levels of R- to S-enantiomers of the active metabolite was lower following gel application, in comparison to a higher ratio of R-enantiomer levels known in oral products, indicating lower potential for adverse events from Anturol, which is being developed to treat symptoms of overactive bladder.

• Neurochem Inc., of Laval, Quebec, said the database for its North American Phase III trial of tramiprosate (Alzhemed) in Alzheimer's disease has been locked and that the analysis is ongoing, though the company's external team of statisticians said an adjustment to the initial statistical model would be necessary to provide accurate results. While Neurochem said the potential statistical model refinement was discussed prior to the study, it has been informed that the adjustment and analysis could take several weeks, perhaps longer, before results are known. The company continues to expect those results to be released during the second quarter.

• Resistentia Pharmaceuticals AB, of Uppsala, Sweden, started a Phase II trial of RP01, an anti-IgE immunotherapy, in allergic patients. About 42 patients will be enrolled in the trial, which is expected to last 52 weeks, with an interim analysis at week 20. The study's primary endpoint is safety and tolerability, though a number of immune markers also will be analyzed as part of an efficacy evaluation. RP01 is designed to induce the immune system to produce antibodies that block immunoglobin E, the key mediator of an allergic response.

• Schering-Plough Corp., of Kenilworth, N.J., said it plans to begin two global Phase III studies of its selective oral antiplatelet therapy, the thrombin receptor antagonist (TRA) SCH 530348. The trials are designed to evaluate the risk reduction provided by TRA-SCH 530348 plus standard antiplatelet therapy (including aspirin and clopidogrel) compared to placebo plus standard antiplatelet therapy in two patient groups: acute coronary syndrome patients and for secondary prevention in patients who have had a prior heart attack or stroke, as well as patients with existing peripheral arterial disease. The studies will each include more than 800 sites in about 30 countries.

No Comments