• AEterna Zentaris Inc., of Quebec, plans to begin a Phase III program with cetrorelix in benign prostatic hyperplasia (BPH) before the end of the year. A first study, involving about 600 patients, will assess the ability of an intermittent dosage regimen of the luteinizing hormone-releasing hormone antagonist in providing prolonged improvement in BPH-related signs and symptoms. The primary efficacy endpoint of this first placebo-controlled study is absolute change in the International Prostate Symptom Score between baseline before beginning treatment and after one year. A second study is expected to begin in the first half of next year and follow a similar format in about 300 patients, followed by a third study of open-label, single-arm design to test cetrorelix's safety in about 600 patients. The company expects to file a new drug application by the middle of 2009.

• AVAX Technologies Inc., of Philadelphia, said the FDA cleared the company's launch of a Phase III registrational study of M-Vax, its AC vaccine therapeutic for metastatic melanoma. The company previously reached an agreement on a special protocol assessment for the trial, which will enroll 387 patients with Stage IV melanoma and randomized 2:1 to M-Vax or placebo. The primary endpoints are best overall antitumor response rate and the percentage of patients surviving two years. Secondary endpoints will include overall survival time, response duration, percentage complete and partial responses, progression-free survival and treatment-related adverse events. Based upon initial assessments, AVAX said an interim analysis could occur in 2008, with the final response rate evaluation expected in 2010 and overall survival data generated in the 2012-2013 time frame.

• EPIX Pharmaceuticals Inc., of Lexington, Mass., reported full results from a Phase IIa trial of EP-2104R, a fibrin-binding thrombus imaging agent, showing that the product was able to detect blood clots not previously seen on magnetic resonance imaging and enhanced images of clots previously seen on MRI. Data were presented at the Radiological Society of North America meeting in Chicago. EPIX anticipates seeking a collaboration to move forward with EP-2104R development.

• Genta Inc., of Berkeley Heights, N.J., began a study to evaluate Genasense (oblimersen sodium) in advanced melanoma patients, in combination with Abraxane (paclitaxel protein-bound particles, Abraxis Oncology Inc.) and Temodar (temozolomide, Schering Plough Corp.). The pilot trial, a follow-up to a randomized Phase III study of Genasense plus dacarbazine that showed benefit across multiple clinical endpoints in advanced melanoma patients who had not previously received chemotherapy, will evaluate the three-drug combination's safety, efficacy, pharmacokinetics and pharmacodynamics in chemotherapy-na ve patients who have normal levels of a key biomarker, serum lactate dehydrogenase. Several dosing schedules will be examined to develop a regimen that may optimize safety and efficacy for additional testing.

• Metabolic Pharmaceuticals Ltd., of Melbourne, Australia, said the first group of patients started treatment with ACV1 in the Phase IIa trial in neuropathic sciatic pain. That study is the first part of a Phase IIa program targeting specific neuropathies. It's designed to investigate the safety and tolerability of ACV1, and to examine the product's effects of the drug in patients. Metabolic expects to have the results in the first half of 2007. The second Phase IIa study, expected to begin in the first quarter of 2007, will target diabetic neuropathic pain and postherpetic neuralgia.

• Pain Therapeutics Inc., of South San Francisco, said Phase I results showed that a single, oral dose of PTI-202 was safe and well tolerated in healthy volunteers, and its release profile appears well-suited to use with a chronic pain population. Also, the abuse-resistant opioid painkiller generated no unexpected adverse events.

• Progen Industries Inc., of Brisbane, Australia, received notification from the FDA that the appropriate chemistry, manufacturing and controls procedures have been put in place to progress its cancer drug PI-88 to Phase III trials. The notification follows Progen's meeting with the FDA, held Oct. 24, and gives Progen the go-ahead to manufacture PI-88 for its upcoming Phase III trial.

• Sangamo BioSciences Inc., of Richmond, Calif., initiated a 100-patient Phase II trial to test the safety and efficacy of SB-509 in diabetic patients with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor, which is designed to up-regulate the vascular endothelial growth factor A gene. Funding support for the trial includes $3 million from the Juvenile Diabetes Research Foundation, which agreed to make the first milestone payment upon regulatory acceptance of the trial.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., said results are delayed from an ongoing Phase III trial of glufosfamide for the second-line treatment of pancreatic cancer. The pivotal data will not be available until next year because an event-driven analysis is to be performed after the study's 258th patient death, and that hasn't happened. Data analysis will occur within four to six weeks thereafter, followed by results. Separately, the company continues to expect top-line results from a Phase II trial of glufosfamide in combination with gemcitabine for first-line treatment of pancreatic cancer by the end of this year, and trial sites should be open and patient screening under way for two Phase II trials of glufosfamide in ovarian and small-cell lung cancers by the end of this year, as well.