• Arena Pharmaceuticals Inc., of San Diego, said an independent echocardiographic data safety monitoring board recommended the continuation of the Phase III BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial, which is evaluating lorcaserin hydrochloride in the treatment of obesity. The planned review involved an evaluation of unblinded echocardiograms performed after six months of dosing, and the resulting valvulopathy data did not meet predetermined stopping criteria. The lorcaserin registration program involves two additional Phase III trials, which Arena plans to initiate later this year. (See BioWorld Today, Sept. 13, 2006.)

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said a meeting with the FDA resulted in a modified development plan for LibiGel (transdermal testosterone gel) in female sexual dysfunction (FSD). In addition to two planned Phase III efficacy trials, the first of which was initiated in December, BioSante will conduct a randomized, double-blind, placebo-controlled, Phase III cardiovascular safety study. The study will follow between 2,400 and 3,100 women for 12 months prior to registration filing and four years following potential approval. BioSante plans to initiate the safety study and second efficacy study by the end of this year or early next year.

• Corcept Therapeutics Inc., of Menlo Park, Calif., saw its shares (NASDAQ:CORT) soar more than 30 percent Tuesday on news that the FDA cleared its investigational new drug application for the cortisol receptor (GR-II) antagonist Corlux in Cushing's Syndrome. Corlux is in Phase III for psychotic depression, and the FDA indicated that a single Phase III trial in Cushing's Syndrome may provide a reasonable basis for filing a new drug application in that indication. Corcept anticipates initiating enrollment in a 50-patient, open-label, Phase III study in Cushing's Syndrome in the fourth quarter. Shares of Corcept rose $1.28 to, or 37.6 percent, to close at $4.68 on Tuesday.

• Phenomix Corp., of San Diego, initiated a Phase IIb trial of the oral protease dipeptidyl peptidase-4 (DPP4) inhibitor PHX1149 for Type II diabetes. The double-blind, randomized, placebo-controlled, 400-patient study will evaluate the effect of 200 mg of PHX1149, 400 mg of PHX1149, or placebo on hemoglobin A1c levels in patients already receiving metformin, glitazone, or a combination thereof. Secondary endpoints include postmeal glucose and fasting blood glucose. The 12-week trial will be followed by a two-year, open-label, follow-on study.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Wyeth Pharmaceuticals, of Collegeville, Pa., initiated three new trials of methylnaltrexone, a peripherally acting mu-opioid receptor antagonist. A new drug application for the subcutaneous version of the drug was filed earlier this year in opioid-induced constipation (OIC). Two of the new trials will investigate the use of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients outside of the palliative care population included in the NDA submission. One study is a Phase III trial in 470 OIC patients with chronic pain not related to cancer. The other is a Phase II study in 260 OIC patients rehabilitating from an orthopedic surgical procedure. The third trial, a Phase III, will investigate intravenous methylnaltrexone for managing postoperative ileus in 500 POI patients following a ventral hernia repair via laparotomy or laparoscopy.

• Sinovac Biotech Ltd., of Beijing, started vaccination of volunteers for its Phase II study with its pandemic influenza H5N1 vaccine. The randomized double-blind study will assess the safety and efficacy of the vaccine, and began with 400 adult volunteers given the whole viron H5N1 Vaccine. The initial results from this study are expected to be available by the end of this year.

• Trubion Pharmaceuticals Inc., of Seattle, reported preliminary data from its randomized, double-blind, placebo-controlled, 276-patient Phase IIb trial of TRU-015 in rheumatoid arthritis. TRU-015 was well tolerated at doses of 200 mg, 400 mg, 800 mg and 1600 mg. The 800-mg dose group met the primary endpoint of significantly improving Disease Activity Score at 12 weeks, while the 1600-mg dose group significantly improved Disease Activity Score at 16 weeks. Trubion said it is working with partner Wyeth to determine the next steps but that an additional trial will likely be needed before proceeding to Phase III. Shares of Trubion (NASDAQ:TRBN) fell $5.89, or nearly 31 percent, to close at $13.18 on Tuesday.

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