• Columbia Laboratories Inc., of Livingston, N.J., completed the treatment phase of its pivotal Phase III study of Prochieve 8 percent (progesterone gel) to prevent recurrent preterm birth. The 669-patient study is designed to expand the Prochieve label beyond infertility and secondary amenorrhea. Preliminary safety data from the preterm birth study is expected in mid-February 2007.

• Exelixis Inc., of South San Francisco, initiated a Phase II trial of XL880 in gastric cancer. The trial will enroll patients with metastatic, poorly differentiated diffuse gastric cancer, with the primary objectives of determining best-confirmed response rate and evaluating the drug's safety and tolerability when administered orally for five consecutive days every two weeks. Secondary objectives include assessing progression-free survival, overall survival, and duration of response and to continue characterizing the pharmacokinetic and pharmacodynamic profiles of XL880.

• InterMune Inc., of Brisbane, Calif., said Osaka, Japan-based Shionogi & Co. Ltd. reported positive results from its Phase III studies of pirfenidone in idiopathic pulmonary fibrosis. Both high and low doses of the drug (600 mgl per day, three times daily and 400 mgl per say, three times daily, respectively) significantly inhibited worsening of the condition compared to placebo. For InterMune, which is evaluating pirfenidone in its own Phase III program in IPF, that news sent its shares (NASDAQ:ITMN) climbing $6.39, or 29 percent, Friday to close at $28.40.

• Oncolytics Biotech Inc., of Calgary, Alberta, started patient enrollment in its UK Phase II study of Reolysin in combination with low-dose radiation in advanced cancer. The trial will enroll up to 40 patients, including about 20 with head, neck and esophageal cancers, to receive two intratumoral doses of Reolysin with a constant localized radiation dose. The company also anticipates future studies of Reolysin, a formulation of the reovirus, in combination with chemotherapy.

• Panacos Pharmaceuticals Inc., of Watertown, Mass., filed an investigational new drug application for its second-generation HIV maturation inhibitor, PA-1050040, and intends to begin Phase I trials in the first quarter of next year. The company expects to file additional INDs for other second-generation maturation inhibitors during 2007, and then will select a candidate based partly on human pharmacokinetics to take into multiple-dosing studies.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said findings from a preliminary analysis of Phase IIa data in eight patients with traumatic brain injury demonstrated that Oxycyte increases brain oxygen tension and glucose metabolism compared to baseline. Treatment with Oxycyte, an oxygen carrier, also favorably affects other brain chemistries that impact clinical outcomes in traumatic brain injury patients.

• UCB SA, of Brussels, Belgium, reported positive top-line results from two Phase III studies of Cimzia (certolizumab pegol), a Fab fragment anti-TNF therapy for rheumatoid arthritis. In both studies, Cimzia, in combination with methotrexate, demonstrated superiority to placebo and showed a statistically significant improvement in the signs and symptoms of RA as measured by all American College of Rheumatology scores. Further results will be released in the first quarter of 2007. UCB also received a complete response letter from the FDA regarding the company's biologics license application for Cimzia in Crohn's disease.

No Comments