• Celtic Pharmaceutical Holdings LP, of Hamilton, Bermuda, and Neurobiological Technologies Inc., of Emeryville, Calif., said an interim report of an open-label extension study in a Phase III program of Xerecept (corticorelin acetate injection) showed that, of 20 subjects, 11 had reduced their dexamethasone dosage during the four-week study, and two took no concomitant dexamethasone. Improvement or resolution of steroid-related conditions was observed in eight of 18 (45 percent) of subjects with such conditions at baseline. Xerecept is being developed as a steroid-sparing alternative to dexamethasone, and the open-label study is designed to evaluate the drug's long-term safety and tolerability in peritumoral brain edema. Data were presented at the Society for Neuro-Oncology meeting in Orlando, Fla.

• Evotec AG, of Hamburg, Germany, initiated a second Phase II study of EVT 201 under an investigational new drug application. The study is designed to assess the hypnotic efficacy of EVT 201 in 135 elderly patients with chronic primary insomnia and daytime sleepiness during seven nights' treatment, and also to determine the effect of improved sleep quality on daytime performance. The primary endpoint is to assess total sleep time, determined by polysomnography. Evotec started the first Phase II trial in September.

• Exelixis Inc., of South San Francisco, said its licensee, Helsinn Healthcare SA, of Lugano, Switzerland, discontinued enrollment in a Phase III trial of becatecarin in biliary tract tumors. Helsinn said a preliminary analysis indicated that the comparator agent, 5-fluorouracil (5-FU), demonstrated a greater-than-expected survival benefit, making it statistically improbable that the final study results could achieve the planned objectives despite some evidence of becatecarin activity. Exelixis in-licensed becatecarin in 2001 from Bristol-Myers Squibb Co., of New York, and subsequently out-licensed it to Helsinn in June 2005.

• FibroGen Inc., of South San Francisco, said results of a Phase Ib study of FG-3019, a fully human monoclonal antibody against connective tissue growth factor, demonstrated that the drug was well tolerated, with no dose-limiting toxicities observed. FG-3019 is in development for Type I and Type II diabetics and patients with microalbuminuria, the earliest clinical sign of diabetic neuropathy. Data were presented at the American Society of Nephrology meeting in San Diego.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., started patient treatment in its Phase Ib trial to evaluate its lead anti-phospholipid immunotherapy agent bavituximab, given in combination with common cancer chemotherapy agents. The trial is expected to enroll up to 12 patients at three clinical sites in India. The Phase trial is designed to test the safety and tolerability of bavituximab over an eight-week administration period when given with standard chemotherapy regimens including docetaxel, gemcitabine and carboplatin/paclitaxel.

• Seattle Genetics Inc., of Bothell, Wash., initiated a Phase I trial of SGN-35 in patients with Hodgkin's disease and other CD30-positive hematologic malignancies. The study is designed to evaluate the safety, pharmacokinetic profile and antitumor activity of the drug in about 40 patients. SGN-35 is an antibody conjugate using the company's technology to empower antibodies by linking them to cell-killing drugs.

• Virax Holdings Ltd., of Melbourne, Australia, said the FDA has allowed an investigational new drug application for Phase II testing of the company's VIR201 vaccine for treatment of HIV/AIDS. The IND application drew on data from the Phase I and IIa trials conducted in Australia, which showed that VIR201 suppressed the HIV viral load in patients by up to a factor of 10.

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