• Ceregene Inc., of San Diego, said the gene therapy CERE-120 for Parkinson's disease was well tolerated and appeared to reduce symptoms by approximately 40 percent (p<0.001), as measured by the Unified Parkinson's Disease Rating Scale motor "off" score, in an open-label Phase I study in 12 patients with advanced disease. Initial results of the study were presented by William Marks, principal investigator of the study and associate professor of neurology at the University of California San Francisco at the American Neurological Association annual meeting in Chicago.

• Cerus Corp., of Concord, Calif., started a Phase I trial of CRS-100, an attenuated strain of Listeria monocytogenes designed to more safely stimulate an immune response. The trial will enroll refractory carcinoma patients with liver metastases. CRS-100 is Cerus' lead immunotherapy product, but the company also markets the Intercept Blood System for platelets in Europe and has other blood safety products in clinical trials. Last month, Cerus settled a class-action lawsuit regarding its stock price decline following a Phase III setback with its Intercept Blood System for red blood cells.

• Corautus Genetics Inc., of Atlanta, said final efficacy results from its GENASIS Phase IIb trial did not achieve a statistically significant difference from placebo in any active dose group of the VEGF-2 gene therapy product for the primary efficacy endpoint, an improvement of at least one minute in exercise tolerance time from baseline to three months. The data indicated considerable overlap in results between the active and placebo groups for the secondary endpoints as well, and no clear dose effect was seen. Preliminary data reported earlier this year hurt the firm's shares, but the stock (NASDAQ:VEGF) again fell, this time dropping 14 cents Tuesday, or 21 percent, to 53 cents.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., received FDA notification that a clinical hold on its lead Ampakine neurology compound CX717 has been lifted. The hold began in March 2006 due to toxicology concerns, and Cortex may resume its previous clinical trials and treat patients within an FDA-specified dose range. The company expects to have further toxicological information available in late 2006, which the FDA will evaluate to determine if clinical trials with higher doses are warranted.

• Cougar Biotechnology Inc., of Los Angeles, reported data from a Phase I trial of CB7630 (abiraterone acetate) in castration refractory prostate cancer following failure of first-line hormone treatments. In the 14 patients tested, CB7630 was well-tolerated at doses up to 2,000 mg/day with no dose-limiting toxicity observed. Of 12 patients evaluated for antitumor activity, eight experienced a confirmed decline in prostate-specific antigen levels of greater than 50 percent, six experienced PSA declines of greater than 90 percent and three experienced partial radiological responses. The data were presented at the National Cancer Research Institute Cancer Conference in Birmingham, UK.

• Halozyme Therapeutics Inc., of San Diego, completed enrollment in a clinical trial of subcutaneous morphine with Hylenex, a liquid injectable indicated as an adjuvant to increase the absorption and dispersion of other injected drugs that includes recombinant human hyaluronidase (rHuPH20). The Increased Flow Utilizing Subcutaneously-Enabled Morphine clinical trial, or INFUSE-Morphine study, is designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex, maximal blood levels after intravenous administration of morphine and to assess safety and tolerability.

• Inspire Pharmaceuticals Inc., of Durham, N.C., started a Phase II trial comparing several formulations and concentrations of epinastine nasal spray for seasonal allergic rhinitis. The trial is the first in a Phase II program that will include clinical and toxicology studies to determine the optimal formulation and dose. Inspire acquired certain exclusive rights to the intranasal dosage form of epinastine in the U.S. and Canada earlier this year from Boehringer Ingelheim International GmbH, of Ingelheim, Germany.

• Momenta Pharmaceuticals Inc., of Cambridge, Mass., started a Phase I study of anticoagulant M118 in Acute Coronary Syndrome (ACS) and expects preliminary data in the first half of 2007. The trial will enroll 36 healthy volunteers and will evaluate M118 administered as an intravenous bolus in single ascending doses compared to placebo. M118 is an engineered heparin that binds anti-thrombin III and thrombin and is Momenta's first clinical compound designed using its complex-sugar engineering technology.

• Theravance Inc., of South San Francisco, said additional results from its ATLAS 1 and ATLAS 2 studies of the antibiotic telavancin reported today at the International Symposium on Resistant Gram-Positive Infections in Niagara-on-the-Lake, Ontario, demonstrated the product's non-inferiority in the clinical cure rate at the follow-up visit to vancomycin in treating complicated skin and skin-structure infections caused by Gram-positive bacteria. Also, the rates of clinical cure, microbiological eradication and overall therapeutic response for telavancin compared favorably to those for vancomycin. Separately, the company began a Phase II study of TD-5108 for treating chronic constipation and other disorders related to reduced gastrointestinal (GI) motility. The randomized, double-blind, placebo-controlled study will enroll about 350 patients to evaluate the safety and efficacy of a range of TD-5108 doses administered once daily for 28 days.

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