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• Cypress Bioscience is initiating its Phase III program evaluating the use of milnacipran as a potential treatment for fibromyalgia syndrome.
• GenVec has entered into a formal collaboration with the National Cancer Institute (NCI) by signing a Cooperative Research and Development Agreement. Steven K. Libutti, MD, of the NCI Surgery Branch will conduct a Phase II clinical study to determine the activity of TNFerade, GenVec’s lead oncology product candidate, in rectal cancer.
• ARYx Therapeutics has initiated a Phase I study to evaluate the safety and pharmacokinetic profile of ATI-2042, an amiodarone analog intended to treat atrial fibrillation.
• Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals have begun an international, multicenter Phase III trial to further evaluate the safety and efficacy of the investigational drug BAY 43-9006, a novel signal transduction inhibitor, in the treatment of advanced renal cell carcinoma (kidney cancer).
• CV Therapeutics has initiated a pivotal Phase III clinical trial of CVT-3146, a selective A2A-adenosine receptor agonist being jointly developed with Fujisawa Healthcare, for potential use as a pharmacologic stress agent in cardiac perfusion imaging studies.
• Repligen Corp. has initiated a clinical trial in healthy volunteers to assess the safety, tolerability, and pharmacokinetic profile of RG1068 (synthetic human secretin) when administered via subcutaneous injection.
• Chiron Corp. is initiating plans for a Phase III trial for tifacogin in patients with severe community-acquired pneumonia. Tifacogin is a recombinant form of tissue factor pathway inhibitor.
• YM BioSciences has received written confirmation from the U.S. Food and Drug Administration that it may initiate a Phase III, or registrational trial, for its lead small-molecule anticancer therapeutic, tesmilifene, in the treatment of metastatic breast cancer.
• ICN Pharmaceuticals is initiating Phase III studies of its antiviral compound, Viramidine, a nucleoside (guanosine) analog that the company intends to develop in oral form for the treatment of hepatitis C.
• GTx has initiated a Phase III clinical trial of toremifene citrate (Acapodene) tablets to reduce the incidence of skeletal fractures and other serious complications of androgen deprivation therapy in men who have advanced prostate cancer.
• Pharmaceuticals Corp. has announced that the FDA has granted orphan drug designation to its drug candidate AEOL 10150 for the treatment of amyotrophic lateral sclerosis.
• XenoPort has initiated Phase I clinical studies of its lead investigational drug, XP13512. XenoPort has designed XP13512 to overcome limitations in the pharmacokinetic properties of gabapentin.