• Biota Holdings Ltd., of Melbourne, Australia, began a Phase I trial of its human rhinovirus drug, BTA-798, for the prevention and treatment of one of the major causes of the common cold. The study is expected to enroll up to 48 participants, and is expected to be completed by December.

• ImClone Systems Inc., of New York, completed patient enrollment in three Phase III trials evaluating its cancer drug, Erbitux (cetuximab). The first of these studies, EPIC, is testing the use of Erbitux in metastatic colorectal cancer after failure of oxaliplatin-based chemotherapy, while the second study, designated EXTREME and sponsored by Darmstadt, Germany-based Merck KGaA, evaluates the drug as a first-line treatment for patients with recurrent and/or metastatic squamous-cell carcinoma of the head and neck. The third study, FLEX, is exploring the use of Erbitux in advanced non-small-cell lung cancer. The FLEX trial also is sponsored by Merck KGaA.

• Incyte Corp., of Wilmington, Del., initiated a second Phase IIb trial, Study 204, to confirm the positive results reported in the first Phase IIb trial, Study 203, which demonstrated that once-daily administration of 200 mg of DFC, a nucleoside analogue reverse transcriptase inhibitor (NRTI), provided the greatest benefit in patients not receiving 3TC or FTC, two approved NRTIs. Study 204 is expected to involve 250 treatment-experienced HIV patients, and is designed to compare DFC to 3TC. The primary endpoint is the percentage of patients who achieve at least a 1.0 log or greater drop in viral load after 24 weeks.

• Neurogen Corp., of Branford, Conn., said Merck & Co. Inc., of Whitehouse Station, N.J., began Phase I development of NGD-8243, a drug candidate for treating pain, and one of several being developed as the result of the companies’ exclusive worldwide alliance to develop oral therapeutics targeting the VR1 receptor. A randomized, double-blind, placebo-controlled trial is being conducted in Europe in healthy volunteers. The initiation of the study triggers a $2 million milestone payment from Merck to Neurogen.

• QuatRx Pharmaceuticals Co., of Ann Arbor, Mich., started a Phase II trial for fispemifene, its candidate to treat the symptoms of andropause, and also started dosing in a Phase III trial of ospemifene, its candidate for postmenopausal vaginal atrophy. The randomized, double-blind, placebo-controlled trial of fispemifene will enroll 100 patients with low testosterone who will receive either 100, 200 or 300 mg of drug or placebo for 28 days. The Phase III trial of ospemifene is a randomized, double-blind, placebo-controlled pivotal study that will enroll 800 postmenopausal women who will receive 30 mg or 60 mg of ospemifene or placebo for 12 weeks.

• SCOLR Pharma Inc., of Bellevue, Wash., said it completed pilot availability testing in Canada of its controlled delivery technology extended-release ondansetron tablets. The results provided further evidence that SCOLR’s patented amino acid CDT-based platform may be a viable alternative to solubility and permeability-enhancing practices. The testing consisted of 30 subjects and indicated the 24-mg tablet formulations might provide higher initial blood levels and extended drug release as compared to the 8-mg Zofran tablet. Ondansetron hydrochloride is the active ingredient in Zofran, London-based GlaxoSmithKline plc’s drug to prevent chemotherapy and radiation-related nausea and vomiting.

• VaxGen Inc., of Brisbane, Calif., said Phase II data of its attenuated smallpox vaccine, LC16m8, demonstrated that 100 percent of patients receiving the vaccine seroconverted and developed a lesion showing the vaccination is working, compared to 86 percent of patients receiving Dryvax, a nonattenuated vaccine. Data were presented at the American Society of Microbiology Biodefense Research meeting in Washington.

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