• Avidex Ltd., of Oxford, UK, said its lead product candidate, RhuDex, successfully has ompleted two Phase I studies looking at safety, tolerability and pharmacokinetics in normal, healthy volunteers. RhuDex is a small-molecule, orally active, T-cell co-stimulation modulator with a similar mode of action to the recently approved rheumatoid arthritis drug Orencia (Bristol Myers Squibb & Co.). RhuDex may offer a new approach in treating RA by blocking the inappropriate T-cell response and blocking the release of inflammatory cytokines. Avidex plans to start a pilot Phase I/II study in RA patients.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., started a Phase I trial with peramivir, the company’s lead influenza neuraminidase inhibitor, to determine the pharmacokinetics and safety of single and multiple doses of an intravenous formulation of the drug in healthy volunteers. The double-blind, randomized, dose-escalating study of peramivir is being conducted in association with the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

• Corgentech Inc., of South San Francisco, reported positive data from a Phase II trial showing that ALGRX 4975, one of three non-opioid pain management drug candidates the company is developing, demonstrated sustained, statistically significant pain relief over placebo in patients with tendinitis of the elbow. The 45-patient study met its primary endpoint of response to ALGRX 4975 in treating pain induced by wrist dorsiflexion four weeks after patients were treated with a single injection of ALGRX 4975 or placebo. At week four, 64 percent (14 of 22) of patients treated with ALGRX 4975 were considered responders, vs. 30 percent (seven of 23) of patients treated with placebo (p=0.0256). Corgentech’s stock (NASDAQ:CGTK) closed Thursday at $9.67, up 82 cents, or 9.3 percent.

• D-Pharm Ltd., of Rehovot, Israel, said its independent safety monitoring board issued a second recommendation to continue the ongoing Phase II study of its neuroprotective agent DP-b99 in acute stroke patients. DP-b99 is an intravenous drug designed to address an array of damaging processes in the brains of stroke patients, and 107 subjects are enrolled in the study.

• Hana Biosciences Inc., of South San Francisco, said it successfully completed all clinical trials of Zensana (ondansetron oral spray) required for FDA registration as an agent to treat chemotherapy-induced nausea and vomiting under section 505(b)(2). Pivotal studies confirm Zensana 8 mg dose is statistically bioequivalent to the current commercially available 8 mg ondansetron (Zofran) tablet. Results also showed that Zensana delivers detectible ondansetron levels statistically faster than the Zofran tablets. The company expects to launch the product in the U.S. in 2007.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said it would begin a pharmacokinetic study of Nebido, a European-approved injectable testosterone preparation for hypogonadism, by the end of this month because the FDA accepted its investigational new drug application. The primary endpoint will require assessment of the average serum testosterone levels at steady state, measured in hypogonadal men receiving the long-acting treatment via intramuscular injection every 12 weeks. The company noted that while European data indicates steady state levels are achieved by the third injection, the FDA advised that it would be preferable to measure at the fourth injection to confirm steady state levels. Indevus agreed with that approach, and assuming positive results, expects to submit a new drug application in the second quarter of next year.

• Myogen Inc., of Denver, said the FDA granted fast-track designation to ambrisentan, the company’s type-A selective endothelin receptor antagonist in Phase III testing for pulmonary arterial hypertension. The once-daily oral therapy already has orphan drug status for that indication in both the U.S. and Europe. Myogen has licensed its overseas rights to GlaxoSmithKline plc, of London.

• Nabi Biopharmaceuticals, of Rockville, Md., said NicVAX, its nicotine conjugate vaccine to treat nicotine addiction and prevent smoking relapse, received fast-track designation, which would provide an expedited review process and up to seven years of marketing exclusivity upon approval. Nabi has completed four Phase I/II studies, demonstrating efficacy at 200 mg administration, with a 33 percent to 40 percent quit rate vs. 9 percent for smokers dosed with a placebo.

• Repligen Corp., of Waltham, Mass., began a Phase II trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. The multicenter, dose-escalating study will include 80 patients who will receive RG2417 or a placebo for six weeks to evaluate the product’s safety and effectiveness on the symptoms of bipolar depression. The trial is being conducted under a development agreement with the Stanley Medical Research Institute in Bethesda, Md., under which Repligen will receive about $1 million in funding.

• Samaritan Pharmaceuticals Inc., of Las Vegas, is starting a second Phase II trial of its lead oral entry inhibitor antiviral agent, SP01A, in treatment-experienced HIV patients. The multicenter, double-blinded, randomized study is designed to accrue patients who are failing current antiviral therapy. They are entered into a two-week washout period, followed by 28 days of monotherapy with SP01A, and the study’s primary analysis is a comparison of the reduction in viral load in SP01A patients vs. those on placebo, as measured from baseline to the end of the study.

• Stem Cells Inc., of Palo Alto, Calif., received approval from the Institutional Review Board of the Oregon Health & Science University to start a Phase I clinical trial of the company’s proprietary human neural stem cell product, HuCNS-SC, to treat infantile and late-infantile neuronal ceroid lipofuscinosis, two forms of a group of disorders often referred to as Batten disease, a rare and fatal neurodegenerative genetic condition affecting infants and children.

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