• Adenosine Therapeutics LLC, of Charlottesville, Va., initiated a two-part Phase Ib study in humans to evaluate apadenoson (ATL146e), a selective adenosine A2A agonist, as an anti-inflammatory agent. The study is designed to establish the drug's safety, demonstrate anti-inflammatory effectiveness in humans and determine the optimal dose. The results will serve as the foundation for multiple Phase II clinical trials involving acute inflammation.

• Amylin Pharmaceuticals Inc., of San Diego, said it is expanding its clinical program in obesity with five additional studies to assess the safety and efficacy of multiple neurohormones used in combination to treat obesity. The first four trials will test pramlintide, an analogue human hormone amylin, in combination with Leptin, PYY 3-36, Leptin plus PYY 3-36, or approved oral obesity agents. The fifth trial will evaluate an amylin mimetic designed with enhanced anti-obesity properties.

• Anesiva Inc., of South San Francisco, started Phase I testing of product candidate 1207, a new topical local anesthetic for numerous pain conditions including naturopathic pain. The study, designed to assess the safety of 1207, will enroll 24 adult healthy male volunteers in up to six dose-escalating cohorts in Australia. The randomized, double-blind, placebo-controlled study also will measure sensory perceptions of touch and warmth following a single topical administration of 1207 compared with placebo.

• Crucell NV, of Leiden, the Netherlands, started a Phase I trial of the AdVac-based tuberculosis vaccine it is developing with AERAS Global TB Vaccine Foundation in Rockville, Md. The open-label study will test the vaccine in a dose-escalation trial involving 24 healthy volunteers. The trial will be funded and managed by Aeras through a contract research organization, PRA Clinical Pharmacology Center in Lenexa, Kan.

• EntreMed Inc., of Rockville, Md., started a multicenter study with its drug candidate MKC-1 in non-small-cell lung cancer patients. MKC-1 is being evaluated in Phase I/II open-label clinical studies against breast cancer and in patients with leukemia. Phase I will assess the safety and maximum tolerated dose of MKC-1 when given orally in combination with pemetrexed Altima, a multi-targeted antifolate. Phase II will assess the antitumor activity and progression-free survival in up to 60 patients with NSCL cancer. MKC-1 is an orally active cell-cycle inhibitor.

• Tanox Inc., of Houston, started dosing a Phase I trial of TNX-650, a humanized monoclonal antibody being evaluated as a treatment for moderate-to-severe asthma. The trial is evaluating a single dose of TNX-650 in 32 healthy volunteers. TNX-650 targets interleukin-13. Tanox also is evaluating the anti-IL-13 effect of TNX-650 as a potential treatment for Hodgkin's lymphoma in an ongoing Phase I trial.

• Theratechnologies Inc., of Montreal, completed the efficacy phase of its first Phase III trial testing TH9507 in HIV-associated lipodystrophy. The Phase III trial is being conducted in 43 centers in the U.S. and Canada examining the safety and efficacy of a daily administration of 2 mg of TH9507 for 26 weeks. The primary endpoint is a reduction of visceral adipose tissue, which is a risk factor for cardiovascular disease and Type II diabetes.

• Titan Pharmaceuticals Inc., of South San Francisco, initiated a Phase III study of Probuphine in opioid dependence. The 150-patient study will evaluate the safety and effectiveness of Probuphine vs. placebo in reducing opioid dependence over 24 weeks of treatment. Probuphine is designed to provide continuous, long-term therapeutic levels of the drug buprenorphine.

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