• KeyNeurotek AG, of Magdeburg, Germany, initiated a European Phase II trial of KN 38-7271, a cannabinoid receptor agonist, in traumatic brain injury patients. The study is expected to involve more than 100 patients and is designed to demonstrate tolerability and efficacy of the drug.

• Neurologix Inc., of Ft. Lee, N.J., finished a Phase I trial of its gene therapy for Parkinson's disease, with statistically significant results. The trial confirmed the safety and tolerability in all 12 patients studied out to one year. Though efficacy was designated only as a secondary outcome, the trial also yielded statistically significant clinical efficacy and neuro-imaging results, the company said. Data were presented at the 36th Annual Meeting of the Society of Neuroscience in Atlanta.

• Rexahn Pharmaceuticals Inc., of Rockville, Md., concluded Phase I trials of its lead oncology candidate, RX-0201, a signal inhibitor aimed at blocking Akt production. The study demonstrated that the dose-limiting toxicity of the drug occurs at 315mg/m2 dose in the form of fatigue, and no other serious adverse reactions were observed. The company expects to file a final report of Phase I results with the FDA in early 2007, followed by the initiation of a Phase II trial in patients with advanced renal-cell carcinoma who have failed previous treatments.

• Sosei Group Corp., of Tokyo, started a Phase II proof-of-principle trial of AD 337, an enantiomer of an approved centrally acting non-opioid analgesic, in fibromyalgia syndrome. The trial is expected to recruit about 100 patients and is designed to investigate the efficacy, safety and tolerability of the drug in female subjects. AD 337 is a serotonin noradrenalin reuptake inhibitor.

• Virax Holdings Ltd., of Melbourne, Australia, filed an investigational new drug application with the FDA for a Phase II trial of VIR201, its therapeutic HIV/AIDS vaccine. VIR201 is based on the company's Co-X-Gene technology. In addition to the proposed U.S. trial, Virax also submitted an application to the South African Medicines Control Council to conduct a Phase I/IIa trial in that region.

• ZymoGenetics Inc., of Seattle, started a Phase I/II study of interleukin-21 in combination with Nexavar (sorafenib) in patients with advanced renal-cell cancer. The study will evaluate safety and preliminary antitumor activity.

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