• Aeolus Pharmaceuticals Inc., of Laguna Niguel, Calif., finished analyzing results from its Phase I multiple-dose study of AEOL 10150, and said the clinical direction for the drug is under consideration, with the most likely targets for an efficacy study being lung cancer and/or head and neck cancer and amyotrophic lateral sclerosis. The 18-patient trial studied three doses of AEOL 10150 or placebo administered subcutaneously, and results showed that the drug was safe and well tolerated at doses up to 2 mg/kg/day. AEOL 10150 is a small-molecule catalytic antioxidant designed to protect healthy cells in radiation therapy.

• AEterna Zentaris Inc., of Quebec City, and its partner, Shionogi & Co. Ltd., of Osaka, Japan, reported positive results for a Phase IIa trial of cetrorelix in benign prostatic hyperplasia, showing that the drug, a luteinizing hormone-releasing hormone antagonist, was safe and well tolerated at all dosage regimens. Data from the trial, which involved about 50 Japanese patients, also showed that patients responded to cetrorelix with a transient reduction of testosterone concentration in blood, which did not reach or remain at the castration level. Based on those results, Shionogi initiated a 300-patient Phase IIb study to assess the efficacy of cetrorelix in BPH in Japanese patients.

• Celldex Therapeutics Inc., of Phillipsburg, N.J., is sponsoring a Phase II trial of its vaccine for treating glioblastoma. The vaccine targets an epidermal growth factor receptor variant, or EGFRvIII. The study will enroll 81 patients whose tumors produce the altered protein. An earlier, small Phase II trial in glioblastoma showed encouraging survival results.

• Evotec AG, of Hamburg, Germany, initiated a Phase I study of EVT 302, a monoamine oxidase B enzyme in development for smoking cessation. The open-label study is designed to access the occupancy of the MAO-B in the brain after administration of single oral doses of the drug by the use of dynamic positron emission tomography. The company plans to start additional Phase I studies during the first half of this year, and pending successful results, will move into Phase II development in mid-2008.

• GPC Biotech AG, of Martinsried, Germany, and Spectrum Pharmaceuticals Inc., of Irvine, Calif., said additional data from a Phase III trial of satraplatin in refractory cancer showed that pain response rates for patients treated with satraplatin plus prednisone (24.2 percent) were statistically superior compared to the pain response rates for patients in the placebo arm (13.8 percent.) Those results were presented at the European Association of Urology Congress in Berlin. GPC and Spectrum completed a rolling new drug application last month, seeking approval of satraplatin in prostate cancer. GPC's European marketing partner, Boulder, Colo.-based Pharmion Corp., plans to file for approval in Europe in the first half of this year. (See BioWorld Today, Feb. 20, 2007.)

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., completed enrollment of the planned 12 evaluable patients in its Phase Ib trial of bavituximab in combination with common chemotherapy agents in advanced cancer patients with metastatic disease who had failed prior therapy. Data from that study are expected to support the initiation of Phase II trials later this year. Bavituximab is a monoclonal antibody designed to target and bind to phosphatidylserine, which is located on the inside of normal cells but becomes exposed on the outside of cells that line the blood vessels of tumors.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., began a Phase I dose-escalation study of Clomet (DMPEN, 4-demethylpenclomedine) in patients with solid tumors. The trial is expected to enroll as many as 25 patients to receive a daily dose of Clomet for three consecutive days as a short infusion for four cycles. Primary objectives include determining the product's safety profile, identifying dose-limiting toxicity, finding the maximum tolerated dose and studying the pharmacokinetics, while secondary objectives will assess preliminary evidence of antitumor activity.

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