• Callisto Pharmaceuticals Inc., of New York, plans to develop Atiprimod for an additional indication based on encouraging clinical results that showed a clear response in a patient with advanced carcinoid cancer, plus other positive data on other carcinoid patients. The company expects to start a new Phase I/II trial in carcinoid cancer patients with advanced tumors in the next few months. A trial begun in March 2005 was designed to assess Atiprimod’s activity in solid tumors and hematologic malignancies.

• CancerVax Corp., of Carlsbad, Calif., filed an investigational new drug application with the FDA for D93, a humanized, monoclonal antibody with an anti-angiogenic and tumor inhibitory mechanism of action. Preclinical studies have demonstrated its ability to reduce angiogenesis and inhibit tumor growth in in vivo models of several types of cancer.

• Cytogen Corp., of Princeton, N.J., presented Phase II data of Quadramet (samarium Sm-153 lexidronam injection) in prostate cancer patients with metastatic bone diseases at the American Society of Clinical Oncology’s Prostate Cancer Symposium in San Francisco. Data showed that within 12 weeks after treatment with Quadramet and docetaxel, prostate-specific antigen levels declined more than 50 percent in 34 percent of patients, and more than 75 percent in 21 percent of patients. In another Phase II study in patients with progressive hormone-refractory prostate cancer with response or stabilization after induction therapy with docetaxel plus estramustine, the combination treatment demonstrated that 69 percent of patients had a PSA response of at least 50 percent, 28 percent had a stabilization of disease and 3 percent progressed.

• Gloucester Pharmaceuticals Inc., of Cambridge, Mass., said its Phase II study of depsipeptide (FK228) in patients with metastatic hormone-refractory prostate cancer had encouraging interim data presented at the American Society of Clinical Oncology 2006 Prostate Cancer Symposium in San Francisco. Radiological responses were evaluated in 17 patients and prostate-specific antigen responses were evaluated in 18 patients. Of those evaluated for radiological response, one achieved a partial response for six months, and two patients achieved stable disease for six months, while an additional five patients showed evidence of disease stabilization but have not yet reached six months. Of those evaluated for PSA response, two achieved a 50 percent or greater decrease in PSA with another patient achieving a 40 percent fall in PSA.

• Medivation Inc., of San Francisco, enrolled 183 patients in its ongoing Phase II trial of Dimebon to treat Alzheimer’s disease, exceeding its projected enrollment target of 166 patients. It has closed enrollment, and expects to announce results in the third quarter of this year. Separately, the company said that in a telephone conversation with the FDA it learned it would be required to conduct additional toxicology studies before receiving approval to start a proposed clinical trial of Dimebon for Huntington’s disease. It filed an investigational new drug application in January.

• Northwest Biotherapeutics, of Bothell, Wash., said preclinical data on the efficacy of a monoclonal antibody to CXCR4 showed a significant reduction in metastases to the lung, as well as a significant reduction in primary breast cancer tumor growth and significant extension of survival. The data were presented at the Cambridge Healthtech Institute’s 13th Annual Molecular Medicine Tri-Conference in San Francisco. Northwest’s stock (OTC BB:NWBT) rose 77 percent, or 27 cents, on Wednesday, to close at 62 cents.

• Nuvo Research Inc., of Markham, Ont., completed an initial analysis of the Phase III data from its long-term, open-label safety study of Pennsaid, a topical, non-steroidal anti-inflammatory used to treat osteoarthritis. The analysis confirms the safety profile of Pennsaid reported previously, and final results will form part of the company’s new drug application submission slated for the middle part of this year. The trial involved more than 300 patients who were administered Pennsaid for 26 weeks and a subset of more than 100 of these patients who were administered the drug for 52 weeks.

• RxKinetix Inc., of Boulder, Colo., concluded its end-of-Phase II meeting with the FDA for RK-0202 in oral mucositis, and is proceeding with its plans for Phase III development. The company recently completed the Phase II trial in head and neck cancer patients who demonstrated a 29 percent lower incidence of WHO Grade 3 or greater oral mucositis, or a 46 percent lower incidence of NCI Grade 3 or greater oral mucositis, when taking RK-0202 vs. placebo.

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