• Bioniche Life Sciences Inc., of Belleville, Ontario, said the FDA approved its investigational new drug application for the first of two Phase III trials of its Mycobacterial Cell Wall-DNA Complex (MCC) for bladder cancer. In this first part of the Phase III program, 105 patients will enter an open-label study to show the efficacy of MCC as therapy in superficial bladder cancer refractory to Bacillus Calmette-Guérin, a live, attenuated strain of Mycobacterium bovis that is standard therapy for bladder cancer. The study, which will begin next quarter, will be conducted in North America and last between three and four years. The design of the program’s second part, in which about 600 patients will be randomized in a double-blinded study to compare MCC to Bacillus Calmette-Guérin as first-line therapy, is under FDA review.

• Bionovo Inc., of Emeryville, Calif., began recruiting participants in its Phase II trial of menopause formula 101 (MF101) for menopausal symptoms. A selective estrogen receptor modulator, the product has not stimulated estrogen dependent tumor formation or uterine proliferation in lab studies. The company expects the study to be completed by the second quarter of 2007.

• Cell Therapeutics Inc., of Seattle, said the FDA designated Xyotax a fast-track product for the treatment of PS2 (poor performance status) women with first-line, advanced non-small-cell lung cancer. The drug is a biologically enhanced version of Taxol, and the company is enrolling patients in the PIONEER trial, the first approval study for lung cancer exclusively targeting women.

• Corgentech Inc., of South San Francisco, said data from two Phase I/II trials of Avrina showed the lowest-tested dose to be the most efficacious in treating eczema. Studied only in one trial, the 0.25 percent dose almost achieved statistical significance (p=0.059) in the analysis of the combined eczema score despite the small patient population. The studies’ primary endpoint was to establish the safety and tolerability profile of the anti-inflammatory product, an NF-kappaB Decoy drug. A preliminary safety review indicated that its topical application was safe and that Avrina was well tolerated at the 0.25 percent dose. The company expects to report clinical data at next month’s American Academy of Dermatology Meeting in San Francisco.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., said the FDA named Ultratrace MIBG (iobenguane I 131) an orphan drug for neuroendocrine tumors such as carcinoid, neuroblastoma and pheochromocytoma. A targeted radiopharmaceutical, it is designed to maximize delivery of radiolabeled MIBG molecules so that neuroendocrine tumors can be diagnosed and treated, and to minimize the amount of non-radioactive MIBG molecules that are delivered in the drug. The compound is in preclinical development, and an investigational new drug application is under FDA review.

• Neurochem Inc., of Laval, Quebec, is planning to begin an 18-month, open-label extension of its ongoing North American Phase III trial of Alzhemed (tramiprosate), its investigational product for Alzheimer’s disease. All patients who complete Phase III can enter the extension, which will start next quarter. Neurochem’s double-blinded, randomized, placebo-controlled Phase III trial includes 1,052 mild to moderate Alzheimer’s patients in the U.S. and Canada, and it is scheduled to be completed in a year.

• Point Therapeutics Inc., of Boston, enrolled the first patient in its second Phase III trial of talabostat in combination with pemetrexed vs. pemetrexed with placebo in patients with metastatic non-small-cell lung cancer. The new study is being conducted as part of a Phase III program comprising two randomized, double-blinded, placebo-controlled trials in up to 800 patients in North America. The first 400-patient trial, evaluating the combination of talabostat with docetaxel vs. docetaxel and placebo, already opened enrollment. Results from both studies are projected for late next year.

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