• Accentia Biopharmaceuticals Inc., of Tampa, Fla., filed a preliminary investigational new drug application with the FDA regarding a proposed pivotal Phase III trial of Revimmune in 270 refractory multiple sclerosis patients. The proposed primary endpoint is improvement in neurologic function rather than the more common endpoint of disease progression. Revimmune is designed to eliminate peripheral immune cells, including those responsible for autoimmunity, while sparing hematopoeitic stem cells in the bone marrow so they can regenerate healthy immune cells.

• ImmunoGen Inc., of Cambridge, Mass., saw its stock (NASDAQ:IMGN) rise 28 cents, or 6.2 percent, to $4.77, on the news that it will receive a $5 million milestone payment from partner Genentech Inc., of South San Francisco. The milestone is tied to Genentech's initiation of a Phase II breast cancer trial with trastuzumab-DM1. The drug links ImmunoGen's cell-killing agent, DM1, with Genentech's HER2-targeting antibody, trastuzumab. The milestone is part of a collaboration the companies entered in 2000. (See BioWorld Today, May 5, 2000.)

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase III trial of PMI-150 (intranasal ketamine) in breakthrough cancer pain. The 90-patient, double-blind, crossover, placebo-controlled study will evaluate pain intensity. PMI-150 has completed emergency analgesic trials and a new drug application is slated for filing in 2008 in that indication. If the cancer pain trial proves successful, Javelin intends to gain approval via a supplemental NDA.

• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, said LX6171, an oral drug candidate for cognitive disorders, successfully completed Phase I trials, and proved to be well-tolerated at all dose levels, with systemic exposure described as "excellent." Over the seven-day trial, no dose-limiting toxicities were observed and exposure levels supported a once-daily dosing regimen. LX6171 is being developed under a product development collaboration with Symphony Capital Partners LP, of New York, and its co-investors. The drug inhibits a membrane protein that is expressed exclusively in the central nervous system.

• Novavax Inc., of Rockville, Md., said it began vaccinating healthy volunteers in the first human trial of its virus-like particle-based pandemic influenza vaccine. The Phase I/IIa randomized, placebo-controlled trial will evaluate the safety and immunogenicity of different doses of the H5N1 clade 2 VLP influenza vaccine in up to 230 healthy adults. Goals include demonstration of safety and selection of a dose for evaluation in a Phase IIb immunogenicity study. The VLP technology creates vaccine particles in cell culture that mimic the 3-dimensional structure of the virus, but do not contain genetic material and cannot replicate.

• OncoGenex Technologies Inc., of Vancouver, British Columbia, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., said preliminary Phase II data show that metastatic hormone refractory prostate cancer (HRPC) patients receiving second-line treatment with OGX-011 plus docetaxel achieved improved survival, longer progression-free survival, and more frequent decreases in prostate-specific antigen levels than patients receiving OGX-011 plus mitoxantrone. Both arms of the trial also received prednisone, and the frequency of adverse events was similar between both arms. The Phase II trial is ongoing, and OncoGenex said it plans to initiate a pivotal Phase III trial of OGX-011 plus docetaxel in HRPC.

• Poniard Pharmaceuticals Inc., of South San Francisco, started a Phase II trial of intravenous picoplatin in combination with docetaxel (Taxotere, Sanofi-Aventis Group) and prednisone in patients with metastatic hormone-refractory prostate cancer. Picoplatin, the company's lead product candidate, is a new generation platinum chemotherapy agent designed to overcome platinum resistance and to prolong the time to relapse after chemotherapy in the treatment of solid tumors, and to have an improved safety profile compared with existing platinum-based chemo drugs.

• YM BioSciences Inc., of Mississauga, Ontario, said it has enrolled the first patients in the 50-patient initial cohort of its Phase II trial of nimotuzumab in combination with irinotecan, for treating colorectal cancer patients who have failed irinotecan-containing regimens. Recruitment of the first cohort is expected to be completed within about eight months. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor.