• Alliance Pharmaceutical Corp., of San Diego, received approval from French authorities to start the Phase II trial for Oxygent (perfluorochemical emulsion) to prevent post-op ileus resulting from hypoxia during major surgery. Alliance intends to begin the trial in the first quarter.
• Cadence Pharmaceuticals Inc., of San Diego, began dosing subjects in a Phase III clinical trial to evaluate intravenous acetaminophen for post-operative acute pain. The pivotal trial, referred to as CPI-APAP-301, is the second trial started as part of Cadence's clinical program to evaluate the efficacy and safety of I.V. APAP for pain and fever in adults and children. I.V. APAP has been marketed by Bristol-Myers Squibb Co., of New York, in Europe since mid-2002, where it is the market leader among injectable analgesics.
• Repros Therapeutics Inc., of The Woodlands, Texas, offered positive interim findings from its Phase II study with Proellex in endometriosis. So far, 34 women of the 39 enrolled have completed three months of dosing, and data show that those given the highest dosage of Proellex (50 mg) achieved statistically significant pain reduction compared to treatment with Lucrin/Lupron (leuprolide, Abbott Laboratories), the standard of care.
• Somaxon Pharmaceuticals Inc., of San Diego, disclosed positive Phase III data from a trial testing Silenor (doxepin) in elderly patients with chronic primary insomnia. The compound demonstrated a statistically significant improvement compared to placebo in the primary endpoint, wake after sleep onset as measured at night one, for both doses studied (1mg: p=0.0053, 3mg: p<0.0001). Statistical significance for this endpoint was also achieved at the end of the 12-week treatment period for both doses studied (1mg: p=0.0330, 3mg: p<0.0001). The company aims to file a new drug application in the third quarter.
• VaxGen Inc., of Brisbane, Calif., said the FDA's Center for Biologics Evaluation and Research informed the company that it is maintaining its clinical hold on the second Phase II trial for the investigational anthrax vaccine. The hold is due to CBER's continued concerns about the vaccine candidate's stability. The Department of Health and Human Services, under its contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of Monday for the company to initiate its next clinical trial for the candidate. The office within HHS that administers the contract has yet to inform VaxGen what direction it intends to take with respect to the contract. (See BioWorld Today, Nov. 6, 2006.)