• Acacia Research Corp., of Newport Beach, Calif., signed a $50 million common stock equity financing commitment from Cornell Capital Partners LP for its CombiMatrix group. Under the terms, Acacia, at its discretion, can draw down funds as needed over the next 24 months and sell registered shares of its AR-CombiMatrix stock to Cornell at a 2.5 percent discount from market price. CombiMatrix said funds will provide financing flexibility as the company further develops its molecular diagnostics platform.
• Ambrilia Biopharma Inc., of Montreal, disclosed positive results of a Phase Ia clinical study for PPL-100, its lead protease inhibitor for the treatment of HIV/AIDS. PPL-100 was found to be safe and well-tolerated, and the pharmacokinetic profile indicates that PPL-100 can be used as a first-line, unboosted once-a-day protease inhibitor for PI-naive patients, and the company believes the compound also can be used as an unboosted once-a-day protease inhibitor for PI-experienced patients infected with drug-resistant HIV strains containing highly prevalent mutations.
• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., disclosed promising data from a Phase IIa study of AN0128, a novel topical anti-inflammatory drug candidate for atopic dermatitis.The study enrolled 103 subjects with mild to moderate AD at eight centers. Study participants received twice-daily treatment for four weeks with either AN0128 Cream 1 percent or vehicle cream. Efficacy was measured by a 6 point (clear, almost clear, mild, moderate, severe, very severe) investigator static global assessment scale. At the end of the four-week treatment period, the study showed 47 percent of the patients enrolled with moderate AD and treated with AN0128 exhibited at least a two grade improvement on the ISGA scale and were judged by investigators to be "clear" or "almost clear" of disease. Twenty-nine percent of those treated with the vehicle cream reached the same endpoint. AN0128 was well tolerated at the site of application.
• Callisto Pharmaceuticals Inc., of New York, executed a sponsored laboratory study agreement with the University of Texas M.D. Anderson Cancer Center to develop the company's Degrasyn class of cancer compounds. The two-year deal is intended to support in vitro and animal model studies. The Degrasyn compounds, which Callisto licensed from M.D. Anderson, are believed to work by selectively promoting degradation in key proteins involved in tumor growth and survival.
• Discovery Laboratories Inc., of Warrington, Pa., said the FDA granted orphan drug designation to Discovery's lead product, Surfaxin, for the prevention of bronchopulmonary dysplasia, also known as chronic lung disease in premature infants. The lung surfactant replacement therapy, previously received orphan drug designation for the treatment of BPD, as well as fast-track designation for both the prevention and treatment of the disease.
• Encysive Pharmaceuticals Inc., of Houston, said the FDA accepted for review its complete response to the March 24 approvable letter for Thelin (sitaxsentan sodium) 100 mg tablets, and issued a new target date of July 24, 2006. Thelin is being evaluated as an oral treatment in pulmonary arterial hypertension. Earlier this month, Encysive received a positive opinion for Thelin from the European Committee for Medicinal Products for Human Use, and the company expects European approval within the next three months. (See BioWorld Today, March 28, 2006, and June 5, 2006.)
• Migenix Inc., of Vancouver, British Columbia, completed enrollment in a Phase IIb study of celgosivir (MX-3253) in combination with Peg-Intron (peginterferon alfa-2b), and Pegetron (peginterferon alfa-2b plus ribavirin) for the treatment of hepatitis C virus infection in genotype 1 patients who were non-responders or partial responders to previous treatment with pegylated interferon-based therapy. A total of 57 subjects have been enrolled. The subjects will be treated for 12 weeks and results are expected to be available in October. The study is being supported in part through an agreement with Schering-Plough Corp., of Kenilworth, N.J.
• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said it ended a time-limited process to explore the potential sale of the company and instead has decided to focus on achieving long-term profitability by increasing sales of its cancer product, Velcade (bortezomib) and advancing its development pipeline. The company began exploring options following an acquisition offer initiated by an unnamed third party. Shares of Millennium (NASDAQ:MLNM) rose 74 cents Thursday, or 8 percent, to close at $10.11.
• Open Biosystems Inc., of Huntsville, Ala., said it intends to defend its claims in lawsuit filed against it by St. Louis-based Sigma-Aldrich Corp. and Oxford, UK-based Oxford Biomedica, alleging that Open Biosystems is infringing on patents exclusively licensed to Sigma-Aldrich. The suit states that Open Biosystems markets and sells its shRNAmir Library to researchers for incorporation into viral particles that infringe on patent claims. In response, Open Biosystems called the lawsuit "unfounded" and continues to operate under a license from the Broad Institute of MIT and Harvard, the developers of the TRC lentiviral libraries, which also are distributed by Sigma-Aldrich.
• Tercica Inc., of Brisbane, Calif., signed distribution agreements with Biologix FZ Co., of Beirut, Lebanon, and Giddi Pharma Co., of Taiwan, to begin distributing Increlex (mecasermin [rDNA origin] injection) in 17 Middle East and North African countries, and Taiwan, respectively. Increlex is the only product that is FDA-approved for the long-term treatment of severe primary IGFD (insulin-like growth factor-1 deficiency). Tercica submitted a marketing authorization application for approval to market it in the European Union for the same indication.