• AmpliMed Corp., of Tucson, Ariz., said the Committee for Orphan Medicinal Products of the European Medicines Agency recommended the granting of orphan medicinal product designation for the company's lead drug, Amplimexon, in pancreatic cancer. If the European Commission approves the recommendation, AmpliMed's drug could be ensured up to 10 years of marketing exclusivity. Amplimexon is in Phase I/II trials to evaluate its safety and efficacy in combination with gemcitabine in patients with previously untreated advanced pancreatic adenocarcinoma, and in combination with dacarbazine in patients with unresectable Stage II or Stage IV malignant melanoma who have not been treated with chemotherapy.
• Array BioPharma Inc., of Boulder, Colo., agreed to extend it lease at its 75,000-square-foot, Longmont, Colo.-based laboratory facility to May 31, 2013, with three five-year options to extend each lease. The company also has the option to expand its leased space by up to an additional 80,000 square feet, and the right to purchase the buildings it occupies. Array BioPharma said this move is intended to expand and consolidate all its research and laboratory-based development in one location.
• DOV Pharmaceutical Inc., of Hackensack, N.J., initiated a Phase III trial of bicifadine, in treating post-operative pain following vaginal hysterectomy. The randomized, placebo-controlled study will involve 100 patients in each treatment arm - bicifadine 400 mg three times a day or placebo - with medication administered for up to five days following surgery. The primary efficacy endpoints are the patients' assessments of pain intensity using a categorical scale, and pain relief based on changes in pain intensity using a visual analogue scale of pain ratings. The trial is one of four pivotal studies required by the FDA to support a new drug application for bicifadine in an acute pain indication, the first of which began in September 2004. (See BioWorld Today, Sept. 27, 2004.)
• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its Ibis division has shipped its first TIGER biosensor system to the U.S. Army Medical Research Institute for Infectious Diseases, which will use it to identify infectious agents for biowarfare defense. Ibis is deploying the system with support from the Defense Advanced Research Projects Agency, under a subcontract from San Diego-based Science Applications International Corp.
• LI-COR Biosciences, of Lincoln, Neb., said it is offering $1.75 million in Genomics Education Matching Funds to high schools, colleges and universities. The program is to be used to acquire LI-COR DNA sequencing systems and software for use by undergraduate students studying molecular biology and related fields. The company's systems are used for sequencing, microsattelites, SNP discovery and reverse genetics research.
• Neorx Corp., of Seattle, watched its shares (NASDAQ:NERX) climb more than 40 percent, or 28 cents, on Friday - one day after announcing a collaboration with The Scripps Research Institute in Palm Beach County, Fla. The stock closed at 97 cents. The research alliance will focus on discovering small-molecule, multi-targeted, protein kinase inhibitors as therapeutic agents, including cancer treatments.
• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., started a collaboration with doctors at Children's National Medical Center, Division of Cardiology, in Washington, to study the effects of thymosin beta 4 (TB4), a naturally occurring peptide, to treat degenerative muscle diseases that often result in cardiomyopathy, characterized by the progressive deterioration and weakness of the heart. The project will study the effects of TB4 in non-human models that have a disease similar to human Duchenne's muscular dystrophy and go on to develop cardiomyopathy. If TB4 is shown to be protective, the drug could advance into clinical trials.
