• Acusphere Inc., of Watertown, Mass., has been notified by Nasdaq that for the previous 30 consecutive business days the bid price of the company's common stock closed below the minimum $1 per share requirement for continued listing. The company has until July 8 to regain compliance.
• Anadis Ltd., of Melbourne, Australia, reported positive results for its milk-derived anti-flu virus antibodies in several animal trials with mice. The antibody significantly decreased disease mortality and significantly interrupted the disease process. The antibody preparation improved the survival rate of infected mice exposed to lethal flu from 0 percent in nontreated mice to up to 60 percent in treated mice. Other trials showed that the disease progress could be delayed for days with a single application. Human trials are expected within 18 months.
• BioDelivery Sciences International Inc., of Raleigh, N.C., said the clinical development program for its lead product, BEMA Fentanyl, will be expanded to the treatment of breakthrough pain associated with chronic pain conditions other than cancer. The expansion will be funded by and coordinated with partner Meda AB, of Solna, Sweden. BDSI and Meda will conduct additional clinical studies in common chronic pain conditions, such as low back pain, arthritis and neuropathic pain. In October BDSI filed a new drug application for BEMA Fentanyl for the treatment of breakthrough pain in opioid tolerant patients with cancer. An FDA decision is expected in August.
• Cell Therapeutics Inc., of Seattle, was granted permission by Italian officials to publish its Italian listing prospectus, which allows the company to complete an equity financing agreement with Societe Generale of France. Societe Generale will purchase up to €60 million worth of Cell Therapeutics stock through January 2009. Societe Generale then will sell its purchased share on the Italian market.
• Genta Inc., of Berkeley Heights, N.J., said the FDA has extended its review of Genta's appeal of the non-approvable decision for a new drug application that proposed the use of Genasense (oblimersen sodium injection) plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia. The company expects that a final decision will be made later in the current quarter.
• International Stem Cell, of Oceanside, Calif., will be providing corneal epithelial cells, derived from its Parthenogenetic stem cells and human keratinocytes (a type of skin cell), for use in clinical trials aimed at creating a tissue transplant technology to improve photorefractive keratectomy. ISCO entered into a research agreement with Paul H. Chen, who has developed the cell transfer technology.
• Pharmion Corp., of Boulder, Colo., submitted a marketing authorization application with the European Medicines Agency for Vidaza (azacitidine for injection) for patients with higher-risk MDS in the European Union. Vidaza has been designated as an orphan medicinal product in the EU for the treatment of MDS, which, if approved, entitles the drug to 10 years of market exclusivity for the approved indication. Vidaza also has orphan status in the EU for acute myeloid leukemia.
• Protalix BioTherapeutics Inc., of Carmiel, Israel, has signed a lease agreement to expand its manufacturing and research facility, providing approximately three times more space than currently in anticipation of the potential commercialization of the company's lead product candidate, prGCD, a therapeutic protein for the treatment of Gaucher disease. The lease is for 7.5 years with options to extend up to 15 additional years.
• Rosetta Genomics Ltd., of Rehovot, Israel, has signed a collaboration agreement with the Henry Ford Health System in Detroit to develop microRNA-based diagnostics and prognostics for brain cancer. The parties will conduct a genomewide molecular analysis of human brain cancer tumors to identify unique microRNA biomarkers that have diagnostic and prognostic potential. When the analysis is completed, Rosetta will perform a microRNA analysis from Formalin Fixed Paraffin Embedded samples received from Henry Ford Hospital.