• Alfacell Corp., of Somerset, N.J., said data published in Advances in Experimental Medicine and Biology show that Onconase significantly enhances the effect of the radiation response in human non-small-cell lung cancer in vitro and in vivo. Research being conducted at the University of Pennsylvania showed that in cell culture studies using A549 human NSCLC cells, Onconase increased the radiation response by inducing inhibition of O2 consumption in tumor cells. The occurrence of apoptosis was increased by Onconase and was dependent on its dosage and length of exposure. Additionally, in animal studies, Onconase significantly increased the radiation-induced tumor growth delay of A549 human NSCLC tumors. Onconase, a natural protein isolated from the leopard frog, is a product candidate based on Alfacell's ribonuclease (RNase) technology.
• Apogee Technology Inc., of Norwood, Mass., entered an agreement with the Vaccine and Infectious Disease Organization to support the advancement of Apogee's intradermal technology for delivery of drugs and vaccines.
• AspenBio Pharma Inc., of Castle Rock, Colo., said its application to list its common stock on the NASDAQ Capital Markets Stock Exchange has been approved. The company anticipates its shares of common stock will begin trading on Nasdaq beginning Aug. 28 under the symbol "APPY." Until then, AspenBio Pharma's common stock will continue to trade on the OTC Bulletin Board under the symbol "APNB."
• Biopure Corp., of Cambridge, Mass., has submitted a draft clinical study protocol to the FDA for compassionate use of the investigational product Hemopure. The proposed open label study would make Hemopure available to patients for the treatment of life threatening or potentially life threatening anemia on a compassionate use basis where blood transfusion is not an option. The product has been available for compassionate use since December 2006. The safety, efficacy and pharmacology of Hemopure have been studied in 22 completed clinical trials. An additional four trials are ongoing.
• Clinical Data Inc., of Newton, Mass., has acquired privately held Epidauros Biotechnologie AG of Bernried, Germany, in a cash deal valued at $11.84 million. With the pharmacogenomics services business Clinical Data gets a portfolio of proprietary genetic biomarkers. The assets include an intellectual property portfolio that includes biomarkers in genes relating to drug transporters such as MDR1, OCT1, MRP1, and cytochrome P450 drug metabolizing genes, such as CYP2B6 and CYP2D6. Michael Lutz, CEO of Epidauros, will join Clinical Data's PGxHealth division as the senior vice president of pharmacogenetic partnerships.
• Etubics Corp., of Seattle, said it has received a $600,000 Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases. The firm said the grant will allow its Vironix-HIV gag vaccine, which is currently in non-human primate trials, to be moved one step closer to clinical trials concentrating on the Gag, Pol and Nef HIV targets.
• Exelixis Inc., of South San Francisco, said partner GlaxoSmithKline, of London, has asked to initiate its review of its MET inhibitor compound XL880 before the compound reaches proof-of-concept. Exelixis expects to deliver the appropriate diligence information to GSK in mid-September, at which point GSK will begin its review to determine whether or not to select XL880 for further development and commercialization.
• GPC Biotech AG, of Munich, is cutting 46 of its 316 employees, or about 15 percent of its total workforce, under a restructuring plan. All affected employees are in the U.S. However, the firm said it plans to retain the personnel needed to re-file a new drug application for satraplatin, an experimental therapy for prostate cancer. GPC Biotech withdrew its application in July after a federal panel of experts advised against approval and told regulators to seek more data. GPC Biotech said it also plans to slow down certain activities related to its 1D09C3 monoclonal antibody and cell cycle inhibitors programs. (See BioWorld Today, July 25, 2007).
• MedImmune Inc., a Gaithersburg, Md., unit of AstraZeneca plc, licensed its reverse genetics technology to Novartis AG, of Basel, Switzerland. Novartis will use the technology to support development and construction of new vaccine strains to produce inactivated human seasonal, pre-pandemic and pandemic influenza vaccines. Reverse genetics is a method by which viruses such as influenza can be generated from segments of DNA, a potentially useful tool when dealing with highly infectious pandemic strains. MedImmune will receive an up-front payment and potentially could receive royalty payments under the nonexclusive deal. Separately, MedImmune unveiled a new pilot laboratory facility located on the same Gaithersburg site as its headquarters. The facility will provide additional capacity and flexibility.
• Microchip Biotechnologies Inc., of Dublin, Calif., TEC Edmonton have entered into an exclusive patent license agreement that allows MBI to commercialize a University of Alberta invention that can improve the development of lab-on-a-chip devices and biosampling procedures. TEC Edmonton is the technology transfer arm of the university. The technology allows trapping of beads on-chip, as well as packing and unpacking the trapping zones, which extends the applications of microfluidic analysis systems, such as those used in biodefense and genomics industries.
• Mirus Bio Corp., of Madison, Wis., has been awarded five federal grants and contracts since January year totaling $5.4 million. Included in the awards are two Phase II Small Business Innovation Research (SBIR) grants totaling $2.4 million to further develop its Dynamic PolyConjugates siRNA delivery platform and alternative nanoparticle technologies, focused primarily on improving potency for liver applications. Also included is one Phase II Department of Defense contract for $1.8 million to optimize the Dynamic PolyConjugates siRNA delivery platform for lung delivery and to develop a treatment against respiratory infections, a Phase I SBIR grant for $300,000 to improve gene expression technologies, and a previously announced Phase II SBIR grant for $900,000 to develop improved labeling technologies for microRNA, which is expected to lead to new research products.