¿ AltaRex Corp., of Waltham, Mass., received a recommendation to continue a North American Phase IIb study of OvaRex Mab from an independent data and safety monitoring board. The board concluded the safety profile of the group receiving OvaRex Mab, a murine antibody, was similar to those of patients receiving a placebo. So far, the study has enrolled 211 of the required 280 patients and enrollment is expected to be finished by the third quarter of this year.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, along with Glaxo Wellcome Inc., of London, have agreed to return to Cellegy the worldwide rights of Glylorin (monolaurin) due to a shift in development priorities within Glaxo¿s research and development program. Glaxo completed a Phase II study of Glylorin for the treatment of ichthyosis vulgaris, a severe dry skin disorder than affects up to 2 million people in the U.S. and Europe. The FDA had agreed to a Phase III trial protocol last October. Cellegy will now seek another partner to complete clinical development and regulatory approvals.
¿ Digene Corp., of Beltsville, Md., received marketing clearance from the FDA for its Hybrid Capture II HPV Test, a DNA-based technology to detect the human papillomarvirus (HPV). Clinical studies confirmed the HPV-transmitted infection is the cause of essentially all cervical cancer. The company hopes to launch the test this spring.
¿ Ergo Science Corp., of Boston, said it will appeal the FDA¿s not-approvable letter for Ergoset tablets for the treatment of Type 2 diabetes. Ergo contends its product demonstrated safety and efficacy. In November, an FDA committee notified Ergo Science that its new drug application was not approvable, citing an overall benefit-to-risk ratio. In January, the company discontinued funding its preclinical development programs and cut its workforce by 75 percent.
¿ Megabios Corp., of Burlingame, Calif., and Gene-Medicine Inc., of The Woodlands, Texas, completed their merger. The combined company will now be known as Valentis Inc., and will have a technology focus of gene delivery and its applications in the development of gene medicines for diseases with high unmet medical needs. The combined company has seven products in clinical development.
¿ OSI Pharmaceuticals Inc., of Uniondale, N.Y., signed a license agreement with BioChem Pharma Inc., of Laval, Quebec, replacing an earlier collaboration that focused on anti-viral drug discovery. Under the terms of the new agreement, OSI will license the rights to the companies¿ joint technology in certain anti-viral targets. OSI will receive a $2 million licensing fee, plus milestones and royalties. In addition, there will be cross-licensed joint technology in HIV, allowing both companies to continue research and development in this area.
¿ Procept Inc., of Cambridge, Mass., and Pacific Pharmaceuticals Inc., of San Diego, said their respective shareholders approved the merger between the two companies. Pacific will become a wholly owned subsidiary of Procept. The company will now have focus on anti-infectives and oncology, and will have three drugs in Phase I and Phase I/II stages.
¿ Synapse Technologies Inc., of Vancouver, B.C., signed a license agreement with Kyowa Medex Co. Ltd., of Tokyo, giving Kyowa exclusivity for promotion of the p97 diagnostic assay for Alzheimer¿s disease in Japan. As part of the agreement, Synapse will receive up-front and pre-launch milestone payments exceeding $1.32 million, in addition to substantial royalties based on sale of the test in Japan.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., filed an investigational new drug application to start a Phase I safety trial to its lead Tapet vector, VNP20009. The single-site trial will investigate the human clinical safety of intratumoral injections of the ¿unarmed¿ Tapet vectors in patients with solid tumors. Tapet vectors are Salmonella bacteria that Vion has genetically engineered for safety and the ability to preferentially target solid tumors over normal tissues for the treatment of cancer.
¿ Vivus Inc., of Mountain View, Calif., reported that its marketing license for Muse (alprostadil) for erectile dysfunction has been granted in France. The approval triggers a $2 million milestone payment to Vivus from Astra AB, of Sodertalje, Sweden.