¿ Cell Genesys Inc., of Foster City, Calif., in collaboration with scientists from Children¿s Hospital Los Angeles and the Monkey Cancer Center of the University of Kentucky, reported that in preclinical trials, Cell Genesys¿ lentiviral gene delivery system showed efficient long-term gene delivery to bone marrow stem cells.
¿ Cel-Sci Corp., of Vienna, Va., started a 30 patient multi-center Phase II cancer trial with Multikine, its immunotherapy drug, in Poland and Czech Republic, in patients with squamous cell carcinoma of the head and neck. The patients will be pretreated with Multikine prior to surgery or radiation. The trial is expected to be completed by the end of the year. Multikine is a natural mixture of human immune system regulators called cytokines.
¿ Connetics Corp., of Palo Alto, Calif., and MGI Pharma Inc., of Minnetonka, Minn., entered into a promotion agreement for Connetics¿ Ridaura and Luxiq products. Under the agreement, MGI Pharma will promote Ridaura (auranofin) and Luxiq (betamethasone valerate) foam to the rheumatology market in the U.S., in exchange for undisclosed promotional fees. Ridaura slows the progression of rheumatoid arthritis and is believe to slow joint destruction. Luxiq is a stabilized foam formulation of betamethasone valerate, a mid-potency corticosteroid for scalp dermatoses.
¿ Duramed Pharmaceuticals Inc., of Cincinnati, said the FDA approved Cenestin, a plant-derived synthetic conjugated estrogens product for moderate to severe vasomotor symptoms associated with menopause. The tablets will be available within 90 days.
¿ Eli Lilly and Company, of Indianapolis, and Chugai Pharmaceutical Co., of Taipei, Japan, entered into a collaborative agreement that will enable Lilly to accelerate the development of its compounds targeted for the Japanese market and access additional selling capacity. Lilly and Chugai will establish a 50-50 joint venture company, the Chugai Lilly Clinical Research Co. Ltd., of Tokyo. This company will manage the development of selected Lilly targets for Japan. In exchange, Chugai will get certain co-promotion and co-marketing rights.
¿ Igen International Inc., of Gaithersburg, Md., reported that Maryland federal court has denied a motion by Roche Diagnostics, of Basel, Switzerland, to amend a preliminary injunction that precludes Roche from marketing its Elecsys products to physicians¿ office laboratories (POL). Igen said the ruling clears the way for Igen to take approximately 200 additional POL customers from Roche. Igen currently is taking over Roche¿s POL customers, which include 300 sites worldwide, and which represent a potential income of $10 million annually.
¿ Maxim Pharmaceuticals Inc., of San Diego, said the independent Data Safety Monitoring Board concluded there were no safety concerns with Maxamine, its anti-cancer drug now in Phase III trials for advanced-stage malignant melanoma and acute myelogenous leukemia. The board recommended the trials continue. They are expected to finish in early 2000.
¿ Pathogenesis Corp., of Seattle, was named in a lawsuit in the U.S. District Court for the Western District of Washington on behalf of common stock purchases of PathoGenesis Corp., from Jan 26, 1999 through March 22, 1999. The complaint charges that PathoGenesis and certain officers issues a series of materially false and misleading statements regard in the market for its principal product tobramycin solution for inhalation (TOBI). (See BioWorld Today, March 24, 1999, p. 1.)
¿ Researchers at the University of California Los Angeles (UCLA) began a Phase II study of SU5416, an angiogenesis inhibitor manufactured by Sugen Inc., of Redwood City, Calif. Previously untreated colon cancer patients will get infusions of SU5416 twice a week, in combination with the standard chemotherapy drugs 5-FU and leucovorin. Principal investigator Lee Rosen also led a 70-patient Phase I study, which ended in December. That study will be profiled on the television show ¿60 Minutes¿ on April 4.