Abgenix Inc., of Fremont, Calif., and Impath Inc., of New York, agreed to focus on the development and commercialization of antibody therapies for a variety of diseases. The Impath Predictive Oncology (IPO) division will expedite screening of potential therapeutic targets and Abgenix's XenoMouse-generated, fully human monoclonal antibody product candidates in the field of oncology using Impath's OptimArray technology platform. IPO also will evaluate target expression in tissue arrays containing normal tissues and malignant specimens enabling Abgenix to identify potential diagnostic and therapeutic products. Financial terms were not disclosed.
Applied Genetics Inc. Dermatics, of Freeport, N.Y., said previously released positive results concerning its topically applied T4N5 Liposome Lotion, Dimericine, were published in the March 24, 2001, issue of The Lancet. The lotion uses liposomes to deliver DNA repair enzymes into the cells of the skin to reverse DNA damaged by sunlight.
Atrix Laboratories Inc., of Fort Collins, Colo., closed enrollment for its Phase III four-month Leuprogel 30 mg leuprolide acetate for subcutaneous depot for injection study for the treatment of advanced prostate cancer. Sustained levels of leuprolide, a luteinizing hormone-releasing hormone agonist, decrease testosterone to suppress tumor growth in patients with hormone-responsive prostate cancer.
AVAX Technologies Inc., of Kansas City, Mo., said it received oral communication from the FDA that clinical activities for both the company's M-Vax and O-Vax autologous cancer vaccines have been placed on clinical hold pending further review by the agency. It said the inquiry does not appear to involve its handling of tumor cells, the preparation of vaccines, or its manufacturing practices, but appears to be the result of evolving agency requirements for cell-derived products as these products progress toward licensure. David Tousley, chief operating officer at AVAX, said in a press release, "While we are disappointed that the FDA has taken this unexpected action, we believe that this development has no long-term impact on the company's future prospects." AVAX's stock (NASDAQ:AVXT) was put on hold Friday afternoon at $1.312, which was up 3.12 cents before the hold.
AVI BioPharma Inc., of Portland, Ore., said one of its gene-targeted therapies has shown potency as an anticancer agent in preclinical mouse research. The company was scheduled to present research findings on the potential therapy at the American Association of Cancer Research annual meeting March 24-26 in New Orleans.
Columbia Laboratories Inc., of New York, named Fred Wilkinson CEO, president and a member of the board. Wilkinson served in various positions at Watson Pharmaceuticals Inc., of Corona, Calif., from 1996 until this appointment.
Enzon Inc., of Piscataway, N.J., said Schering-Plough Corp., of Madison, Wisc., was notified verbally by the FDA that priority review status has been assigned to Schering's supplemental biologics license application seeking marketing approval for Peg-Intron powder for injection for use in combination therapy with Rebetol Capsules. Peg-Intron is for treatment of chronic hepatitis C in patients not previously treated with interferon alpha who have compensated liver disease and are at least 18 years of age. Peg-Intron is a longer-acting form of Schering's Intron A that uses PEG technology developed by Enzon.
Exelixis Inc., of South San Francisco, delivered several novel insecticide targets for assay development and high-throughput screening to Bayer AG, of Leverkusen, Germany, for its joint venture with Bayer's crop protection business group, Genoptera LLC. The delivery of the genes triggered undisclosed milestone payments to Exelixis. The joint venture is a continuation and expansion of the collaboration between the companies struck in 1998 and extended in 1999. (See BioWorld Today, Jan. 12, 2000.)
Human Genome Sciences Inc., of Rockville, Md., began a Phase I trial with Albuferon in patients infected with hepatitis C. The study will enroll approximately 40 patients and will be an open-label trial conducted at multiple centers. Albuferon is created by fusing interferon alpha to albumin.
Medicure Inc., of Winnipeg, Manitoba, said studies reconfirmed its lead compound, MC-1, can reduce scar formation and mortality and improve heart function in a recognized heart attack model after delayed administration. MC-1 was able to reduce scar size when administered up to eight hours after occurrence of the coronary blockage. MC-1 is in a Phase I study.
Novartis Ophthalmics, the eye health unit of Novartis AG, of Basel, Switzerland, and QLT Inc., of Vancouver, British Columbia, said the European Commission granted marketing authorization for Visudyne for the treatment of subfoveal choroidal neovascularization secondary to pathologic myopia. Visudyne is approved for the treatment of predominantly classic subfoveal caused by age-related macular degeneration.
Phase-1 Molecular Toxicology Inc., of Santa Fe, N.M., named Vincent Kazmer as CEO. Kazmer was executive vice president and chief financial officer of NetGenics Inc., of Cleveland.
RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., is now listed on the OTC Bulletin Board, moving from its listing on the Pink Sheets.
SafeScience Inc., of Boston, said its cancer drug, GBC-590, demonstrated positive clinical activity in colorectal cancer patients in a Phase IIa trial, and that it plans to conduct an expanded Phase IIb trial. Five of 23 patients in the Phase IIa trial showed tumor stabilization for periods from two to six months before disease state progression was observed, with one patient showing a period of tumor shrinkage.
SuperGen Inc., of Dublin, Calif., said its board authorized an additional stock repurchase program of 1 million shares of its common stock. On Sept. 28, the board also authorized the repurchase of 1 million shares.
Variagenics Inc., of Cambridge, Mass., said it developed a high-throughput computational method for analyzing the functional consequences of certain single nucleotide polymorphisms that can predict which of the subset of SNPs that encode amino acid substitutions are most likely to affect the function or stability of a target protein. The study detailing the method was published in the March 23, 2001, issue of Journal of Molecular Biology.