¿ Abgenix Inc., of Fremont, Calif., said an investigational new drug application was filed with the FDA by Pfizer Inc., of New York, for a fully human monoclonal product candidate for the treatment of cancer. The candidate was generated by Abgenix's XenoMouse technology, and this milestone triggers an undisclosed payment to Abgenix. The collaboration, dating to December 1997, has been expanded over the years and now includes up to five antibody candidates named by Pfizer.
¿ American Biogenetic Sciences Inc., of Copiague, N.Y., said an article published in Circulation found that the blood-clotting protein fibrinogen seems to be a common pathway by which other risk factors cause heart disease. The study used the company's FDA-approved functional intact fibrinogen test in 2,632 patients in the Framingham Offspring Study, a continuation of the same study begun more than 50 years ago.
¿ Array BioPharma Inc., of Boulder Colo., signed a multiyear agreement to provide Immunex Corp., of Seattle, access to small-molecule libraries for screening against Immunex's high-throughput assays. Immunex will gain non-exclusive access to Array's libraries while Array retains an exclusive option to enter into a lead-optimization agreement with Immunex to develop leads generated. Financial terms were not disclosed.
¿ Aurora Biosciences Corp., of San Diego, and Ceres Inc., of Los Angeles, signed a license agreement for Aurora's green fluorescent protein technology for Ceres to use in in vitro and in vivo research and development activities and to provide selected services to third parties. The agreement includes an up-front technology access fee, annual license fees and royalties on services provided to third parties. Aurora also has an option to acquire equity in Ceres.
¿ Avanir Pharmaceuticals Inc., of San Diego, filed a new drug submission with the Canadian Therapeutic Products Programme for docosanol 10% cream for the treatment of cold sores. Avanir has requested the product be accorded non-prescription status. Docosanol 10% cream, which will be sold in the U.S. consumer market as Abreva, was approved by the FDA as an OTC product in July.
¿ Axys Pharmaceuticals Inc., of South San Francisco, achieved a milestone in its collaboration with Aventis on Cathespin S, an enzyme believed to play a role in asthma. Cathespin S is a member of a family of cysteine proteases, enzymes that are responsible for the cleavage and breakdown of other natural proteins in normal biological processes. Axys demonstrated in vivo efficacy of a compound synthesized by Axys in a model of asthma. The company believes Aventis will formally nominate a clinical development candidate for the treatment of asthma upon the successful completion of these activities.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, completed a private placement of 1.5 million shares of common stock, raising $11.6 million. Cellegy self-managed the financing, with participants being Baker/Tisch Investments in New York, Capital Research & Management in San Francisco, and Framlington in the UK. Capital Research and Framlington are new investors. Cellegy has two drug candidates, Anogesic and Testrex, undergoing Phase III clinical trials and will look to file new drug approval applications for them in 2001 if the trials are completed successfully.
¿ CEL-SCI Corp., of Vienna, Va., received an approval for funding of a Phase II Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases to further develop a proprietary herpes simplex vaccine. This grant was awarded following the successful completion of a Phase I grant. The Phase II grant, worth about $764,000 over two years, will support the development of an HSV vaccine based on CEL-SCI's L.E.A.P.S. technology.
¿ Ciphergen Biosystems Inc., of Fremont, Calif., said the underwriters have exercised in full their overallotment option in connection with its initial public offering, purchasing 825,000 shares of common stock at the initial offering price of $16. This brings the total shares offered to about 6.33 million, raising $101.2 million for the company before underwriting discounts, commissions and other offering expenses. (See BioWorld Today, Oct. 2, 2000, p. 1.)
¿ Connetics Corp., of Palo Alto, Calif., entered into an agreement with Alza Corp., of Mountain View, Calif., to develop an advanced drug delivery system for Connetics' proprietary recombinant human relaxin drug candidate. The development will focus on applying Alza's implantable delivery technology, the DUROS system, to expand delivery options for relaxin. Relaxin is a naturally occurring hormone with a broad spectrum of biological activities including the inhibition of fibrosis and the promotion of vasodilation and angiogenesis.
¿ Coulter Pharmaceuticals Inc., of South San Francisco, entered a collaboration with Cobra Therapeutics Ltd., of Keele, UK, to develop and commercialize Cobra's platform gene expression technology, Ubiquitous Chromatin Opening Elements. The technology is a new class of gene expression elements that induce productivity from genes introduced into target cells. Coulter will pay Cobra an up-front payment of #1 million (US$1.46 million) and event-based milestones and sublicense fees.
¿ Cubist Pharmaceuticals Inc., of Cambridge, Mass., achieved a milestone in its ongoing, three-year collaboration with Novartis Pharma AG, of Basel, Switzerland. Cubist will receive a payment of $500,000 for the delivery of a validated target and a high-throughput screening assay for anti-infective drug discovery.
¿ Direct Therapeutics Inc., of Redwood City, Calif., opened enrollment for two Phase I/II clinical trials using its DTI-015 drug candidate for the direct treatment of glioblastoma multiforme, the most common form of brain cancer. DTI-015 contains the chemotherapeutic drug carmustine, also know as BCNU, dissolved in absolute ethanol.
¿ Endovasc Ltd. Inc., of Montgomery, Texas, submitted an investigational new drug application to the FDA for Liprostin, its liposomal encapsulated prostaglandin E-1. Liprostin will be tested in patients who have lost circulation in their lower limbs and are in critical danger of requiring amputation.
¿ Genometrix Inc., of The Woodlands, Texas, signed an agreement with Schering-Plough Research Institute, of Madison, N.J., allowing SPRI to access the GenoVista Partnership Program, making available Genometrix's high-throughput sample analysis services using customized VistaArray microarrays for genotyping and gene expression applications and the VistaLogic Information System. SPRI will use the program for research, discovery and clinical trial applications.
¿ Genzyme Molecular Oncology Inc., of Framingham, Mass., initiated two Phase I/II clinical trials, one in melanoma and one in kidney cancer. Both trials will utilize a novel technology called dendritic/cancer cell fusion, technology that combines a patient's dendritic cells with his inactivated tumor cells in a chemical fusion procedure. The fused cells are injected back into the patient in order to stimulate an immune response against the patient's cancer. Genzyme has licensed the technology from the Dana-Farber Cancer Institute and is providing funding through the Dana-Farber/Partners CancerCare.
¿ Incyte Genomics Inc., of Palo Alto, Calif., licensed U.S. Patent numbers 5,716,785 and 5,891,636, and related patents, to American Home Products Corp., of Madison, N.J., for internal use in creating gene expression data with Affymetrix GeneChips arrays. Financial terms were not disclosed.
¿ Inspire Pharmaceuticals Inc., of Durham, N.C., filed an investigational new drug application with the FDA for INS37217 Respiratory for the treatment of cystic fibrosis. Inspire is developing the product with Genentech Inc., of South San Francisco, as part of a collaboration to develop P2Y(2) agonists including INS365, which is currently in Phase I/II evaluation for chronic bronchitis. INS37217 Respiratory is designed to enhance the lung's innate mucosal hydration and mucociliary clearance mechanisms.
¿ InterMune Pharmaceuticals Inc., of Burlingame, Calif., started a Phase III clinical trial to evaluate the safety and efficacy of Actimmune Injection for the treatment of idiopathic pulmonary fibrosis. The company has similar trials planned for ovarian cancer, cystic fibrosis and non-tuberculosis mycobacterial infections. Actimmune is currently marketed in the United States for the treatment of chronic granulomatous disease and severe, malignant osteopetrosis.
¿ Ligocyte Pharmaceuticals Inc., of Bozeman, Mont., received the Tibbetts Award for being a model of excellence for the Small Business Innovation Research program. Ligocyte was awarded a $3.3 million SBIR grant last year to develop an asthma therapy based on its nanoparticle technology.
¿ Myogen Inc., of Denver, received a Small Business Innovation Research grant from the National Institutes of Health. Myogen will use the grant to develop compounds that inhibit a key control pathway associated with cardiac hypertrophy.
¿ Nabi, of Boca Raton, Fla., received funding from the National Institute of Drug Abuse to support preclinical and clinical development of Nabi NicVAX, its experimental vaccine against nicotine dependence. The funding is available immediately and is approximately $850,000 for year one, then recommended at $815,000 for year two, about $1 million for year three and roughly $1.2 million for year four.
¿ Neurogenetics Inc., of San Diego, said a study published in the September issue of Neuron links a new mechanism-based therapeutic approach, licensed by Neurogenetics from Massachusetts General Hospital, to Alzheimer's disease. The paper reports the discovery of a key link between two cellular abnormalities associated with the disease - mutations in genes encoding presenilin proteins and an altered handling of calcium inside cells.
¿ Orphan Medical Inc., of Minneapolis, submitted a new drug application for Xyrem (sodium oxybate) oral solution as a treatment for the symptoms of narcolepsy. Xyrem is intended to treat cataplexy and to improve the symptoms of excessive daytime sleepiness.
¿ Pain Therapeutics Inc., of South San Francisco, said results from a safety and efficacy Phase II dose-ranging study evaluating its new drug for pain, PTI-701, were positive. The study was conducted in 300 patients experiencing moderate to severe pain following oral surgery. The patients had less pain than those receiving placebo and those receiving hydrocodone/acetaminophen.
¿ Proteome Inc., of Beverly, Mass., expanded its subscription agreement with Janssen Research Foundation (JRF) and The R.W. Johnson Pharmaceutical Research Institute (PRI), members of the Johnson & Johnson family of companies. It includes access to Proteome's databases for human genome research, the Human Proteome Survey Database and the G Protein-Coupled Receptor Proteome Database. Under the expanded agreement, JRF and PRI will continue to access Proteome's model organism databases and are the first to obtain access to the full BioKnowledge library.
¿ Rosetta Inpharmatics Inc., of Kirkland, Wash., released the Rosetta Resolver Expression Data Analysis System, Version 1.6. Enhancements to the system include the addition of several new clustering algorithms and the disclosure of elements of the system's Application Program Interface.
¿ SignalGene Inc., of Montreal, signed a service agreement with CroMedica Prime Inc., of Vancouver, British Columbia, for the provision of genotyping services in which SignalGene will use its pharmacogenomics platform for the genotyping of drug-metabolizing enzymes on samples collected by CroMedica Prime from participants in its clinical trials. CroMedica Prime is a Phase I clinic at Vancouver Hospital and Health Service Centre.
¿ StressGen Biotechnologies Corp., of New York, said Phase II data confirm activity of HspE7, a novel immunotherapeutic, in the treatment of human papillomavirus-related anal dysplasia. Data indicate that HspE7 converts 75 percent of patients from high-grade to low-grade anal dysplasia at six months, potentially eliminating the need for surgery. HspE7 is a recombinant fusion protein composed of heat shock protein 65 from Mycobacterium-bovis BCG and the protein E7 from HPV type 16.
¿ Theratechnologies Inc., of Saint Laurent, Quebec, received a C$10 million (US$6.65 million) institutional investment, allowing it to accelerate the development of the technologies created by Pharma-G, an emerging proteomics company that it recently acquired. Theratechnologies will issue 666,667 shares of common stock at $15 each to the financial institutions investing.
¿ Valentis Inc., of Burlingame, Calif., said results from a Phase I/IIa clinical trial for advanced melanoma were positive and concluded that treatment with interleukin-2 plus Superantigen-B combination gene medicine appears safe. The study is being conducted under a physician-sponsored investigational new drug application submitted to the FDA in April 1998 and examines the safety and efficacy of the two-gene combination in Valentis' proprietary lipid-based formulation that was directly injected into tumors.
¿ Variagenics Inc., of Cambridge, Mass., achieved its second milestone with Covance Inc., of Princeton, N.J., by delivering 16 validated genotyping assays to be incorporated into Covance's clinical trial designs for its pharmaceutical customers. The company said Covance has increased its funding commitment to develop genotyping assays and has dedicated additional personnel to oversee the promotion of its pharmacogenomics services.