¿ AEterna Laboratories Inc., of Quebec City, Quebec, said patient recruiting for the pivotal Phase II trial on progressive multiple myeloma continues in about 35 investigative centers in Canada, the United States and Europe. The study aims to evaluate the efficacy of its product, Neovastat, as a monotherapy treatment in about 120 patients who do not respond to standard therapies. Results are expected by the end of 2002.
¿ Avanir Pharmaceuticals Inc., of San Diego, said its subsidiary, Xenerex Biosciences, entered an antibody agreement with Eos Biotechnology Inc., of South San Francisco, for Xenerex to generate fully human monoclonal antibodies to three cancer-target antigens provided by Eos. Eos will evaluate the antibodies for potential development of therapeutic treatments for the selected cancers. Xenerex will receive research fees for the use of its monoclonal antibody technology and could receive license fees and milestones, plus royalty payments on sales. Eos will be responsible for manufacturing, product development and marketing of any products. Financial terms were not disclosed.
¿ Biopure Corp., of Cambridge, Mass., announced preliminary efficacy results from a pivotal Phase III trial showing Hemopure eliminated the need for red blood cell transfusion in patients undergoing elective orthopedic surgery. Approximately 95 percent of patients receiving Hemopure avoided red blood cell transfusion for at least 24 hours and more than 60 percent avoided blood throughout the six-week study period. Biopure is preparing to file an electric biologics license application in the United States in 2001, followed by an application in Europe in 2002, for perioperative use of Hemopure.
¿ Celgene Corp., of Warren, N.J., said investigators from the Arkansas Cancer Research Center and the Dana-Farber Cancer Institute presented preliminary results from the company¿s Phase I/II tests of Revimid, its lead immunomodulatory drug for treatment of multiple myeloma. Celgene said that more than 60 percent of the late-stage patients treated were responding or had their disease stabilized by Revimid therapy.
¿ CuraGen Corp., of New Haven, Conn., said its scientists discovered a new member of the platelet-derived growth factor family named PDGF-D. The protein occurs naturally in the human body and may have application as a therapeutic because of its cellular activity and biochemical properties. CuraGen scientists are evaluating fully human monoclonal antibodies for inhibiting the function of this protein as a potential therapeutic to treat cancer and cardiovascular and kidney diseases. The protein¿s activity is discussed in the May 1, 2001, issue of Nature Cell Biology.
¿ CV Therapeutics Inc., of Palo Alto, Calif., said at the Deutsche Banc Alex. Brown 2001 Health Care Conference in Baltimore that its Phase I trial of CVT-3146 supports initiation of Phase II trials. The Phase I trial met the primary objective of providing data on safety and tolerability over a range of doses. The product is a selective short-acting coronary vasodilator and is being jointly developed with Fujisawa Healthcare Inc., of Deerfield, Ill.
¿ Deltagen Inc., of Menlo Park, Calif., and Vertex Pharmaceuticals Inc., of Cambridge, Mass., entered a collaboration to provide Vertex with access to Deltagen¿s proprietary DeltaBase product. Vertex will have nonexclusive access to a subset of DeltaBase that contains in vivo mammalian gene function information in kinases, proteases and other gene families selected by both companies. Vertex also will have access to corresponding DeltaBase intellectual property rights to develop and commercialize products. In exchange, Deltagen will receive certain milestone and royalty payments. The initial term is three years, with a two-year extension option. Financial terms were not disclosed.
¿ Demegen Inc., of Pittsburgh, said an article on a study suggesting its candidate, P113, may prevent and treat Candida-based fungal infections was published in the May 2001 issue of Antimicrobial Agents and Chemotherapy. P113 has a favorable spectrum of activity against pathogens responsible for oral candiasis and no adverse effects have been reported in trials of a mouth rinse formulation in more than 400 patients.
¿ Emisphere Technologies Inc., of Tarrytown, N.Y., completed the dosing phase of a Phase I trial to evaluate oral heparin tablets using its proprietary delivery agent SNAD (sodium N-[10(-2 hydroxybenzoyl)amino] decanoate). The formulation was well tolerated and no serious side effects were reported.
¿ Eukarion Inc., of Bedford, Mass., published preclinical results using its synthetic catalytic scavenger compounds in a mouse model of amyotrophic lateral sclerosis. The data were published in the May 2001 issue of Neuroscience Letters. The compounds are aimed at preventing oxidative stress, a cellular process that contributes to many degenerative and disease states.
¿ Gene Logic Inc., of Gaithersburg, Md., said AstraZeneca plc, of London, subscribed to the GeneExpress Suite of databases, including the BioExpress Module and ToxExpress Module, for use in AstraZeneca¿s drug discovery and development programs. Financial terms were not disclosed.
¿ ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said that Schering-Plough Corp., of Madison, N.J., said its Japanese subsidiary, Schering-Plough K.K., submitted a new drug application to the Ministry of Health, Labor and Welfare seeking marketing approval for Rebetol Capsules for use in combination with interferon alfa-2b injection (Intron A) for the treatment of chronic hepatitis C. Rebetol is an oral formulation of ribavirin, discovered and developed by scientists at ICN as a synthetic nucleoside analogue with antiviral activity.
¿ IDEC Pharmaceuticals Corp., of San Diego, received a complete review letter from the FDA regarding the biologics license application for Zevalin. The company will provide an overview of the letter in a webcast conference call on Thursday.
¿ ImmunoGen Inc., of Cambridge, Mass., began enrollment for a third Phase I/II clinical trial of huC242-DM1/SB-408075, its lead Tumor-Activated Prodrug for the treatment of colorectal, pancreatic and certain non-small-cell lung cancers. The study is designed to evaluate the product in a more dose-intensive regimen.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., said Agouron Pharmaceuticals Inc., of La Jolla, Calif., agreed to pay Isis¿ division, Ibis Therapeutics, a $2.5 million research milestone. The payment is related to the identification of novel RNA targets and the screening of small molecules for the discovery and development of new drugs as part of their collaboration.
¿ Layton BioScience Inc., of Sunnyvale, Calif., said clinical-grade human neuronal cells will be the subject of a second phase of research into the safety and efficacy of implanting human neuronal cells into the brains of stroke patients by the Stanford University Medical Center and the University of Pittsburgh. The Phase IIb trial will test the implant procedure in 18 patients who have suffered basal ganglia strokes within the past six years.
¿ Lynx Therapeutics Inc., of Hayward, Calif., and AniGenics Inc., of Chicago, will use Lynx¿s Megasort and Megatype technologies to identify genes associated with commercially valuable traits in certain food animal species. The collaboration will seek to create gene expression profiles and identify single nucleotide polymorphisms markers that could impact marker-assisted breeding and result in potentially reduced production costs or enhanced product differentiation in the supermarket. Lynx will receive payments for performing genomics discovery services and royalties on sales of products and services from AniGenics. Also, Lynx retains rights to human health care applications of any discoveries and will pay royalties to AniGenics on any related products or services. Further financial specifics were not disclosed.
¿ NeoGenesis Inc., of Cambridge, Mass., and Microcide Pharmaceuticals Inc., of Mountain View, Calif., entered a collaborative research and development agreement to discover and develop new classes of antibiotics. The agreement will use a specified number of proprietary bacterial in vivo essential gene targets from Microcide¿s Valid microbial genomics platform, together with NeoGenesis¿ ALIS screening system and its mass-coded NeoMorph small-molecule libraries. Microcide will have worldwide product development and commercialization rights on products that result from the collaboration. Financial terms were not disclosed.
¿ Northwest Biotherapeutics Inc., of Bothell, Wash., presented data from its Phase I/II trial of DCVax-Prostate, its dendritic cell-based immunotherapy for late-stage prostate cancer patients. Company officials said data appear to substantiate the company¿s assertion that immune tolerance in elderly patients with advanced prostate cancer can be overcome safely with DCVax.
¿ Oncologic Inc., of Richmond, Calif., said it successfully achieved specific localization and retention of its proprietary SPR compounds inside targeted cancer cells. The localization, the company said, is the first step in its process for treatment of solid tumors.
¿ Peregrine Pharmaceuticals Inc., of Tustin, Calif., opened a Phase I trial at Stanford University to evaluate the use of Cotara in patients with biliary system and pancreatic cancers. Another trial just opened at Stanford will evaluate the use of Cotara for treatment of soft-tissue sarcomas. A third Phase I trial will evaluate the use of Cotara in combination with radiofrequency ablation as a treatment for liver tumors. Cotara is in a Phase II trial for brain cancer, and Peregrine said it expects to begin a Phase II trial in brain cancer later this year.
¿ Silicon Genetics Inc., of Redwood City, Calif., said PerkinElmer Life Sciences Inc., of Boston, licensed SGI¿s GeNet web-enabled data repository. PerkinElmer plans to use GeNet in its Micromax microarray screening business. Financial details were unavailable.
¿ Strakan Group Ltd., of Galashiels, Scotland, came to terms with three institutional investors for a #30.5 million (US$43.5 million) financing. LMS Capital and 3I, both of London, and Warburg Pincus & Co. LLC, of New York, participated in the round. Strakan focuses on treatments for bone and skin diseases.