¿ Antisoma plc, of London, said it licensed a version of a proven anticancer agent from the German Cancer Research Center, of Heidelberg, Germany. No financial terms were disclosed in the deal for thioplatin, a tumor-targeting version of a platin, a platinum-based solid tumor therapeutic.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., signed a broad collaborative agreement with Geneva Pharmaceuticals Inc., of Denver, to develop and manufacture prescription generic dermatology products over a 10-year period. Geneva will market the products developed by Atrix under a profit-sharing agreement. Geneva is a member of the Novartis AG group of companies.
¿ Celgene Corp., of Warren, N.J., said a research paper published in Blood (Vol. 96, No. 9) reports data that suggest Celgene's IMiDs, structural analogues of thalidomide, may be beneficial in the treatment of multiple myeloma. Data demonstrate the compounds have a dose-dependent effect on multiple myeloma cells, and show IMiDs are active against multiple myeloma cell lines that are resistant to other anti-myeloma agents.
¿ Cell Therapeutics Inc., of Seattle, received permission from the FDA to begin clinical studies of CT-2103, its anticancer therapeutic, in the U.S. The company plans to initiate Phase I and Phase II trials of the compound in lung, ovarian, breast and colon cancers later this year and in early 2001.
¿ Corixa Corp., of Seattle, said it presented additional data from its Phase III randomized trial of Melacine for the treatment of stage III melanoma, to the Southwest Oncology Group at the Society of Biological Therapy meeting in Seattle. Data from the 689-patient trial indicated a significant benefit in terms of disease-free survival in the total patient population. The company expects the data to support the filing of a biologics license application with the FDA in 2001. (See BioWorld Today, Sept. 28, 2000.)
¿ Enzo Biochem Inc., of Dallas, said researchers in Israel achieved complete suppression of hepatitis B-associated human liver cancer and significant reduction of mortality in mice in a preclinical animal study of the company's immune regulation product, EHT899. The compound is in a Phase II clinical study.
¿ Enzon Inc., of Piscataway, N.J., said that a Schering-Plough Corp., of Madison, N.J., pivotal Phase III test of PEG-Intron in combination with Rebetol showed the combination to be effective against hepatitis C viral infection, producing a 54 percent rate of sustained virologic response. Previous data showed PEG-Intron to be about twice as effective as Intron-A, Schering-Plough's non-pegylated version. (See BioWorld Today, May 2, 2000.)
¿ EpiGenesis Pharmaceuticals Inc., of Cranbury, N.J., said it began a randomized, double-blind Phase I study to assess tolerability and pharmacokinetics of inhaled EPI-2010 for asthma. EPI-2010 is a respirable antisense oligonucleotide that preclinical studies have shown may prevent the body's manufacture of certain disease-causing receptor proteins. In animal models, it was effective for nearly seven days and appeared to be broken down within the lung, causing no systemic toxicity.
¿ Genzyme Transgenics Corp., of Framingham, Mass., said a malaria vaccine protein under development using its technology has elicited protection against malaria in primates. The scientific paper detailing this study was presented Monday at the 49th Annual Meeting of the American Society of Tropical Medicine and Hygiene in Houston. Genzyme Transgenics produced a version of the Merozoite Surface Protein 1 that successfully protected Aotus nancymai monkeys in a preclinical vaccine study conducted by the National Institute of Allergy and Infectious Diseases.
¿ Inkine Pharmaceuticals Co. Inc., of Blue Bell, Pa., released the proposed trade name for CBP-1011. Based on a nationwide survey conducted with leading gastroenterologists and hematologists, Colirest was selected as the trade name for CBP-1011 for inflammatory bowel disease and Hematrol was selected as the trade name for idiopathic thrombocytopenic purpura. Both names will be subject to future regulatory acceptance.
¿ Inspire Pharmaceuticals Inc., of Durham, N.C., reported positive results from studies in rabbits of gel formulations of two P2Y2 receptor agonists on vaginal mucosal health. The trials indicated the compound produced a significant increase in vaginal lubrication and maturation indices compared to placebo. Another study, this one mapping primate female reproductive tract receptors, confirmed the presence of P2Y2 receptor gene expression on the vaginal and endocervical mucosal surfaces.
¿ Nastech Pharmaceutical Co. Inc., of Hauppauge, N.Y., said it is beginning patient accrual for a Phase II trial of Apomorphine HCl intranasal formulation for the treatment of male erectile dysfunction. It presented intranasal apomorphine data for male and female sexual dysfunction at the Female Sexual Function Forum over the weekend in Boston. In a previous pilot Phase II study, 82 percent of men reported "satisfactory erections" after a .50 mg dose of Nastech's Apomorphine. Only 47 percent reported the same results after taking Viagra and 33 percent after taking a nasal placebo. Also, Nastech said its formulation achieved a faster onset of therapeutic effect while attaining a lower incidence of adverse events than Viagra.
¿ Karo Bio AB, of Stockholm, Sweden, extended its drug discovery collaboration with Merck & Co. Inc., of Whitehouse Station, N.J., for two years. The collaboration, begun in October 1997, focuses on novel therapeutics for diseases targeting estrogen receptors alpha and beta.
¿ Maxygen Inc., of Redwood City, Calif., and SIGA Technologies Inc., of New York, signed a research collaboration to develop novel vaccines, combining SIGA's patented vaccine delivery system with Maxygen's proprietary antigens for generating an immune response. Terms were not disclosed.
¿ National Institutes of Health researchers found a gene in female mice essential for egg development beyond the two-cell stage after fertilization. The research promises to offer insight into unexplained infertility in women and into the ways an organism progresses into a complex organism. The findings were published in the November issue of Nature Genetics. In separate news, the NIH said researchers described in the November issue of Nature Structural Biology the 3-D structure of a protein used by paramyxoviruses to latch onto, penetrate and exit cells of the respiratory tract. The NIH said the research reveals clues for effective new drugs and shows the benefits of structural biology in guiding drug design.
¿ Novuspharma Inc., of Milan, Italy, is seeking EUR216 million (US$181.6 million) in its initial public offering. The 2.5-million-share offering is expected to price on Nov. 2. Novuspharma spun off from Hoffmann-La Roche Inc., of Nutley, N.J., following Roche's acquisition of Boehringer Mannheim GmbH, of Mannheim, Germany.
¿ Select Therapeutics Inc., of Cambridge, Mass., said its Canadian subsidiary submitted an investigational new drug submission to conduct clinical trials of its verotoxin formulation, VeroPulse, for the ex-vivo purging of tumor cells from autologous stem cells in patients with multiple myeloma to the Therapeutics Products Program of Health Canada. STI said the compound has shown significant ability to reduce levels of tumor cells containing autologous stem cells in multiple myeloma.
¿ SignalGene Inc., of Montreal, entered an agreement with Allied Clinical Research Inc., of Missisauga, Ontario, to provide genotyping services under its Clinical Pharmacogenomics Services offering. SignalGene will apply its pharmacogenomics platform for the genotyping of drug-metabolizing enzymes on samples collected by the contract research organization.
¿ Triangle Pharmaceuticals Inc., of Durham, N.C., said patients in a Phase I/II dose-escalating trial of its anti-hepatitis B virus drug, Coviracil, exhibited significant antiviral response at all doses. The 24-week, double-blind, randomized trial included 98 patients with chronic hepatitis B. Median reductions in viral load from baseline of 2.3 log10, 2.9 log10, and 3 log10 were observed for 25 mg, 100 mg and 200 mg, respectively, and hepatitis B DNA was less than 4,700 copies/ml in 61 percent, 24 percent and 22 percent of patients who received 200 mg, 100 mg and 25 mg, respectively.
¿ XTL Biopharmaceuticals Ltd., of Rehovot, Israel, called data from a Phase I trial of HBV-ABsXTL (XTL-001) in chronic hepatitis B virus-infected patients promising. XTL-001 is a combination of two high-affinity human monoclonal antibodies. The company said the compounds showed an ability to bind to hepatitis B particles and reduce serum viral titers and HbsAg levels in vivo in a safe and tolerable way.