¿ Alteon Inc., of Ramsey, N.J., said an academic team has released results of a preclinical study that demonstrated the ability of ALT-711 to decrease the thickening of the heart that may occur as a result of hypertension, and to improve the function of the endothelium. These results were presented at the American Heart Association¿s 55th Annual Fall Conference and Scientific Sessions of the Council for High Blood Pressure Research in Anaheim, Calif. The researchers tested ALT-711¿s ability to selectively break the cross-linking of collagen that contributes to cardiovascular disease in aging and diabetes.
¿ Bioenvision Inc., of New York, said the IRB has approved a Phase II trial of Modrastane in androgen-independent prostate cancer at Dana-Farber/Partners Cancer Care Inc., of Boston. Modrastane has marketing approval in the United Kingdom for advanced breast cancer. In clinical trials the drug gave response rates above 40 percent when used as second- or third-line treatment in post-menopausal women with hormone-sensitive breast cancer. Modrastane has been shown to modulate binding of hormone to the ¿second¿ estrogen receptor, ER(beta), and to have an allosteric inhibition of ER(alpha).
¿ Biomira Inc., of Edmonton, Alberta, said results from its Phase I study of BLP25 vaccine were published in the August 2001 edition of Clinical Lung Cancer. The article is titled ¿Phase I Study of the BLB25 Liposomal Vaccine for Active Specific Immunotherapy in Stage IIIbv-IV Non-Small-Cell Lung Cancer.¿ The trial involved 16 evaluable patients with NSCLC. The company is in a Phase II program with the vaccine.
¿ Celgene Corp., of Warren, N.J., presented preclinical data at the 5th World Congress on Inflammation in Edinburgh, Scotland. The data demonstrated that SPC 839, Celgene¿s small-molecule IkB kinase-2 inhibitor, potently regulates the expression of pro-inflammatory genes, including tumor necrosis factor alpha. These results indicate that SPC 839 may have therapeutic benefit in treating a variety of serious inflammatory diseases and cancer.
¿ CIMA Labs Inc., of Eden Prairie, Minn., said its board authorized an extension of the temporary stock repurchase program that expired at the close of the market on Friday. The plan was implemented Sept. 17 and allows for the purchase, from time to time, of up to $20 million of its issued and outstanding common stock.
¿ Cubist Pharmaceuticals Inc., of Lexington, Mass., released results expanding on data published in the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy Abstracts, a conference rescheduled for Dec. 16-19 in Chicago. In addition to achieving microbiologic endpoints, the additional data suggest trends in improved clinical response in certain difficult-to-treat patient populations when using Cidecin vs. current standards of therapy. The results represent additional data from Cubist¿s Phase III trial of Cidecin for complicated skin and soft-tissue infection caused by Gram-positive pathogens. (See BioWorld Today, March 15, 2001.)
¿ Discovery Partners International Inc., of San Diego, and The Genetics Co. Inc., of Zurich, Switzerland, signed a collaborative research agreement to identify drug leads for the treatment of colon cancer. The goal of the agreement is to test thousands of chemical substances in a high-throughput screen for their ability to block the activity of a critical protein and to inhibit uncontrolled cell division.
¿ Exelixis Plant Sciences, a Portland, Ore., subsidiary of Exelixis Inc., received a National Science Foundation award to develop technologies to identify novel genes in rice, with the aim of improving production. The SBIR award will fund work to identify the genes that make rice resistant to stress and disease. The research funds will support Exelixis in the application of its proprietary (ACTTAG) gene activation technology to the identification of targeted traits in rice.
¿ Forbes Medi-Tech Inc., of Vancouver, British Columbia, received approval to start a Phase I/II trial of its cholesterol-lowering pharmaceutical, FM-VP4, at Amsterdam Medical Center, University of Amsterdam. The drug reduced serum cholesterol in preclinical studies and may represent an alternative strategy in the management of dyslipidermia. Forbes plans to file an IND application with the FDA later this year.
¿ Genaera Corp., of Plymouth Meeting, Pa., said it was awarded up to $1.7 million from the Cystic Fibrosis Foundation to develop a new drug, Lomucin, that inhibits the excess production of mucus that clogs the small airways in chronic diseases like cystic fibrosis, asthma and COPD. The Therapeutics Development Program grant will support early clinical evaluation involving CF patients. Lomucin is based on the discovery by Genaera scientists of a gene, hCLCA1, that regulates abnormal mucus production. An IND in the United States is planned for August 2002.
¿ Generex Biotechnology Corp., of Toronto, presented data at the 37th annual meeting of the European Association for the Study of Diabetes in Glasgow, Scotland, suggesting that Oralin, Generex¿s oral insulin spray, may be a safe and effective replacement for injected insulin in the treatment of Type I and Type II diabetes patients. Oralin is delivered as a fine spray to the buccal cavity via Generex¿s RapidMist device, where the formulation is rapidly absorbed through the buccal mucosa and into the bloodstream. The presentation evaluated the 15-week efficacy of a low dose of oral insulin spray in patients failing on diet and exercise to improve post-prandial glucose profile and HbA1c. Generex¿s stock (NASDAQ:GNBT) gained 75 cents Monday, or 24 percent, to close at $3.83.
¿ Helicon Therapeutics Inc., of Farmingdale, N.Y., elected John Tallman president and CEO. Tallman, a Helicon director, was the founder and previously chief scientific officer of Neurogen Corp. Tallman succeeds George Carmany III. Helicon is a functional genomics company with technology in the area of memory formation.
¿ Heska Corp., of Fort Collins, Colo., said it received approval from the Canadian Food Inspection Agency to sell Flu Avert I.N., a vaccine against equine influenza, in Canada. Heska has granted Novartis Animal Health Canada Inc., of Mississauga, Ontario, exclusive distribution rights to market and sell the vaccine in Canada.
¿ Human Genome Sciences Inc., of Rockville, Md., said it completed enrollment in a Phase IIa trial evaluating repifermin (keratinocyte growth factor-2) as a systemically administered treatment for cancer therapy-induced mucositis. The double-blind, placebo-controlled study began in early 2000 and is being conducted in patients who undergo chemotherapeutic conditioning regimens for autologous hematopoietic stem cell transplantation. Repifermin is a novel human protein that stimulates proliferation, differentiation and migration of epithelial cells. Additional trials are evaluating repifermin as a treatment for venous ulcers and ulcerative colitis.
¿ Inflazyme Pharmaceuticals Ltd., of Richmond, British Columbia, said it received approval to begin two separate Phase I human clinical trials with two oral anti-inflammatory compounds: IPL550,260 and IPL512,602. These compounds are structurally diverse and have been derived from a new class of leukocyte-suppressing compounds. In preclinical studies, compounds in the class exhibited a general anti-inflammatory effect via inhibition of leukocyte accumulation at the inflammatory site. The Phase I studies are designed to study pharmacokinetics, safety and tolerability.
¿ MedImmune Inc., of Gaithersburg, Md., said data from its initial clinical studies with siplizumab (MEDI-507) as a potential treatment for psoriasis were presented at the European Society of Dermatological Research, held in Stockholm, Sweden, late last week. The presentation built upon preliminary data described in June, providing longer-term safety analysis for two trials using intravenous administration and new clinical data for a trial using subcutaneous administration. Overall in these studies, siplizumab was found to be generally well tolerated and to improve psoriatic disease, as measured by Psoriasis Area and Severity Index score, via both intravenous and subcutaneous administration.
¿ NeoTherapeutics Inc., of Irvine, Calif., said its NeoOncoRx oncology subsidiary will initiate two Phase II studies of Neotrofin in patients with chemotherapy-induced neuropathy during the fourth quarter. Both studies will include 50 patients for six months of treatment at the NYU Medical Center. One study will look at Neotrofin¿s ability to protect patients from chemotherapy-induced neuropathy, which limits the amount of anticancer drugs that can be given to some individuals, and the second will study the drug¿s efficacy in treating neuropathy resulting from chemotherapy.
¿ NetGenics Inc., of Cleveland, said it released the first version of its DiscoveryCenter software, which allows life science companies to integrate public and proprietary data. The software now integrates bioinformatics and cheminformatics data.
¿ Neurogen Corp., of Branford, Conn., said it began Phase I testing of the lead candidate from its C5a receptor antagonist program. The candidate, NGD 2000-1, is an orally active drug that blocks the activity of the C5a protein at its receptor. The C5a protein is believed to play a key role in inflammatory disorders, such as rheumatoid arthritis. Neurogen said it is the first company to discover and advance into human testing an orally active C5a receptor antagonist. In the ongoing Phase I study, Neurogen is assessing the safety and pharmacokinetic properties of escalating single doses of NGD 2000-1 in normal, healthy volunteers.
¿ Organogenesis Inc., of Canton, Mass., said it expects to begin commercializing three of its own products during the fourth quarter. These products will be marketed directly by Organogenesis using its own marketing personnel and targeted sales force. The company expects to begin selling its first two products, the FortaPerm bioengineered tissue support product and the FortaGen bioengineered tissue repair product, in mid-October. A cosmetic regenerative skin complex product is expected to be launched within a few months.
¿ Oxford GlycoSciences plc, of Abingdon, UK, said a clinical investigator presented results from clinical studies on OGT 918 in Type I Gaucher disease at the 13th Workshop of the European Study Group on Lysosomal Diseases, in Woudschoten, the Netherlands. Results showed progressive improvements at 24 months. Positive data also were seen in a six-month study. The company filed an NDA for the product in August. (See BioWorld Today, Aug. 22, 2001.)
¿ Pangene Corp., of Fremont, Calif., said it received a grant for innovative breast cancer treatments from the California Breast Cancer Research Program. The grant supports development of drugs inhibiting DNA repair proteins. Pangene discovered DNA repair proteins overexpressed in breast and many other tumors. Overexpression of DNA repair proteins in breast and other cancers causes resistance to radiation and DNA-damaging chemotherapy.
¿ Paradigm Genetics Inc., of Research Triangle Park, N.C., and Bayer AG, of Leverkusen, Germany, announced the discovery and validation of the 250th herbicide target in their commercial partnership. The most promising of these herbicide targets are converted into ultra-high-throughput chemical screening assays by Paradigm and used by Bayer to identify new herbicide products.
¿ Solexa Ltd., of Cambridge, UK, said it closed a US$17 million private equity financing round led by Schroeder Ventures Life Sciences, of London and Boston, which was joined by new investors Oxford Bioscience Partners Boston, Amadeus Capital Partners of London, and founding investor Abingworth Management, of London and Palo Alto, Calif. Solexa is developing technology that uses very dense arrays of single molecules for massively parallel sequencing.