¿ Aerogen Inc., of Sunnyvale, Calif., presented the results of its second Phase II insulin study using the Aerodose insulin inhaler, at the CIBC World Markets 12th Annual Health Care Conference in New York. The results revealed a linear dose-response relationship for both drug absorption and metabolic effect following both inhalation and subcutaneous administration of insulin. Twenty-four Type II diabetes patients each received two of three dosage levels of 8, 16 or 24 units of subcutaneously injected insulin and corresponding doses of inhaled insulin.
¿ Agouron Pharmaceuticals Inc., of La Jolla, Calif., reported data on the long-term extension (LTE) phase of its pivotal study 511, examining immunologic reconstitution, efficacy and safety of Viracept (nelfinavir myselate) in combination with AZT and 3TC in HIV patients. Of those patients who were virologically suppressed in the pivotal trial, the majority maintained antiretroviral activity and achieved substantial replenishment of CD4 lymphocytes during four years of therapy. LTE patients had a mean CD4 cell count of 310 cells/uL and a mean of 204,000 copies/mL of plasma HIV RNA. Results were presented at the European Conference on Clinical Aspects and Treatment of HIV Infection in Athens, Greece.
¿ Alexion Pharmaceuticals Inc., of Cheshire, Conn., acquired worldwide commercial rights from the University Medical Center of Nijmegen, the Netherlands, related to newly discovered cell surface proteins, DC-SIGN, found exclusively on human dendritic cells and a related receptor, L-SIGN. Alexion received rights related to these molecules and any associated therapeutic product candidates, including already identified monoclonal antibodies. Products are expected to have applications in autoimmune diseases, inflammation, cancer, transplantation and infectious diseases.
¿ Amphora Discovery Corp., of Research Triangle Park, N.C., said it is leasing 25,000 square feet in the Alexandria Technology Center in Research Triangle Park for its corporate headquarters. Amphora plans to hire as many as 100 employees over the next 18 months, chiefly in the areas of biological sciences, engineering and information technology.
¿ Applied Gene Technologies Inc., of San Diego, signed a manufacturing and marketing agreement with AsiaGen, of Tainan, Taiwan, to combat the tuberculosis pandemic in China, India and the Pacific Rim. Applied Gene Technologies will receive an up-front payment for the development of tuberculosis diagnostics using its Tessera Array Technology. In return, Applied Gene Technologies will grant exclusive rights to market and manufacture the product in Asia.
¿ BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reported positive results of preclinical testing of its Bio-Air calcium phosphate nanoparticulate delivery system for improved effectiveness of insulin administered by injection or inhalation. The trial in diabetic mice examined delivery proteins subcutaneously and into the lungs. Subcutaneously, Bio-Air extended the hypoglycemic effect of insulin from four to five hours to 10 to 15 hours compared to insulin alone. When administered into the lungs, Bio-Air with insulin reduced blood glucose levels by 60 percent, vs. 30 percent in mice administered the same amount without Bio-Air. The results were presented at the Diabetes Technology Meeting in San Francisco.
¿ CIMA Labs Inc., of Minneapolis, said it began repurchasing its common stock on the open market under an existing plan whereby the company can buy back up to $20 million of its shares.
¿ Connetics Corp., of Palo Alto, Calif., said results from its Phase IV trial of OLUX for the treatment of corticosteroid-responsive dermatoses demonstrated statistically significant improvement over placebo for the treatment of mild-to-moderate body psoriasis. The 279-patient, placebo-controlled, randomized, double-blind, Phase IV study was conducted at 17 clinical centers. Based on preliminary data, the trial demonstrated that patients treated with OLUX, administered twice daily for 14 days, experienced a statistically significant improvement (p <0.0001). The trial showed that 67 percent of treated patients had complete or almost complete clearance of disease compared with 21 percent of placebo patients.
¿ Dragon Pharmaceuticals Inc., of Vancouver, British Columbia, said the Drug Controller General of India issued regulatory clearance for the import and sale of Dragon¿s recombinant erythropoietin in India. Dragon also said it entered a marketing and licensing agreement with Emcure Pharmaceuticals Ltd., of Pune, India, for the distribution of the drug in India and throughout the South Asian subcontinent, as well as in markets in sub-Saharan Africa.
¿ ExonHit Therapeutics, of Paris, entered into its first U.S. collaboration, with Allergan Inc., of Irvine, Calif. Allergan will access ExonHit¿s Signal-Hit technology to identify new molecular targets for its drug discovery program. They will collaborate on the study of tissue obtained from Allergan¿s disease model system following treatment with drug candidates. Allergan will have the option to take a commercial license for therapeutic and diagnostic rights to selected clones. ExonHit will retain intellectual property rights to non-purchased clones. Allergan will provide ExonHit with technology access fees; if Allergan exercises its options, Allergan also will make milestone and royalty payments.
¿ Genta Inc., of Berkeley Heights, N.J., began a randomized trial with its lead antisense compound, Genasense, for the treatment of patients with non-small-cell lung cancer (NSCLC). The multicenter trial is designed to compare Genasense plus Taxotere (docetaxel), belonging to Aventis Pharma Inc., of Frankfurt, Germany, to Taxotere alone for patients with advanced NSCLC who have failed initial therapy.
¿ GPC Biotech AG, of Munich, Germany, exclusively in-licensed Bryostatin-1 from Arizona State University. Bryostatin-1 is in a number of Phase II trials in combination with other therapeutics for several indications, including esophageal cancer. In addition, GPC acquired an exclusive worldwide license from Stanford University to develop and commercialize synthetic analogues of Bryostatin-1, known as Bryologs. Provided the ongoing trials are successful, GPC intends to advance Bryostatin-1 through Phase III studies in combination with Taxol for the treatment of esophageal cancer. GPC also may design other trials to evaluate the compound in additional indications.
¿ Hemispherx Biopharma Inc., of Philadelphia, is extending the expiration date to 5 p.m. EST on Nov. 21 for its warrant conversion. The shares can be converted at $4 per share.
¿ Kosan Biosciences Inc., of Hayward, Calif., extended its collaboration to Dec. 28, 2002, with the R.W. Johnson Pharmaceutical Research Institute (RWJPRI) and Ortho-McNeil Pharmaceutical Inc., both New Brunswick, N.J.-based Johnson & Johnson companies. Kosan is producing novel macrolide antibiotic leads using its technology to genetically engineer microbial biosynthetic pathways. RWJPRI is collaborating with Kosan on the research program and is responsible for development of the compounds. Ortho-McNeil and affiliates would undertake the marketing and sale of any drugs resulting from this collaboration. The collaboration agreement was previously scheduled to terminate this Dec. 28.
¿ NeoTherapeutics Inc., of Irvine, Calif., said its anticancer subsidiary, NeoOncoRx Inc., signed an agreement with Bristol-Myers Squibb Co., of New York, to develop Elsamitrucin, which induces single-strand DNA breaks. The agreement grants NeoOncoRx worldwide rights to develop and market Elsamitrucin, the company¿s third cancer drug in Phase II or III trials in the 10 months since NeoOncoRx was created. The company intends to initiate a Phase II study of Elsamitrucin, which also works by inhibiting topoisomerase II, in non-Hodgkin¿s lymphomas to further define its efficacy in this disease. The multicenter U.S. study will include 40 to 50 patients.
¿ Oncotech Inc., of Tustin, Calif., and The Johns Hopkins Cancer Center entered into a collaborative study to identify genetic factors that can be used to save uterine cancer patients from unnecessary exploratory surgery. The study¿s purpose is to determine genes and proteins that can stratify uterine cancer patients according to their risk of metastasis. Biopsies from 175 women with uterine cancer currently are being evaluated.
¿ Oxxon Pharmaccines Ltd., of Oxford, UK, progressed its hepatitis B virus pharmaccine candidate into Phase I trials to evaluate the safety and immunogenicity of the two-stage vaccine regimen. The two-stage regimen primes the immune system with one vaccine candidate and then boosts the immune response with the other. The 24-patient trial will assess components of the vaccine individually and in combination.
¿ Palatin Technologies Inc., of Princeton, N.J., reached an agreement with the U.S. Army to test its experimental LeuTech system to detect the inhaled form of anthrax. The initial study, to begin this week, will be conducted at the Walter Reed Army Medical Center in Washington. Palatin said that if results of the clinical trial demonstrate LeuTech is effective, the company would discuss possible distribution of the product with the FDA. The company¿s stock (AMEX:PTN) gained $1.37 Monday, or 35 percent, to close at $5.31.
¿ Peplin Biotech Ltd., of Brisbane, Australia, was offered an A$3.2 million (US$1.6 million) R&D START grant by AusIndustry to accelerate development of its new-generation, anticancer drugs. The company plans to use the funds as part of a three-year, $8.7 million research project designed to complete development of a topical drug to treat non-melanoma skin cancer, including basal cell and squamous cell carcinoma. Phase II trial results of the drug showed a 94.7 percent complete response with the most common skin cancers under 16 mm in diameter.
¿ Proacta Therapeutics Ltd., of Auckland, New Zealand, was formed by Cancer Research Ventures Ltd., of London; Auckland UniServices Ltd., of Auckland; and the Institute of Cancer Research, of London, to develop new strategies to treat cancer. The company is focused on developing new treatment modalities directly targeting the tumor. Its prodrug activation strategies include a number of proprietary enzymes delivered to the tumor by gene therapy. Proacta said it holds 21 patent families.
¿ Protein Design Labs Inc., of Fremont, Calif., released promising preliminary results from its ongoing Phase I/II trial of SMART Anti-Gamma Interferon Antibody in patients with moderate-to-severe Crohn¿s disease, results that support a move into Phase II trials. To date, 29 Crohn¿s disease patients have been entered and evaluated in the first stage of the double-blind, randomized, placebo-controlled multicenter trial. In the initial stage, patients are randomized to receive a single escalating dose of SMART Anti-Gamma Interferon or placebo. Patients who receive active drug and have a predefined reduction of the Crohn¿s Disease Activity Index after four weeks may be entered into the second stage, in which they receive either three additional doses of the drug or placebo at four-week intervals.
¿ Zarix Inc., of Berwyn, Pa., said the FDA granted orphan drug designation to Thymitaq (nolatrexed dihydrochloride) for the treatment of hepatocellular carcinoma HCC. Thymitaq, a thymidylate synthase inhibitor, is an oncology agent that is being developed to treat several different cancers. It is being studied in a multicenter trial in the U.S., Canada, Europe and South Africa for the treatment of unresectable hepatocellular carcinoma (liver cancer).
¿ Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., reported discoveries in its muscle biology program, achieved using its Functionomics technology platforms. In papers to be published in the November 2001 issue of Nature Cell Biology, scientists define the key molecular mediators that cause muscle growth, and then genetically overstimulate these so as to induce muscle growth in animal models. In a paper currently available online as a ScienceExpress report and to be published in a future issue of Science, Regeneron scientists define two key genes responsible for muscle shrinkage and atrophy, and then genetically delete these in animal models and thus block muscle atrophy.
¿ Remedyne Corp., of Santa Barbara, Calif., signed a collaborative research and development agreement with Merial Ltd., of the UK, to jointly develop medicines to enhance the health and well being of animals based on Remedyne¿s DNA Adenine Methylase (DAM) technology. Merial will retain rights to animal health applications, and Remedyne will retain rights for human health applications of the technology. Merial will provide research and development support for two years to Remedyne in order to conduct feasibility studies on a number of DAM-based vaccine product candidates. During the two-year agreement, Merial will have the right to execute an exclusive worldwide license for all animal health applications identified in the research process. The agreement provides for Remedyne to receive initiating payments and certain developmental milestone payments.
¿ Scil Biomedicals GmbH, of Martinsried, Germany, initiated a Phase Ib trial to evaluate SMART (humanized) Anti-L-Selectin in psoriasis patients. The double-blind, randomized, placebo-controlled, multiple-dose trial is slated to enroll 18 patients suffering from moderate to severe, eruptive, plaque-type psoriasis. The trial is expected to improve the condition of the patients by preventing the migration of leukocytes into the skin and reducing the release of mediators. Also, neutrophils and dendritic cells are hindered to act as antigen-presenting cells by blocking their interaction with T lymphocytes. Scil holds licensing rights from Protein Design Labs Inc., of Fremont, Calif., to develop, market and manufacture Anti-L-Selectin in trauma and non-trauma indications.
¿ The Donald Danforth Plant Science Center, of St. Louis, opened its doors at a dedication event. The Danforth Center is the product of a partnership between the Missouri Botanical Garden, Monsanto Co., Purdue University, the University of Illinois at Urbana-Champaign, the University of Missouri-Columbia and Washington University. Its mission is fourfold: to increase understanding of plant biology, apply new knowledge to benefit human nutrition, develop new technologies, and educate.
¿ Vical Inc., of San Diego, received a $3 million payment from Merck & Co. Inc., of Whitehouse Station, N.J. Merck has begun human testing of a prime-boost vaccine regimen that employs Vical¿s naked DNA nonviral gene delivery technology to combat HIV. Under terms of a 1997 licensing agreement, the payment extends the term of Merck¿s exclusive worldwide rights to use Vical¿s naked DNA technology to develop and market therapeutic vaccines against both HIV and the hepatitis B virus.