¿Access Pharmaceuticals Inc., of Dallas, said it commenced a Phase I clinical study of the polymer platinate AP 5280 designed to determine maximum tolerable dosage. The compound is designed to improve the effectiveness of platinum-based therapy while reducing side effects.
¿Alexion Pharmaceuticals Inc., of New Haven, Conn., said the FDA granted fast-track status for its 5G1.1-SC for the treatment of patients undergoing cardiopulmonary bypass surgery. The company, which is developing the product with Procter & Gamble, also said it completed enrollment in a 1,000-patient Phase IIb efficacy trial of the product in that indication. 5G1.1-SC is a fully humanized single-chain monoclonal antibody that has been shown to potently block inflammation caused by the complement system.
¿Avanir Pharmaceuticals Inc., of San Diego, said it relocated its corporate headquarters and commercial development operations to an expanded facility that also houses the company's newly formed Xenerex Biosciences subsidiary. The new facility is leased for eight years and has 27,000 square feet of space.
¿Aviron Inc., of Mountain View, Calif., said it sold 244,272 shares to Acqua Wellington Asset Management LLC for $8 million, or $32.75 per share. Net proceeds from the sale will be used, the company said, for operating costs and capital expenditures, and may include costs of FluMist regulatory filings, manufacturing and commercialization.
¿Cadus Pharmaceutical Corp., of New York, said a U.S. federal court of appeals ruled in favor of Cadus by overturning a 1998 judgment in a patent infringement suit brought by Sibia Neurosciences Inc. (since bought by Merck & Co. Inc.). Cadus said the court ruled the claims asserted in Sibia's U.S. Patent No. 5,401,629 were invalid. They relate to the use of cells, engineered to express any type of cell surface receptor and a reporter gene, used to report results in screening of compounds against target assays.
¿Generex Biotechnology Corp., of Toronto, said it received a commitment from a private investment fund to purchase up to $50 million of common stock. Ladenburg Thalmann & Co. arranged the commitment. The company's ability to draw on the commitment is subject to a number of limitations and conditions, and therefore the company said the extent to which it would be able to draw upon the facility is uncertain. Generex's lead platform technology involves the buccal delivery (absorption through the inner cheek walls) of large-molecule drugs. The first application is an insulin formulation, called Oralgen and Oralin, administered as a fine spray.
¿Genzyme General, of Cambridge, Mass., published the results of its clinical trial of Fabrazyme on the web site of the American Society of Human Genetics. Fabrazyme is Genzyme's investigative enzyme replacement therapy for patients with Fabry disease. The trial results were highly statistical significant (p<0.0001) in clearing GL-3 from the blood vessels in the kidney. The company filed a BLA with the FDA in June.
¿GlycoDesign Inc., of Toronto, said it has expanded its collaboration with Seikagaku Corp., of Tokyo, to include drug development and licensing for cardiovascular diseases, cancers and diabetes. If Seikagaku (SKK) exercises all options in the new agreement, the deal could be valued at C$25 million (US$16.9 million). The companies signed a research and development deal in November 1999 to identify small-molecule, orally active Core 2 transferase inhibitors displaying anti-inflammatory activity. The extended agreement gives SKK additional drug development and licensing options in cardiovascular diseases, cancer and diabetes. GlycoDesign will receive an undisclosed up-front equity investment, milestones and success payments in each new disease area, and royalties on future sales. GD will use the money to accelerate its Core 2 discovery program, including the company's Phase II clinical trials, and to complete preclinical work for its cardiovascular product V21, an anti-thrombotic agent.
¿ImClone Systems Inc., of New York, said it entered an agreement with Lonza Group Ltd. Switzerland subsidiary Lonza Biologics, allowing Lonza to become a second source manufacturer of ImClone's lead cancer therapeutic, IMC-C225.
¿LION Bioscience AG, of Heidelberg, Germany, said it released genomeSCOUT 1.0, a genome comparison and analysis software system developed primarily for the analysis of microbial genomes. The software uses comparative genomics to provide insight on the functionality, differences and conservation of the growing number of sequenced genomes.
¿Maxim Pharmaceuticals Inc., of San Diego, said the FDA has designated the company's lead drug candidate, Maxamine, for priority review. The company submitted an NDA to the FDA in July seeking approval for the drug as an adjuvant to interleukin-2 (IL-2). The company completed its Phase III trial of the compound in March, and results show that the drug, in combination with IL-2, improved survival in advanced metastatic melanoma patients with liver metastases compared to treatment with IL-2 alone.
¿Novapharm Biotech Inc., of Scarborough, Ontario, announced the changing of its name to Viventia Biotech Inc. The name was approved by shareholders and the change will be completely implemented in four weeks.
¿Oxxcon Pharmaccines Ltd., of Oxford, UK, said it licensed TRAP DNA codes of an antigen from Plasmodium falciparum, a parasite that causes the majority of malarial fatalities in humans, from Imperial College Innovations Ltd., of London. The license allows for the worldwide use of the TRAP DNA codes in Oxxcon's Prime Boost Technologies for the treatment and/or prophylaxis of malaria in humans.
¿Pharmacyclics Inc., of Sunnyvale, Calif., said two Phase I studies of Xcytrin Injection have been initiated. They are sponsored by a National Cancer Institute IND. The first safety study will involve two dosing regimens after preoperative radiotherapy after induction chemotherapy in patients with Stage IIIa non-small-cell lung cancer. The second study will examine Xcytrin in combination with radiosurgery in patients with primary brain tumors.
¿Protein Design Labs Inc., of Fremont, Calif., said it will adapt a murine antibody from Eli Lilly and Co., of Indianapolis, for human use. Lilly will develop the resulting humanized antibody as a therapeutic. PDL will receive an up-front fee of $1.7 million, milestone payments, annual maintenance fees and royalties on the sales of any resulting product.