* CellPro Inc., of Seattle, received an investigational device exemption from the FDA to begin clinical trials with its new product, the Ceprate B-Cell Depletion System. It will be used with the company's Ceprate SC Stem Cell Concentration System to reduce the number of B cells in mobilized peripheral blood used for autologous hematopoietic transplantation in patients with relapsed non-Hodgkin's lymphoma. The trial will evaluate the safety and efficacy of B cell purging, combined with a CD34+ cell enrichment of mobilized peripheral blood.
* CoCensys Inc., of Irvine, Calif., said its potential new therapy for migraine headaches has shown efficacy in Phase II studies. The trial used ganaxolone, a synthetic version of naturally occurring neuroactive steroids known as epalons, which have been found to suppress inflammation in the lining of the brain. The study results were reported at a conference,
* Cor Therapeutics Inc., of South San Francisco, received $8 million from partner Schering-Plough Corp., of Madison, N.J., as a milestone in connection with the acceptance for review of the centralized marketing authorization application seeking European approval of Integrilin (eptifibatide) for patients with unstable angina and non-Q-wave myocardial infarction. The drug, a GP IIB-IIIa inhibitor shown to block platelet aggregation and blood clots, would also be used as an adjunct to percutaneous transluminal angioplasty. The application was submitted by Schering-Plough to the European Union's European Medicines Evaluation Agency.
* Genzyme Corp., of Cambridge, Mass., said its new drug application for Thyrogen (recombinant human thyroid stimulating hormone) has been granted priority review status by the FDA. Genzyme's European marketing application was accepted as fileable and will undergo review. The U.S. and European marketing applications were submitted in December. (See BioWorld Today, Dec. 19, 1997, p. 1.)
* Immune Complex Corp., of San Diego, was awarded a Phase II Small Business Innovative Research (SBIR) Grant from the National Institutes of Health. The firm plans to use the funds to develop reagents that will make possible the in vitro analysis of drug metabolism. The $750,000 award will be combined with a recent $600,000 SBIR contract. In the research, human cytochrome P450s, which enhance solubility of drugs in the body and allow them to be eliminated more quickly, will be used to determine metabolism profiles.
* Perkin-Elmer Corp., of Norwalk, Conn., said the federal district court in Boston has vacated its March 1997 ruling in PerSeptive BioSystems Inc.'s patent infringement lawsuit against Amersham Pharmacia Biotech, of Uppsala, Sweden. The court entered a new order finding PerSeptive's three original perfusion chromatography patents unenforceable, because the company failed to include two inventors who, according to a January 1996 ruling, should have been added. The new order allows Framingham, Mass.-based PerSeptive, which completed a merger with Perkin-Elmer last month, to appeal the 1996 ruling on the inventors.
* Atrix Laboratories Inc., of Fort Collins, Colo., began a program to repurchase up to $10 million of the company's common stock, on the open market or in private transactions, from time to time as conditions warrant. The program will end on Dec. 31, 1998. Late last year, Atrix, which develops, manufactures and markets products based on its Atrigel biodegradable polymeric technology, raised $50 million in a private placement. (See BioWorld Today, Nov. 25, 1997, p. 1.)
* CellPro Inc., of Seattle, said it received notice that the Biological Response Modifiers Advisory Committee of the FDA will meet on March 24 to discuss expansion of the label indication for CellPro's Ceprate SC Stem Cell Concentration System to include selection of peripheral stem cells. The proposed label expansion says selection of peripheral blood stem cells results in a greater than 100-fold reduction in the number of tumor cells present in the autograft. In October of last year, the company submitted data to the FDA from a Phase II clinical trial involving 134 multiple myeloma patients.
* Mycogen Inc., of San Diego, filed motions in federal district court in Wilmington, Del., asking the court to set aside a Feb. 5 verdict that two patents held by Mycogen are not valid. The patents were the basis of an infringement suit brought by Mycogen against three competitors, including St. Louis-based Monsanto Co., and related to products that allegedly infringed Mycogen's patents covering Bacillus thuringiensis gene synthesis technology used to make plants insect-resistant.