¿ Aastrom Biosciences Inc., of Ann Arbor, Mich., initiated patient enrollment in a controlled clinical trial to evaluate its CB-I cord blood cell therapy in the treatment of adult leukemia patients. The trial is designed to assess the effect that CB-I cord blood cells can have on enabling successful recovery of normal blood and immune system function following aggressive chemotherapy or radiation therapy.
¿ Arcus Therapeutics LLC, a joint venture between Peregrine Pharmaceuticals Inc., of Tustin, Calif., and Oxigene Inc., of Watertown, Mass., said it will receive royalty payments on the net sales of all drugs commercialized by SuperGen Inc., of Dublin, Calif., using Arcus' Vascular Targeting Agent technology as it relates to vascular endothelial growth factor.
¿ Axonyx Inc., of New York, gave an update on Phenserine, its lead Alzheimer's drug that is in a Phase II proof-of-concept trial. Enrollment has reached the halfway point and it hopes to have the last patient entered into the study in the spring. The study has a 16-week design and Axonyx should be able to unblind the study in the fall. Also, its amyloid inhibitory peptide program has moved into preclinical status at Serono SA, of Geneva, Switzerland, its partner, with an indication that human studies could begin in 2002.
¿ Charles River Laboratories International Inc., of Wilmington, Mass., through its subsidiary Charles River Laboratories Inc., said it completed the acquisition of Primedica Corp., of Worcester, Mass., from Genzyme Transgenics Corp., of Framingham, Mass. The signing of the definitive agreement to purchase Primedica was announced on Feb. 7.
¿ Gemini Genomics plc, of Cambridge, UK, expanded its research initiative to identify all the genes responsible for depression and anxiety disorders by acquiring rights to examine and commercialize discoveries arising from data and DNA samples collected over the last 10 years from The Free University in Amsterdam, the Netherlands. The data will enable Gemini to replicate and validate its findings against other population groups and also analyze other conditions.
¿ Gilead Sciences Inc., of Foster City, Calif., and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said Roche submitted Tamiflu (oseltamivir phosphate) to the European authorities for regulatory approval for the treatment of influenza A and B in adults and children and the prevention of influenza A and B in adolescents and adults.
¿ Hemosol Inc., of Toronto, said its marketing authorization application for Hemolink has been submitted and is awaiting review by the United Kingdom Health Authority, the Medicines Control Agency. The results of a Canadian/UK Phase III trial in coronary artery bypass grafting surgery, completed in July, form the basis of the filing. The application seeks approval to market Hemolink for use in surgery to reduce or avoid the use of donor red blood cells.
¿ Human Genome Sciences Inc., of Rockville, Md., said its product, BLyS, received orphan drug designation from the FDA for its first indication, the treatment of common variable immunodeficiency. BLyS is a protein made by the human body that stimulates the production of antibodies.
¿ Idun Pharmaceuticals Inc., of San Diego, and Selective Genetics Inc., also of San Diego, signed a license agreement for the use of Idun's Bcl-2 gene. Selective Genetics will utilize the gene in conjunction with its proprietary delivery technologies for the development of gene therapy products for tissue repair and regeneration.
¿ Infectech Inc., of Sharon, Pa., signed an investment banking and advisory agreement with Josephberg Grosz & Co., of New York. Josephberg Grosz will assist Infectech in obtaining financing.
¿ Insmed Inc., of Richmond, Va., said results of two Phase II trials of its lead oral insulin sensitizer, INS-1, indicated statistically significant efficacy. A Phase II trial in polycystic ovarian syndrome (PCOS), a 223-patient, double-blind, placebo-controlled, dose-ranging study designed to evaluate the incidence of hyperandrogenic anovulation in women diagnosed with PCOS and the effects of INS-1 on that population, found a statistically significant difference in ovulation rates between the treatment group and placebo (p<0.05). A Phase II trial in dyslipidemia, an exploratory, 160-patient, double-blind, placebo-controlled study designed to evaluate the effect of INS-I on lipid profiles in nondiabetic dyslipidemic subjects, showed that the treatment group exhibited no change in LDL cholesterol levels or total cholesterol levels, and data indicated that the treatment group exhibited a decrease in apolipoprotein B levels compared to no significant reduction in the placebo group. INS-1 was well tolerated by all subjects in both trials.
¿ Inspire Pharmaceuticals Inc., of Durham, N.C., said positive Phase II results of INS365 Ophthalmic for the treatment of dry eye disease will be presented at the upcoming Association for Research in Vision and Ophthalmology meeting in Ft. Lauderdale, Fla., on May 3.
¿ Pall Corp., of East Hills, N.Y., and Genicon Sciences Corp., of San Diego, entered an agreement to apply Pall's membrane technology and Genicon's RLS technology to the development of an enhanced system for the labeling, detection and study of biological analytes for the pharmaceutical, biotechnology, genomics and diagnostic industries. Terms of the agreement were not disclosed.
¿ Praecis Pharmaceuticals Inc., of Cambridge, Mass., said underwriters of its follow-on public offering exercised in full their overallotment option and purchased approximately 1.1 million shares, bringing total net proceeds of the offering to about $175.8 million. Credit Suisse First Boston Corp., Salomon Smith Barney Inc. and CIBC World Markets Corp., all of New York, underwrote the offering. (See BioWorld Today, Feb. 16, 2001.)
¿ Procyon BioPharma Inc., of Montreal, said its investigational new drug application to complete Phase II studies for Fibrostat has been approved by the Canadian Therapeutics Products Program branch of Health Canada. The IND was filed in late December by Crystaal, the Canadian marketing division of Biovail Corp., of Toronto, which is the development partner for Fibrostat in Canada.
¿ Sequenom Inc., of San Diego, launched its homogeneous MassEXTEND (hME) assay, a new product offering for the large-scale analysis of genetic variations, or single nucleotide polymorphisms. The hME assay differs from Sequenom's proprietary MassEXTEND assay by having all reactions occur on a single plate, eliminating the need for sample transfers.
¿ Vivus Inc., of Mountain View, Calif., and Tulane University Health Sciences Center in New Orleans said research conducted to determine the effects of selective type 5 phosphodiesterase (PDE5) inhibitors when given alone or in combination with a nitric oxide donor or alprostadil (PGE1) was published in the March 2001 issue of The Journal of Urology. Data from the studies demonstrated that intracavernosal injection of a selective PDE5 inhibitor combined with PGE1 produced erectile responses that were greater than when the PDE5 inhibitor was administered alone or in combination with a nitric oxide donor.
¿ Zeptosens AG, of Witterswil, Switzerland, secured CHF14 million (US$8.3 million) in a second-round financing. The round was led by TVM Techno Venture Management, of Munich, Germany, and joined by Swiss Life Private Equity Partners, of Switzerland, and private investors. It said the capital will be used for development and production of its proprietary microarray readout system, ZeptoReader, and also for the development of ZeptoGene DNA and the ZeptoMark protein microarray product family.