Agouron Pharmaceuticals Inc., of La Jolla, Calif., started a pilot Phase II trial evaluating the matrix metalloprotease inhibitor prinomastat in combination with chemotherapy for patients with newly diagnosed glioblastoma multiforme following surgery and radiation therapy. The objectives of the study are to assess trends in efficacy and safety of prinomastat in combination with temozolomide.
Atrix Laboratories Inc., of Fort Collins, Colo., said it completed its stock repurchase program, which was announced in February 1998. A total of $11.5 million principal amount of its 7 percent convertible notes and 157,000 shares of stock were purchased for about $10 million. The company's board also approved a new repurchase program to acquire up to $10 million of the company's common stock or notes. It will terminate on Dec. 31, 2000.
Cel-Sci Corp., of Vienna, Va., said its HIV vaccine for HIV-1 subtype C, HGP-30W, is nearing the end of a Phase II study in the Netherlands. Preliminary results suggest the vaccine is safe and induced both cellular and humoral immune responses.
Dynavax Technologies Corp., of Berkeley, Calif., and Stallergenes SA, of Antony, France, signed an agreement to develop treatments for seasonal allergies in Europe using Dynavax's proprietary immunostimulatory oligonucleotide sequences (ISS). The initial focus of the collaboration will be the clinical development of AIC, a highly purified form of the main ragweed allergen, Amb a 1, linked to multiple ISS. Under terms of the agreement, Stallergenes will have the option to acquire commercial rights in Europe for Dynavax's technologies in return for equity investments, research and development funding and milestone and royalty payments. Dynavax will retain all commercial rights to products outside of Europe and to the development of ISS products for other indications. Financial terms were not disclosed.
FibroGen Inc., of South San Francisco, said its scientists produced gelatin by recombinant means using yeast and transgenic plants, such as tobacco. Currently, gelatin is manufactured from collagen, derived from animal carcasses, which carries the potential for contamination and adverse immunological reactions associated with vaccines, the company said. The company's new process could produce gelatins to be tailored for individual uses.
GeneFormatics Inc., of San Diego, appointed John Chiplin as president and CEO. Chiplin has almost 20 years of experience in the high technology and scientific software markets. He most recently served as CEO of Superscape plc, a virtual reality technology company. GeneFormatics is an early-stage company focused on research, development and commercialization of novel function prediction methods for the identification of biologically relevant targets.
Gliatech Inc., of Cleveland, said the FDA granted approval of an investigational new drug application, allowing the company to initiate Phase II trials of Perceptin to treat attention deficit hyperactivity disorder. Phase I studies showed Perceptin is safe, well tolerated and amenable to once daily dosing, the company said.
LifeCell Corp., of Branchburg, N.J., completed a private equity financing of 925,000 shares of the company's common stock for a total of about $4 million. The shares were purchased by the Tail Wind Fund Ltd., of London, at $4.20 per share. The financing included the issuance of 200,000 warrants priced at a 30 percent premium to the purchase price. Representatives of Ladenburg Thalmann & Co. Inc. acted as adviser to LifeCell for the transaction.
Lorus Therapeutics Inc., of Toronto, said anti-tumor studies with GTI 2040 resulted in complete tumor regressions when used in combination with certain chemotherapeutic agents. Results were based on in vivo studies using recognized human kidney cancer, colon cancer and melanoma models.
Microcide Pharmaceuticals Inc., of Mountain View, Calif., started Phase I trials of the antibiotic RWJ-54428. Microcide said it will receive a significant milestone payment from the R.W. Johnson Pharmaceutical Research Institute, a subsidiary of Johnson & Johnson, of New Brunswick, N.J.
Novartis Pharmaceuticals Inc., of East Andover, N.J., is the developer of Exelon, which scientists said may be effective in enhancing activities of daily living (ADLs) in patients with mild to moderately severe Alzheimer's disease. Results from three Phase III double-blind, placebo-controlled studies found that patients treated with Exelon experienced less decline in ADLs than patients treated with placebo. About 50 percent more patients on Exelon showed a clinically significant improvement from baseline in ADLs.
Ortec International Inc., of New York, filed for FDA approval to market its product to treat the critical skin diseases epidermolysis bullosa, Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Marketing approval for Composite Cultured Skin is being sought under a humanitarian device exemption, which allows patients access to devices that can potentially improve their outcomes for critical diseases or conditions that affect fewer than 4,000 people in the U.S. a year. Ortec said it may receive notification from the FDA within 75 days.
Oxigene Inc., of Boston, said it signed a letter of intent with Bristol-Myers Squibb Co., of New York, for the development and commercialization of Oxigene's new class of anti-cancer therapies, including the lead compound, combretastatin A4 prodrug (CA4P). The transaction is subject to further medical, technical, business, financial and legal due diligence.
Oxis International, of Portland, Ore., said it assigned rights to its patents relating to its polyalkylene glycol (PEG) technology to an undisclosed party. PEG enhances the duration of biological activity and safety of a variety of proteins and peptides. Oxis received an up-front cash payment of $600,000 and will receive an additional cash payment of $225,000 upon FDA approval of the first U.S. product covered by the patents.
Pozen Inc., of Chapel Hill, N.C., said the company acquired an exclusive worldwide license to a novel serotonin receptor antagonist discovered by F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The compound, MT 500, will be the first drug developed specifically as a migraine prophylactic agent. Under terms of the agreement, Pozen assumes responsibility for development, regulatory approval and commercialization throughout the world and agreed to pay Roche certain consideration upon commercialization of the product. At its option, Roche may reacquire and commercialize the product subject to the payment of certain milestones and royalties to Pozen.
Procyon BioPharma Inc., of Montreal, completed the second phase of a private placement with proceeds of C$2 million from Quebec-based T2C2 and Innovatech du Grand Montreal, as well as from European and other investors. This brings the proceeds of the entire private placement to C$3 million (US$2 million). The company will issue 12 million common shares at 25 cents per share to investors in the private placement.
Pharmacyclics Inc., of Sunnyvale, Calif., said a Phase I trial of Xcytrin (motexafin gadolinium) injection for treating children with a brain stem tumor called intrinsic pontine glioma was started by the Children's Cancer Group. The goal of the dose-ranging study is to determine the Xcytrin dose and administration schedule that can be given safely with radiation. It also aims to evaluate localization of Xcytrin in the affected tumors using MRI.