• Advanced Biotherapy Inc., of Los Angeles, entered an agreement to conduct joint clinical investigations with the Russian Federation Ministry of Health/State Institute of Transplantation and Artificial Organs. The institute will conduct human studies of select organ transplant patients using Advanced Biotherapy's investigational antibody therapies to evaluate them in preventing or halting organ transplant rejection.

• Computer Sciences Corp., of El Segundo, Calif., said DynPort Vaccine Co. LLC, a joint venture between CSC and Porton International Inc., of London, completed a second Phase I trial to evaluate the safety of vaccinia immune globulin, an antiserum used to counteract adverse reactions to smallpox vaccination. No serious adverse events were reported. The study involved 33 healthy volunteers.

• Corixa Corp., of Seattle, and GlaxoSmithKline plc, of London, began selling Bexxar (tositumomab and iodine I-131 tositumomab) through a therapeutic regimen that includes four office visits over one to two weeks. The administration culminates in a patient-specific therapeutic dose of the drug, which was approved about a month ago for patients with CD20+ follicular non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituxan (rituximab, Genentech Inc. and IDEC Pharmaceuticals Inc.) and has relapsed following chemotherapy. (See BioWorld Today, July 1, 2003.)

• Draximage Inc., of Mississauga, Ontario, a subsidiary of Draxis Health Inc., received Health Canada approval to initiate two Phase II studies of Infecton, a radiopharmaceutical diagnostic imaging agent for detecting and determining the location of infection in patients with difficult-to-diagnose signs and symptoms. Infecton combines ciprofloxacin with technetium, a radioisotope. The first trial will involve diabetic patients with bacterial infections of the foot. Enrollment is expected to be complete at the end of 2003.

• Gilead Sciences Inc., of Foster City, Calif., entered a licensing agreement with Japan Tobacco Inc., of Tokyo, under which Japan Tobacco will commercialize products in Gilead's HIV portfolio in Japan. The agreement includes Viread (tenofovir disoproxil fumarate), Emtriva (emtricitabine) and a future co-formulation of the products. Gilead will receive an up-front fee and could receive additional payments for milestones achieved. Japan Tobacco also would pay royalties. Japan Tobacco will submit applications for Viread and Emtriva to Japanese regulatory authorities in the near future, Gilead said.

• GTC Biotherapeutics Inc., of Framingham, Mass., entered definitive agreements with certain institutional and accredited investors for a private placement of common stock and common stock purchase warrants. GTC agreed to sell an aggregate of about 3.6 million shares at $2.55 per share. The investors also will receive warrants to purchase about 900,000 shares of GTC's stock at $3.30 per share. The financing would raise about $12.2 million if all warrants were exercised. GTC said it would use proceeds for general corporate purposes, including funding GTC's clinical trials and operations. GTC initiated a clinical trial in Europe with recombinant human antithrombin, a human blood plasma protein. It also is developing a recombinant human serum albumin and a malaria vaccine. GTC's stock (NASDAQ:GTCB) fell 56 cents Thursday, or 18.7 percent, to close at $2.44.

• Inspire Pharmaceuticals Inc., of Durham, N.C., said the FDA conferred priority review status on its new drug application for diquafosol tetrasodium ophthalmic solution, its dry eye treatment. The decision sets the target date for initial FDA action at six months from June 27. Inspire said it continues to expect FDA notification of acceptance for its filing in September. Its stock (NASDAQ:ISPH) gained $4.08 Thursday, or 37 percent, to close at $15.10.

• Inverness Medical Innovations Inc., of Waltham, Mass., a provider of consumer health care and professional diagnostics products, as well as devices, said it will acquire Applied Biotech Inc., of San Diego, from Apogent Technologies Inc. Inverness will acquire all of the stock of Applied Biotech in exchange for 692,506 shares of its common stock and additional consideration of either a payment of $13.4 million in cash at the closing of the acquisition or a payment of $5 million in cash at the closing and a one-year $8.4 million subordinated promissory note. The acquisition is expected to close in August. Applied Biotech focuses on diagnostic products in the areas of women's health, infectious diseases and drugs-of-abuse testing.

• Lipomics Technologies Inc., of West Sacramento, Calif., signed a research collaboration and option agreement with GlaxoSmithKline plc, of London, for drug discovery and diagnostic development. Lipomics will evaluate the effects of drug compounds on metabolism and establish the mechanism of drug response using TrueMass lipid analysis and customized Surveyor and Insight graphical representations of lipid metabolism.

• OxiGene Inc., of Watertown, Mass., said results of independent animal studies demonstrate the potential role of Combretastatin A4 Prodrug (CA4P) in preventing and treating certain retinal degenerative diseases. Findings of the study were published in the current issue of Investigative Ophthalmology and Visual Science. The study was designed to gauge CA4P's ability to suppress the development of choroidal neovascularization (CNV), a condition in which aberrant blood vessels beneath the retina leak blood and fluid into the retina. In both groups of mice in the study, daily intraperitoneal injections of CA4P resulted in a "significant reduction" in CNV, OxiGene said.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., initiated patient screening for its Phase II study of Prosaptide for the treatment of neuropathic pain associated with HIV/AIDS. The study is being co-sponsored by the Neurologic AIDS Research Consortium and the AIDS Clinical Trial Group. Prosaptide, a peptide derived from the human nerve growth protein prosaposin, is believed to be a peripherally acting analgesic, in contrast to central nervous system acting products.

• Schering-Plough Corp., of Kenilworth, N.J., said the FDA approved Rebetol (ribavirin) Oral Solution and Capsules for use in the treatment of pediatric hepatitis C. The new drug application was submitted in January and received priority review. Rebetol Capsules are approved in the U.S. for use in combination therapy with Intron A for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha-interferon or who have relapsed following alpha-interferon therapy. Rebetol Capsules also are indicated in combination with PEG-Intron (peginterferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon and are at least 18 years of age.

• Sirna Therapeutics Inc., of Boulder, Colo., said the SEC declared effective the company's registration statement for the offering of stock through the distribution of subscription rights to stockholders. The offering has a maximum value of $5 million. Stockholders of record as of July 21 will receive subscription rights to purchase 0.61 of a share of common stock for each share of common stock already owned. The offering will expire Aug. 29. Sirna is focused on nucleic acid-based therapeutics involving RNA interference.

• SurroMed Inc., of Mountain View, Calif., entered an agreement with MediBic, of Tokyo, in which MediBic and SurroMed will collaborate on the development of biomarker discovery product offerings. MediBic will act as SurroMed's exclusive sales representative in Japan for SurroMed's biomarker discovery solutions. SurroMed's integrated biomarker discovery program combines sample preparation techniques with high-resolution mass spectrometric methods for the differential analysis of biological samples.

• The BioBalance Corp., of New York, a wholly owned subsidiary of New York Health Care, released the results of a randomized study in which a formulation containing its biotherapeutic agent, Probactrix, appeared to control diarrhea and other abdominal symptoms commonly associated with HIV infections and treatment. Results showed that the product significantly reduced gastrointestinal complaints in as early as three to five days after initiation of Probactrix. In the treatment arm, there was improvement noted in bowel movement frequency during therapy (p<0.001) and one month after stopping administration of the Probactrix formulation (p<0.01).

• ViroLogic Inc., of South San Francisco, was awarded three Small Business Innovation Research grants from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md., for more than $3 million over three years. The grants will support the development of analytical and database tools to facilitate the identification and characterization of drug resistant strains of HIV and assays that will aid in the preclinical and clinical evaluation of the next generation of antiviral therapeutics.

• VIRxSYS Corp., of Gaithersburg, Md., began dosing in a Phase I/IIa lentiviral vector trial in HIV-positive patients. The privately held company said the trial involves the first-ever use of a lentiviral vector in humans designed to inhibit the replication of HIV. The patient was infused with autologous T cells modified with VIRxSYS' lentiviral vector, VRX496, with a goal to place the disease into permanent remission by creating a mass of VRX496-enabled CD4 T cells in the patient's body to suppress HIV infection and restore the body's immune system. Patients will be tested at three and six months, and then once yearly for 15 years. VIRxSYS said it would compile early safety follow-up data for the first patient by next month.