• AGY Therapeutics Inc., of South San Francisco, said it discovered a gene involved in brain damage following stroke and also discovered genes that could lead to therapies or diagnostic tests for Alzheimer's disease. It presented results from the discoveries at the 32nd annual Society for Neuroscience meeting in Orlando, Fla.

• Alkermes Inc., of Cambridge, Mass., completed a Phase I trial of an inhaled formulation of epinephrine called AIR Epinephrine. The trial evaluated the product against the standard epinephrine delivered with an intramuscular auto-injection system. Results showed systemic bioavailability of the inhaled formulation and delivery of clinically active dosage levels of epinephrine. The product was developed using Alkermes' AIR technology for the pulmonary delivery of dry powder aerosols.

• Amgen Inc., of Thousand Oaks, Calif., said its business meeting, originally scheduled for Nov. 21, has been moved to Feb. 25. It said it would provide guidance for 2003 in a conference call Dec. 12. The company said it is rescheduling the meeting to provide a "clearer, long-term picture" of Amgen, and to allow the company to address such issues as the re-launch of Enbrel and the supply of the drug; a decision on the Transkaryotic Therapies Inc., of Cambridge, Mass., appeal; and the progress of Amgen's efforts to correct inaccuracies released in the CMS OPPS rule. Last week, Amgen said a government reimbursement program called Amgen's anemia drug, Aranesp, "functionally equivalent" to a similar product, Procrit, made by Johnson & Johnson, of New Brunswick, N.J. Amgen called the classification a "mischaracterization." UBS Warburg downgraded Amgen Wednesday, changing its rating from "buy" to "hold." Amgen's stock (NASDAQ:AMGN) lost $3.87 Wednesday, or 7.7 percent, to close at $46.21.

• Aphton Corp., of Miami, received approval and plans to initiate a clinical trial in Europe for patients suffering from gastroesophageal reflux disease. The trial will examine, among other endpoints, whether G17DT might be efficacious in providing symptomatic relief to patients suffering from the disease. Aphton is in discussions with current and potential strategic partners to license the GERD product worldwide, in return for an up-front fee, milestone payments, payments for conduction clinical trials and royalties.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., signed a nonexclusive worldwide license agreement with Bristol-Myers Squibb Co., of New York, giving BMS the right to conduct pharmaceutical research and development covered by Ariad's NF-(kappa)B patents, retroactive to Sept. 8, 1998. Ariad will receive an up-front license fee and annual license fees, and could receive milestone payments. Also, it would receive royalties on approved products. Financial terms were not disclosed. NF-(kappa)B is considered a biological switch that can be turned off in cells to treat various disease conditions, Ariad said. Ariad's stock (NASDAQ:ARIA) climbed 96 cents Wednesday, or 31.6 percent, to close at $3.98.

• AstraZeneca plc, of London, denied rumors that its cancer drug, Iressa, would be placed before the FDA Oncologic Drugs Advisory Committee over concerns centered on interstitial lung disease and interstitial pneumonia. AstraZeneca said Iressa received in September a recommendation from the panel for accelerated approval in advanced non-small-cell lung cancer after disease progression following at least two chemotherapy agents, and AstraZeneca has been working with the FDA since then to provide all requested information. It said "recent questions regarding the incidence of interstitial lung disease, including interstitial pneumonia cases" have been "fully discussed" with the FDA. It also said that "speculation regarding the need for further discussion regarding Iressa" at the upcoming ODAC meeting in December "is unfounded." (See BioWorld Today, Sept. 25, 2002.)

• BioTrove Inc., of Cambridge, Mass., raised $5.25 million in a second round of private financing from a syndicate of new investors to expand the company's two core platforms designed to improve the efficiency and productivity of drug discovery: the Living Chip and the Lab-on-a-Tape. The round was led by Catalyst Health and Technology Partners and includes investments from CB Health Ventures, Zero Stage Capital and BioFrontier Partners.

• Compugen Ltd., of Tel Aviv, Israel, said that NV Organon, of Oss, the Netherlands, and Procter & Gamble Co., of Cincinnati, licensed its Z40000 fully automated system for designing, analyzing and controlling large-scale 2-D gel experiments for proteomic research. Z4000, launched in February 2000, is based on computational technologies designed to enable the management and analysis of large-scale protein experiments.

• Cypress Bioscience Inc., of San Diego, said a presentation titled "Antidepressant and Locomotor Effects of Milnacipran in Outbred and Inbred Strains of Mice," was given at the Society for Neuroscience's 32nd annual meeting in Orlando, Fla., on Monday. Cypress' milnacipran is a norepinephrine reuptake inhibitor being developed for the treatment of fibromyalgia syndrome and other chronic pain disorders. It was found that acute administration of milnacipran produced dose-dependent decreases in immobility time in the forced swim test, a marker of antidepressant activity.

• Dendreon Corp., of Seattle, demonstrated that a version of its anti-Her-2/neu cancer vaccine, APC8024, currently being tested in patients with breast, ovarian and colon cancer, is effective in the treatment of cancer in mice. The results are published in the current issue of the International Journal of Cancer. Results demonstrated that all tumor-bearing mice treated with three injections of the vaccine showed greatly prolonged survival and remained healthy throughout the study.

• Endovasc Ltd. Inc., of Montgomery, Texas, signed an agreement with Philip Morris, of New York, in which Philip Morris extended a grant for a one-year period to further study the potential for practical use of Endovasc's nicotine-based heart treatment, Angiogenix. Angiogenix is already approved for Phase III trials by the FDA. It has been proven to recruit the body's own stem cells that help grow new heart vessels predicted to relieve chest pain and improve heart function, the company said.

• Genta Inc., of Berkeley Heights, N.J., collaborating with Aventis SA, of Frankfurt, Germany, is initiating two trials of Genasense in combination with platinum-based chemotherapy in colorectal cancer and solid tumors. The trials will be sponsored by the National Cancer Institute in Bethesda, Md. The colorectal cancer trial will evaluate Genasense in combination with Eloxatin, 5-florouracil and leukovorin. The solid tumor study will evaluate Genasense in combination with carboplatin and paclitaxel. Genasense is currently in multiple, late-stage trials in malignant melanoma, multiple myeloma, chronic leukemia and non-small-cell lung cancer.

• Genzyme Molecular Oncology, of Framingham, Mass., a division of Genzyme Corp., began a Phase I/II trial in kidney cancer that uses a vaccine made from combining the patient's own cancer cells with immune-stimulating cells to fight the disease. The cells are then delivered back to the patient in form of a vaccine, through multiple injections to the upper thighs and lower abdomen. Up to 20 patients with advanced kidney cancer are expected to be treated in the trial.

• Guilford Pharmaceuticals Inc., of Baltimore, initiated a Phase II trial of its neuroimmunophilin ligand, GPI 1485, for the treatment of Parkinson's disease. The trial is a multicenter, randomized, double-blind, placebo-controlled evaluation of GPI 1485 in patients with mild to moderate Parkinson's disease. The primary endpoint in the study is a 50 percent or greater reduction in the loss of dopamine transporters as measured by I-123 Beta Cit Spect imaging.

• Innovative Technology Acquisition Corp., of New York, acquired 100 percent of BioSource Therapeutics Inc., a life science biotechnology corporation dedicated to the research and development of dietary supplements that address the effects of epidemic viral infections. Innovative Technology identifies and acquires nutraceutical products and companies. Financial details of the acquisition were not disclosed.

• Inologic Inc., of Seattle, was awarded a $97,000 Small Business Innovation Research grant from the Bethesda, Md.-based National Institutes of Health unit, the National Heart, Lung and Blood Institute. The grant was awarded to study the cellular effects of Inologic's drugs for the treatment of cystic fibrosis.

• Inspire Pharmaceuticals Inc., of Durham, N.C., reported results from a Phase II trial of INS37217 intranasal in 101 patients with upper respiratory infections. Results demonstrated statistically significant improvement (p<0.05) compared to placebo in post-nasal drip and malaise at multiple doses and on multiple days over the 14-day study period. Positive and consistent trends also were demonstrated across multiple other symptoms as compared to placebo, including improvements in rhinorrhea, nasal congestion, cough, facial pain and pressure, and sleep disturbance. The 10 mg/ml dose delivered twice daily is the dose that will be taken into the first Phase III study, it said.

• Invitrogen Corp., of San Diego, signed a worldwide exclusive agreement with Novozymes A/S, of Bagsvaerd, Denmark, to distribute Invitrogen's product, rProtease, a microbially produced alternative to animal trypsin, for mammalian and insect cell culture purposes. Financial details were not disclosed.

• LaunchCyte LLC, of Pittsburgh, said it received a $150,000 Opportunity grant from the state of Pennsylvania. The Opportunity grant program was established to secure job-creating economic development opportunities through the preservation and expansion of existing industry, as well as attracting economic development prospects to Pennsylvania. LaunchCyte creates, seeds and harvests life science innovations, it said.

• NewBiotics Inc., of San Diego, and ChromaVision Medical Systems Inc., of San Juan Capistrano, Calif., said they would evaluate NewBiotics' anticancer drug candidate, Thymectacin, in colon cancer patients. The companies will complete a blinded study on tissue samples from patients enrolled in NewBiotics Phase I and Phase II trials to evaluate the significance of quantitating a specific protein marker of tumor resistance as predictive of response to therapy. ChromaVision will receive an undisclosed fee per specimen for providing knowledge and analyzing patient samples. Other financial terms were not disclosed.

• Organogenesis Inc., of Canton, Mass., received notice from the American Stock Exchange on Oct. 29 indicating that the company fails to comply with the exchange's continued listing standards as a result of its Chapter 11 bankruptcy filing, its failure to file its quarterly report for the period ended June 30, and the deterioration in its financial condition resulting from cumulative net losses, working capital deficiency, stockholder's deficit and recurring negative cash flow. Amex notified the company that it will file an application with the SEC to delist and deregister Organogenesis' common stock from the exchange.

• Pharmagenesis Inc., of Palo Alto, Calif., began Phase I trials for PG490-88Na, a derivative of a compound from an herb widely used in Chinese medicine. The trial is accruing patients with advanced solid tumors who have failed standard therapy. The patients will be sequentially assigned to receive intravenous infusions of PG490-88Na at escalating dose levels.

• Sanguine Corp., of Pasadena, Calif., said it has received "numerous requests" for the use of its product, PHER-02, an oxygen-carrying synthetic substitute for red blood cells. The company said the U.S. Navy has expressed interest in using the product in animal studies in decompression sickness. Also, Rutgers University requested that PHER-02 be used in a study involving the detection of blood doping in racehorses. Sanguine said it is "reviewing each request carefully."

• StemCells Inc., of Palo Alto, Calif., said that results of a pilot study evaluating the use of its human neural stem cells in a preclinical stroke model were presented at the Society for Neuroscience's 32nd annual meeting in Orlando, Fla. Results of the study showed that the transplanted cells are capable of surviving in the immunosuppressed rat, migrating toward the stroke site and initiating the process of differentiating into neurons. Behavioral tests were performed out to four weeks post-transplant, and no improvement in function was observed at those early time points. StemCells' stock (NASDAQ:STEM) rose 21 cents Wednesday, or 36.8 percent to close at 78 cents.