¿ Aastrom Biosciences Inc., of Ann Arbor, Mich., said it discovered a way to grow human stem cells outside the body from cord blood. The procedure, based on Aastrom's medium-exchange technology, improves stem cell production 10-fold compared to Aastrom's CB-I Therapy Kit, which is in a clinical trial to treat patients with leukemia and other blood diseases. The discovery could provide cancer patients with higher doses of stem cells in a transplantation setting, enhancing the probability of a successful outcome.
¿ Alliance Pharmaceutical Corp., of San Diego, said it received $20 million as previously reported from Baxter Healthcare Corp., of Deerfield, Ill., as part of its licensing agreement concerning Oxygent. Alliance also received a prepaid royalty of $10 million from PFC Therapeutics LLC, a company formed by the parties to oversee the development, manufacturing, marketing, sales and distribution of Oxygent in the U.S., Canada and Europe. Each party invested $5 million for equal ownership of PFC. Oxygent is being evaluated in Phase III studies for its effectiveness in reducing or eliminating the need for donor blood transfusions in surgical patients. Alliance and Baxter formed the licensing deal earlier this month. (See BioWorld Today, May 15, 2000, p. 1.)
¿ Aphton Corp., of Houston, and UK scientists presented results at the annual meeting of the American Gastroenterological Association of Phase II trials in pancreatic cancer. In a multicenter trial of 22 patients, treatment with the anti-G17 immunogen improved survival by 43 percent over the present standard of care, gemcitabine. In separate trials with patients with colorectal cancers and stomach cancers, the anti-G17 immunogen induced a high antibody immune response in the patients. In an animal study of human polyps, it was demonstrated that two species of gastrin, G17 and gly-extended G17, are critical in the transition from the polyp stage to malignant cancer. The study also showed that the anti-G17 immunogen resulted in a large extension of survival that was statistically significant (p=.0002). Additional studies also showed the anti-G17 immunogen disrupts a gastrin autocrine/paracrine loop that results in the proliferation of tumors.
¿ Axon Instruments Inc., of Foster City, Calif., said it entered into an agreement with AstraZeneca plc, of London, to develop an automated electrophysiology system for higher-throughput drug screening. As part of the collaboration, AstraZeneca will supply a prototype instrument and key technology to Axon, which will develop it into a drug screening system for non-exclusive use by AstraZeneca.
¿ BioQuest Inc., of Houston, said it signed its merger agreement with Biokeys Inc., of San Diego. Under the agreement, first announced in February, BioQuest will undergo a reverse stock split resulting in 7 million shares outstanding. It will issue the shares to Biokeys shareholders in exchange for all the outstanding shares of privately held Biokeys. The combined company will have 14 million shares, and will continue to trade on the Pink Sheets under the symbol HIVX. Shareholders still need to vote on the merger. (See BioWorld Today, Feb. 25, 2000, p. 3.)
¿ Biosyntech Canada Inc., of Laval, Quebec, said it signed a collaborative agreement with Biomet Inc., of Warsaw, Ind., in which BST-GEL will be studied as a carrier for growth factor and gene delivery to accelerate fresh fracture repair of bones. BST-GEL, which comes as a liquid formulation, is injected in the body and reacts to normal body temperature to form a soluble gel allowing for the retention and controlled release of incorporated therapeutics without affecting their molecular structure.
¿ Celgene Corp., of Warren, N.J., presented data at the annual meeting of the American Gastroenterological Association on studies using Thalomid (thalidomide) and a proprietary class of tumor necrosis factor alpha (TNF-alpha) modulators, or selective cytokine inhibitory drugs (SelCIDs), in inflammatory diseases. Researchers said that three members of the SelCIDs were more potent inhibitors of TNF-alpha and interferon gamma in lamina propria mononuclear cells than thalidomide. Inhibition has been shown to be of clinical benefit to treat Crohn's disease. The second-generation SelCID compounds were more active than the lead SelCID that is being tested in a pilot Phase II Crohn's disease trial, the researchers said. Celgene also said its researchers found in a study of 169 cancer patients treated with Thalomid that 30 percent demonstrated a greater than 50 percent reduction in paraprotein levels, with 14 percent experiencing a complete or near-complete response. A majority of patients also experienced reduction in the percentage of plasma cells in bone marrow and an increase in hemoglobin levels.
¿ Chiron Corp., of Emeryville, Calif., and the National Institute of Public Health (NIPH), of Oslo, Norway, said they initiated their agreement to collaborate on the development of vaccines to fight meningitis B and C. They will collaborate to obtain European market authorization for NIPH's meningitis B vaccine. Together, they also will jointly develop a vaccine combining NIPH's meningococcal B vaccine with Chiron's meningococcal C conjugate vaccine Menjugate.
¿ DeCode Genetics, of Reykjavik, Iceland, and Partners HealthCare System Inc., of Boston, signed a strategic research agreement to pioneer new diagnostic and therapeutic approaches to common illnesses and to develop bioinformatics to improve the quality of healthcare. The three-year agreement will enable the parties to identify and compare disease-causing genes or loci responsible for diseases and to research new genes and discover approaches to prevent and treat common diseases.
¿ Forbes Medi-Tech Inc., of Vancouver, British Columbia, said results of a 12-week preclinical study of FM-VP4 show the compound reduces cholesterol levels by 75 percent and decreases blood fat levels by 44 percent. The compound was tested for effects when administered orally on lipid metabolism in apolipoprotein E-deficient mice.
¿ Hemispherx Biopharma Inc., of Philadelphia, said its licensing partner, Bioclones Ltd., of South Africa, initiated Ampligen treatment of severe chronic fatigue syndrome on a named patient, cost recovery basis in Africa.
¿ Ilex Oncology Inc., of San Antonio, Texas, said its board approved an increase in the number of authorized shares of the company's common stock from 40 million to 100 million.
¿ Ivax Corp., of Miami, said it entered into a license option agreement with the Center for Blood Research Inc. (CBR), an affiliate of the Harvard Medical School. Ivax and CBR's subsidiary, CBR Laboratories Inc., will develop a drug to treat cystic fibrosis (CF) lung disease. The collaboration is based on a recombinant monocyte/neutrophil elastase inhibitor, which will be delivered to the lungs of CF patients in an Ivax inhalation device. Ivax will negotiate with CBR for a worldwide exclusive license.
¿ Lexicon Genetics Inc., of The Woodlands, Texas, said it filed suit for patent infringement against Deltagen Inc., of Menlo Park, Calif., alleging that Deltagen infringes on U.S. Patent No. 5,789,215, under which Lexicon holds an exclusive license. The patent covers methods of engineering the animal genome using isogenic DNA technology. Lexicon uses this method to produce custom knockout mice in its homologous recombination program.
¿ NicOx SA, of Sophia-Antipolis, France, said positive preclinical results in mouse models of liver disease with a new nitric oxide-releasing derivative of ursodeoxycholic acid demonstrated that the compound is significantly more effective than ursodeoxycholic acid in protecting against inflammation and apoptosis. NCX 1000 inhibits apoptosis in vivo and in vitro in models where ursodeoxycholic acid is non-effective and inhibits pro-inflammatory cytokine production from inflamed tissues, the company said.
¿ Phytomedics Inc., of Dayton, N.J., said it consummated a strategic equity investment from Poalim Investments Ltd., one of Israel's largest financial enterprises. No further details were disclosed.
¿ Senetek plc, of Napa, Calif., said it entered into a research and development collaboration with Tel Aviv University-Ramot and the Weizmann Institute of Science-Yeda to develop novel compounds for the topical treatment of sexual dysfunction. Senetek will receive exclusive rights to 17 patented novel compounds to treat male and female sexual dysfunction. One analogue, Stearyl-Norleucine-VIP, has completed animal testing with no toxicity and is ready to enter Phase I trials to treat female sexual dysfunction and erectile dysfunction.
¿ SignalGene Inc., of Montreal, said it signed a collaboration with the National Research Council of Canada's Institute for Biological Sciences in the field of neurodegenerative diseases. The objective is to identify novel targets to develop drugs to treat central nervous system disorders, such as Alzheimer's and Parkinson's diseases. Each party will assume its own costs and share in the commercialization of findings.
¿ SuperGen Inc., of San Ramon, Calif., said in two Phase I studies, combination therapy involving rubitecan showed efficacy in an umber of solid tumors that were unresponsive to prior chemotherapy regimens. In the first study, 13 patients with refractory tumors were treated with a combination of rubitecan and Gemzar. Two patients had 50 percent or more shrinkage of their tumors and two others had stable disease. In a second study, nine patients were treated with rubitecan and cisplatin. One patient experienced a full serological remission after two courses, and one patient experienced a partial remission.
¿ Synsorb Biotech Inc., of Calgary, Alberta, said it received approval from Canadian authorities to ship emergency supplies of Synsorb Pk to hospitals in the Walkerton, Ontario, region in response to the E. coli outbreak in the area. Synsorb Pk has been granted fast-track designation by the FDA. It is in Phase III trials to prevent the progression to hemolytic uremic syndrome in children who have contracted verotoxigenic E. coli infections.
¿ The Juvenile Diabetes Foundation International, of New York, said it launched the JDF Center for Genetic Medicines to Treat Type I diabetes and its complications at Mount Sinai School of Medicine. The center is a $2 million research project to be conducted over three years. Its goal is to develop gene therapy medicines that will treat and help to prevent the complications of Type I diabetes.
¿ VaxGen Inc., of Brisbane, Calif., said it prevailed in two European patent disputes, confirming its exclusive rights to vaccines containing key proteins for preventing AIDS. The Opposition Division of the European Patent Office upheld two patents licensed exclusively to VaxGen that were challenged by Chiron Corp., of Emeryville, Calif. They cover specific forms of the envelope proteins known as gp120 and gp160, methods for manufacturing the proteins, and their use for the prevention and treatment of HIV/AIDS. The patents originally were filed by Genentech Inc., of South San Francisco.
¿ Watson Pharmaceuticals Inc., of Corona, Calif., said it will acquire all of the outstanding stock of Schein Pharmaceutical Inc., of Florham Park, N.J., in a two-step transaction of a cash tender and a taxable stock merger. The cash tender offer will be at $19.50 per share of Schein common stock. Each Schein share will be converted into $23 worth of a Watson common stock. At least 24.5 million shares of Schein common stock must be tendered under the agreement.