Abgenix Inc., of Fremont, Calif., entered a collaboration with U3 Pharma AG, of Martinsried, Germany, for fully human monoclonal antibody therapies directed against validated drug targets selected from U3's portfolio. Abgenix will use its XenoMouse and/or XenoMax human antibody technologies to generate and select fully human antibodies against U3 targets. Both parties will conduct in vitro and in vivo studies of the antibody candidates, and will have the right to develop and commercialize antibody products discovered during the collaboration. The parties will share equally in development costs and potential resulting profits.
Advanced Tissue Sciences Inc., of La Jolla, Calif., filed a Form S-3 shelf registration statement with the Securities and Exchange Commission for the issuance of up to 10 million shares of its common stock. ATS may issue shares from time to time in one or more future financings, at prices and on terms to be determined at the time of issuance. Its stock (NASDAQ:ATIS) fell 43 cents Wednesday, or 28.67 percent, to close at $1.07.
Advanced Viral Research Corp., of Yonkers, N.Y., said its immunomodulator-type drug, Product R, was approved by Israeli regulatory authorities for a Phase I trial. The trial will study the treatment with injectable Product R of patients with hematopoietic and lymphoid tumors, including acute lymphocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma, who also manifest symptoms of cachexia, or severe weight loss and body wasting.
AEterna Laboratories Inc., of Montreal, said its Phase III study of Neovastat in kidney cancer will be completed in less than 12 months. AEterna added that positive results would enable it to be the first to market an angiogenesis inhibitor in oncology. The company also said that a strategic growth plan during the next few years includes potential acquisitions to position AEterna as an international developer of cancer therapies.
AnVil Inc., of Burlington, Mass., entered a collaboration with Applied Biosystems Group, of Foster City, Calif., an Applera Corp. business, to verify the existence of dark genes predicted by computers, but whose presence have not yet been confirmed. AnVil will apply its analytical and high-dimensional visualization technologies to tracking down unknown genes. AnVil will provide analytics knowledge in confirming methods for gene expression analysis and subsequent integration with DNA sequencing and Applied Biosystems' Taqman data. Financial terms were not disclosed.
Aphton Corp., of Miami, reported positive interim results from its clinical trial with patients with metastatic stomach cancer who were treated with its G17DT and chemotherapy consisting of cisplatin and 5FU. Of 58 evaluable patients, 28 had either a partial or a complete tumor response for an overall tumor response rate of 48.3 percent. One patient had a complete response and 27 had a partial response. Also, 21 more patients, or 36.2 percent, had stable disease. A total of 84.5 percent had either tumor shrinkage or stable disease.
Avanir Pharmaceuticals Inc., of San Diego, completed a Phase II/III trial investigating the safety and effectiveness of Neurodex in treating emotional lability in 116 patients with amyotrophic lateral sclerosis. The double-blind, controlled, multicenter trial studied three patient groups consisting of patients taking Neurodex, patients taking dextromethorphan alone, and patients taking the enzyme inhibitor alone. Avanir expects to release final data in July. If successful, Avanir plans to begin a pivotal Phase III clinical trial with multiple sclerosis patients.
BioTransplant Inc., of Charlestown, Mass., completed a 4-million-share offering at $2.50 each for net proceeds of $9.7 million. The shares of common stock were offered through a prospectus supplement pursuant to BioTransplant's effective shelf registration statement. BioTransplant intends to use net proceeds for working capital and other general corporate purposes. In connection with the offering, BioTransplant agreed to consider the nomination to its board of up to two additional individuals designated by the purchasers.
Cognia Corp., of New York, was awarded a $1 million, two-year Small Business Innovation Research Phase II grant from the National Institutes for General Medical Sciences to further develop its protein database system. The award will fund the final phase of development of a curation and relational database system with proprietary graphic user interfaces that provide researchers with unique network and pathway builder tools, as well as advanced search algorithms. It allows Cognia to accelerate population of the database with curated information on the highly regulated ubiquitin-proteasome pathways.
Copernicus Therapeutics Inc., of Cleveland, presented at the American Society of Gene Therapy meeting in Boston data showing that its compacted DNA formulation can successfully reconstitute the faulty chloride channel in airway epithelial cells in cystic fibrosis (CF) mice. In a study, CF mice were exposed to compacted DNA nanoparticles containing a normal copy of the CF gene. Treated CF mice demonstrated evidence of normal CF chloride channel expression and near-normal channel function.
Genelabs Technologies Inc., of Redwood City, Calif., presented at this week's National Medicinal Chemistry Symposium in San Diego research on its novel antifungal compounds. Initial optimization efforts for compounds that target DNA have yielded a number that have activity against a wide panel of fungal species. A representative compound, GL406349, was tested in vivo and found to be dose-dependently effective over vehicle control in improving survival in a mouse model of systemic infection with Candida albicans.
Helix BioMedix Inc., of Bothell, Wash., completed a $3 million private financing. The company sold $3 million in promissory notes that mature on Dec. 31, 2002. The proceeds will be used to fund ongoing programs focused on the commercialization of Helix's library of antimicrobial peptides.
Immuno-Designed Molecules SA, of Paris, said it will expand its North American activities by creating a U.S. base, IDM Inc., of Irvine, Calif. Its offices and laboratories, home to 17 new employees, will work on a recent FDA agreement on a Phase III trial in ovarian cancer.
ImmunoGen Inc., of Cambridge, Mass., presented at this week's National Medicinal Chemistry Symposium in San Diego positive data on its taxane derivatives. Data show the derivatives can be linked to tumor-targeting monoclonal antibodies and are more potent than Taxol (paclitaxel) in vitro against both taxane-responsive and multi-drug-resistant cancer cell lines. ImmunoGen said the taxane derivatives broaden its Tumor-Activated Prodrug technology platform.
Kosan Biosciences Inc., of Hayward, Calif., was awarded a $2 million Advanced Technology Program grant from the National Institute of Standards and Technology to support fundamental research in the de novo assembly of polyketide synthases (PKS) by combinatorial biosynthesis. The grant was awarded to support Kosan in seeking to solve the problem of combining modules from different PKS genes to make a novel, productive PKS that produces a desired polyketide. Kosan plans to use a combinatorial approach to develop a comprehensive set of rules with high predictive power on how to combine modules.
MDS Pharma Services Inc., of Montreal, introduced its Small Molecule Development Program aimed at providing consulting services for drug development. MDS said the program provides an initial, standardized small-molecule development plan from which specific plans based on individual client needs may be developed. It is designed to optimize lead candidate selection and preclinical development, establish clinical proof of concept and progress candidates through clinical development and market registration faster.
Nabi Biopharmaceuticals Corp., of Rockville, Md., began Phase I testing of NicVAX, or Nicotine Conjugate Vaccine, its investigational vaccine designed to help the body develop antibodies that bind to nicotine and block it from reaching the brain. In preclinical studies, NicVAX generated antibodies that reduced nicotine levels in the brain by up to 64 percent and blocked the effects of nicotine at relatively high doses. The study will examine NicVAX's safety and ability to stimulate the immune system in 20 healthy, nonsmoking adults who will be randomly assigned NicVAX or placebo. Safety and antibody levels against nicotine will be measured.
Nanogen Inc., of San Diego, entered into a collaboration with NASA's Ames Research Center under which Nanogen provided a NanoChip Molecular Biology Workstations to NASA in exchange for commercialization rights to NASA-developed intellectual property and assays. NASA will use the Nanogen platform to develop and validate protocols for specific single nucleotide polymorphism and short tandem repeat analyses related to mission requirements. Also, NASA will evaluate NanoChip technology to potentially develop biosensors for astrobiology and biomedical applications.
NeoTherapeutics Inc., of Irvine, Calif., raised $1.66 million through the sale of common stock and warrants to three institutional investors. NeoTherapeutics issued about 6.7 million shares at approximately 25 cents each. In addition, NeoTherapeutics issued 200,000 warrants exercisable at 45 cents per share, and 593,548 warrants exercisable at 27.5 cents each, raising an additional $252,000.
Neurocrine Biosciences Inc., of San Diego, presented at this week's Associated Professional Sleep Societies meeting in Seattle data from two Phase I pharmacokinetic trials with indiplon (NBI-34060). Results indicate no significant differences in the pharmacokinetic profiles in elderly subjects relative to younger adults after single and repeated dosing. In addition, no significant differences were observed in female subjects relative to males.
NPS Pharmaceuticals Inc., of Salt Lake City, said clinical supplies of Preos, its drug candidate in a Phase III trial for the treatment of osteoporosis, are sufficient to allow the trial to proceed without interruption or modification until late September. NPS added that Preos met all release specifications - continued monitoring indicates that none of this material has deteriorated in quality, and testing of reference samples retained by NPS confirms the quality of previously released material.
Pharsight Corp., of Mountain View, Calif., said it is expanding its clinical development partnership with Pfizer Inc., of New York. Pharsight has supplied technology to Pfizer's Sandwich, UK, and Ann Arbor, Mich., sites since 1998. The new agreement expands the relationship to Pfizer's Groton, Conn., and La Jolla, Calif., sites. Terms of the new agreement were not disclosed.
Symyx Technologies Inc., of Santa Clara, Calif., signed a multiyear extension of its research and development collaboration with the Dow Chemical Co., of Midland, Mich., to focus on the discovery of catalysts to produce polyolefins. Dow will continue to fund Symyx's discovery efforts and will have exclusive rights to commercialize materials discovered within the collaboration. Symyx will receive royalties in connection with the sale of any products commercialized under the agreement. The companies have collaborated since January 1999.
The National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases, of Bethesda, Md., completed a study that found no association between the use of an anti-HIV treatment that uses a combination of drugs during pregnancy and an increased risk of birth complications such as premature delivery and stillbirth. The study appears in today's issue of the New England Journal of Medicine.
Transkaryotic Therapies Inc., of Cambridge, Mass., released preliminary results of a Phase I/II study of iduronate-2-sulfatase (I2S), its investigational enzyme replacement therapy to treat Hunter syndrome. The randomized, double-blind, placebo-controlled trial, in which 12 patients were randomized to receive 0.15, 0.5, or 1.5 mg/kg doses of I2S or placebo as an intravenous infusion every other week over six months, demonstrated reductions in levels of glycosaminoglycan, the toxic substrate that accumulates in patients with Hunter syndrome. There also were reductions in liver and spleen size, as well as evidence of clinical activity in several areas, including pulmonary function and joint mobility.
Vertex Pharmaceuticals Inc., of Cambridge, Mass., began a Phase I trial of VX-702, an orally administered inhibitor of p38 mitogen-activated protein kinase, targeting the treatment of inflammatory diseases. The double-blind, placebo-controlled, randomized trial is designed to evaluate the safety, tolerability and pharmacokinetics of VX-702 in approximately 50 healthy volunteers. Blood samples will be analyzed to determine the ability of different doses of VX-702 to inhibit experimentally induced cytokine production using specific biochemical assays.