AGY Therapeutics Inc., of South San Francisco, signed agreements with the University of Chicago; Baylor College of Medicine; the University of California, Davis; and the Institute of Enzymology in Budapest, Hungary, to identify drug targets for certain central nervous system diseases and obesity. AGYs imAGYne platform technology will be used in all four collaborations. Financial details were not disclosed.
Aviron Inc., of Mountain View, Calif., said the Vaccines and Related Biological Products Advisory Committee of the FDA is scheduled to evaluate FluMist, Avirons intranasal influenza vaccine, at a July 26-27 meeting. Aviron submitted a biologics license application for FluMist to the FDA on Oct. 31.
Axonyx Inc., of New York, completed patient enrollment in its Phase II proof-of-concept Alzheimers disease trial with Phenserine. It expects to report final results of the trial in the fall. It said it is planning Phase III trials, scheduled to begin next year, based on the progress of the Phase II trial. Tests have shown Phenserine has the ability to inhibit the formation of beta-amyloid precursor protein, believed to play a role in Alzheimers.
Cephalon Inc., of West Chester, Pa., said Actiq, for the management of breakthrough cancer pain in patients with malignancies who are receiving and who are tolerant to opioid therapy, was granted marketing authorization in 16 European countries. The product was approved Oct. 9 for sale in the United Kingdom.
Crucell N.V., of Leiden, the Netherlands, and Vaxin Inc., of Birmingham, Ala., will jointly develop two new types of vaccines suitable for injection-free administration. The companies will combine Crucells PER.C6 cell line and related vaccination technology with Vaxins skin delivery system for vaccines, EasyVax. They will share profits and costs. Further financial details were not disclosed.
Cyanotech Corp., of Kailua-Kona, Hawaii, initiated a clinical trial of BioAstin to measure its effectiveness in reducing LDL cholesterol while increasing HDL cholesterol. The study also will test if BioAstin can alter other serum markers in a double-blind, placebo-controlled trial taking place with 44 patients. BioAstin is a formulation of the microalgae, Haematococcus pluvialis.
Deltagen Inc., of Menlo Park, Calif., delivered the fourth quarterly installment of its mammalian gene function data to its DeltaBase subscribers. The DeltaBase database now includes 250 potential genomic drug targets from gene families of most interest to the pharmaceutical industry, including G protein-coupled receptors, ion channels and proteases, the company said.
Dyax Corp., of Cambridge, Mass., said its board adopted a shareholders rights plan. The company said the plan was adopted to ensure all Dyax shareholders receive fair and equal treatment in the event of any unsolicited offer of takeover attempt to acquire Dyax. The plan was not adopted in response to any specific effort to acquire Dyax, the company said.
Generex Biotechnology Corp., of Toronto, said data from studies presented at this weeks American Diabetes Association conference in Philadelphia indicate that Oralin, its oral insulin formulation, may be used in place of injected insulin to treat Type I and Type II diabetes. Oralin is delivered as a spray to the buccal cavity via Generexs Rapidmist device.
ImmunoGen Inc., of Cambridge, Mass., and BioInvent International AB, of Lund, Sweden, signed a manufacturing supply agreement to produce one of ImmunoGens monoclonal antibodies. BioInvent, through BioInvent Production AB, will perform process qualification and manufacturing of the antibody. Financial details were not disclosed.
Infigen Inc., of Deforest, Wis., said the worlds first herd of cloned dairy cows is in milk production at the companys farms. The milk will be evaluated and compared with milk from noncloned Holsteins as part of the companys review to be shared with the FDA and the National Academy of Sciences. The 18 cloned 2-year-old cows began production following calving, beginning in December 2000.
Intronn LLC, of Raleigh, N.C., received a two-year Phase II Small Business Innovative Research Grant of $2.5 million from the National Institute of Diabetes, Digestive and Kidney Diseases of the National Institutes of Health, of Bethesda, Md. The grant is to develop the therapeutic potential of Intronns patented spliceosome-mediated RNA trans-splicing technology in cystic fibrosis.
ISTA Pharmaceuticals Inc., of Irvine, Calif., completed patient enrollment in one of its two Phase III trials for Vitrase, its drug in development for the treatment of severe vitreous hemorrhage. The trial has reached its target of 680 patients and is being conducted in the United States, Mexico and Canada. Its other Phase III study is being conducted in nine countries outside North America. Vitrase has received fast-track designation for the indication from the FDA.
Maas BiolAB LLC, of Honolulu, formed its wholly owned Swedish subsidiary, NeuroPharma AB, which will be the vehicle for Maas European development of Cyclosporin Neuroprotection. Also, the company made three appointments to its international management team: Gregory Batcheller, Andreas Inghammar and Philippe Racape.
Matrix Pharmaceutical Inc., of Fremont, Calif., began enrollment in a Phase II study in patients with primary liver cancer using IntraDose (cisplatin/epinephrine injectable gel). The open-label, multicenter study will evaluate 60 patients with hepatocellular carcinoma. Endpoints include tumor response, duration of tumor response and survival. Matrix filed a new drug application with the FDA in January for IntraDose to treat refractory or recurrent head and neck cancer.
MGI Pharma Inc., of Minneapolis, said the FDA granted fast-track designation for the use of irofulven, MGIs anticancer compound, in patients with gemcitabine-refractory pancreatic cancer. Irofulven is in a series of trials for the treatment of solid tumors and in a pivotal Phase III trial for patients with pancreatic cancer.
Milkhaus Laboratory Inc., of Providence, R.I., will conduct a clinical trial of its product, ML-04, for the treatment of chronic prostatitis. The company expects the trial to begin in the third quarter.
MPM Capital LP, of Cambridge, Mass., said that its BioVentures II group of funds acquired a major ownership stake in Kourion Thereapeutics, of Dusseldorf, Germany, for up to EUR12 million (US$10.3 million). The proceeds will fund Kourions research and development activities in stem cells.
Phylos Inc., of Lexington, Mass., said a study published in the Journal of Biological Chemistry (volume 276, No. 24) demonstrates the use of its PROfusion technology, together with its tissue proteome libraries, for the discovery of new proteins that interact with a protein in apoptosis. The study reports that the PROfusion technology identifies cellular proteins that interact with one another, giving rise to a method for understanding the complexity of the proteome, the company said.
Sangamo BioSciences Inc., of Richmond, Calif., signed a definitive purchase agreement to acquire Gendaq Ltd., of London. Sangamo will issue about 2.1 million shares of common stock to acquire all of Gendaqs outstanding shares, and will reserve an additional 125,000 shares to assume all of Gendaqs outstanding options. The transaction is expected to be completed next quarter and values Gendaq at approximately $30 million. Sangamo will acquire Gendaqs research team of 16 scientists, 22 patent applications and two issued patents, and more than $5 million in cash. (See BioWorld Today, May 31, 2001.)
Serono SA, of Geneva, Switzerland, said an article published in this weeks issue of Neurology reports the results of PRISMS, a four-year study of interferon beta-1a (Rebif) in the treatment of relapsing-remitting multiple sclerosis. The conclusions of the study, involving 560 patients, give support to the use of Rebif at high dose (44 mcg) three times per week. The company also said the study suggests early treatment of MS results in benefits over later treatment.
Telik Inc., of South San Francisco, started a Phase II trial with TLK286, its product for advanced non-small-cell lung cancer. Patients will receive TLK286 once every three weeks until disease progression. Telik initiated Phase II trials in colorectal cancer and ovarian cancer in March and May, respectively.
The Forsyth Institute, of Boston, said its researchers discovered an antigen for a vaccine against dental caries. The antigen, reported in the July issue of Infection and Immunity, gives rise to greater immune responses than do many previously tested antigens, the institute said. The antigen is a component in a new formulation of a mucosal vaccine that can be squirted into the nose.
Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., said they completed patient enrollment in T20-301, a Phase III trial of T-20 ongoing in North America and Brazil. T-20 is a fusion inhibitor for the treatment of HIV. The primary analysis for the trial will occur when all patients reach 24 weeks of treatment. A second Phase III trial, T20-302, is enrolling patients at centers in Europe and Australia.
United Therapeutics Corp., of Silver Spring, Md., said the FDAs Cardiovascular and Renal Drugs Advisory Committee will discuss the benefit-to-risk profile of its drug, Remodulin (formerly UT-15), at its meeting scheduled Aug. 9-10.
Visible Genetics Inc., of Toronto, said the FDA completed the review of its 510(k) submission for the Trugene HIV-1 Genotyping Test and OpenGene system. The FDA has found Visible Genetics product to meet its requirements for clearance, subject to ordinary course labeling and other routine issues to be addressed during the de novo process, or after clearance, the company said. The FDA issued a not substantially equivalent letter to VGI, saying the product cannot be cleared as a 501(k) device because there is no similar legally marketed product in this category. VGI said it will now file a petition asking the FDA to classify its product as a Class II device based on its safety compared to other products. (See BioWorld Today, Sept. 6, 2000.)
VitaGen Inc., of La Jolla, Calif., completed the first closing of its Series C financing, raising about $14 million. Investors were JP Morgan Partners, of New York; BD Ventures, of Franklin Lakes, N.J.; Merrill Lynch Ventures, of New York; Perseus Biotech Advisors (New York Life), of New York; Tullis-Dickerson & Co., of Greenwich, Conn.; Essex Woodlands Health Ventures, of Montgomery, Texas; Pacific Horizon Ventures, of Seattle; Paragon Venture Partners II, of Menlo Park, Calif.; Alta Partners, of San Francisco; Radius Ventures, of New York; Triad Ventures Ltd. II, of Houston; and BCM Technologies, of Houston. New investors were Orbitex Management, of New York; Banc One Venture Partners, of Chicago; and CDIB U.S. Biotech, of Chicago. VitaGen said it should close a subsequent closing of the Series C shortly. The company is the first to develop a human cell-based bioartificial liver assist system intended to improve the standard of care for patients suffering from liver disease and failure.
Waratah Pharmaceuticals Inc., of Montreal, formed a collaborative research agreement with the Muttart Diabetes Center at the University of Alberta Medical Center in Edmonton, Alberta. Financial terms were not disclosed.
ZymeTx Inc., of Oklahoma City, said it will not challenge the delisting of its stock from Nasdaq, and therefore will not pursue a reverse stock split. ZymeTx develops technology to produce products for the diagnosis and treatment of viral diseases, viral management and disease surveillance.