¿ Advanced Biotherapy Inc., of San Diego, completed a private placement of $1.5 million of convertible subordinated debt to finance its new corporate strategy of advancing its drug development programs. It will focus on developing an anti-interferon-gamma drug product to be used for the treatment of autoimmune diseases. It has made some management changes to pursue these goals. Paul Marangos, Alexander Cappello and John Bendheim have been added to its board. Marangos is now chairman and CEO, while the former CEO, Edmond Buccellato, resigned but will continue to serve on the board.
¿ Advanced Viral Research Corp., of Yonkers, N.Y., said scientists from the Advanced Viral Research Institute are presenting research at the HIV DART 2000 conference taking place through today in San Juan, Puerto Rico. The research suggests Product R may have clinical efficacy in the therapy of HIV-1-infected patients by stimulating immune attacks against virally infected cells and by down-regulating viral co-receptors on target T cells. It appears to mitigate the toxicity of nucleoside analogues and protease inhibitor-type drugs used to treat AIDS. Product R is a peptide nucleic acid-type immunomodulator, termed a "switch-type" immunomodulator.
¿ Applied Molecular Evolution Inc., of San Diego, and Biosynexus Inc., of Rockville, Md., entered an agreement to develop an optimized prophylactic agent for staphylococcus bacterial infection in neonatal and pediatric populations. Applied Molecular will receive research and development funding, additional payments if certain milestones are achieved, and royalties on any product sales.
¿ AVI BioPharma Inc., of Portland, Ore., completed preclinical studies using its Neugene antisense technology targeting the liver enzyme, cytochrome P450. The studies showed that Neugenes would alter expression of cytochrome P450 3A4 (CYP 3A4) in the liver. CYP 3A4 is a liver enzyme that regulates metabolism of about 60 percent of all FDA-approved drugs and drugs broken down by this enzyme stayed in an active form longer. AVI said it expects to begin human trials in early 2001.
¿ British Biotech plc, of Oxford, England, and BresaGen Ltd., of Adelaide, Australia, entered a collaborative agreement to develop and commercialize BresaGen's E21R, its compound that has completed Phase I trials in patients with solid tumors and is targeted initially for the treatment of acute myeloid leukemia. Under the terms, British Biotech will make an equity investment of $1 million in BresaGen by issuing 1.1 million new shares at A$1.67 (US92 cents) per share. It will make up-front and milestone payments totaling $7 million on the successful development and approval of E21R. Further milestone payments of $6 million for each indication also will be paid to BresaGen, as well as royalties on sales.
¿ Cell Genesys Inc., of Foster City, Calif., began construction of a multiproduct manufacturing facility, located in Hayward, Calif., to meet the clinical production requirements for Phase III studies and potential product launches. The 41,000-square-foot facility will be used to manufacture its GVAX cancer vaccines as well as other gene therapy products, including those for hemophilia and cancer. The facility is expected to be fully validated and online by mid-2002.
¿ Ceres Inc., of Los Angeles, and The Institute for Genomic Research, of Rockville, Md., said they are collaborating to identify the structure of genes and their encoded proteins in the chromosomes of the plant species Arabidopsis thaliana, which is used for genetic studies of agricultural crops and other plants.
¿ Copernicus Therapeutics Inc., of Cleveland, signed a research and development agreement with the U.S. Naval Medical Research Center to explore uses of Copernicus' PLASmin Complexes in the development of a malaria DNA vaccine. The complexes will be tested by a Navy team of investigators and several routes of delivery will be explored.
¿ Enzon Inc., of Piscataway, N.J., said the European Union's Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products issues a positive opinion to Schering-Plough Corp., of Madison, N.J., recommending approval of Pegintron injection and Rebetol capsules as combination therapy for the treatment of both relapsed and naove adult patients with histologically proven chronic hepatitis C. The opinion serves as the basis for a European Commission approval, typically issued in three to four months.
¿ Ganeden Biotech Inc., of Cleveland, said its nonantibiotic therapy demonstrated a statistically significant reduction in density and duration of multiple strains of vancomycin-resistant enterococci in replicated animal testing. It said it believes its therapeutic model will be effective against antibiotic-resistant staphylococcus, campylobacter, escherichia and clostridium. Ganeden focuses on therapeutic products based on the properties of lactic acid-producing bacteria.
¿ Genzyme Corp., of Cambridge, Mass., said newly created Genzyme Biosurgery began trading, under the Nasdaq symbol GZBX. There are approximately 37 million Genzyme Biosurgery shares outstanding.
¿ Geron Corp., of Menlo Park, Calif., said it entered two agreements to license its nuclear transfer technology to generate cloned poultry. AviGenics Inc., of Athens Ga., and Origen Therapeutics Inc., of Burlingame, Calif., obtained option rights to nonexclusively license nuclear transfer technology for use in avian species. Geron will receive equity in AviGenics and Origen in exchange for the option rights. Terms of the licenses include additional equity and a share in future revenues generated from products under the licenses.
¿ GlycoDesign Inc., of Toronto, signed a three-year research collaboration with the Institute for Biological Sciences at the National Research Council, where they will invest a total of C$4.1 million (US$2.7 million). Proceeds will be used to characterize new glycobiology drug targets from a number of bacteria including Helicobacter pylori. The collaboration will focus on surface carbohydrates, already demonstrated to play a role in H. pylori infection.
¿ GPC Biotech AG, of Martinsried, Germany, received a DM2.5 million (US$1.1 million) research grant from the BMBF (German Federal Ministry of Research) under the Eureka research initiative. During the three-year Eureka project, GPC and its research partner, Eurogentec SA, of Seraing, Belgium, will develop approaches to mapping disease signaling pathways of major types of human cancer.
¿ ICOS Corp., of Bothell, Wash., and Texas Biotechnology Corp., of Houston, said their partnership venture, ICOS-Texas Biotechnology L.P., initiated a Phase I study of TBC3711, an oral endothelin A receptor antagonist. It also expects to initiate a Phase IIb/III trial with sitaxsentan, also an endothelin A receptor antagonist, in the first quarter of 2001.
¿ Maxim Pharmaceuticals Inc., of San Diego, is facing a class action lawsuit filed by Bernstein Liebhard & Lifshitz LLP, of New York, on behalf of purchasers of Maxim's publicly traded securities between Jan. 5 and Dec. 13. The case is pending in the U.S. District Court for the Southern District of California with Maxim; Larry Stambaugh, president and CEO of Maxim; and Dale Sander, executive vice president and chief financial officer named as defendants. The complaint alleges the issuance of materially false and misleading information regarding the company's condition and prospects. The case stems from an FDA advisory committee's 14-0 vote to recommend against approval of Maxim's product Maxamine. Wolf Popper LLP, of New York, filed a similar suit. (See BioWorld Today, Dec. 14, 2000.)
¿ NeoTherapeutics Inc., of Irvine, Calif., said subsidiary NeoGene Technologies Inc. raised $2 million through the private placement of preferred stock with Societe Generale, of France. The stock is convertible into approximately a 4 percent ownership interest. Proceeds from the sale will be used to fund the expansion and ongoing research activities of NeoGene.
¿ North American Scientific Inc., of Chatsworth, Calif., closed its public offering of 2.5 million shares, including 180,000 shares by selling stockholders, at $17.875 per share. CIBC World Markets Corp., of New York, acted as lead manager for the offering, with UBS Warburg LLC, of Stamford, Conn., and Leerink Swann & Co. Inc., of Boston, acting as co-managers. The underwriters exercised their option to purchase an additional 375,000 shares to cover overallotments. Gross proceeds were $51.4 million with net proceeds being $44.7 million.
¿ Nymox Pharmaceutical Corp., of Maywood, N.J., said its management and members of its board intend to purchase in the open market up to 1 million shares of Nymox's outstanding common stock. It is expected that the purchases will take place over a period of up to 18 months.
¿ Odyssey Pharmaceuticals Inc., of San Ramon, Calif., entered a license agreement with Becton, Dickinson and Co., of Franklin Lakes, N.J., to grant Odyssey the sole right and license to certain proprietary substrates for cell-based gene function and high-throughput screening applications. The compounds are fluorescent and chromogenic substrates for beta-lactamase. Under the license, Odyssey has the worldwide rights to make, use and sell the compounds for cell-based drug discovery and gene function assays.
¿ OSI Pharmaceuticals Inc., of Uniondale, N.Y., said Pfizer Inc., of New York, opened an investigational new drug application for Phase I trials in the U.S. to evaluate a small-molecule anticancer drug designed to inhibit angiogenesis. The compound was developed to block tumor-induced angiogenesis, or blood vessel growth, which has been shown to play a role in the development of solid tumors.
¿ ProQuest Investments, of Princeton, N.J., said it completed its first close for its second life sciences/oncology-focused venture capital fund, named ProQuest II, in four weeks and exceeded $100 million. It said it expects to close the remainder of the fund in 2001, with a goal of $200 million. It plans to invest in biotechnology, pharmaceutical, medical device and Internet health-care companies treating cancer and related diseases.
¿ Shire Pharmaceuticals Group plc, of Andover, England, signed a research, development and licensing agreement with CeNeS Pharmaceuticals plc, of Cambridge, England, for the development of CeNeS' dopamine D1 agonist program for the treatment of Parkinson's disease. Shire will make milestone payments and pay CeNeS royalties on products developed under the agreement. Shire has also made an equity investment in CeNeS of #500,000 (US$738,000) at a price of 62 pence per share and will fund all development work. Depending on the achievement of future milestones, Shire may subscribe for a further #500,000 of CeNeS shares at the then-current market price.
¿ Targeted Genetics Corp., of Seattle, initiated treatment of the first patient in a Phase II study of tgDCC-E1A in combination with radiation therapy for the treatment of head and neck squamous cell carcinoma. A Phase II study on tgDCC-E1A as a single agent was completed in May and the new study is open to adult patients with recurrent or progressive, inoperable squamous cell carcinoma of the head and neck who have had previous radiation therapy. E1A is a tumor-inhibitory gene that studies have shown can induce apoptosis.
¿ Third Wave Technologies Inc., of Madison, Wis., entered a research collaboration with the Wellcome Trust's business subsidiary, Catalyst BioMedica Ltd., of London, and Cambridge University to provide its proprietary Invader operating system-based products to help discover the genetic differences that predispose certain people to Type I diabetes and other inflammation-related diseases. Third Wave can commercialize certain resultant discoveries.
¿ Valentis Inc., of Burlingame, Calif., presented results from preclinical studies demonstrating a synergistic increase in antitumor response by a gene medicine that combines interleukin-12 and interferon-alpha genes for the treatment of solid tumors, at the Ninth International Conference on Gene Therapy of Cancer in San Diego. The gene medicine is in a Phase II trial and up to 40 patients will be enrolled in the study, expected to be completed in the first quarter of 2002.