¿ Agritope Inc., of Portland, Ore., received a U.S. Department of Agriculture Small Business Industrial Research Phase II grant of $265,000 to develop virus-resistance technology for raspberry plants. This award follows the completion of a USDA SBIR Phase I grant in 1999 that supported the successful development of the core virus-resistance technology.
¿ Antigenics Inc., of New York, initiated a Phase II clinical trial of lead product Oncophage, a cancer vaccine, in patients with sarcoma, or soft tissue cancer. The trial is the ninth in humans and covers the seventh indication for Oncophage, a heat shock protein. The 20-patient trial's primary objective will be safety, efficacy and tolerance in patients with recurrent metastatic or unresectable soft tissue sarcoma. The therapeutic is in a Phase III clinical trial in renal cell carcinoma and in seven other Phase II or I/II trials for five other cancer indications.
¿ Applied Biosystems Inc., of Foster City, Calif., served Affymetrix Inc., of Santa Clara, Calif., with a complaint of patent infringement related to a suit originally brought in July. Applied Biosystems alleged that Affymetrix infringed on five patents related to technology for making oligonucleotides.
¿ Biogen Inc., of Cambridge, Mass., began a new investigator-run clinical trial to assess the long-term effect of treatment with Avonex in delaying the development of multiple sclerosis. The study is designed to follow up the Champs study, published last month in the New England Journal of Medicine, that showed early treatment with Avonex significantly reduced the rate at which those individuals at high risk developed clinically definite MS. The new study will be called Champions.
¿ Biogen Inc., of Cambridge, Mass., said data from an in vitro study showed that Avonex (interferon beta-1a), the company's multiple sclerosis treatment, is more potent on a mass basis than Rebif and Betaseron, other commercially available beta interferons. The study, performed independent of Biogen, was presented at the 125th Annual Meeting of the American Neurological Association in Boston. Results indicated that Avonex more easily suppressed the secretion of immunoglobulin G antibodies, which are increased in MS patients.
¿ Bioject Medical Technologies, of Portland, Ore., and Serono International SA, of Geneva, Switzerland, expanded their exclusive licensing agreement for Bioject's Vitajet 3 needle-free injection system to cover exclusive worldwide usage for all current and future Serono growth hormone products and indications. The agreement reached in January covered the delivery of Serono's recombinant human growth hormone for the treatment of pediatric growth hormone deficiency, Saizen. The expansion covers both Saizen and Serostim, a high-dose formulation of growth hormone currently marketed for the treatment of AIDS wasting, and exclusive options for Serono to use all new technologies developed by Bioject in the delivery of growth hormones.
¿ Chiron Corp., of Emeryville, Calif., said the UK Medicines Control Agency and the Irish Medicines Board approved its meningococcal C conjugate vaccine, Menjugate, for immunizing infants 2 months and older against meningococcal disease caused by Neisseria meningitidis serogroup C. Menjugate was approved in the UK for adults, adolescents and children over 1 year old in March, and in Ireland in August.
¿ Diatos SA, of Paris, raised $13.16 million through an international private financing co-led by GIMV, of Belgium, and InterWest Partners, that included Societe Generale Asset Management, of France; AGF Private Equity, of France; Sopartec, of Belgium; and founding investor Sofinnova Parnters, of France. Diatos said the funding allows it to accelerate the development of core research programs and move lead product candidates through early stage clinical trials in cancer and infectious diseases.
¿ DNAPrint Genomics Inc., of Sarasota, Fla., merged with SDE Holdings 1 Inc., an SEC 12g full reporting company, by acquiring all of the issued and outstanding stock of SDE. The merger allows DNAPrint to file its 211 application with the National Association of Securities Dealers as a successor full reporting company to become listed on the OTC Bulletin Board. DNAPrint expects to file its 8-K 12g3 within the next few days, and will apply to the NASD immediately after the filing.
¿ DoubleTwist Inc., of Oakland, Calif., and Hitachi Ltd., of Tokyo, agreed to a license purchase agreement covering DoubleTwist's suite of bioinformatics software for marketing and distribution in the Asia-Pacific region. Hitachi will provide the bioinformatics services via a virtual private network.
¿ Epimmune Inc., of San Diego, completed a private placement valued at $2 million for 500,000 shares at $4 each to private investor Peter Allard. Upon the close of the transaction Epimmune has about 9.3 million shares outstanding. Epimmune said the investment will aid in the funding of HIV vaccine clinical trial initiation.
¿ Ergo Science Corp., of Boston, settled a dispute with Louisiana State University, paying the institution $3.05 million. The dispute rose from royalty payments owed to LSU stemming from a joint collaborative agreement Ergo entered with Johnson & Johnson, of New Brunswick, N.J., to develop and commercialize Ergoset for the treatment of Type II diabetes and obesity.
¿ Gliatech Inc., of Cleveland, responded to the FDA's Form 483, which questioned aspects of the company's pivotal trial for Adcon-L gel, its biopolymer for the inhibition of post-surgical scarring and adhesions following tendon and peripheral nerve surgery. Those questions helped quash Gliatech's planned merger with Guilford Pharmaceuticals Inc., of Baltimore, in August. Gliatech proposed re-evaluating magnetic resonance imaging data for the patient population from the trial, and is retaining consultants to comprehensively evaluate its clinical study processes for management and training. Gliatech also added personnel in its clinical research and quality assurance departments. (See BioWorld Today, Aug. 30, 2000.)
¿ Hemosol Inc., of Toronto, received regulatory approval for its investigational new drug application for its cell therapy program for chronic myeloid leukemia (CML). The 15-patient Phase I study will explore the feasibility of expanding gamma-delta T cells from patients with advanced CML for re-infusion as a treatment of residual disease.
¿ Incara Pharmaceuticals Inc., of Research Triangle Park, N.C., said data indicate its lead catalytic antioxidant molecule significantly reduced brain damage with administration as late as 7.5 hours after the obstruction of blood flow in an animal model of stroke. The molecule is one of a family of molecules that inactivates reactive oxygen species including superoxide, hydrogen peroxide and peroxynitrate, in a manner similar to naturally occurring enzymes.
¿ Incyte Genomics Inc., of Palo Alto, Calif., agreed to license its LifeExpress gene expression database to Bristol-Myers Squibb Co., of New York. Financial terms were not disclosed, but Incyte said it could receive milestone payments and royalties related to commercialization of products developed with the database technology or information.
¿ Infigen Inc., of DeForest, Wis., was awarded a $1.8 million grant from the National Institute of Science and Technology to develop its genomics-based approach for increasing the speed, efficiency and success of cloning farm animals for medical and agricultural applications, production of pharmaceutical proteins, food products and replacement organs.
¿ Interferon Sciences Inc., of New Brunswick, N.J., acquired a $100,000 option to purchase about half of the stock of Metacine Inc., an anticancer vaccine company using dendritic cell technology developed at the University of Pittsburgh Medical Center. Metacine currently is testing a compound in a Phase I clinical trial at the university for melanoma, and the company expects an additional Phase I trial of an autologous vaccine using a patient's own tumor cells to create an immune response to begin within a year. The 60-day option may be exercised for the purchase of 43 percent of Metacine in exchange for ISI stock, cash and services after a third-party review of Metacine's technology is delivered to ISI.
¿ Lorus Therapeutics Inc., of Toronto, moved its lead antisense anticancer drug, GTI-2040, into Phase II trials. GTI-2040, according to interim results from a Phase I/II clinical trial in patients with advanced or metastatic solid tumors or lymphomas, demonstrated safety and tolerability in addition to early signs of disease stabilization.
¿ Lynx Therapeutics Inc., of Hayward, Calif., and Molecular Engines Laboratories SA (MEL) entered a two-year research collaboration to identify differentially expressed genes associated with tumor reversion. The collaboration will use Lynx's Megasort technology to analyze cancer cells provided by MEL. Lynx will receive payments from MEL for the genomic discovery services and royalties from the commercialization of any products or services stemming from the collaboration. Further financial terms were not disclosed.
¿ Myogen Inc., of Denver, received a Small Business Innovation Research grant from the National Institutes of Health to fund research for development of long-term heart muscle cell culturing technology. Myogen's lead therapeutic, an oral formulation of enoximone, entered Phase III clinical trials earlier this year.
¿ Myriad Genetics Inc., of Salt Lake City, introduced ProSpec, a proteomic target identification and validation technology that complements the company's ProNet technologies with the use of mass spectrometry to identify protein complexes. It uses a combination of ProNet's version of yeast two-hybrid and mass spectrometry to deliver structural information about 3-D protein complexes.
¿ Nortran Pharmaceuticals Inc., of Vancouver, entered an exclusive worldwide licensing agreement for the development and marketing of its antiarrhythmic drug candidate with London-based AstraZeneca plc. AstraZeneca will pay an up-front payment in addition to milestone and royalty payments and all development and marketing costs for the single small-molecule antiarrhythmic candidate, allowing Nortran to continue development of other antiarrhythmics in its pipeline.
¿ Orphan Medical Inc., of Minneapolis, received priority review status for its Xyrem (sodium oxybate) oral solution from the FDA. Orphan submitted an NDA for Xyrem on Oct. 2. Xyrem is designed to treat symptoms of narcolepsy.
¿ Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., received about $6 million from the National Institutes of Health for the development of therapies and vaccines for HIV. The funding consists of a $4 million research grant, two Phase I Small Business Innovation Research grants totaling $1.2 million, and a research contract for $800,000. The research grant covers production and testing of a vaccine candidate that more faithfully mimics the viral envelope glycoproteins gp120 and gp41, and the SBIR grants cover transgenic dairy animal production of PRO 542, an antibody-like molecule that neutralizes HIV, and HIV infection laboratory and animal models testing of PRO 140, a monoclonal antibody against the virus' CCR5 fusion co-receptor. The year-long research grant funds production and preclinical testing of novel gp120 subunit vaccines.
¿ QLT Inc., of Vancouver, British Columbia, reported its third quarter financial results showing that, behind the strong sales of Visudyne (US$31 million), it had a net income of C$4.25 million (US$2.8 million) compared to a net loss of C$9.7 over the same period in 1999. Commercial Visudyne sales in North America represented US$22 million, or about 71 percent of total Visudyne sales in the third quarter.
¿ StressGen Biotechnologies Corp., of Victoria, British Columbia, closed its public offering of 6.5 million common shares at C$7 per share, 500,000 more shares than proposed in the original prospectus, raising C$45.5 million (US$29.9 million). It filed for the offering in September, seeking C$46.2 million. Some of the proceeds will be used to fund development for its lead product, HspE7. The underwriting syndicate for the offering was led by BMO Nesbitt Burns Inc. and included CIBC World Markets Corp. and Goepel McDermid Inc. (See BioWorld Today, Sept. 22, 2000.)
¿ Synt:em Inc., of Paris, and Morphochem AG, of Munich, Germany, entered a flexible framework collaboration to co-discover and co-develop novel therapeutics. The shared-contribution, shared-benefits agreement calls for the co-discovery, co-validation and co-development of products up to clinical trials. The first project the companies will focus on will be antiviral compound discovery.
¿ Theratechnologies Inc., of Saint-Laurent, Canada, filed an investigational new drug application with Canada's Health Protection Branch to begin a Phase II clinical trial on ThGRF 1-44, a growth hormone-releasing factor analogue, focused on sleep. The crossover, randomized, double-blind, placebo-controlled study is designed to assess the peptide's safety and efficacy with two doses in 12 healthy male subjects, and to determine the compound's effect in a seven-day treatment on slow-wave sleep.
¿ Viragen Inc., of Plantation, Fla., said subsidiary Viragen (Scotland) Ltd. initiated production of human monoclonal antibodies for treatment of melanoma and other cancers in conjunction with the Memorial Sloan-Kettering Cancer Center, of New York. The Viragen antibodies will be delivered to Memorial Sloan-Kettering for in vitro experiments to examine each antibody's binding ability and immune defense delivery capacity with tumor cells.