¿ Alkermes Inc., of Cambridge, Mass., completed enrollment in the first clinical trial of its proprietary injectable sustained-release formulation of naltrexone, an FDA-approved drug used for the treatment of alcoholism and opiate abuse. The drug is currently available in a daily oral form. Medisorb naltrexone is based on Alkermes' Medisorb injectable sustained-release drug delivery technology. Based on early data, Alkermes is preparing for larger efficacy trials. Data from the trial will be presented at the 39th annual meeting of the American College of Neuropsychopharmacology in December.
¿ Antex Biologics Inc., of Gaithersburg, Md., said its wholly owned subsidiary, AntexPharma, formed a collaboration with Lyotropic Therapeutics LLC, of Charlottesville, Va., to formulate Antex's antibiotic candidates with Lyotropic's LyoCell nanoencapsulation drug delivery system.
¿ AtheroGenics Inc., of Atlanta, said it completed enrollment in the Canadian Antitoxidant Restenosis Trial (CART-1), a Phase II clinical trial designed to assess the safety and efficacy of orally administered AGI-1067, a novel, selective anti-inflammatory compound with antitoxidant properties, in prevention of restenosis after angioplasty. The 300-patient trial is for the lead compound of the worldwide collaboration with Schering-Plough Corp., of Madison, N.J.
¿ Aurora Biosciences Corp., of San Diego, said it signed a new deal with Merck & Co. Inc., of Whitehouse Station, N.J., that focuses on identification of novel chemicals that modulate a particular ion channel target. Merck will provide a target and a compound library, while Aurora will develop the assay, which will use its voltage sensor probes, and screen the compounds. Aurora will receive undisclosed research payments and potential research and development milestones, as well as royalties on resulting marketed products.
¿ Avax Technologies Inc., of Kansas City, Mo., said its investigational autologous cell vaccine, O-Vax, received orphan drug designation from the FDA. Avax is conducting a Phase II multicenter clinical trial on O-Vax and is currently enrolling patients in the U.S.
¿ Aventis Pharmaceuticals Inc., the U.S. unit of Frankfurt, Germany-based Aventis S.A., and De Novo Pharmaceuticals Ltd., of Cambridge, UK, entered a collaboration under which Aventis has paid a technology access fee and will provide research funding for 12 months. De Novo will apply its platform of proprietary computer algorithms to provide patentable small-molecule leads for Aventis.
¿ AVI BioPharma Inc., of Portland, Ore., said it completed preclinical studies of Nugene antisense technology in cancer therapy, and it believes the studies will form the basis of an investigational new drug application filing with the FDA and commencement of a Phase Ib/II study near the end of the year. The data, which indicated the compound Oncomyc-NG targets the oncogene c-myc, shows promise in blocking tumor growth, prevents coronary artery occlusion following balloon angioplasty and inhibits progression of polycyctic kidney disease, was presented at the 7th CaP CURE prostate cancer scientific retreat last weekend in Incline Village, Nev.
¿ BioReliance Corp., of Rockville, Md., said it opened its new 58,000-square-foot manufacturing facility adjacent to its corporate headquarters and laboratories. The facility is believed to be the first of its kind, a contract facility for the manufacture of viral-based products at commercial market scale and under cGMP regulations.
¿ Compaq Computer Corp., of Houston, said it will invest $100 million in early-stage life sciences companies in working in genomics, bioinformatics and related areas, involving direct investments and investments in venture capital funds. Compaq said a "significant" investment already has been made in Applied Genomic Technology Capital Fund LP, of Cambridge, Mass.
¿ DepoMed Inc., of Menlo Park, Calif., initiated a Phase II human trial comparing Metformin GR with the currently marketed immediate-release metformin formulation. The study is meant to compare glycemic control achieved with Metformin GR and the immediate-release metformin formulation in patients with Type II diabetes. It also will look at the incidence and severity of side effects.
¿ Discovery Partners International Inc., of San Diego, said its division, Irori Inc., delivered its first NanoKan Ultra High Throughput Synthesis System for Aventis Pharma AG's Drug Innovation and Approval facility at Tucson, Ariz. NanoKan systems are based on Irori's Directed Sorting process, a split-and-pool approach to synthesizing compounds using labeled miniaturized microreactors.
¿ EDEN Bioscience Corp., of Seattle, completed an $87 million initial public offering, selling 5.8 million shares at $15 each. The total is the amount the company proposed when it registered for the sale in July. The plant technology company focuses on developing, marketing and manufacturing products that are better than existing plant-protection and yield-enhancement products. Its lead product, Messenger, which is based on naturally occurring proteins called harpins, was approved in April. Merrill Lynch & Co. and Stephens Inc. led the offering. Co-managers were George K. Baum & Co. and Ragen MacKenzie Inc.
¿ EluSys Therapeutics Inc., of Pine Brook, N.J., said it entered a collaboration with the U.S. Army Medical Research Institute of Infectious Diseases to develop treatments for anthrax and other biowarfare agents. EluSys and the USAMRIID will develop antibodies to the principal anthrax toxins for incorporation into EluSys' Heteropolymer technology, a monoclonal antibody-based system designed to enable the body to use its own red blood cells to efficiently remove and destroy blood-borne pathogens.
¿ EraGen Biosciences Inc., of Alachua, Fla., said it licensed its proprietary AEGIS (An Expanded Genetic Information System) synthetic DNA base pair technology to Bayer Diagnostics Inc., of Tarrytown, N.Y. AEGIS allows for detection and manipulation of DNA samples. Bayer will utilize the system in its proprietary branched DNA technology for nucleic acid testing, including its viral load test for HIV, the Bayer HIV-1 RNA 3.0 Assay.
¿ Keryx Biopharmaceuticals Inc., of Boston and Jerusalem, said it got approval to proceed to U.S. Phase III trials of KRX-101 (sulodexide), a drug being developed for diabetic nephropathy. Keryx plans now to design a study protocol for submission to the FDA.
¿ Genomica Corp., of Boulder, Colo., licensed its Discovery Manager software, a suite of tools for integrating genotype, epidemiological and clinical data, to Genome Therapeutics Corp., of Waltham, Mass. Financial terms were not disclosed. Genome Therapeutics will use the software in building its proprietary pharmacogenomics effort, Drug Rescue.
¿ Hollis-Eden Pharmaceuticals Inc., of San Diego, received clearance from the South African Medicines Control Council (MCC) to initiate additional clinical studies in HIV-infected patients with its lead investigational drug candidate, HE2000. The new studies will include a Phase II pilot trial to assess the ability of HE2000 to delay the onset of opportunistic infections in patients with late-stage HIV infection. A Phase I/II trial utilizing a new subcutaneous formulation of the drug has been OK'd, and the MCC cleared the company to provide continued access to HE2000 therapy beyond the planned one-year stopping point for patients showing benefit from the treatment.
¿ IDEC Pharmaceuticals Inc., of San Diego, said it received a "completed review" letter from the FDA regarding the supplemental new drug application for Rituxan, which was submitted in late 1999 based on studies in non-Hodgkin's lymphoma indications for which the product is not already indicated. IDEC said it will talk with the FDA about finalizing revisions to the package insert information. Genentech Inc., F. Hoffmann-La Roche Ltd. and Zenyaku Kogyo Co. Ltd. are partners on the drug.
¿ Ilex Oncology Inc., of San Antonio, Texas, said NM-3, its orally active small-molecule inhibitor of angiogenesis, has entered into Phase I clinical trials in France. NM-3 is thought to be a candidate for complementing radiation therapy.
¿ Imgenex Corp., of San Diego, was awarded a Small Business Innovation Research grant of $100,000 from the National Institutes of Health to develop monoclonal antibodies recognizing multiple signaling molecules involved in the genetics and maintenance of osteoporosis. The development of these previously unavailable antibodies may allow more reliable prediction and earlier detection of osteoporosis.
¿ Infigen Inc., of DeForest, Wis., and Imutran Ltd., a UK-based subsidiary of Novartis Pharma AG, reported in the October 2000 issue of Nature Biotechnology that two litters of cloned pigs were successfully produced using nuclear transfer technology, and more litters are on the way. Somatic cells cultured for eight to 22 days were fused with enucleated oocytes to produce the embryos. The companies said the feat demonstrates the commercial feasibility of porcine cloning.
¿ Insmed Inc., of Richmond, Va., registered for a proposed public offering of 6 million shares of common stock, 5 million of which will be offered by the company and 1 million by selling shareholders. The offering would raise about $75.3 million for the company if it sold 5 million shares at the $15.0625 opening stock price Tuesday, when the company disclosed the deal. The stock (NASDAQ:INSM) closed Wednesday at $13. The company is developing INS-1, an oral insulin sensitizer, for Type II diabetes and polycistic ovary syndrome, as well as SomatoKine, an IGF/BP3 complex for types I and II diabetes. Underwriting the offering is Robertson Stephens Inc., Banc of America Securities LLC and Prudential Vector Healthcare Group.
¿ Labopharm Inc., of Laval, Quebec, completed its first preclinical pilot study with an unnamed pharmaceutical company to develop a controlled-release formulation of Oxybutynin, a drug used to control urinary incontinence. Another study is under way to test the resulting formulations.
¿ Large Scale Biology Corp., of Vacaville, Calif., said its genomics division completed the fifth milestone in its collaboration with Dow Chemical Company and Dow AgroSciences LLC, of Indianapolis, with the delivery of a fully functional proprietary metabolic pathway database. The collaboration dates to 1998.
¿ Ligand Pharmaceuticals Inc., of San Diego, said it earned a $900,000 milestone payment from partner Pfizer Inc., of New York, related to Pfizer's initiation of Phase III trials of lasofoxifene, a selective estrogen receptor modulator being developed to prevent osteoporosis in postmenopausal women. The milestone is payable in Ligand shares currently held by Pfizer. Ligand is entitled to further milestones and, if approved, royalties of 6 percent on net sales.
¿ MGI Pharma Inc., of Minneapolis, started a Phase II liver cancer trial with irofulven, its anticancer compound, to evaluate its safety and efficacy in patients with inoperable liver cancer. Irofulven is the first product from MGI's family of proprietary anticancer compounds called acylfulvenes.
¿ NeuralStem Biopharmaceuticals Ltd., of College Park, Md., said it received a $500,000 investment from the state of Maryland's Enterprise Investment Fund, a program that supports early-stage technology companies by providing matching funds to private investment. The state received Series B preferred stock. The company plans to use the money to expand its internal genomics program.
¿ OSI Pharmaceuticals Inc., of Uniondale, N.Y., said Pfizer Inc., of New York, formally transferred the IND dossier for OSI-774 to OSI ahead of the schedule the two agreed upon in May. Rights were returned to OSI so Pfizer could meet FTC requirements related to its acquisition of Warner-Lambert Co. OSI now assumes full managerial and operational control of the clinical program for OSI-774, which is in ongoing Phase II studies. (See BioWorld Today, Sept, 15, 2000, p. 1.)
¿ SangStat Medical Corp., of Fremont, Calif., was awarded a Small Business Innovation Research grant for an undisclosed sum to study RDP58, SangStat's small-molecule TNF synthesis inhibitor, in SIV-infected monkeys. The funding will cover the expenses of SangStat's collaboration with Satya Dandekar at UC Davis.
¿ Telik Inc., of South San Francisco, received a Small Business Innovation Research grant from the National Institutes of Health to support the application of Trap, Telik's proprietary chemogenomics drug discovery technology. Trap is used to identify new small-molecule modulators of caspase 3, an enzyme that plays a role in central nervous system diseases and many types of cancer.
¿ Viragen Inc., of Plantation, Fla., said the National Institutes of Health's Department of Health and Human Services granted it an exclusive worldwide license to patent applications covering apoptosis-inducing agents and methods, anti-notch-1 monoclonal antibodies for inducing cellular differentiation and apoptosis and foreign filings applications covering apoptosis-inducing agents and methods. Viragen will use the technology to develop a drug that directly triggers apoptosis for use in cancer therapy.