¿ Adolor Corp., of Exton, Pa., said it started enrollment in a Phase III trial of ADL 8-2698 in patients with opioid bowel dysfunction. The double-blind, placebo-controlled, multicenter trial is expected to enroll about 160 patients, 18 years or older, in the United States for a dosing period of 21 days. In March, Adolor began a Phase III trial for ADL 8-2698 in post-operative ileus. ADL 8-2698 is an oral, nonabsorbed small-molecule opioid receptor antagonist that works locally in the gastrointestinal tract. (See BioWorld Today, March 20, 2001.)
¿ Alteon Inc., of Ramsey, N.J., started a Phase IIb SAPPHIRE (Systolic And Pulse Pressure Hemodynamic Improvement by Restoring Elasticity) trial of its lead A.G.E. crosslink breaker compound, ALT-711, in patients with isolated systolic hypertension. The trial will evaluate ALT-711¿s ability to lower systolic blood pressure and pulse pressure in aging and diabetic patients. The oral compound will be tested in 450 patients at 40 sites in the U.S., and involve four doses and placebo. Enrollees will receive ALT-711 tablets once a day for six months, in addition to their existing medications.
¿ ARCH Venture Partners, of Chicago, closed its $380 million seed and early stage venture capital fund to commercialize business opportunities in technologies involving life sciences, biotechnology, genomics, information technology, communications, optical networking and physical sciences. The ARCH Venture Fund V LP will bring total capital under management to more than $700 million.
¿ Arena Pharmaceuticals Inc., of San Diego, entered into an agreement with the ICI group, of London, to apply Arena¿s CART technology to olfactory and gustatory G protein-coupled receptors. The initial stage of research will last at lease six months, and Arena said it will use CART to develop olfactory and/or gustatory GPCR assays for ICI and then screen using compounds supplied by ICI. This is Arena¿s first agreement for the application of CART outside of the pharmaceutical sector. Additional terms of the deal were not released.
¿ Avigen Inc., of Alameda, Calif., received two notices from the FDA that its adeno-associated viral vectors containing the gene for human coagulation factor IX, Avigen¿s Coagulin-B, qualify for orphan drug designation. The company reported that one designation covers the vector for intramuscular delivery and the second covers the vector for liver delivery of its gene therapy for patients with moderate to severe hemophilia B.
¿ Biomax Informatics AG, of Martinsried, Germany, said Millennium Pharmaceuticals Inc., of Cambridge, Mass., licensed the BioRS Integration and Retrieval Plus system (version 4.0). Millennium will use the high-speed data retrieval system as a bioinformatics tool as part of its existing technology platform, Biomax said.
¿ BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said it requested and was granted permission to voluntarily delist its common stock from the Canadian Venture Exchange. The stock will stop trading effective at the close of business on July 20. The company¿s stock will continue to trade on the OTC Bulletin Board in the U.S. under the BTPH trading symbol.
¿ Celera Genomics Group, of Rockville, Md., signed an agreement with the National Cancer Institute. The agreement outlines the terms and conditions under which individual NCI principal investigators may elect whether or not to purchase access to Celera¿s analytical tools and database products, including the fruit fly, human and mouse genomes. Subscribers will access the database information through the Celera Discovery System.
¿ Celgene Corp., of Warren, N.J., released positive results from a study published in the July 15 edition of Blood. The study reported two-year event-free and overall survival rates of 20 percent and 48 percent, respectively, in a follow-up of a Phase II trial of 169 advanced and refractory multiple melanoma patients given Thalomid as a single-agent treatment. Researchers also found higher response rates (63 percent vs. 45 percent) and longer survival time (54 percent vs. 21 percent) in patients who received higher dosing (greater than or equal to 42 grams) of Thalomid in a three-month period.
¿ Consensus Pharmaceuticals Inc., of Medford, Mass., and Vertex Pharmaceuticals Inc., of Cambridge, Mass., entered into a collaborative agreement in which Consensus will provide Vertex with substrates and chemical analysis of the catalytic site requirements for 10 targets in the protease gene family. The agreement also will entail the cloning, production and kinetic assessment of novel protease targets. Vertex has the right to develop and market products resulting from the collaboration in exchange for which Consensus will receive certain research support and milestone payments. Financial terms were not disclosed.
¿ Cray Inc., of Seattle, said it is collaborating with the National Cancer Institute to develop bioinformatics research tools. By using ultra-fast Cray supercomputers originally used by the government, NCI and Cray are developing genome analysis software designed to identify and analyze genes involved in cancer and other diseases.
¿ Discovery Laboratories Inc., of Doylestown, Pa., began patient enrollment in its multinational Phase III trial evaluating Surfaxin for the prevention and treatment of idiopathic respiratory distress syndrome in premature infants. Approximately 1,500 patients will be enrolled in North and South America and Europe. The trial is intended to provide the basis for FDA approval. Surfaxin is being evaluated in a separate Phase III trial in meconium aspiration syndrome in full-term newborns, as well as a Phase II trial in acute respiratory distress syndrome in adults. (See BioWorld Today, April 5, 2001.)
¿ DoubleTwist Inc., of Oakland, Calif., said the genomic annotation XML format used to create its annotated human genome database is now freely available as an open standard to the life sciences community. The company¿s Architecture for Genomic Annotation, Visualization and Exchange allows users to manage, visualize and share annotations of genomic sequences using the document type definition and associated tools.
¿ Durect Corp., of Cupertino, Calif., adopted a stockholders rights plan. The rights issued as part of the plan initially will trade with shares of the company¿s common stock. The distribution of the rights will be payable to stockholders of record as of July 20, and will expire on July 6, 2011. The rights are not exercisable until 10 days after a person or group announces the acquisition of 17.5 percent or more of Durect¿s outstanding common stock or announces a tender offer resulting in more than 17.5 percent ownership.
¿ Endovasc Ltd. Inc., of Montgomery, Texas, said data showing nicotine is capable of affecting the formation of new blood vessels following heart attack or stroke were published by Stanford University. Endovasc has the worldwide, exclusive license for nicotine receptor agonist.
¿ Generex Biotechnology Corp., of Toronto, reported closing two separate private placements. The company said that the terms of the two transactions were similar and consisted of the sale of common stock to accredited investors for $9.25 per share. For each share of common stock, investors received a three-year warrant to purchase 0.25 shares at an exercise price of $10.175 per share. Gross proceeds from both placements totaled US$11 million. Generex said it would use the funds for research and development and general corporate purposes. The company focuses on buccal delivery of large-molecule drugs.
¿ HiberGen Ltd., of Dublin, Ireland, granted Sequenom Inc., of San Diego, an exclusive license to its proprietary SNaPIT genotyping technology for use with mass spectrometry. Sequenom has the right to develop and commercialize reagent kits and software based on HiberGen¿s technology for use with its MassARRAY high-throughput screening technology. Terms were not disclosed.
¿ Incyte Genomics Inc., of Palo Alto, Calif., and Secant Technologies Inc., of Cleveland, partnered to market and further develop Incyte¿s Genomics Knowledge Platform (GKP). Incyte will continue to market GKP to the life sciences community and support existing customers. The partnership will provide Secant with the exclusive license to assume further development and marketing of GKP and for Incyte to make an equity investment in Secant. The companies also will collaborate on professional services and support offerings for GKP customers. Financial terms were not disclosed.
¿ Inflazyme Pharmaceuticals Ltd., of Richmond, British Columbia, closed its public offering of 3.75 million common shares at $2.70 per share. Gross proceeds of the offering are C$10.125 million (US$6.6 million) prior to exercise of the overallotment option, in which underwriters can purchase an additional 562,500 shares. RBC Dominion Securities Inc. was lead underwriter. Others were CIBC World Markets, Yorkton Securities Inc. and Dlouhy Merchant Group Inc. The company said net proceeds would primarily be used to accelerate the research and clinical development of its IPL550,260, IPL512,602 and IPL567,092 candidates. Inflazyme develops small-molecule therapies for the treatment of inflammatory disease.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it filed a patent infringement suit against Sequitur Inc., of Natick, Mass., in the U.S. District Court, Southern District of California. The suit alleges infringement of U.S. Patent No. 6,001,653, a patent owned by Isis and one Isis contends is used in Sequitur¿s Antisense Functional Genomics Program.
¿ Medinox Inc., of San Diego, started a Phase I/IIa trial designed to evaluate the safety, tolerability and preliminary efficacy of NOX-100 in sepsis patients. The trial will take approximately one year to complete, and will be conducted at Stanford University and the University of Pittsburgh Medical Center. NOX-100 is the first in a series of small-molecule, nitric oxide (NO)-blocking agents that are designed to bind and inactivate the excessive amounts of NO that are produced during inflammatory disease conditions.
¿ Metabolex Inc., of Hayward, Calif., reported beginning a Phase I trial of its lead investigational drug, MBX-102. The drug is a single isomer of racemic drug previously studied in human clinical trials as a potential treatment for lowering lipids. The company reported that in animal models, MBX-102 had the ability to lower glucose by reducing insulin resistance, as well as lowering total cholesterol and triglycerides.
¿ NicOx SA, of Sophia Antipolis, France, said the National Cancer Institute in the U.S. awarded a second research grant for the company¿s nitric oxide-releasing aspirin compounds to scientists at the American Health Foundation in Valhalla, N.Y. The objective of the research is to study the effect of the aspirin derivatives, including the lead compound NCX 4016, on the chemoprevention of colon cancer. The grant totals roughly $2 million, and the studies will be conducted over five years.
¿ Protein Therapeutics Inc., of Tucson, Ariz., started enrollment for a Phase II trial of oral human gammaglobulin for patients with severe juvenile rheumatoid arthritis. The trial is an eight-week, double-blind, placebo-controlled study followed by an open-label trial extension that will allow all participants the opportunity to continue treatment with the drug. Approximately 50 patients will be enrolled from three children¿s hospitals in Southern California.
¿ Viventia Biotech Inc., of Toronto, took legal action against the National Research Council of Canada (NRC) to protect its intellectual property from an assertion on co-inventorship by the NRC. The NRC said it has rights to the current single-chain version of Viventia¿s H11, a fully human monoclonal antibody. Viventia said it hired the NRC to perform established molecular biology procedures that were well documented and that did not constitute co-inventorship.
¿ Xanthon Inc., of Research Triangle Park, N.C., obtained a worldwide license from Xenometrix Inc., a subsidiary of Discovery Partners International Inc., of San Diego, for access to gene expression profiling claims in U.S. and European patents. The nonexclusive license covers the collection of gene expression profiles using all platforms, including biochips, high-density microarrays and other high-throughput methods.
¿ Xenova Group plc, of Slough, UK, said that after reviewing recently submitted toxicology and clinical study results, the FDA released the company¿s TA-CD anti-cocaine addiction vaccine product candidate from clinical hold. The TA-CD Phase IIa study was placed on precautionary hold in August 2000 following observation that a related product caused eye irritation in preclinical studies. The company said it plans to initiate a new Phase II cocaine challenge study in the U.S. in the near future.