¿ Affymetrix Inc., of Santa Clara, Calif., and Johns Hopkins School of Medicine, of Baltimore, scientists said they improved gene chip technology by making it a practical method for rapidly determining the sequence of genetic building blocks for the first time. The advance is reported in the November issue of Genome Research. The gene chips, or microarrays, are dotted with a microscopic grid of hundreds of thousands of tiny segments of DNA determined by the Human Genome Project. A new analysis method lets the team identify and focus on the chips¿ more reliable information. Until now, ways to analyze the chips were unable to distinguish highly accurate data from less reliable information. Using gene chips and their new analysis, the scientists were able to accurately determine the order of 2 million blocks of each of 40 individuals¿ genomes in just a year, a fraction of the time required by traditional technology.
¿ Arakis Ltd., of Cambridge, UK, and Penwest Pharmaceuticals Co., of Patterson, N.Y., entered a three-year alliance to develop up to six orally delivered performance-enhanced medicines for the treatment of pain conditions. The new pain treatment products will be jointly developed in the clinic during the alliance and will be created by combining Penwest¿s oral drug delivery capability with Arakis¿ ability to enhance known pharmacological agents through the use of new biological information.
¿ Astralis LLC, of Florham Park, N.J., and Hercules Development Group, of Boulder, Colo., closed their definitive merger agreement. Simultaneously with the closing, Hercules completed an equity financing of $3.2 million to assist Astralis in the development, testing and commercialization of Psoraxine, a drug that brought about clinical remission in psoriasis during clinical trials conducted in Venezuela. Hercules also changed its name to Astralis Pharmaceuticals Ltd. (See BioWorld Today, Oct. 1, 2001.)
¿ Boston Life Sciences Inc., of Boston, said scientists at Children¿s Hospital in Boston identified and isolated a previously unknown naturally occurring nerve growth factor that can potentially stimulate regeneration of the optic nerve. The optic nerve growth factor is produced uniquely by inflammatory cells. The purified factor causes nerve cells of the retina to produce axons in vitro. The axons correspond to those produced in in vivo regeneration of the optic nerve itself. The company said it will work with the hospital to get the new nerve regenerative factor into clinical testing in glaucoma as soon as possible.
¿ Cambridge Antibody Technology Group plc, of Melbourn, UK, announced follow-up results of a Phase II trial using CAT-152 (lerdelimumabin; human anti-TGFB monoclonal antibody) patients undergoing surgery for glaucoma and cataract. CAT-152 is designed to prevent excessive post-operative scarring, which is the major reason glaucoma surgery can fail to lower intraocular pressure in the long term. The trial studied 56 patients who were undergoing combined glaucoma and cataract surgery, and patients were randomized to receive either CAT-152 or matching placebo in a series of four subconjunctival injections that were given on the day of surgery, the day after surgery and a week after surgery.
¿ Corvas International Inc., of San Diego, said enrollment in the multicenter Phase IIb study of UK-279,276 (formerly known as neutrophil inhibitory factor, or rNIF) being conducted by Pfizer Inc., of New York, has been completed in accordance with the study protocol design. The primary goal of the study is to determine the dose-response relationship of UK-279,276 for efficacy and toleration in patients suffering from ischemic stroke. The protocol includes a three-month follow-up period. Corvas has a strategic alliance with Pfizer for the development and commercialization of UK-279,276. (See BioWorld Today, Feb. 25, 1997.)
¿ Flamel Technologies SA, of Lyon, France, said it entered into an agreement with an undisclosed biopharmaceutical company to investigate the application of its Medusa controlled-release protein and peptide delivery technology to an existing and specific class of proteins. The work will be fully funded by Flamel¿s partner. Terms of the agreement were not disclosed.
¿ Galapagos Genomics NV, of Mechelen, Belgium, entered a broad functional genomics collaboration with Pharmacia Corp., of Peapack, N.J., involving the use of Galapagos¿ PhenoSelect expression platform for gene target identification and validation applications. Galapagos will construct a gene library for Pharmacia to identify and validate drug targets in a broad range of disease areas.
¿ Genta Inc., of Berkeley Heights, N.J., expanded its relationship with the U.S. National Cancer Institute for new clinical trials involving Genta¿s lead antisense compound, Genasense. Pursuant to an existing Cooperative Research and Development Agreement, NCI has solicited new proposals from investigators to study Genasense in combination with anticancer therapy. Specific trials were requested in a broad group of diseases, including cancer of the prostate, breast, lung, colon, bladder, ovary, uterus, kidney and pancreas, as well as in Merkel cell tumor and non-Hodgkin¿s lymphoma.
¿ Gilead Sciences Inc., of Foster City, Calif., initiated the first Phase I clinical trial of GS7836, an anticancer nucleoside analogue, in Canada. The trial is designed to evaluate the safety, tolerability and toxicity of GS7836 in up to 40 patients at two sites. The study will enroll patients with a variety of solid tumors refractory to standard therapy or for which no curative therapy exists. The dose of GS7836 will be escalated in successive cohorts of patients to determine the maximum tolerated and recommended Phase II doses. Gilead licensed GS7836 from Southern Research Institute, of Birmingham, Ala., in December 2000.
¿ Guava Technologies Inc., of Burlingame, Calif., launched the Guava Personal Cytometer, calling it the world¿s first benchtop cellular analysis system. The company said it brings cellular analysis to the laboratory benchtop. The integrated system, composed of the Guava PC instrument and laptop computer, software and reagents, streamlines the assays most critical to cellular and molecular biologists ¿ cell counting and viability, protein expression and apoptosis.
¿ Labopharm Inc., of Laval, Quebec, signed a global licensing agreement with Aventis Pharmaceuticals Inc., of Bridgewater, N.J., the U.S. pharmaceuticals division of Aventis Pharma AG, to incorporate Labopharm¿s controlled-release technology, Contramid, into Allegra. Under the formulation and license agreement, Labopharm will receive milestone payments and would earn royalties on product sales of the new formulations. Allegra is Aventis¿ product indicated for the treatment of seasonal allergic rhinitis.
¿ Medicure Inc., of Winnipeg, Manitoba, filed a preliminary prospectus for a public offering of units for gross proceeds of up to C$10 million (US$6.3 million). Each unit will consist of one common share and one common share purchase warrant exercisable for a period of 24 months. The price of the units will be determined in the context of the market. The exercise price of the warrants will be 125 percent of the price of the units. The net proceeds of the offering will be used for the planned Phase II clinical trial of MC-1, the company¿s lead product, as well as for its continuing drug discovery and development efforts in cardiovascular medicine.
¿ Myriad Genetics Inc., of Salt Lake City, and Fleury Laboratories, of Sao Paulo, Brazil, formed a collaboration to market Myriad¿s predictive medicine products throughout Brazil. This program will focus initially on cancer, with BRACAnalysis, Colaris and Myriad¿s new Melaris predictive medicine products. The Melaris melanoma product was launched this month in the U.S. and patient specimens are being accepted for analysis at Myriad.
¿ Orchid BioSciences Inc., of Princeton, N.J., entered an agreement with GlaxoSmithKline plc, of London, to collaborate on a genome-wide validation of single nucleotide polymorphisms for pharmacogenetic studies. Orchid will develop SNP assays using well-established human DNA panels and will conduct ultra-high-throughput genotyping analyses. GlaxoSmithKline will select SNP candidates from Orchid¿s design database. Data generated by this agreement can be used in genetic association and linkage disequilibrium whole genome studies. Financial terms were not disclosed.
¿ Pieris Proteolab AG, of Weihenstephan, Germany, released a human Anticalin library based on its Anticalin technology. The new library, named Theracalin, uses a fully human protein scaffold derived from the lipocalin family of proteins and contains more than 10 billion unique, human Anticalins suited for protein-based therapeutic drug development.
¿ Protea Biosciences Inc., of Morgantown, W.V., signed an agreement with the West Virginia Research Corp., also of Morgantown, for the development and commercialization of discoveries made in the core proteomics laboratory of the West Virginia University Health Sciences Center. The core proteomics laboratory is an advanced technology center that rapidly identifies proteins in human cells, providing new potential targets for drug development in cancer and other human diseases.
¿ Syngenta Biotechnology Inc., of Research Triangle Park, N.C., and Egea Biosciences Inc., of San Diego, entered into a collaboration to design and engineer plants that will resist pests through the incorporation of genes for naturally occurring molecules. Egea will use its gene synthesis technology to engineer extremely long pieces of DNA, over 30,000 bases in total, that encode a series of genes that when introduced into a plant will produce organic molecules. The genes to be synthesized were discovered by Syngenta scientists from natural sources.
¿ SuperGen Inc., of Dublin, Calif., said data from a study of its cancer drug pentostatin (Nipent) showed that it is a major component of a new, less-toxic regimen that also includes photophoresis and reduced-dose total body irradiation administered to cancer patients prior to allogeneic bone marrow transplants. The treatment consisted of photophoresis, reduced-dose total body irradiation and continuous infusion of pentostatin. Of 40 evaluable patients, there were 30 complete responses, five partial responses and two with progressive disease, for an overall response rate of 85 percent. The 100-day overall survival was 82 percent. The data were presented at the 19th Annual Symposium on Innovative Cancer Therapy for Tomorrow in New York.
¿ Theratechnologies Inc., of Saint Laurent, Quebec, and Bachem Ltd., of Bubendorf, Switzerland, entered into an agreement for the development of a large-scale manufacturing process that would enable Peptix, Theratechnologies¿ peptide synthesis subsidiary, to develop the active ingredient ThGRF, a growth hormone-releasing factor, at a competitive cost. The peptide is used in part for Theratechnologies¿ clinical trials, but the manufacturing process will be used primarily for commercialization of the peptide.