¿ Alpha Innotech Corp., of San Leandro, Calif., and Proteome Systems, of Sydney, Australia, formed an agreement under which Alpha Innotech will manufacture its AlphaImager and FluorChem imaging systems for incorporation with Proteome Systems¿ ProteomeIQ integrated proteomics platform. The ProteomeIQ platform includes integrated systems for sample preparation, protein mixture separation, protein image acquisition and analysis, protein characterization and identification, data management and system control.
¿ Amgen Inc., of Thousand Oaks, Calif., presented data from a long-term study of patients with chronic renal insufficiency, at the World Congress of Nephrology in San Francisco. The Study of Treatment for Renal Insufficiency Data and Evaluation (STRIDE) Registry is designed to examine provider practice patterns and outcomes, as well as quality of life. Data on the disease¿s economic impact also will be collected. The registry will study approximately 3,700 patients from across the country. There currently are 1,300 patients enrolled.
¿ Antigenics Inc., of New York, said the FDA designated Oncophage, the company¿s personalized cancer vaccine, a fast-track product for the treatment of renal cell carcinoma.
¿ Artificial Life Inc., of New York, entered a partnership agreement with BeFutur Biotechnologies SA, of Geneva. The companies will cooperate on stem cell research, simulation and analysis of cell growth patterns, regenerative medicine and product and vaccine development. Financial terms were not disclosed.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., completed enrollment in its Phase III study for Atrisone dapsone topical gel in SMP technology, for treatment of acne. Trial results are expected to be analyzed and available in April. Also, Atrix reported positive initial data in its study of Atrisone for relief of itching associated with severe burns. The Atrix SMP technology provides a platform for water-soluble drugs to be delivered topically.
¿ BioVex Ltd., of London, entered into a collaborative agreement with AstraZeneca plc, of London, in the area of gene target validation. AstraZeneca will evaluate the ability of BioVex¿s NeuroVEX vectors to efficiently transduce the cells and tissues of the nervous system in order to study the function of genes that may be viable targets for the therapy of neurodegenerative disorders. The vectors give efficient, nontoxic and stable gene transfer to the cells and tissues of the nervous system, the company said.
¿ Cellular Genomics Inc., of Branford, Conn., named its president, Louis Matis, to the additional role of CEO. Matis joined the company in September 2000 as president and chief scientific officer. Prior to Cellular, Matis spent eight years at Alexion Pharmaceuticals Inc.
¿ Cerus Corp., of Concord, Calif. and Baxter Healthcare Corp., of Deerfield, Ill., presented preclinical data showing the ability of Helinx technology to inactivate Trypanosoma cruzi, a parasite that causes Chagas disease, during the American Association of Blood Banks meeting in San Antonio. The parasite, related to the agent that causes African sleeping sickness, can be transmitted through blood transfusion, but there currently are no routine screening tests for this pathogen. The two companies are collaborating to develop Intercept Blood Systems, which use Helinx technology to make safer blood transfusions.
¿ Chiron Corp., of Emeryville, Calif., and Gen-Probe Inc., of San Diego, presented data that support the feasibility of a single nucleic acid amplification test to simultaneously detect the presence of HIV-1, hepatitis B virus and hepatitis C virus in donated blood, during the American Association of Blood Banks meeting in San Antonio. The findings show the viability of Gen-Probe¿s transcription-mediated amplification technology in amplifying three unique viral targets (one DNA and two RNA) without compromising sensitivity for any single target. The tests were conducted with a Triplex Assay being developed by the companies. Researchers showed that the assay¿s sensitivity was similar to one currently being studies under an investigational new drug application.
¿ Cyclacel Ltd., of Dundee, Scotland, said CYC202, its lead cyclin dependent kinase inhibitor drug candidate, completed Phase Ia evaluation and is entering multicenter Phase Ib trials. CYC202 (R-roscovitine) is a small-molecule inhibitor of CD 2, an enzyme target of the body¿s own anticancer genes, such as tumor suppressor p21. The objectives of the Phase Ib trials are to determine the safety, maximum tolerated doses and pharmacokinetic profile of CYC202 capsules administered orally to cancer patients. If Phase Ib is completed successfully, Cyclacel plans to move CYC202 to the next stage of development next year.
¿ D-Pharm Ltd., of Rehovot, Israel, said Shire Pharmaceuticals Group plc, of Andover, UK, is initiating Phase II trials for the anti-epileptic agent, SPD 421. The compound, previously known as DP-VPA, was discovered and licensed to Shire in March 2000 subsequent to a successful Phase I trial in 60 health volunteers. D-Pharm retained responsibility for production of SPD 421 both for clinical studies and marketing. SPD 421 is a phospholipid derivative of valproic acid, a drug widely used for the treatment of epilepsy.
¿ Entomed SA, of Strasbourg, France, is collaborating with the Shanghai Institute of Entomology from the Institutes for Biological Sciences of the Chinese Academy of Sciences. This agreement will lead to the Shanghai Institute providing Entomed with insect extracts with high pharmacological activity from which Entomed intends to develop new drugs for a range of therapeutic areas. The one-year collaboration can be extended to three years. It is designed to allow the company to benefit from the insect biodiversity in China, and the Chinese long-standing understanding of insects and their empirical use in traditional medicine. Entomed is looking for promising drug candidates in the areas of microbial infections, cancer, inflammation and wound healing.
¿ Genome Therapeutics Corp., of Waltham, Mass., reported its researchers, along with those at Creighton University in Omaha, Neb., discovered a gene responsible for high bone density. Using members of a large extended family, some of whom displayed the high bone mass trait, scientists identified a single amino acid exchange in a protein receptor responsible for above average bone mineral density. The finding is part of an alliance between GTC and Wyeth-Ayerst Laboratories, a division of Madison, N.J.-based American Home Products Corp., for genomics-based osteoporosis drug discovery and is expected to be a pathway to novel products to treat the disease.
¿ Genset SA, of Paris, confirmed that it continues to work towards finalizing its equity line financing, a process it figures will take two to three months. In July, Genset signed an agreement with an intermediary to put the equity line in place. But it conflicted with new requirements in France for such a move, meaning Genset has to work within the new conditions to adopt the financial instrument.
¿ Innate Pharma SAS, of Marseilles, France, moved into new laboratories to enhance development of its treatment methods. Formed in 1999, Innate develops antitumoral therapies primarily by manipulating nonconventional lymphoid immunity.
¿ Genzyme General, a division of Genzyme Corp., of Cambridge, Mass., will begin marketing Thryogen (thryotropin alfa for injection) this month in Europe. Thryogen is a recombinant human thyroid-stimulating hormone indicated for use in the management of patients being followed up for recurrence of well-differentiated thyroid cancer. On Sept. 19, the Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency adopted a positive opinion on Thyrogen¿s manufacturing process, necessary for its commercialization. Thryogen was approved for marketing in Europe last year and has been available on a named-patient basis since then.
¿ Hybrigenics SA, of Paris, and Institut Pasteur, of Paris, signed an exclusive collaboration in functional proteomics applied to infectious diseases. The agreement extends the scientific alliance between Hybrigenics and Institut Pasteur initially launched in 1998. The new agreement provides an expanded framework for collaborations between Hybrigenics scientists and Institut Pasteur research teams to validate therapeutic targets to discover novel treatments for infectious diseases. The new agreement also grants Hybrigenics exclusive rights to exploit the results derived from the collaboration.
¿ Incyte Genomics Inc., of Palo Alto, Calif., said the U.S. District Court for the Northern District of California granted a victory to Incyte by issuing a summary judgment ruling on Oct. 3 regarding the remaining two disputed claims of the ¿two-color¿ patent presently issued to Affymetrix Inc., of Santa Clara, Calif. Over the past few months, there have been several recent summary judgment decisions in its patent litigation with Affymetrix. Two of those decisions invalidate certain patent claims that Affymetrix has asserted against Incyte, Incyte said. Another holds that Incyte¿s commercially available CDNA microarrays do not infringe other Affymetrix patent claims. Affymetrix responded in a separate release that the court denied Incyte¿s motion that Affymetrix Patent No. 5,744,305 was invalid, rejecting Incyte¿s argument that ¿predefined region¿ was not adequately described in the patent¿s specification.
¿ Infigen Inc., of Deforest, Wis., terminated its agreement with Pharming Holding NV, of Leiden, the Netherlands, to commercialize Infigen¿s transgenic technologies. The termination also means Pharming and its subsidiaries must cease using intellectual property previously licensed by Infigen. The termination follows a restraining order granted to Infigen by a Wisconsin court that constrained Pharming from selling or transferring transgenic cattle produced by Infigen. Pharming previously had announced it entered receivership.
¿ Lorus Therapeutics Inc., of Toronto, entered into an exclusive seven-year distribution agreement in Latin America with Faulding (Canada) Inc., of Montreal. Faulding will market and sell Virulizin, to treat malignant melanoma, in Mexico. Lorus will receive royalties on sales and will be responsible for manufacturing. Faulding will share in any additional clinical costs the companies deem appropriate in Mexico and the rest of Latin America. The deal also gives Faulding the option to enter into agreements to sell Virulizin in Brazil and Argentina.
¿ Neurochem Inc., of Saint-Laurent, Quebec, received a C$1.4 million (US$898,875) grant from the FDA for a Phase II/III study of Neurochem¿s product, Fibrillex. The trial is under way. Neurochem also received orphan medicinal product designation in Europe for Fibrillex to treat secondary amyloidosis. The randomized, double-blind, placebo-controlled trial is being conducted at 14 sites in the United States, Europe and Israel.
¿ Orchid Biosciences Inc., of Princeton, N.J., released www.autoprimer.com, a web site at which Orchid customers can design polymerase chain reaction and extension primers to use with the company¿s SNP-IT single nucleotide polymorphism scoring technology. Orchid is offering the web-based software tool for free.
¿ Oxford Biomedica plc, of Oxford, UK, released interim results from a Phase I/II trial of its anticancer therapeutic vaccine, TroVax. Initial results of the 12-patient trial show the drug to be safe and well tolerated, and the vaccine induced an immune response against the tumor antigen OBA1 in colorectal cancer. The results report success of the trial¿s primary endpoints. TroVax is a gene-based therapeutic vaccine designed to stimulate a patient¿s immune system to mount a response to recognize and destroy cancer cells.
¿ Proteome Sciences plc, of Cobham, UK, completed its $7 million Series A preferred stock financing of Intronn Inc., of Raleigh, N.C. This will fund Intronn¿s spliceosome-mediated RNA trans-splicing technology known as Smart, a broad platform technology with potential applications in therapeutics and discovery. It can reprogram the vast majority of human, plant and animal genes to correct genetic errors, confer a new function to a cell or create novel gene products, it said. AEA Investors Inc., of New York, and Research Corporation Technologies Inc., of Tucson, Ariz., invested in the round, though Proteome remains the largest shareholder.
¿ Proteomic Research Services Inc., of Ann Arbor, Mich., said it has begun operations after having been divested from Genomic Solutions Inc., also of Ann Arbor. Genomic Solutions holds a minority interest in the new venture and has contracted for PRS to perform specific proteomic research services activities. The new venture will market and provide a variety of proteomic outsourcing services to pharmaceutical and biotechnology companies, academic and government institutions, as well as Genomic Solutions.
¿ Syrrx Inc., of San Diego, was awarded $100,000 from the National Center for Research Resources of the National Institutes of Health to conduct Phase I Small Business Innovative Research studies related to developing next-generation, high-throughput crystallization products. The grant will fund a project to develop Agincourt, which uses approximately 100 times less protein than conventional crystallization approaches and is capable of producing one 96-well plate per minute.
¿ V.I. Technologies Inc., of Watertown, Mass., said the Inactine system was more effective than gamma irradiation in the functional inactivation of white blood cells in red blood cell units in preclinical studies. The company said these findings increase the possibility that the Inactine treatment could be used to prevent transfusion-associated graft-vs.-host disease in red blood cells. Inactine technology is designed to inactivate a wide range of known and unknown viruses, bacteria and parasites. Most recently, it has demonstrated an ability to remove prions.
¿ XenoPort Inc., of Palo Alto, Calif., was awarded an Advanced Technology Program grant for $2 million from the National Institute of Standards and Technology, a division of the U.S. Department of Commerce. The two-and-a-half-year program will develop and apply technology designed to make possible the oral administration of poorly absorbed drugs, including macromolecules, by harnessing the body¿s natural ability to ferry nutrients and other molecules from the intestines into the bloodstream.