• Cancer Research Technology Ltd., of London, and the University of Cambridge entered a collaboration with Cyclacel Ltd., of Dundee, Scotland, and a major unnamed pharmaceutical company to develop tools for target validation and drug discovery based on RNA interference. The collaboration, to be funded in part by Cancer Research UK, aims to establish RNAi as a viable tool for transient or persistent gene knockdown in mammalian cells and whole animals such as a mouse.

• EGeen International Corp., of Redwood City, Calif., completed its first venture capital round totaling $4.25 million. EGeen, which focuses on population genetics and drug and diagnostic target discovery, said it will use the funding to continue building the Estonian Gene Bank Foundation database and to expand its related commercial activities. Draper Fisher Jurvetson ePlanet Ventures led the round with participation from Small Enterprise Assistance Funds and Biobank Technology Ventures.

• Etiologics Ltd., of Oxford, UK, a gene-to-drug discovery company, appointed Chris Ashton as CEO. Ashton was formerly with Orchid Biosciences Inc., of Princeton, N.J., where he was a member of the executive management team.

• Focus Technologies Inc., of Herndon, Va., was awarded by the FDA a five-year, $2.1 million optioned contract to develop a proactive and comprehensive assessment of antimicrobial resistance. The contract, titled "Surveillance of the Emergence of Antibiotic Resistance," will grant the FDA access to The Surveillance Network, Focus Technologies' real-time antibiotic resistance database, providing the agency capabilities to evaluate the development of antimicrobial agents intended to treat patients in the area of antimicrobial resistance.

• Galapagos Genomics NV, of Mechelen, Belgium, reported publication of a study in the November 2002 issue of Nature Biotechnology demonstrating the use of its arrayed adenoviral expression libraries for gene function discovery. Data showed that large collections of arrayed adenoviruses harboring human genes could be used efficiently to discover gene functions. Combining Galapagos' arrayed adenoviral technology with disease-relevant cellular assays allows researchers to discover functionally discovered targets in a rapid high-throughput mode.

• Galileo Laboratories Inc., of Santa Clara, Calif., reported publication of a study in the Nov. 14, 2002, issue of the New England Journal of Medicine of a completed clinical trial targeting C-reactive protein [CRP] reduction in end-stage renal failure patients. Galileo's GLI-8545 resulted in a 52 percent (p=0.01) reduction in serum CRP when orally administered to patients diagnosed with dialysis-dependent end-stage renal disease.

• Generex Biotechnology Corp., of Toronto, reported that on Oct. 29, the Appellate Division of the New York Supreme Court issued a decision and order affirming a lower court's order vacating a New York Stock Exchange arbitration panel's award granting Sands Brothers & Co. Ltd. warrants for 1.53 million shares of the company's stock. The Appellate Division's decision and order modified the lower court's order by remanding the issue of damages to a new panel of arbitrators, expressly limiting that issue to reliance damages, which are not to include an award of lost profits. Reliance damages are out-of-pocket damages incurred by Sands.

• Genzyme Biosurgery, a division of Genzyme Corp., of Cambridge, Mass., reported at the American Heart Association meeting in Chicago, positive preliminary data from its first clinical trial using autologous cell therapy to treat heart disease. The trial tested the safety and feasibility of using a transplant of a patient's own cells to stop or reverse damage resulting from a heart attack, therapy designed to slow or halt a heart attack patient's progression to congestive heart failure. The 10 patients appear to show an improvement in ejection fraction, which typically worsens in patients who have had a heart attack and whose hearts are weakening.

• HealthCare Ventures LLC, of Princeton, N.J., reported the final closing on HealthCare Ventures VII, comprising $350 million of limited partnership interests. As it has since 1985, HealthCare Ventures said it will continue to create, finance and manage biopharmaceutical companies.

• Hemispherx Biopharma Inc., of Philadelphia, entered an agreement under which Sigma-Aldrich Fine Chemicals, a division of Sigma-Aldrich Corp., of St. Louis, would manufacture the active ingredient for Hemispherx's lead RNA-based platform drug, Ampligen. Prior to this arrangement, Ampligen was produced solely outside the country. Financial terms were not disclosed.

• HTS Biosystems Inc., of Hopkinton, Mass., and Ciencia Inc., of Hartford, Conn., were awarded a Phase II grant from NASA Johnson Space Center for Protein Microarrays for Bioreactor Bioproduct Monitoring. The grant provides $600,000 to further the Space Station Cellular Biotechnology Program at NASA, which is developing advanced facilities, including cell culture systems to conduct microgravity research in cell biology onboard the space station.

• Hybridon Inc., of Cambridge, Mass., reported publication of a study in the October 2002 issue of Nucleic Acids Research describing the enhanced immunomodulatory activity of CpG DNA molecules linked through their 3' ends (immunomers), as demonstrated in cell culture and murine models. Hybridon said the data further confirms previously reported data that linking CpG DNA through the 5' end abrogates immunostimulatory activity, and that adding alkyl-linkers in substitution of certain nucleotides in the 5' flanking region - but not the 3' flanking region - increases immunostimulatory activity, also as demonstrated in cell culture or murine models. Data begin to elucidate the molecular basis for CpG DNA recognition by receptors that results in immune stimulation and highlight the sequence and structural changes in CpG DNA that may potentiate or neutralize immunostimulatory activities in a predictable fashion.

• Inspire Pharmaceuticals Inc., of Durham, N.C., said it would discontinue development of INS365 Respiratory for chronic bronchitis, a program that has been on hold since January, and instead would focus on higher-priority programs including dry eye and allergic rhinitis. Inspire's partner, Kissei Pharmaceutical Co. Ltd., of Tokyo, said it would discontinue Japanese development and returned to Inspire all Japanese rights to INS365 Respiratory. Inspire, which has received from Kissei nonrefundable payments of $7.2 million in cash and equity based on the September 1998 agreement, will receive no further payments, resulting in no further impact on 2002 or 2003 revenue projections.

• Keryx Biopharmaceuticals Inc., of Cambridge, Mass., said its board authorized a stock repurchase program of up to 2.5 million shares of common stock. Keryx's president and CEO said he does not believe that the company's "low stock price" is justified given its "current condition and future prospects."

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., and Schering-Plough Corp., of Kenilworth, N.J., reported at the American Heart Association meeting in Chicago results from an ongoing national quality improvement initiative examining adherence to American College of Cardiology and AHA treatment guidelines for chest pain disorders. It was revealed that use of a recommended class of drugs, known as glycoprotein IIb-IIIa inhibitors, reduced in-hospital death by 46 percent. Data also showed that only 31 percent of eligible patients were treated with a GP IIb-IIIa inhibitor within 24 hours, as recommended by the guidelines.

• Morphochem AG, of Munich, Germany, said that one of its leading programs, inhibitors of blood coagulation Factor Xa, led to the identification of orally available anti-thrombotics in preclinical studies. Details of the studies will be presented at a meeting of investment analysts and pharmaceutical executives in Basel, Switzerland, Thursday. A series of low-molecular-weight compounds that demonstrate direct inhibition of Factor Xa have been synthesized using Morphochem's integration evolutionary chemistry.

• NeoPharm Inc., of Lake Forest, Ill., initiated a Phase I/II trial of LE-SN38, its NeoLipid liposomal formulation of SN38, the active metabolite of the cancer drug CPT-11, which is used for colorectal cancer. NeoPharm said it designed LE-SN38 as an easy-to-use formulation to minimize preparation time and improve administration. CPT-11 (irinotecan) is a chemotherpeutic prodrug marketed as Camptosar in the U.S. by Pharmacia Corp., of Peapack, N.J.

• NeoTherapeutics Inc., of Irvine, Calif., said founder Alvin Glasky resigned from its board, effective immediately. Until his August retirement, Glasky served as the chairman, CEO and chief scientific officer for NeoTherapeutics, which in-licenses drugs to treat cancer.

• Probiodrug AG, of Halle, Germany, and Synt:em SA, of Nimes Cedex, France, entered a collaboration to combine Probiodrug's library of small molecules as effectors of certain drug targets with Synt:em's Pep:trans technology, a re-engineering technology that helps compounds reach their target across complex biological membranes. The companies aim to develop new chemical entities able to cross the blood-brain barrier and thus to develop new effective drugs to treat diseases of the central nervous system such as multiple sclerosis. The companies will share developmental costs and revenues.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said it filed an investigational new drug application with the FDA requesting permission to begin a Phase I trial of thymosin beta 4 (TB4). If the IND is allowed, the company said it anticipates initiating the trial early next year to evaluate the safety and efficacy of TB4 for the treatment of chronic dermal wounds. TB4 is a naturally occurring 43-amino-acid peptide and the major actin-sequestering molecule in mammalian cells.

• Syrrx Inc., of San Diego, determined the detailed atomic structures of three cancer-associated proteins: Aurora-A kinase, focal-adhesion kinase and ephrin receptor A2. Syrrx is using atomic resolution data from these structures to aid in the design of drugs to treat breast cancer, prostate cancer, colon cancer, melanoma and thyroid carcinoma. Information regarding the discoveries is being published in the November 2002 issue of Structure. The structures were determined using Syrrx's high-throughput structural biology platform, which uses automation and Syrrx's Nanovolume Crystallization technology to crystallize disease-causing proteins.

• Targeted Genetics Corp., of Seattle, and collaborators at the University of Texas M.D. Anderson Cancer Center in Houston reported data demonstrating that E1A, the company's tumor suppressor gene, when given with its systemic gene delivery system, resulted in a reduction in tumor growth, and in some cases, complete elimination of tumors in animal models of cancer. The data were published in the current issue of Cancer Research in an article titled "Systemic Gene Therapy in Human Xenograft Tumor Models by Liposomal Delivery of the E1A Gene."

• Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., reported at the International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland, data from a second pivotal Phase III study demonstrating that Fuzeon (enfuvirtide), in combination with other antiretrovirals, provided benefit to treatment-experienced HIV patients at 24 weeks regardless of patient demographics, baseline disease stage or treatment history. Also, a survey of treatment-experienced patients participating in the Fuzeon pivotal studies found that twice-daily subcutaneous administration was manageable for the majority of patients through 24 weeks of treatment with patient education and support. Trimeris said the data further support and confirm the robustness of 24-week Phase III data for the drug. The companies two months ago submitted to the FDA a new drug application. (See BioWorld Today, Sept. 18, 2002.)

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., updated its business at an investor meeting. Among a number of pipeline highlights, Vertex said that VX-385, a third-generation HIV protease inhibitor being developed with GlaxoSmithKline plc, of London, began Phase I development. It also is the third HIV protease inhibitor resulting from the collaboration to advance into the clinic.