• Affymax Inc., of Palo Alto, Calif., began enrolling patients in a second Phase II trial of Hematide, a synthetic, peptide-based erythropoiesis-stimulating agent being developed for the production of red blood cells to treat anemia in patients with chronic kidney disease and cancer. The study will evaluate repeat intravenous injections of Hematide in maintaining hemoglobin levels in patients on hemodialysis.
• Albany Molecular Research Inc., of Albany, N.Y., entered a two-year research collaboration with the National Institute of Neurological Disorders and Stroke aimed at developing treatments for spinal muscular atrophy, a degenerative neuromuscular disease. Under the agreement, AMRI will provide fee-for-service medicinal chemistry lead optimization on target compounds, including design and synthesis of analogues, as well as analysis of associated structure-activity relationships. The company can retain ownership of chemistry-related intellectual property resulting from the collaboration, as well as commercial rights to discovered products.
• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, and partner, Cook Inc., of Bloomington, Ind., said the first two peripheral arterial disease (PAD) patients outside the U.S. have been treated with a paclitaxel-coated stent. The trial is evaluating Cook's Zilver PTX drug-eluting vascular stent to determine whether drug-eluting stents are as effective in treating PAD as they are in treating heart disease.
• Cell Signaling Technology Inc., of Beverly, Mass., agreed to use its PhosphoScan technology in a partnership with Johnson & Johnson Pharmaceutical Research & Development, a division of New Brunswick, N.J.-based Johnson & Johnson, to identify phosphorylation sites and prospective biomarker kinase targets. Financial terms were not disclosed.
• ChemDiv Inc., of San Diego, helped gain a $9 million three-year grant from the National Institutes of Health to develop the New Mexico Molecular Library Screening Center, which will be centered at the University of New Mexico Health Sciences Center. The center will be part of a network of nine national facilities working to identify opportunities in three main areas: new pathways to discovery, research teams of the future and re-engineering the clinical research enterprise.
• Diversa Corp., of San Diego, delivered to DuPont Bio-Based Materials, of Wilmington, Del., a set of candidate enzymes under the companies' biorefinery program that exceed the initial performance targets set by the U.S. Department of Energy. The achievement triggered two milestone payments to Diversa totaling more than $500,000, one for meeting the DoE requirements and the other for exceeding them. The goal of the program is to develop a cost-effective process to convert corn and other biomass feedstocks to sugars for production of fuels and chemicals.
• Durect Corp., of Cupertino, Calif., started dosing in the third and final cohort of the Phase II dose-escalation study in hernia patients in Australia for its post-operative pain relief depot, Saber-Bupivacaine. The company anticipates about 60 patients will be enrolled.
• Dynavax Technologies, of Berkeley, Calif., said it exceeded expectations in enrolling children in its clinical trial of its AIC ragweed allergy immunotherapy. The study enrolled 315 subjects aged 6 to 15 years in less than two and a half months, exceeding the original expectation of 280 subjects. The trial is designed to support a pivotal study scheduled to begin in the first half of 2006.
• Hercules Technology Growth Capital Inc., of Boston, entered an agreement to provide $10 million debt financing to the U.S. subsidiary of Labopharm Inc., of Laval, Quebec. Proceeds will be used for general corporate purposes, including the commercialization of the company's once-daily formulation of tramadol in Europe. HTGC also has been granted the option to invest up to $1 million in Labopharm's next equity financing under the same terms, conditions and pricing offered to participating investors.
• Infinity Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase I trial of IPI-504, the company's heat-shock protein 90 (Hsp90) inhibitor and lead investigational cancer agent. Research shows that inhibition of Hsp90 forces apoptosis.
• InterMune Inc., of Brisbane, Calif., completed patient enrollment in its Phase III trial of daily Infergen in combination with ribavirin to treat patients chronically infected with hepatitis C virus who have failed to respond to a previous course of therapy with pegylated interferon alfa-2 plus ribavirin. Results suggest sustained virologic response rates that are substantially higher than alternative treatments for PEG-nonresponders, InterMune said. Results should be available in the first half of 2007.
• Ixion Biotechnology Inc., of Alachua, Fla., closed a transaction in which it transferred assets, liabilities and employees relating to its oxalate technology to a subsidiary of Q-Med AB, of Uppsala, Sweden, its former majority shareholder. In the split out, Ixion received almost all of Q-Med's Ixion stock, $344,000 in cash and debt forgiveness of more than $6 million. Ixion also retained more than $175,000 in grant funds from the National Institutes of Health for research. As a result, Ixion's co-founder Weaver Gaines has reassumed the title of president and CEO and rejoined the board.
• Jivan Biologics Inc., of Berkeley, Calif., launched a full-splice variant microarray service in partnership with MOgene LC, of St. Louis. The service will provide drug companies and academic researchers with experimental results from their biological samples using Jivan's splice arrays together with MOgene's hybridization and data analysis services.
• Keryx Biopharmaceuticals Inc., of New York, reported plans to offer 5 million shares of its newly issued common stock in an underwritten public offering. The offering will be made pursuant to Keryx's effective shelf registration statement filed Oct. 13. Keryx also expects to grant the underwriters a 30-day option to purchase 780,000 shares to cover overallotments. JPMorgan Securities Inc. is acting as the sole book-running manager in the offering, with Bear, Stearns & Co. Inc. acting as co-lead manager.
• MacroPore Biosurgery Inc., of San Diego, changed its name to Cytori Therapeutics Inc. to reflect the company's focus and progress in the development of regenerative therapeutics using adult stem cells derived from adipose. The company will continue to trade its shares on the Frankfurt Stock Exchange under the symbol "XMP," and MacroPore Biosurgery will become a division of Cytori.
• Millennium Pharmaceuticals Inc., of Cambridge, Mass., initiated a multicenter Phase II trial of MLN1202 in about 40 patients with relapsing-remitting multiple sclerosis (MS). MLN1202, a humanized monoclonal antibody, is designed to block CCR2 chemokine receptors and prevent the infiltration of immune cells into inflammatory sites. The CCR2 chemokine pathway is believed to play a central role in a number of inflammatory conditions, including MS.
• NeoRx Corp., of Seattle, treated the first patient with picoplatin, its next-generation intravenous platinum therapy, in a Phase II trial in small-cell-lung cancer. The open-label, multicenter study is opening at clinical sites throughout the U.S. and Canada to enroll patients with the disease.
• Neuren Pharmaceuticals Ltd., of Auckland, New Zealand, expanded its agreement with the Walter Reed Army Institute of Research in Washington to develop the company's second compound, a neuroprotectant designated NNZ-2566, as a therapy for traumatic brain injury. Under the existing agreement, Walter Reed funds half of the preclinical research, which has shown that the benefit of NNZ-2566, administered following injury, increased the reduction in neurological deficit by up to 70 percent. Neuren retains all future commercial rights outside of the U.S. military.
• NicOx SA, of Sophia-Antipolis, France, obtained positive results from a pilot Phase II study for HCT 1026 in osteopenia, which showed a significant reduction in bone resorption markers following treatment. The trial reached its primary endpoint, with 24 percent of patients achieving a response. HCT 1026 is a nitric oxide-donating derivative of flurbiprofen.
• NPS Pharmaceuticals Inc., of Salt Lake City, said the FDA accepted for review the company's new drug application for Preos (parathyroid hormone) for the treatment of osteoporosis in postmenopausal women. NPS submitted the application May 10 based on data from 13 studies, including a Phase III trial of 2,600 patients. A similar application to market Preos in Europe, under the name Preotact, is under review by the European Medicines Agency. (See BioWorld Today, Oct. 25, 2004.)
• Primera Biosystems Inc., of Providence, R.I., closed an $11 million private placement of Series A preferred stock to a group of investors, including San Francisco firms MPM Capital and Burrill & Co., along with the Malaysian Technology Development Corp. in Kuala Lumpur. The financing will enable Primera to develop instrument systems and disease-specific diagnostic reagents kits for commercialization. The company is developing a gene-expression analysis system, STAR (Scalable Transcription Analysis Routine), that is designed to combine features of real-time PCR and DNA microarray technologies.
• Rigel Pharmaceuticals Inc., of South San Francisco, will initiate an offering of 3 million shares of common stock under an existing shelf registration statement, with an estimated overallotment option of 450,000 shares. Credit Suisse First Boston and Lehman Brothers Inc. will act as joint bookrunners for the offering. Rigel develops small-molecule drugs to treat asthma and allergy, rheumatoid arthritis and cancer.
• SRI International, of Menlo Park, Calif., and the European Bioinformatics Institute in Hinxton, UK, expanded the BioCyc collection of pathway/genome databases to include databases for 160 organisms. The BioCyc databases contain information about biochemical pathways.
• StemCell Pharma, of Las Vegas, acquired exclusive rights on two types of products containing placenta-derived stem cells. The products include a line of anti-aging/aging control products in oral form and cosmetics from face creams to hair products.
• Transgene SA, of Strasbourg, France, said its offering of shares and warrants raised a total of €34.9 million (US$42.1 million). The company sold about 4.7 million units at €7.50 each. Net proceeds of €32.6 million will be used to fund Phase II trials of the company's therapeutic vaccines to treat cancer and infectious diseases.
• VaxGen Inc., of Brisbane, Calif., completed enrollment of 153 volunteers in a Phase I/II trial designed to evaluate the safety of and immune response to its attenuated smallpox vaccine candidate, LC16m8. LC16m8 was licensed in Japan and forms the basis of that country's strategic national stockpile of smallpox vaccine. Data from the trial will be presented at a scientific meeting later this year.
• XenoPort Inc., of Santa Clara, Calif., completed a Phase I trial of XP19986, a transported prodrug of R-baclofen. The objective was to assess safety, tolerability and pharmacokinetics of three different formulations in healthy adult volunteers. One formulation was an immediate-release formulation, while the other two were intended to release XP19986 in a more sustained fashion. The trial indicated that XP19986 was well tolerated with a few mild adverse events.
