• Affymax Inc., of Palo Alto, Calif., said results of its Phase I study of Hematide, a product designed to stimulate red blood cell production, demonstrated that single doses of the drug resulted in dose-dependent increases in circulating reticulocytes in healthy volunteers. At the highest dose tested, the company said Hematide achieved a clinically and statistically significant increase in hemoglobin from baseline that was sustained for at least a month. Affymax expects to initiate Phase II studies for the treatment of anemia in patients with chronic kidney disease by mid-year and in cancer patients later in 2005.

• Ambion Inc., of Austin, Texas, entered an agreement via its Ambion Diagnostics unit with Wyeth Pharmaceuticals, a division of Madison, N.J.-based Wyeth, to continue its alliance in the development and supply of cGMP-grade RNA that will be incorporated as a component in Wyeth's vaccine program. Ambion will optimize synthesis and purification of long RNA molecules suitable for use in the production of human therapeutics, and RNA transcripts will be manufactured at Ambion's cGMP facilities. Financial terms were not disclosed.

• AmCyte Inc., of Los Angeles, announced the transplantation of the first Type I diabetic patient in North America to receive islets without long-term immune-suppression. The company said the transplanted islets are protected from rejection by patients' immune systems with its microencapsulation technology. The study's primary endpoints are safety assessments of the procedure at 180 days with secondary endpoints looking at the function of the transplanted insulin-producing islet cells.

• Applied Biosystems Group, of Foster City, Calif., announced a collaboration to provide the FDA's National Center for Toxicological Research with access to the company's Expression Array System and Rat Genome Survey Microarray to investigate the toxicity of a common class of diabetes drugs using samples provided by the NCTR. As part of the collaboration, Applied Biosystems will use its Expression Array System to investigate the molecular basis of liver toxicity associated with certain diabetes drugs, including Rezulin (troglitazone), which was withdrawn from the market in 2000. The collaboration was announced at the 44th annual Society of Toxicology Meeting in New Orleans.

• Arexis AB, of Gothenburg, Sweden, entered a collaboration with CMC Biopharmaceuticals A/S, of Copenhagen, Denmark, to produce recombinant human BSSL (bile salt-stimulated lipase) for its upcoming cystic fibrosis and preterm infant clinical trials. CMC will provide Arexis with BSSL for the trials that are part of Arexis' BSSL program that uses its patented human recombinant enzyme to target fat malabsorption.

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, closed its initial public offering of 8.3 million common shares at $11 per share, raising about $90 million. Proceeds are expected to be used to fund the Phase III trial of CellCept (mycophenolate mofetil), an immunosuppressive agent, for lupus. The company said funds also will be put toward two ongoing Phase III studies of CellCept in myasthenia gravis and pemphigus vulgaris, as well as for market research, CellCept product launch and general and corporate purposes. (See BioWorld Today, March 7, 2005.)

• Australian Cancer Technology, of Sydney, Australia, said that the board appointed Leonard Firestone U.S-based CEO and director. Firestone served as CEO, president, chief medical officer and director of Manhattan Pharmaceuticals Inc. Australian Cancer is an oncology drug development company developing the Pentrys cancer vaccine.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said results of a Phase III extension study of rhASB (galsulfase) in mucopolysaccharidosis VI (MPS VI) demonstrated that patients who received the drug for an additional 24 weeks - 48 weeks total - continued to experience improved endurance, as measured by the change in 12-minute walking distance. Patients receiving rhASB once a week for the additional 24 weeks improved their mean walk distance by 36 meters, for a total of 145 meters for the entire 48-week period. Data were presented at the annual meeting of the Society for Inherited Metabolic Diseases in Pacific Grove, Calif.

• Biota Holdings Ltd., of Melbourne, Australia, and Aerogen Inc., of Mountain View, Calif., signed an agreement for the development of CS-8958, one of the new LANI (long-acting neuraminidase inhibitor) compounds being developed by Biota and Sankyo, suitable for use with Aerogen's Aeroneb Go Micropump Nebulizer as a flu antiviral. The development work will be funded under a $5.6 million grant to Biota from the National Institutes of Health in Bethesda, Md.

• Boston Life Sciences Inc., of Boston, completed a $5 million private placement of common stock. Under the terms of the financing, the company issued 2 million shares at a purchase price of $2.50 per share. The company focuses on research and clinical development of diagnostic and therapeutic products for central nervous system disorders. Its lead product candidate, Altropane, is in Phase III trials for the diagnosis of Parkinson's disease and in Phase II for the diagnosis of attention deficit hyperactivity disorder.

• Cellegy Pharmaceuticals Inc., of South San Francisco, granted exclusive distribution rights for Tostrex to PT Kalbe Farma, of Jakarta, Indonesia, for parts of the Far East. Tostrex is indicated for the treatment of male hypogonadism. In December, the product was approved by the Medical Products Agency in Sweden. Cellegy will provide PT Kalbe Farma the Tostrex regulatory dossier. PT Kalbe Farma will be responsible for all regulatory filings, sales, marketing and distribution of Tostrex in various regions in the Far East. PT Kalbe Farma has been granted distribution rights in 11 countries in the Far East, including Indonesia and Thailand.

• Crucell NV, of Leiden, The Netherlands, said Galapagos Genomics NV, of Mechelen, Belgium, is considering a Euronext stock exchange listing this year. Crucell holds a 20.8 percent interest in Galapagos, which was co-founded by Crucell in 1999 to exploit its human cell-expression platform PER.C6 in the field of functional genomics. The primary reason for the listing is to raise additional funds for Galapagos.

• Curis Inc., of Cambridge, Mass., said the recent online issue of the Journal of the American Society of Nephrology contains a preclinical report demonstrating that treatment with BMP-7 results in amelioration of two major complications of chronic kidney disease. The report is authored by researchers from the Washington University School of Medicine in St. Louis. Investigators demonstrated that BMP-7 treatment prevents renal osteodystrophy and vascular calcification by stimulating the rate of skeletal mineralization.

• CV Therapeutics Inc., of Palo Alto, Calif., and Solvay Pharmaceuticals Inc., of Marietta, Ga., entered a co-promotion agreement for Aceon. Aceon is the U.S. brand name of perindopril, an ACE inhibitor with tissue activity. In Europe, perindopril is marketed under several brand names, including Coversyl.

• DeCode Genetics Inc., of Reykjavik, Iceland, began enrolling subjects in a Phase I trial for DG041, the company's developmental compound for peripheral arterial occlusive disease. The trial will evaluate the safety as well as the pharmacokinetic and pharmacodynamic profile of DG041. DG041 is a first-in-class, orally administered small molecule.

• Diversa Corp., of San Diego, was awarded two biodefense contracts totaling $4.8 million from the U.S. Department of Defense. The first contract, for $2.5 million, will support the second year of Diversa's program for "Rapid Antibody-Based Biological Countermeasures." The second contract, for $2.3 million, will provide funding for the second year of Diversa's program for "Enzyme-Based Active Decontamination" of chemical and biological agents.

• Eidogen Inc., of Pasadena, Calif., and Sertanty Inc., of San Diego, Calif., completed a merger to create Eidogen-Sertanty Inc., a knowledge-based drug discovery solutions provider with cheminformatics and structural informatics products. Financial terms were not disclosed.

• Elite Pharmaceuticals Inc., of Northvale, N.J., said all of the originally issued 516,558 shares of its Series A preferred stock have been converted into shares of common stock. The conversion rate was 10 shares of common stock plus a fraction of a share for each share of preferred stock. Elite has a pipeline of six products under development for indications in the area of cardiovascular, pain management, allergy and infection.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., signed an agreement with St. Louis-based Monsanto Co. and the U.S. Department of Agriculture for providing U.S. soybean plant breeders with technology for more accurate and efficient plant breeding research. The intent of the project is to map single nucleotide polymorphism DNA markers in soybeans, creating a molecular genetic map of the soybean that includes a large number of SNP DNA markers, along with existing simple sequence repeat markers. The collaborators said they plan to make the information available.

• Immtech International Inc., of Vernon Hills, Ill., said data confirm that all patients tested in a Phase IIb trial of oral DB289 remained clear of the African sleeping sickness trypanosomiasis three months after concluding treatment. The 30 patients enrolled in the extended-dosage trial received DB289 twice a day for 10 days, and all had cleared the parasite during the initial treatment period. Patients will be monitored again at six, nine and 12 months post-treatment. Immtech intends to soon start a pivotal Phase III trial.

• Lorus Therapeutics Inc., of Toronto, discovered that IL-17E, a component of the immune system, participates in the mechanism of Virulizin-mediated cancer activity, further elucidating the mechanism of action of that drug, which is in a fully enrolled pivotal Phase III trial for the treatment of pancreatic cancer. Virulizin has demonstrated favorable safety and efficacy in Phase I and II trials by stimulating the immune system to attack and destroy tumor cells.

• Maxim Pharmaceuticals Inc., of San Diego, said the European Commission granted orphan drug designation to Ceplene (histamine dihydrochloride) in acute myeloid leukemia. Maxim has completed a Phase III study of Ceplene plus IL-2 (Proleukin) compared to the standard of care for patients in first or subsequent remission.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said data presented at the American College of Cardiology Annual Scientific Sessions in Orlando, Fla., showed that glycoprotein IIb-IIIa inhibitors and Integrilin were pivotal components in the strategy to reduce the risk of heart attack and death in patients undergoing percutaneous coronary intervention. In the Clear Platelets study, Integrilin provided superior platelet inhibition and prevention of heart muscle damage associated with elective coronary stenting vs. clopidogrel alone. The data also were published in the March 2005 issue of Circulation, the journal of the American Heart Association.

• Neurochem Inc., of Montreal, completed its public offering of 4 million common shares, which were sold in the U.S. and Canada at $15.30 per share and resulted in gross proceeds of $61.2 million. UBS Investment Bank acted as the sole book-running manager, and CIBC World Markets Corp., Piper Jaffray & Co., Desjardins Securities Inc., Wells Fargo Securities LLC, BMO Nesbitt Burns Inc. and Fortis Securities LLC acted as co-managers. The company intends to use proceeds primarily to fund Phase III trials of its Alzheimer's disease product, Alzhemed. (See BioWorld Today, March 7, 2005.)

• NuGEN Technologies Inc., of San Carlos, Calif., entered a collaboration with the nonprofit consortium AMDeC Foundation Inc. to provide RNA-amplification systems to the consortium's member institutions, as well as provide sponsorship for AMDeC initiatives and statewide on-site training programs. NuGEN has three Ovation Systems for amplifying and labeling RNA for gene-expression analysis. Financial terms were not disclosed.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., completed enrollment in its pivotal Phase III trial comparing a five-day treatment of Factive (gemifloxacin mesylate) tablets to an approved seven-day treatment of community-acquired pneumonia of mild to moderate severity. The non-inferiority, double-blind study has enrolled more than 460 patients at about 100 sites in the U.S. and Europe. The company expects to complete data analysis in the coming weeks and plans to file a new drug application by the end of this year.

• PamGene International BV, of Hertogenbosch, the Netherlands, secured a €2 million grant from SenterNovem, a Dutch government agency, for collaborative research. The funding is for the development of bioinformatics and systems biology on PamGene's PamChip Array platform, which will help in the understanding of biological pathways. The company also said it is participating in a consortium project under the European Union Sixth Framework Programme on the investigation of mitochondrial diseases, and it is part of a collaboration with the Netherlands Proteomics Centre to further develop proteomics research.

• Pharming Group NV, of Leiden, the Netherlands, said Health Canada approved the company's clinical trial application for recombinant human C1 inhibitor, expanded for the treatment of hereditary angioedema. Pharming said it will assess the safety and efficacy of the product, which is in a Phase III trial in Europe. The company also expanded clinical studies in the U.S. after filing an investigational new drug application with the FDA.

• Tanox Inc., of Houston, completed enrollment in its Phase II trial of TNX-355 in HIV. The trial, which has enrolled the target of 80 patients, is a three-arm, double-blind, placebo-controlled study evaluating the safety and efficacy of TNX-355, as assessed by viral load reduction.

• The Immune Response Corp., of Carlsbad, Calif., said Phase II data showed that long-term Remune treatment was effective in delaying virologic failure during antiretroviral treatment interruption. The Phase II study conducted in Spain also showed a correlation to the magnitude of HIV-specific immune responses induced in studied patients. And in antiretroviral-na ve patients treated with Remune, a second Phase II study, conducted in Italy, demonstrated stabilization of CD4+ cell counts, as well as several positive trends in key markers believed to indicate immune responses against HIV.

• V.I. Technologies Inc., of Watertown, Mass., filed a registration statement for a proposed rights offering of its common stock with a maximum value of about $5.5 million through the distribution of subscription rights to all of its shareholders of record as of March 9. Under the terms of the offering, shareholders will receive 0.8 subscription rights for each share of common stock they own, entitling them to collectively purchase up to 27.5 million shares of Vitex stock, at an exercise price of 20 cents per share. That is the same pricing as in the $20 million private placement announced in December, which also included warrants and is expected to close with the company's merger with Panacos Pharmaceuticals Inc., of Gaithersburg, Md. Vitex said, if the offering is fully subscribed, its shareholders should be able to maintain their ownership positions in the company before and after the effects of the financing and the merger.