• Affymax Inc., of Palo Alto, Calif., initiated a Phase II trial of Hematide, a synthetic peptide-based erythropoiesis-stimulating agent (ESA) being developed to treat anemia in patients with chronic kidney disease (CKD) and cancer. The randomized, double-blind, placebo-controlled, dose-escalation study will evaluate a single intravenous injection of Hematide in CKD patients who are not on dialysis and have not had prior ESA treatment.

• Arakis Ltd., of Little Chesterford, UK, said its rheumatoid arthritis drug, AD 452, recently completed a Phase IIa trial. Results showed that AD 452, a small-molecule, disease-modifying drug designed to reduce joint inflammation and destruction and pain, as well as preserve mobility, was well tolerated at the three dose levels tested when administered in combination with standard methotrexate treatment. Arakis said it will advance the product to a Phase IIb program to determine efficacy.

• Australian Cancer Technology, of Sydney, Australia, submitted a drug master file to the FDA for its cancer vaccine adjuvant, GPI-0100. The company's objective in developing GPI-0100 and a related series of compounds is to improve the effectiveness of therapeutic vaccines designed to treat pathogens such as genital herpes and cancers of the breast, prostate, kidney and lung.

• Bavarian Nordic A/S, of Copenhagen, Denmark, said its quality-control laboratory at the Kvistgard site has been granted authorization by the Danish Medicines Agency to perform its own analysis and release on production batches of Imvamune smallpox vaccine and MVA-BN products for use in the company's development programs. Bavarian Nordic also reported that all other activities to prepare for the commercial manufacture at the Kvistgard site are proceeding as planned, and expects to produce 60 million doses of Imvamune vaccine per year beginning in September 2005.

• Biogen Idec Inc., of Cambridge, Mass., and Fumapharm AG, of Lucerne, Switzerland, said a Phase III trial of the oral fumarate BG-12 for psoriasis met its primary endpoint of a statistically significant improvement over placebo. The multicenter, double-blind, placebo-controlled study enrolled 175 patients that received treatment or placebo for 16 weeks. The data will support a filing for market authorization in Germany this year. Additional Phase III studies are required for filings in the U.S. and the rest of Europe. Biogen Idec said a Phase II study of BG-12 in relapsing-remitting multiple sclerosis began last November.

• Bio-Rad Laboratories Inc., of Hercules, Calif., made a proposal to BioSource International Inc., of Camarillo, Calif., to acquire all of its outstanding shares for $8.50 per share in cash. Bio-Rad already owns nearly 5 percent of the outstanding shares of BioSource. The offer is a 21 percent premium to BioSource's closing price on April 5 and a 30 percent premium to its three-year average closing price. Based on Tuesday's closing price, BioSource was valued at about $68 million. Bio-Rad's offer values it at more than $82 million. The proposal, in letter form, was made to the BioSource board. BioSource's board has turned down Bio-Rad's attempts to merge in the past. Bio-Rad is a manufacturer and distributor of life science research products and clinical diagnostics. BioSource provides life science researchers with the basic reagents used for signal transduction, cytokine and immunology research.

• Cardiome Pharma Corp., of Vancouver, British Columbia, released final results for a clinical study of oxypurinol in 20 congestive heart failure patients, showing a statistically significant improvement in left ventricle ejection fraction. The study involved intravenous dosing of 400 mg of oxypurinol and was open-label with no placebo group.

• CellCentric, of Cambridge, UK, received new funding of £250,000 (US$467,379) from the Rainbow Seed Fund. The investment enabled a new commercial relationship with the Babraham Institute, also of Cambridge. CellCentric has exclusive rights to epigenetic-related intellectual property generated at the institute. CellCentric will use its discovery platform to develop a variety of products for cancer based on proteins and small molecules.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, launched a multicenter Phase II study of Ceflatonin (homoharringtonine) in combination with Gleevec (imatinib mesylate, Novartis AG) in patients with chronic myelogenous leukemia who have developed resistance to Gleevec. About 20 percent of patients have primary resistance to Gleevec and another 20 percent develop resistance after 14 months. Agents with synergistic mechanisms of action, such as Ceflatonin, are needed for use in combination with tyrosine kinase inhibitors to limit resistance and increase the chances of a cure, ChemGenex said.

• Infectech Inc., of Sharon, Pa., changed its name to Nanologix Inc., following a March 30 meeting, during which a proposal to reverse split the company's common stock was turned down due to resistance from minority shareholders. The company focuses on the research and development of technologies for the production of bacteria and disease testing kits, cancer therapy, alternative fuel sources and the remediation of toxic materials.

• InNexus Biotechnology Inc., of Vancouver, British Columbia, published a review on TransMab technology. TransMabs are monoclonal antibodies to intracellular targets, modified by InNexus' SuperAntibody Technology to penetrate or translocate into cells, bind to their targets and regulate cellular activities. The review is titled "TransMabs: Cell-penetrating antibodies, the next generation" and was published in Expert Opinion on Biological Therapy.

• Lifebank USA, of Cedar Knolls, N.J., said that human placenta-derived stem cells that are pluripotent, or have the ability to become different types of tissue, can be isolated with a perfusion technology from placenta so they are available for potential treatment applications, according to a study presentation at the International Conference on Stem Cells Research and Therapeutics in San Diego. The objective of the study was to use a perfusion method to recover pluripotent stem cells from human placenta after birth, culture them, and characterize the cells from a surface marker and differentiation perspective.

• Living Cell Technologies Ltd., of Adelaide, Australia, reported the long-term survival of encapsulated pig islets in a man with Type I diabetes. The cells were retrieved after being in the patient's abdomen for almost nine years. A 40-year-old man with Type I diabetes received a transplant of an early prototype of LCT's DiaBCell in 1996, as part of an approved clinical trial. The pig islet transplants were intended to release insulin and restore control of blood glucose levels. The pig islets were prepared in an alginate capsule to protect them from immune rejection and no immune-suppressive drugs were needed for the transplant.

• NPS Pharmaceuticals Inc., of Salt Lake City, said results of two separate analyses of its Phase III TOP study data corroborate previous findings that Preos (parathyroid hormone) improves bone microarchitecture and reduces the incidence of first and subsequent vertebral fractures in high-risk post-menopausal osteoporotic women. Data from the 18-month, 2,600-patient study, which included a bone biopsy study using micro-computed tomography and a vertebral fracture study, were presented at the National Osteoporosis Foundation 6th International Symposium on Osteoporosis in Washington. Early results of the trial were reported in the fall at the American College of Rheumatology meeting. (See BioWorld Today, Oct. 25, 2004.)

• Oncolytics Biotech Inc., of Calgary, Alberta, received FDA clearance to begin a Phase I trial to investigate the systemic delivery of Reolysin as a treatment for patients with advanced or metastatic solid tumors. During the open-label, dose-escalation study, single doses will be administered intravenously to patients with selected advanced or metastatic solid tumors that are refractory to standard therapy or for which no standard therapy exists. Oncolytics said the primary objective will be to determine the maximum tolerated dose, dose-limiting toxicity and safety profile, while secondary objectives include the evaluation of viral replication, immune response and evidence of antitumor activity.

• Palatin Technologies Inc., of Cranbury, N.J., and King Pharmaceuticals, of Bristol, Tenn., formed a scientific advisory board to provide guidance on the development of PT-141 for the treatment of both male and female sexual dysfunction. Palatin said PT-141 is the first compound in a new drug class called melanocortin receptor agonists that is being evaluated in Phase II trials to assess the efficacy of safety profiles of varying doses in men experiencing erectile dysfunction and in women experiencing female sexual dysfunction.

• Pfizer Inc., of New York, withdrew Bextra from the U.S. and European markets due to FDA concerns of the cardiovascular risk of non-steroidal anti-inflammatory drugs (NSAIDs) and the product's risk of rare but serious skin reactions. Bextra's risk of skin reactions is described in its label, but the cardiovascular risks of COX-2 inhibitors came to light when Whitehouse Station, N.J.-based Merck & Co. Inc. removed Vioxx from the market last year. Pfizer said it respectfully disagrees with the FDA's position regarding the overall risk to benefit profile of Bextra. The FDA decided on Thursday to require boxed warnings of potential cardiovascular risk for all COX-2 pain relievers and all NSAIDs, including Pfizer's Celebrex and older drugs such as ibuprofen and naproxen.

• PharmaMar SA, of Madrid, Spain, said its marine-derived cancer drug, Yondelis (trabectedin), was granted orphan drug designation by the FDA in ovarian cancer. The drug is partnered with Johnson & Johnson Pharmaceutical Research & Development LLC, a division of Johnson & Johnson, of New Brunswick, N.J. The European Commission granted orphan drug status to Yondelis in the same indication in Europe in 2003.

• Plexxikon Inc., of Berkeley, Calif., formed an agreement under which Invitrogen Corp., of Carlsbad, Calif., will profile Plexxikon's kinase inhibitor libraries. Those libraries represent drug discovery assets based on eight scaffolds, or chemotypes, with co-crystal structural information available and pharmaceutical properties profiles for many compounds.

• Protein Polymer Technologies Inc., of San Diego, initiated actions for an immediate delisting of its common stock from the Borse-Berlin-Bremen Stock Exchange in Germany. The stock was listed without the company's knowledge, consent or authorization. The company intends to pursue a listing of its stock on the American Stock Exchange.

• Regenera Ltd., of Perth, Australia, granted an exclusive global license to Alcon Manufacturing Ltd., an affiliate of Alcon Inc., of Fort Worth, Texas. The license involves a product that is used to assist in visualization of the vitreous fluid during a surgical procedure of the eye known as vitrectomy. The terms require a series of payments by Alcon, including an up-front license fee, milestone and royalty payments of double-digit royalties in the U.S. and single-digit royalties elsewhere. The duration of the license corresponds to the life of the subject patent rights.

• Senetek plc, of Napa, Calif., extended its agreement through 2011 with a major research foundation for rights to manufacture and sell diagnostic monoclonal antibodies used for research in various disease states such as Alzheimer's in exchange for royalties. The company also finalized an amendment to its April 2004 agreement with marketing partner Signet Laboratories Inc., of Dedham, Mass. Signet will manufacture, market and distribute the monoclonal antibodies licensed to Senetek in exchange for revenue sharing.

• Sepracor Inc., of Marlborough, Mass., said Lunesta now is available by prescription in pharmacies nationwide. The product was approved by the FDA in December for the long-term treatment of insomnia. It has been studied in patients for up to a year and in about 30 clinical trials enrolling more than 4,700 patients. (See BioWorld Today, Dec. 17, 2004.)

• Synthetic Blood International Inc., of Costa Mesa, Calif., said Richmond-based Virginia Commonwealth University Medical Center received approval from its investigational review board to open patient enrollment for Synthetic Blood's Phase II trial of Oxycyte, the company's perfluorocarbon blood substitute and therapeutic oxygen carrier. The trial, which will administer Oxycyte to hip revision surgery patients who experience mild to moderate blood loss during surgery, is expected to be the first in a series of planned Phase II studies to focus on surgery and indications for therapeutic oxygen.

• XenoPort Inc., of Santa Clara, Calif., said results from a Phase IIa trial demonstrated that its product candidate XP13512 provided statistically significant and clinically relevant benefits to patients with post-herpetic neuralgia when administered twice per day. The study enrolled 101 patients and determined that the drug was associated with a reduction in pain and a reduction in sleep interference compared to placebo. XP13512 is a transported prodrug of gabapentin (marketed as the brand Neurontin by New York-based Pfizer Inc.), and demonstrated in the trial an average 17 percent increase in the steady-state average blood concentration of gabapentin compared to dosing with Neurontin.