• Adventrx Pharmaceuticals Inc., of San Diego, said data collected from its ongoing CoFactor Phase II trial in metastatic colorectal cancer and a recent preclinical study that compared toxicity and antitumor activity of CoFactor used in combination with 5-flourouracil and other agents will support filings with the FDA and European officials to begin late-stage trials. CoFactor is a biomodulator designed to enhance the activity of 5-FU. The data will be presented next week at the American Association for Cancer Research annual meeting in Anaheim, Calif.

• Ambion Diagnostics, of Austin, Texas, a division of Ambion Inc., granted Cepheid Inc., of Sunnyvale, Calif., nonexclusive worldwide rights to incorporate Armored technology in its products and processes for in vitro molecular diagnostics. Ambion Diagnostics will make custom reagents for Cepheid in Ambion's cGMP development and manufacturing facility. Armored RNA technology is a system jointly invented and developed by Ambion and Cenetron Diagnostics Inc., also of Austin, for the packaging of RNA in bacteriophage coat proteins to protect and stabilize RNA.

• Cangene Corp., of Toronto, and Baxter Healthcare Corp., of Deerfield, Ill., said the FDA approved the liquid formulation of Cangene's WinRho SDF, used to treat immune thrombocytopenic purpura. WinRho SDF is derived from human plasma and is designed to provide an alternative to the lyophilized therapeutic, which eliminates the need for reconstitution prior to administration. Baxter received exclusive rights from Cangene last month to market and distribute WinRho SDF in the U.S.

• Cell Therapeutics Inc., of Seattle, said that the medical and scientific director of the Institute for Myeloma & Bone Cancer Research presented data from a multicenter Phase II trial of a Trisenox combination regimen, known as MAC (melphalan, Trisenox and vitamin C), in relapsed or refractory multiple myeloma patients. The data showed that 22 of the 37 patients evaluated achieved an objective response, with eight patients experiencing a decrease in serum M-protein of 50 percent or more and 14 patients experiencing a decrease in serum M-protein of between 25 to 49 percent. Of the 29 patients who had failed prior thalidomide or lenolinamide therapy, 14 patients responded to the Trisenox regimen.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, said recent clinical data on its lead morphine-6-glucuronide (M6G) by an academic group at King's College in London further supported the potential of M6G as a treatment for post-operative pain, focusing on its potential for administration under patient-controlled analgesia. Data indicated that M6G has an analgesic potency similar to morphine, but causes lower respiratory depression and reduced nausea, and researchers noted significantly less sedation in the M6G group compared to the morphine group. The results were published in Anesthesiology.

• The Centre for Human Genetics, at the University of Bremen in Germany, reported in a recent issue of American Journal of Pathology their findings on a signaling molecule called "High Mobility Group Protein B1," which appeared to be a signal sent by tumor cells that induce the sprouting of blood vessels that supply tumors with oxygen. The study concluded that the molecule might be a promising target for therapeutics aimed at blocking the angiogenetic signal to reduce tumor cell growth.

• CureTech Ltd., of Yavne, Israel, completed its Phase I trial of CT-011, a humanized monoclonal antibody directed against a B7 family-associated protein, in patients with advanced hematological malignancies. The purpose of the study was to evaluate the safety and determined the maximum tolerated dose of CT-011 single intravenous administration in cancer patients. Despite the advanced stage of their disease, clinical responses have been observed in five patients. One patient has exhibited a partial response for more than eight months and two additional patients have had no disease progression for more than seven months. Minimal response to treatment has been observed in two additional patients. Four other patients, with an average of three months of follow up, are alive with active disease.

• Diversa Corp., of San Diego, signed an agreement with Cargill Health and Food Technologies, of Minneapolis, to discover and develop novel enzymes to produce an undisclosed product. Diversa will receive up-front payments and research funding, and is entitled to milestone payments, license fees and royalties. The companies will develop the product by combining Diversa's enzyme product-development platform with Cargill's bioprocessing and commercial expertise.

• EntreMed Inc., of Rockville, Md., presented positive preclinical data for 2-methoxyestradiol (2ME2) in rheumatoid arthritis at the 18th annual meeting of the Canadian Society for Immunology held earlier this month in Whistler, British Columbia. Data demonstrated activity of 2ME2 in an adjuvant-induced arthritis animal model. Results showed that 2ME2 inhibits disease development and severity, and it inhibits both inflammatory cell migration to the joints and articular cartilage damage.

• Hemispherx Biopharma Inc., of Philadelphia, presented data at the 18th International Conference on Antiviral Research in Barcelona, Spain, showing an experimental Ampligen treatment in chronic fatigue syndrome improved exercise duration up to two times more than approved drugs. Ampligen increased the percentage improvement in endurance more than 15 percent over the placebo group. Maximal oxygen consumption increased tenfold with Ampligen vs. placebo.

• Isolagen Inc., of Houston, leased an 86,500-square-foot facility in Exton, Pa., to serve as its site for product development, manufacturing and commercialization of the Isolagen Process, as well as its corporate headquarters. The company will have lease payments at a discount of about 30 percent to 40 percent for the first three years of the 13-year lease, and Pennsylvania will provide the company tax credits, cash grants, training grants and low-interest equipment loans. Isolagen specializes in the development and commercialization of autologous cellular therapies for soft- and hard-tissue regeneration.

• Karo Bio AB, of Huddinge, Sweden, reported that Merck & Co. Inc., of Whitehouse Station, N.J., discontinued development of a clinical stage candidate identified in their collaboration. Development was discontinued due to adverse findings in ongoing animal studies. Merck continues to study a backup compound in preclinical testing. In addition, other estrogen receptor compounds arising from the Karo Bio and Merck collaboration continue to be evaluated. The collaboration with Merck was initiated in November 1997 with the objective of developing new treatments in the field of estrogen receptors.

• Mutabilis SA, of Paris, and Chiron Vaccines, a unit of Emeryville, Calif.-based Chiron Corp., announced a license agreement to use Mutabilis' research to develop a new prophylactic vaccine. Terms of the agreement provide for the payment of license fees, milestone fees and royalties to Mutabilis. Further financial details and the exact vaccine target were not disclosed.

• Protein Polymer Technologies Inc., of San Diego, appointed William Plamondon CEO. Thomas Parmeter, PPTI's former CEO, will remain chairman, and Donald Kaplan will continue as president and chief operating officer. Plamondon currently is president and CEO of R.I. Heller & Co. PPTI is focused on developing products to improve medical and surgical outcomes.

• PTC Therapeutics Inc., of South Plainfield, N.J., said data from a Phase I multiple-dose study of PTC124 indicated there were no symptomatic drug-related adverse events at any dose level, and PTC124 achieved target plasma concentrations associated with activity in preclinical models. Results were presented at the 57th annual meeting of the American Academy of Neurology meeting in Miami Beach, Fla. PTC124, an orally administered drug designed to target nonsense mutations, is being investigated as a potential treatment for Duchenne's muscular dystrophy and cystic fibrosis, with the potential to treat other genetic disorders.

• Reliant Pharmaceuticals Inc., of Liberty Corner, N.J., is extending its promotion agreement with Novartis AG, of Basel, Switzerland, for cholesterol-lowering drugs Lescol (fluvastatin sodium) and Lescol XL (fluvastatin sodium extended-release tablets). Reliant began promoting the drugs in January 2001 under a five-year agreement, and, according to the extended agreement, will continue to promote the Lescol product family through 2007.

• Sepracor Inc., of Marlborough, Mass., reported preliminary results from its second six-month Phase IIIb/IV randomized, double-blind, placebo-controlled safety and efficacy study of Lunesta brand eszopiclone for the treatment of insomnia. The study, which included 828 patients with chronic insomnia, augments the findings in Sepracor's first six-month study of Lunesta. The long-term study included a two-week discontinuation phase, which showed no evidence of treatment-related rebound insomnia or withdrawal symptoms. In the study, nightly use of Lunesta 3 mg resulted in a statistically significant improvement compared with placebo in patient-reported measures of sleep latency, sleep maintenance, total sleep time and sleep quality (p<0.0001).

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., launched a Phase II trial to evaluate SPI-153 in treating patients with hormone-dependent prostate cancer. The Phase II trial will evaluate the effects of the candidate on hormonal levels, in particular, testosterone, as well as on objective antitumor responses. The trial will be conducted in Europe under a collaboration with AEterna Zentaris Inc., of Quebec, the licensor of SPI-153 (D-63153). (See BioWorld Today, Aug. 13, 2004.)

• VasoGenix Pharmaceuticals Inc., of Lenexa, Kan., said it has signed a worldwide agreement with QLT USA Inc., a subsidiary of Vancouver, British Columbia-based QLT Inc. to develop a sustained-release formulation of VasoGenix's calcitonin gene-related peptide (CGRP) using QLT's Atrigel biodegradable sustained-release drug delivery system. Under the terms of the agreement, VasoGenix has contracted with QLT to develop the delivery system for the product and has the option to acquire an exclusive worldwide royalty-bearing license. VasoGenix said CGRP is designed to treat cardiac conditions.

• VaxGen Inc., of Brisbane, Calif., said the U.S. District Court for the Northern District of California dismissed without prejudice the amended complaint filed in March 2003 against VaxGen. Separately, the company also announced that the California Superior Court for San Mateo County has scheduled a hearing for April 29 to consider a proposed settlement in a related shareholders' derivative lawsuit. Both lawsuits relate to certain public disclosures concerning an experimental AIDS vaccine the company no longer is developing. The plaintiffs still might file another amendment to their complaint, which charged VaxGen and certain of its officers and directors with SEC violations. The company reported in February 2003 that its trial of AidsVax failed to show a statistically significant reduction of HIV infection within the study population as a whole. (See BioWorld Today, Feb. 23, 2003.)