• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said results of its Phase III trial of pexelizumab were published in the May 19, 2004, issue of the Journal of the American Medical Association. A summary of data from the 3,099-patient study, which examined the terminal complement inhibitor's efficacy in patients undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass, were first reported last fall at the American Heart Association meeting in Orlando, Fla. It showed that pexelizumab might beneficially impact inflammation and ischemia/reperfusion, thereby reducing the frequency and severity of myocardial infarction following CABG surgery. (See BioWorld Today, Nov. 11, 2003.)

• Axcan Pharma Inc., of Mont St.-Hilaire, Quebec, said results reported at the Digestive Disease Week conference in New Orleans indicated that Ursodeoxycholic Acid-Disulfate reduced the formation of colorectal tumors by 50 percent in a rat proof-of-concept toxicity study. The product, a non-absorbed bile acid, is a derivative of ursodiol intended for prevention of recurrence of colorectal polyps.

• BioBalance Corp., of New York, said results reported at the Digestive Disease Week meeting in New Orleans showed that use of Probactrix resulted in a clinical response in 12 of 18 patients with proximal inflammation of the small intestine, also called mucosal IBD. They had a marked reduction in abdominal symptoms and improvement in well-being after completing the four- to six-week course. In the 12 patients, pretreatment capsule endoscopy revealed significant inflammation in the proximal small bowel, while post-therapy capsule endoscopy showed significant improvement paralleling the observed clinical improvement.

• Bioenvision Inc., of New York, extended its exclusive option to manufacture, market and distribute its lead drug clofarabine to treat pediatric and adult acute leukemias in Japan and Southeast Asia. It obtained the option extension from the inventor of clofarabine, Southern Research Institute. Bioenvision is actively seeking a co-marketing partner to convert the option into a license on terms to be agreed upon between Bioenvision and SRI. The company's North American partner, San Antonio-based ILEX Oncology Inc., completed a new drug application in March for clofarabine to treat refractory or relapsed acute leukemia in children.

• BioMarin Pharmaceutical Inc., of Novato, Calif., closed its purchase of Ascent Pediatrics Inc., a pediatrics business that had operated as a subsidiary of Medicis Pharmaceutical Corp., of Scottsdale, Ariz. The acquisition includes Orapred, a drug for asthma in children, and a 66-person sales force that calls upon U.S. pediatricians. The acquisition was announced in April. (See BioWorld Today, April 22, 2004.)

• Corgentech Inc., of South San Francisco, said patient enrollment began in the Phase I/II study of E2F Decoy (edifoligide) to prevent arteriovenous graft failure in patients with end-stage renal disease who require hemodialysis. The trial will enroll 60 patients at up to 20 sites in the U.S. Initial data should be available in the first half of 2005. Corgentech is jointly developing and commercializing E2F Decoy with New York-based Bristol-Myers Squibb Co. The product also is in two Phase III trials for coronary artery bypass graft failure and peripheral bypass graft failure to prevent vein-graft failure.

• Corus Pharma Inc., of Seattle, completed the final closing of its recent Series C round of financing with an additional $5 million, bringing the total to $65 million. The funds will be used to advance Phase II studies of Corus 1020, an inhaled antibiotic for pseudomonal infections in cystic fibrosis patients, and Corus 1030, a treatment for oral corticosteroid-dependent asthma, as well as for eventual Phase III studies and to increase its pipeline. (See BioWorld Today, April 13, 2004.)

• Genencor International Inc., of Palo Alto, Calif., manufactured research sample quantities of enzymes that will neutralize sarin gas and certain other organophosphate-based nerve agents. The company is providing the samples to formulators that will develop them into sprays, foams and detergents to be used by military and civilian responders, such as firefighters and police. Genencor developed the enzymes in collaboration with the U.S. Army Edgewood Chemical Biological Center.

• Gilead Sciences Inc., of Foster City, Calif., said the FDA granted priority review status to the NDA for the fixed-dose co-formulation of its HIV drugs Viread and Emtriva. Gilead submitted the application in March and anticipates a decision by September. The proposed tablet would contain 300 mg of Viread (tenofovir disoproxil fumarate) and 200 mg of Emtriva (emtricitabine) and would be administered in combination with at least one other HIV product. The FDA approved Viread in 2001, and Emtriva was cleared for marketing in 2003. (See BioWorld Today, March 16, 2004.)

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., said Phase I/II data reported at the Digestive Disease Week conference in New Orleans showed that NM283 demonstrated consistent, dose-related antiviral effects in adult patients with chronic hepatitis C. The patient cohort that received the highest overall dose exposure of the once-daily oral treatment achieved a mean viral load reduction of 92 percent within 15 days of treatment. Among the NM283-treated patients in the trial to date, 87 percent previously had failed interferon-based therapies. All were infected with HCV genotype 1.

• ImmunoGen Inc., of Cambridge, Mass., said that Shire BioChem Inc., of Laval, Quebec, intends to sell all 4 million shares of its ImmunoGen common stock. Shire BioChem would receive all net proceeds from the sale, and no longer will have a stake in ImmunoGen. JP Morgan Securities Inc. and SG Cowen & Co. LLC are acting as joint book-running managers for the offering.

• Inpharmatica Ltd., of London, signed a discovery collaboration agreement with Procter and Gamble Pharmaceuticals Inc. (P&GP), a subsidiary of The Procter & Gamble Co., of Cincinnati. P&GP will fund a research program at Inpharmatica and pay additional license fees to use discoveries arising from the collaboration. Inpharmatica's flagship discovery platform, PharmaCarta, will play a key role in the collaboration. The collaboration goal will be to develop robust computational structure models and identify chemotypes for families of human G protein-coupled receptors.

• The Institute for OneWorld Health in San Francisco completed enrollment and treatment of 667 patients in India suffering from visceral leishmaniasis. The Phase III trial, which is evaluating use of an injectable form of paromomycin being developed by the U.S.-based nonprofit organization, will conclude with final follow-up patient exams in November. The company said it would apply early next year, seeking Indian regulatory approval to use paromomycin. The study is funded largely by the Bill & Melinda Gates Foundation.

• Juvaris BioTherapeutics Inc., of Pleasanton, Calif., received a Phase I Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases in Bethesda, Md. The grant will fund initial studies for the development of a vaccine against Pseudomonas aeruginosa in collaboration with the University of California at San Francisco. The vaccine approach uses Juvaris' cationic lipid-DNA complexes combined with a Pseudomonas-specific antigen discovered by UCSF collaborators to generate antibody- and cell-mediated immune responses.

• Maxim Pharmaceuticals Inc., of San Diego, said preclinical results demonstrated the ability of histamine to prevent lipopolysaccharide (LPS)-induced liver injury in a rodent model. The addition of histamine reduced pro-inflammatory cytokines and substantially increased survival in LPS-induced liver injury after partial liver resection. The current model is an extension to work done last fall showing the ability of histamine to accelerate liver regeneration after partial hepatectomy. It used a much higher dose of LPS, which was lethal in animals, but proved highly protective with a 92 percent survival rate when histamine was added to the dose.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said that in the final survival endpoint analysis of the Phase III confirmatory study comparing Velcade to high-dose dexamethasone, Velcade produced a statistically significant survival benefit. Called APEX, the study was designed to include survival as a secondary endpoint and allowed crossover for patients experiencing disease progression on high-dose dexamethasone to receive Velcade. Both interim data and final survival analysis will be presented at next month's American Society of Clinical Oncology meeting in New Orleans. The product was approved a year ago for multiple myeloma. Millennium's stock (NASDAQ:MLNM) gained 94 cents Tuesday to close at $14.50.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., said its board elected Thomas McLain, the company's current president and CEO, as chairman. Nabi applies its knowledge of the human immune system to its products.

• NovaRx Corp., of San Diego, fully enrolled its Phase II lung cancer trial more than a year ahead of schedule. The multicenter study is evaluating the safety and efficacy of a therapeutic vaccine designed to enhance a patient's own immune system in order to fight cancer. The product consists of non-small-cell lung cancer cell lines, originally derived from lung cancer patients, that are genetically modified through the introduction of a gene that blocks transforming growth factor-beta (TGF-beta).

• OxiGene Inc., of Waltham, Mass., said interim data reported at the International Conference on Vascular Targeting meeting in Miami Beach, Fla., showed that Combretastatin A4 Prodrug (CA4P) appears to be well tolerated, with no CA4P-related serious adverse events or dose-limiting toxicities. Among the women with advanced ovarian carcinoma, objective responses were observed in two patients resistant to previous platinum-based chemotherapy. Of nine ovarian cancer patients enrolled to date, levels of a marker for ovarian cancer called CA-125 were reduced in five. That includes one patient with a greater than 50 percent reduction in tumor volume. Phase I/II data of CA4P's use in patients with wet age-related macular degeneration revealed that in one patient, the area of choroidal neovascularization in the study eye decreased by about 100 microns. The drug was well tolerated up to doses of 36 mg/m2 and the side effects observed were increased blood pressure and pulse and an increase in QTc interval below clinical significance.

• ParAllele BioScience Inc., of South San Francisco, said findings from a Type II diabetes study at the Biology of Genomes meeting at Cold Spring Harbor Laboratories uncovered several new genetic risk factors for diabetes and confirmed certain genetic risk factors found by others. Using its single nucleotide polymorphism (SNP) discovery and genotyping technologies, the company first identified all common and rare SNPs among functional regions of a large number of candidate genes in a Type II diabetes population. ParAllele then analyzed hundreds of diabetic patients and controls to detect associations between the complete set of SNPs and diabetes. The study was funded by F. Hoffmann-La Roche Ltd., of Basel, Switzerland.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said previously published data reported at the International Conference on Vascular Targeting meeting in Miami Beach, Fla., showed that its anti-phospholipid antibody 3G4 significantly enhances the effectiveness of chemotherapy. Preclinical findings from a study of breast cancer tumors treated with 3G4 and docetaxel showed that the combination therapy resulted in 93 percent inhibition of human breast cancer growth, compared to 68 percent and 60 percent in groups treated with docetaxel or 3G4 alone. Separate data reported at the Angiogenesis Conference in London gave a historical overview of past research and an outlook for future research programs for Peregrine's 2C3 antibody technology. It works by inhibiting vascular endothelial growth factor from inducing the formation of blood vessels in solid tumors.

• ProMetic Life Sciences Inc., of Montreal, said its ProMetic BioSciences Ltd. subsidiary met its first two milestones in a collaboration with Serono SA, of Geneva. Mimetic Ligands were identified to purify the target protein of interest to Serono, ProMetic said, and their performance relative to established acceptance criteria has been reproduced in the laboratories of both companies. In March, ProMetic entered the collaborative agreement that could represent up to $1.3 million in development and milestones fees this year.

• Tanox Inc., of Houston, said that its collaborators Novartis Pharma AG, of Basel, Switzerland, and Genentech Inc., of South San Francisco, began a Phase III trial of Xolair (omalizumab) in pediatric allergic asthma patients. The randomized, double-blind, placebo-controlled, global, multisite trial will enroll about 570 patients between the ages of 6 and 12. The primary objective of the one-year study is to evaluate the efficacy and safety of Xolair, a recombinant humanized monoclonal antibody to IgE approved for treatment of adults and adolescents with asthma. (See BioWorld Today, June 23, 2003.)

• Valeant Pharmaceuticals, of Costa Mesa, Calif., said 24-week Phase II data reported at the Digestive Disease Week conference in New Orleans showed that a smaller portion of patients who received Viramidine 800-1200 mg/day had hemoglobin levels less than 10 g/dL or greater than or equal to 2.5 g/dL drop from baseline, compared to patients who received ribavirin (48 percent vs. 82 percent, respectively). Viramidine is a nucleoside analogue being developed in oral form for chronic hepatitis C in conjunction with a pegylated interferon.

• Xechem International Inc., of New Brunswick, N.J., reported that its subsidiary, Ceptor Corp., entered an agreement with a consortium of investors to provide $1.1 million of six-month bridge debt financing. The bridge lenders will be entitled to about 6.4 percent of Ceptor's fully diluted capitalization (inclusive of Xechem's 52.4 percent share ownership). Ceptor expects to repay the bridge loan with the proceeds of subsequent financing, although no commitments have yet been obtained for such financing. The prior holders of more than 80 percent of Ceptor's common stock agreed to waive their rights to receive any milestone payments from Xechem.