• Advanced Viral Research Corp., of Yonkers, N.Y., initiated a Phase II trial in the U.S. for AVR118. The study will examine AVR118 in patients with advanced cancer who are suffering from symptoms of progressive disease. Advanced Viral is collaborating with the Biomedical Research Alliance of New York and is actively recruiting patients. About 40 adult patients with advanced cancer are expected to be entered in the study.

• American Pharmaceutical Partners Inc., of Schaumburg, Ill., said the class-action lawsuit and a related suit filed against the company, its officers and American BioScience Inc. voluntarily have been dismissed by the plaintiffs. The suits claimed that the defendants made false and misleading statements regarding Abraxane, which gained approval in January as a treatment for breast cancer. No payment was made to the plaintiffs in connection with the dismissals. (See BioWorld Today, Jan. 11, 2005.)

• Antisoma plc, of London, signed an agreement with Raylo Chemicals, of Edmonton, Alberta, for the manufacture of AS1411 (formerly AGRO100), Antisoma's aptamer drug in trials for cancer. The company said it chose the manufacturer because of Raylo's previous success in the production of aptamers and other oligonucleotides, such as Macugen, developed by New York-based companies Pfizer Inc. and Eyetech Pharmaceuticals Inc. AS1411 is manufactured by extracting the nucleotides from salmon sperm and then linking them chemically to form an oligonucleotide.

• BioBalance Corp., of New York, a wholly owned subsidiary of New York Health Care Inc., said it entered a manufacturing and supply agreement with Benchmark Biolabs Inc., of Prairie Village, Kan., in which Benchmark will manufacture ProBactrix for BioBalance's proposed clinical trials of ProBactrix in the U.S. The product would be manufactured in a facility in Lincoln, Neb. Financial terms of the agreement were not disclosed.

• Bioniche Life Sciences Inc., of Belleville, Ontario, said positive results were seen in three recent feedlot studies by the University of Nebraska using the E. coli 0157:H7 cattle vaccine. The company said in one study 73 percent fewer animals detectably shed the bacteria in their manure while receiving three does of vaccine. Another study showed that after three doses, about 97 percent had no detectable bacterial colonization, and the third study, involving 19 feedlots and 21,691 cows, showed the vaccine was effective in commercial feedlot settings, with about 75 percent of the cattle having no detectable bacterial colonization.

• Critical Therapeutics Inc., of Lexington, Mass., initiated an open-label Phase IIIb study of its investigational drug Zyflo Filmtab (zileuton tablets) for patients with asthma who previously have benefited from Zyflo and require it to control their asthma. In addition, the FDA approved the enrollment in the study of patients with mastocytosis, an orphan disease involving new or abnormal cell growth, in which Zyflo is deemed essential for the treatment of symptoms, the company said. Zyflo is the only 5-lipoxygenase inhibitor approved in the U.S. for the treatment of asthma in adults and children 12 years of age and older, the company said.

• Cytomedix Inc., of Rockville, Md., signed a sales agreement with KOL Bio-Medical Instruments Inc., of Chantilly, Va., to represent the company in select East Coast U.S. territories for six months under a commission fee structure, subject to renewal, regarding AutoloGel therapy. The product is in a blinded, multicenter trial testing its use in healing diabetic foot ulcers.

• Enanta Pharmaceuticals Inc., of Watertown, Mass., received a milestone payment from its EP-013420 East Asia development and commercialization partner, Shionogi & Co. Ltd., of Osaka, Japan. The milestone reflects the initiation of Phase I studies for the community antibiotic, which was renamed S-013420 by Shionogi for development in East Asia. First in class, EP-013420 is a bridged bicyclic ketolide that was designed by Enanta to have optimal pharmacokinetics and to provide broad treatment against respiratory pathogens, including several multidrug-resistant strains for which traditional macrolides, penicillins and fluoroquinolones no longer are effective.

• GammaCan International Inc., of Givat Shmuel, Israel, received approval to initiate a Phase II trial of GCAN 101 in Israel. The 30-patient study will evaluate the product in metastatic melanoma, metastatic prostate or colon cancers, and the company said it expects to expand the trial to a number of medical centers throughout the country. The GCAN 101 therapy is based on intravenous immunoglobulin.

• Generex Biotechnology Corp., of Toronto, reported results of a recently completed Phase IIb study of Oral-lyn in which Oral-lyn replaced rapid-acting insulin in patients with Type I diabetes mellitus. The trial involved 10 patients. A comparison of a daily nine-point glucose profile of each patient between the Oral-lyn regimen and injected regular human insulin indicated Oral-lyn, administered as a pre-meal insulin in a divided dose schedule, produced glucodynamic profiles comparable to that produced by injected regular human insulin.

• La Jolla Pharmaceutical Co., of San Diego, said the FDA is unlikely to grant accelerated approval for the company's lupus renal disease treatment, Riquent. La Jolla plans to continue the ongoing clinical benefit trial and to continue discussions with the FDA about adding a higher dose to the study. The company received an approvable letter for Riquent in October, saying positive results from the ongoing trial would support final approval. Monday, the company's stock (NASDAQ:LJPC) fell 51 cents, or 42.5 percent, to close at 69 cents. (See BioWorld Today, Oct. 18, 2004.)

• Ligand Pharmaceuticals Inc., of San Diego, said it reached a settlement agreement in a recent patent-interference action initiated against two patents owned by the Burnham Institute and SRI International but licensed to Ligand. The company said Burnham and SRI will concede before the U.S. Patent and Trademark Office that Ligand has priority to all the disputed claims relating to bexarotene, the active ingredient in its Targretin products. Ligand said the settlement also reduces the royalty rate to SRI and Burnham while extending the royalty payment term.

• Locus Pharmaceuticals Inc., of Blue Bell, Pa., entered a research agreement with Scios Inc., of Fremont, Calif., whereby Locus will apply its molecular fragment technology focused on protein kinases. Locus uses one of the largest privately owned supercomputer clusters to identify relevant binding sites on protein targets, generate small-molecule ligands that bind to those sites and simultaneously optimize the compounds for appropriate "drug-like" properties, Locus said. Financial terms were not disclosed.

• MediciNova Inc., of San Diego, started enrollment of patients in a new Phase I study with MN-221 in the U.S. The agent is for the management of preterm labor and was licensed in 2004 from Kissei Pharmaceutical Co. Ltd., of Nagano, Japan. MN-221 is a selective beta-2 agonist that has shown potential in delaying premature delivery of infants due to the early onset of labor in expectant mothers, the company said.

• Merial Ltd., of Duluth, Ga., launched its inactivated vaccine, Gallimune Flu H5N9, developed for use against the pathogenic avian influenza virus H5N1 that has affected the Asian poultry industry and been linked to 29 human deaths. Merial said that once vaccinated, chickens can be differentiated from infected birds through the use of the DIVO (Differentiating Infected from Vaccinated Animals) serological diagnostic test. Gallimune Flu H5N9 joins Trovac AIV H5 as the company's second introduction of avian influenza vaccines.

• MIV Therapeutics Inc., of Vancouver, British Columbia, executed a letter of intent to acquire Sahajanand Medical Technologies, of Surat, India. The companies expect they will enter a definitive agreement within the next 30 days, pending the successful completion of routine-required auditing procedures. MIV expects SMT to generate about $20 million in revenues next year.

• Modular Genetics Inc. (MGI), of St. Louis, and Monsanto Co., of Woburn, Mass., formed a relationship to advance Monsanto's protein-optimization platform. MGI developed and patented protein-optimization platforms, which are used for the screening, identification and assembly of proteins for research. Monsanto will gain an exclusive license to use MGI's platform for use in agricultural applications. Financial terms were not disclosed.

• Multiple Myeloma Research Foundation, of New Canaan, Conn., awarded three grants worth $400,000 to researchers focused on identifying and validating molecular targets with therapeutic potential. The grants were given to James Bradner, of the Dana-Farber Cancer Institute; Robert Orlowski, of the University of North Carolina at Chapel Hill; and Allan Weissman, of the Center for Cancer Research at the National Cancer Institute-Frederick.

• Neurological Technologies Inc., of Richmond, Calif., had an end of-Phase II meeting with the FDA regarding Viprinex (ancrod), a product in clinical development for the treatment of acute ischemic stroke. As a result of the meeting, the company continues to move forward with its plan to begin a Phase III program this summer.

• Oxford BioMedica plc, of Oxford, UK, said Nature Medicine published a paper demonstrating efficacy of the company's LentiVector technology in an animal model of inherited amyotrophic lateral sclerosis. The paper described the delivery, by the LentiVector technology, of a specific RNAi molecule that shuts down the gene that causes the disease. Data show that delivery of the molecule was very efficient, and there was a 100 percent extension of the time to onset of the disease, as well as a 70 percent increase in survival.

• Pharmacyclics Inc., of Sunnyvale, Calif., said patient enrollment has been completed in its pivotal Phase III trial of Xcytrin (motexafin gadolinium) injection for the potential treatment of lung cancer patients with brain metastases. The randomized, controlled study has enrolled 550 patients at 94 medical centers in the U.S., Canada, Europe and Australia. It is comparing the safety and efficacy of whole-brain radiation therapy (WBRT) alone to WBRT plus Xcytrin, with the primary endpoint being the time to neurologic progression.

• Prana Biotechnology Ltd., of Melbourne, Australia, began the Phase I trial of PBT2 with the dosing of its first subject in Utrecht, the Netherlands. PBT2 is the first completely Prana-discovered compound, and a successor to PBT1 to treat Alzheimer's disease. The compound has demonstrated significantly greater effectiveness than PTB1 in lowering plaque in the transgenic mouse model in in vitro and in vivo testing.

• Repligen Corp., of Waltham, Mass., entered a development agreement with the Stanley Medical Research Institute to receive funding for a Phase I trial to assess the oral bioavailability of Repligen's formulation of uridine. The study is expected to enroll patients next quarter, and follows Repligen's preliminary findings in animal models and patients that uridine might be useful in treating the depressive symptoms of bipolar disorder.

• Sepracor Inc., of Marlborough, Mass., said the FDA approved its new drug application for Xopenex HFA (levalbuterol tartrate) inhalation aerosol, a hydrofluoroalkane metered-dose inhaler for the treatment or prevention of bronchospasm in adults and children with reversible obstructive airway disease. The company expects to launch the product around the end of the year, during the peak asthma season. Xopenex inhalation solution, which gained approval in 2002, had revenues of $319.8 million in 2004.

• Tripos Inc., of St. Louis, received an $860,000 Phase II Small Business Innovation Research grant from the National Institutes of Health. The company will use the funds to create a full-scale library design system for use by medicinal chemists at its research facility, Tripos Discovery Research Centre.

• V.I. Technologies (Vitex) Inc., of Watertown, Mass., said it has closed its merger with Panacos Pharmaceuticals Inc., of Gaithersburg, Md., Under the terms of the merger, Vitex will issue about 227.5 million shares to Panacos stockholders to acquire all outstanding shares of Panacos. Vitex also said it has closed a $20 million private placement of common stock and warrants that was a condition to closing the merger. The completion of the merger also allowed Vitex to regain compliance with the $10 million minimum stockholders' equity requirement for continued listing on Nasdaq, and called for Vitex to add three members to its board. Herb Hooper and Eric Linsley, previously Panacos directors, replaced Vitex board members David Tendler and Doros Platika, and John Fletcher joined the board to bring it to a total of nine members. (See BioWorld Today, March 11, 2005.)

• VirtualScopics LLC, of Rochester, N.Y., said it is providing analytical and other imaging services to Wyeth Pharmaceuticals, a division of Madison, N.J.-based Wyeth, for use in a Phase I trial for an investigational biopharmaceutical being studied in muscle-wasting conditions. Financial terms of the deal were not disclosed.