• Abbott Laboratories, of Abbott Park, Ill., expanded its immunology clinical trials program to include studies evaluating the potential of Humira (adalimumab) in psoriasis and psoriatic arthritis. Humira is the first human monoclonal antibody approved by the FDA for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis, who have had insufficient response to one or more traditional disease-modifying anti-rheumatic drugs and can be used alone or in combination with methotrexate.

• Actelion Ltd., of Allschwil, Switzerland, began its European Union launch of Zavesca, the first oral treatment for Type 1 Gaucher's disease. Now available to patients in the UK, a named-patient program allows commercial access to the drug through international pharmacies, if so permitted by local regulations. Zavesca (miglustat) is a small molecule developed by Oxford GlycoSciences plc, of Oxford, UK, for the treatment of patients with mild to moderate Gaucher's disease for whom enzyme replacement therapy is unsuitable. Actelion is the license holder for Zavesca in all territories worldwide, with the exception of Israel.

• AltaRex Corp., of Waltham, Mass., said it would present new OvaRex in vitro results in two separate oral presentations at this week's Keystone Symposium in Keystone, Colo. AltaRex said the data will further elucidate the mechanism by which OvaRex MAb interacts with target tumor-associated antigen CA125 and the immune system to elicit potent T-cell responses specific for CA125 expressing tumors of ovarian origin. Additional laboratory data addressed the observed synergy between chemotherapy and OvaRex treatment by further demonstrating the mechanism by which antibody/antigen complexes are processed in the presence of chemotherapy-induced dying tumor cells.

• American BioHealth Group LLC, of San Diego, reported at last week's Association for Research in Otolaryngology meeting in Daytona Beach, Fla., positive preclinical data on technology related to hearing loss prevention and treatment - technology licensed exclusively from the U.S. Navy. The data demonstrated that administration of the antioxidant N-acetylcysteine (NAC) decreased acute noise-induced hearing loss due to loud impulse noise exposure. The findings extended previous research indicating that NAC is protective against loud continuous noise such as jet engine noise.

• Anadys Pharmaceuticals Inc., of San Diego, completed Phase Ia studies of its lead compound, ANA245, for the treatment of hepatitis C infection. Information on the studies was presented at the AASLD conference "Hepatitis C New Drug and Clinical Trials Development" in Chicago. Anadys said it expects to begin Phase Ib studies shortly in a program designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ANA245 following intravenous administration to chronically infected patients.

• Avigen Inc., of Alameda, Calif., said it would receive a $2.5 million payment from Bayer AG, of Leverkusen, Germany, allowing its Bayer Biological Products Division in Research Triangle Park, N.C., to continue developing Coagulin-B, a gene therapy under clinical investigation for hemophilia B. The collaboration, entered into in November 2000, included a $15 million purchase of Avigen stock, milestone payments, funding of the clinical trial and AAV vector manufacturing costs, and now the option payment to support the hepatic route of administration. Avigen also will receive a royalty on net sales for its intellectual property, as well as a share of Coagulin-B sales. Avigen will manufacture the product for worldwide distribution. (See BioWorld Today, Nov. 20, 2000.)

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., completed its Phase II/III trial of Bio-E-Gel (estradiol gel) topical gel to treat menopausal symptoms. The double-blind, placebo-controlled, 161-patient trial, conducted in the U.S. and Canada, was designed to define the lowest effective dose of Bio-E-Gel to reduce the severity and frequency of moderate to severe hot flushes in menopausal women. BioSante said an end-of-Phase II/III meeting is planned with the FDA, while a pivotal Phase III trial is scheduled to begin later this year.

• Boston Biomedica Inc., of West Bridgewater, Mass., adopted a shareholders rights plan. The company said the plan was not adopted in response to any effort to acquire Boston Biomedica, and its board is not aware of any such effort.

The Cleveland Clinic in Cleveland said its researchers identified a new protein marker that leaks into the bloodstream when central nervous system barriers are breached. The marker could be used to detect disease and to determine when the body may be more or less receptive to medications. Results of the research were published in the March 1, 2003, edition of The Journal of Neuroscience.

• Genomic Solutions Inc., a wholly owned subsidiary of Harvard Bioscience Inc., of Holliston, Mass., entered an agreement to purchase substantially all of the assets of Genomic Instrumentation Services Inc., doing business as GeneMachines. Genomic Solutions will purchase GeneMachines' assets for about $8.3 million in cash and the assumption of certain specified liabilities. GeneMachines develops high-throughput instrumentation for DNA and protein microarray production, nucleic acid sample preparation and DNA synthesis. The transaction is expected to close later this month.

• GlycoGenesys Inc., of Boston, said that Bradley Carver, its president, CEO and board member, was elected interim board chairman, replacing Brian Hughes, who resigned from the board on Feb. 24.

• ImClone Systems Inc.'s founder and former CEO, Samuel Waksal, pleaded guilty Monday to conspiracy and wire fraud for evading $1.2 million in sales taxes related to art purchases over the last three years. Late last year Waksal, of New York, pleaded guilty to bank fraud, securities fraud and other related felonies after being accused of tipping off family and friends ahead of releasing the FDA's pending rejection of the cancer drug Erbitux. Waksal is expected to be sentenced by a federal judge in New York on the ImClone-related charges March 17. (See BioWorld Today, Oct. 16, 2002; Oct. 8, 2002; and Jan. 3, 2002.)

• Matritech Inc., of Newton, Mass., said the FDA approved its NMP22 BladderChek, which detects bladder cancer proteins in urine, as an aid in diagnosing bladder cancer. The point-of-care test, which provides results in 30 minutes while the patient is in the physician's office, will be permitted for the expanded use upon successful completion of a routine manufacturing facility inspection, Matritech said.

• Memory Pharmaceuticals Corp., of Montvale, N.J., said its MEM1414 compound was selected by Hoffmann-La Roche Inc., of Nutley, N.J., as a clinical candidate to treat Alzheimer's disease. Memory said it used its technology platform to optimize MEM1414 for efficacy and safety. Roche and Memory reported a broad alliance in July 2002 for development and commercialization of potential treatments for neurological diseases such as Alzheimer's and mild cognitive impairment, as well as for psychiatric conditions such as depression. (See BioWorld Today, July 31, 2002.)

• NeuroSearch A/S, of Ballerup, Denmark, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, began a Phase II study of NS2330 in advanced Parkinson's disease. The placebo-controlled, multicenter, European, 250-patient trial is expected to be completed in the second half of next year. Boehringer plans to begin another clinical study later this year in the U.S.

• Newron Pharmaceuticals SpA, of Milan, Italy, reported the publication of positive preclinical data on NW-1029, its lead pain program product, in the journal Pain. The data showed that NW-1029 has potent and long-lasting antihyperagesic and anti-allodynic activity in models of chronic pain. The company, which is focused on developing central nervous system therapies, said the compound also has an excellent therapeutic index. NW-1029, which has entered clinical trials, was well tolerated without signs of neurological impairment at high doses.

• Norwood Abbey Ltd., of Melbourne, Australia, appointed the Bank of New York to act as depositary in the establishment of an American depositary receipt program. The ADR program will allow Norwood Abbey's shares to be traded initially in the Over-the-Counter market in the U.S. It is called a Sponsored Level One ADR program. Norwood Abbey subsequently plans to apply to list its ADRs on Nasdaq. It is expected that the ADRs will be available for trading on the OTC markets by mid-year, according to the drug delivery and immunology company that features three drug platforms in various stages of commercialization and development.

• Oxford BioMedica plc, of Oxford, UK, said it received approval to begin a Phase II trial of its cancer vaccine TroVax in up to 15 patients receiving chemotherapy for colorectal cancer. More specifically, the trial, scheduled to begin within two months, is targeted for patients receiving chemotherapy for the first time to treat metastatic or inoperable cancer. Its endpoints include the immune response to TroVax and its safety in conjunction with 5-fluorouracil, leukovorin and irinotecan.

• Perlegen Sciences Inc., of Mountain View, Calif., reported the publication of a paper in the latest issue of Genome Research. The paper describes findings suggesting that genomic rearrangements, not single base pair changes in DNA, provide the genetic basis for the difference between humans and nonhuman primates such as the chimpanzee.

• Prolysis Ltd., of Oxford, UK, entered a collaboration with the Sir William Dunn School of Pathology at the University of Oxford to combat antibiotic-resistant bacteria. The three-year, £1.6 million (US$2.5 million) partnership is designed to produce validated antibiotic targets amenable to inhibition by small molecules, methodology to identify the biological function and pathway of genes, technology to develop assays in the absence of functional information and a tool kit of methods to identify the targets of novel antibiotics. Prolysis, which was spun out of the university in 1998, has first option to exploit all of the intellectual property arising from the collaboration.

• Sierra Pacific Research Co., of Carson City, Nev., said preliminary lab results showed its spray-on solution of Bio-Decon antibacterial agent kills both Gram-negative and Gram-positive bacteria, including the vegetative and spore types of Bacillus anthracis (anthrax). Results showed a 4 percent solution of Bio-Decon disabled 96 percent of Anthrax colony-forming units within two minutes of exposure. Continued exposure for 60 minutes increased the kill ratio to more than 99 percent, Sierra said.

• Thuris Corp., of Irvine, Calif., expanded an ongoing research collaboration with Sigma-Tau Industrie Farmaceutiche Riunite SpA, of Rome, to develop compounds to combat brain inflammation. Thuris is broadening experiments into living animals. Further routes of inquiry include the production of combination therapeutics for use across a host of brain disorders characterized by inflammation. Financial terms were not disclosed.

• Tm Bioscience Corp., of Toronto, entered a nonexclusive license agreement with bioMerieux SA, of Marcy l'Etoile, France, to use the latter's Factor II (prothrombin) and Factor V Leiden gene patents in Tm's recently launched Tag-It Mutation Detection kits for coagulation disorders. The Tag-It coagulation kits are the first in a menu of genotyping kits that Tm said it would launch this year.

• Versicor Inc., of King of Prussia, Pa., and Biosearch Italia SpA, of Milan, Italy, completed their merger, creating a trans-Atlantic company focused on the discovery, development, manufacture and commercialization of antibiotic and antifungal agents for tough-to-treat infections. The new company's stock will continue to trade under the ticker symbol "VERS" on Nasdaq in the U.S. and began to trade Monday under the ticker symbol "VER" on the Nuovo Mercato in Italy, until new corporate name, identity and ticker symbols are approved by the board. The companies reported their $260 million stock-swap merger last summer. (See BioWorld Today, Aug. 1, 2002.)