• Abbott Laboratories, of Abbott Park, Ill., said new data on Humira (adalimumab) from the largest anti-TNF study conducted in Europe - the ReAct trial (Research in Active Rheumatoid Arthritis) - reaffirmed the drug's safety and efficacy seen in pivotal clinical trials. Those results, along with other data about Humira's sustained benefit beyond five years and ability to inhibit the progression of rheumatoid arthritis, were presented this week at the European League Against Rheumatism annual congress in Berlin.

• Amgen Inc., of Thousand Oaks, Calif., and Wyeth, of Madison, N.J., said new results from the TEMPO trial demonstrated that Enbrel (etanercept) therapy enabled significantly more rheumatoid arthritis patients to achieve clinical remission at two years, compared to patients treated with methotrexate alone. Results were presented at the European League Against Rheumatism annual congress in Berlin.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, completed enrollment in its vascular wrap study about six months earlier than anticipated. Angiotech developed a treatment solution for poor blood flow to the legs to prevent the obstructing scar from forming at the site of bypass connection. It is based on the same technology and drug platform as Natick, Mass.-based Boston Scientific Corp.'s Taxus coronary stent, which uses paclitaxel as a coating.

• Aphton Corp., of Miami, began submission of regulatory documentation to the Swiss Agency for Therapeutic Products for the registration of G17DT as monotherapy in patients with advanced pancreatic cancer who are either unable to tolerate or elect not to take chemotherapy. Anti-gastrin G17DT targets the hormone gastrin 17 to treat gastrointestinal cancers. Aphton's anti-gastrin targeted immunotherapy induces patients to produce antibodies that bind and neutralize the hormones gastrin 17 and gly-gastrin (a gastrin precursor), which are known to be involved in tumor progression in those cancers.

• Avanir Pharmaceuticals Inc., of San Diego, reported that the underwriter of the recently reported public offering exercised its option to purchase about an additional 3 million shares from Avanir at the public offering price of $1.27 per share to cover overallotments. About 22.6 million shares were sold through the public offering, resulting in gross proceeds to the company of about $28.7 million. (See BioWorld Today, May 27, 2004.)

• Bioniche Life Sciences Inc., of Belleville, Ontario, said positive data of Mycobacterial Cell Wall-DNA Complex (MCC) showed its ability to inhibit cell division and induce apoptosis of canine cancer cells. Data also showed that MCC stimulated the synthesis of cytokines by canine immune cells. Cancer is the leading cause of non-accidental death in dogs. Previously, MCC was shown to possess anticancer activity against human bladder cancer. Bioniche has completed Phase II trials of MCC in bladder cancer and is preparing for a pivotal Phase III trial in North America and Europe.

• Centocor Inc., of Malvern, Pa., and Schering-Plough Europe, of Brussels, Belgium, a unit of Schering Plough Corp., of Kenilworth, N.J., said data released from a Phase III trial of Remicade (infliximab) showed improvement in both the arthritis and psoriasis associated with psoriatic arthritis. In the trial, Remicade provided a 70 percent improvement (as measured by ACR 70) in symptoms of arthritis in nearly one-third of patients, compared with only 2 percent of patients on placebo, at 24 weeks. In patients with psoriasis that involved 3 percent or more of their body surface, 40 percent achieved a 90 percent or more improvement in PASI score, while 21 percent achieved 100 percent improvement in PASI score.

• CytRx Corp., of Los Angeles, reported research findings by an independent investigator regarding RIP140, a nuclear hormone co-repressor that regulates fat accumulation. The findings demonstrated RIP140 was successful in regulating the function of key genes involved in energy metabolism in animal models, information that could be used to fight obesity, the company said. The findings were published in the June 1, 2004, issue of the Proceedings of the National Academy of Science.

• GenoMed Inc., of St. Louis, said the second case of West Nile virus encephalitis has responded quickly to its treatment approach. The treatment is showing a 100 percent response rate among 13 immunocompetent patients. When treated during their episode of West Nile virus encephalitis, patients have responded within 24 hours. If the company's clinical trial proves successful, it expects to charge a licensing fee beginning in 2005 for use of its protocol, for which a patent is pending.

• Hemosol Corp., of Toronto, negotiated an agreement in principle with the Medical and Related Sciences Discovery District to form an alliance that will see Hemosol provide a range of services, including testing and test development, process development and manufacturing. In addition, Hemosol would be a source of strategic counsel for the implementation of manufacturing strategies.

• Integrated DNA Technologies Inc., of Coralville, Iowa, signed a license agreement with Promega Corp., of Madison, Wis., that will allow IDT, an oligonucleotide manufacturer, to make and sell oligos for use in DNA-directed RNA interference applications. IDT became the first commercial oligonucleotide manufacturer in the U.S. to obtain a license to sell ddRNAi-related oligos under Promega's licensing program. IDT has acquired nonexclusive rights under patents exclusively licensed to Promega by Benitec Ltd., of Queensland, Australia, and the Commonwealth Scientific and Industrial Research Organization to sell custom ddRNAi-related oligonucleotides and related services.

• Inverness Medical Innovations Inc., of Waltham, Mass., said it was appointed the exclusive worldwide distributor for the Simplify D-dimer rapid test manufactured by AGEN Biomedical Ltd., of Brisbane, Australia. D-dimer is a protein that is released into the circulatory system during the process of fibrin blood clot breakdown. Its measurement in the blood is used in diagnosing deep-vein thrombosis and pulmonary embolism.

• Keryx Biopharmaceuticals Inc., of New York, initiated a clinical program for KRX-0401 (perifosine), an oral AKT inhibitor for treating cancer. The first Phase II trial will evaluate the safety and efficacy of KRX-0401 as a single agent in patients with non-small-cell lung cancer who have progressed despite standard therapy. In addition to that trial, KRX-0401 is in nine Phase II single-agent trials in six tumor types.

• NicOx SA, of Sophia-Antipolis, France, presented Phase II results on its lead CINOD compound, HCT 3012, at the European League Against Rheumatism annual congress in Berlin. The results demonstrate that after six weeks' treatment with HCT 3012, osteoarthritis patients experienced pain relief equivalent to rofecoxib. At equi-analgesic doses, patients treated with rofecoxib experienced an increase in systolic blood pressure. In contrast, HCT 3012 showed no statistical difference compared to placebo.

• Procyon Biopharma Inc., of Montreal, presented a favorable resistance profile of its HIV protease inhibitor, PL-100, at the XIIIth International HIV Drug Resistance Workshop in the Canary Islands of Spain. Assessed by in vitro susceptibility testing with a reporter gene-based phenotypic assay, on average, PL-100 showed superior antiviral activity against existing protease inhibitor-resistant viruses in treatment-experienced patients or in those patients newly infected with similar resistant strains.

• Repligen Corp., of Waltham, Mass., said a Phase I trial of RG2133, a prodrug of uridine, demonstrated that administration of RG2133 in patients with bipolar disorder or major depression appeared to be safe, did not induce mania - a potential side effect of existing therapies - and provided early evidence of a clinical effect.

• SuperGen Inc., of Dublin, Calif., said results from three ongoing studies of Nipent (pentostatin for injection) were reported during this week's annual meeting of the American Society of Clinical Oncology in New Orleans. Data demonstrated that pentostatin used in combination with other chemotherapeutic agents was active, well tolerated and did not increase the toxicity of the combination regimen.

• ViroLogic Inc., of South San Francisco, presented 13 studies using its HIV drug-resistance technologies by company scientists and collaborators at the XIIIth International HIV Drug Resistance Workshop being held in the Canary Islands of Spain. The studies underscore the utility of the company's products and resources in enabling the effective management of HIV infection, as well as the development of new drugs and treatment strategies, the company said. Several of the studies provide early insight into the mechanisms of resistance to the newest class of antiviral drugs called cell-entry inhibitors.

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