• Adherex Technologies Inc., of Research Triangle Park, N.C., began a Phase I/II trial of eniluracil combined with 5-fluorouracil (5-FU) in Asian patients with liver cancer. The Phase I dose-escalation part of the study, which is expected to enroll about 25 patients with hepatocellular cancer, is intended to establish dosing safety and the combination's schedule in that patient population. The Phase II part is expected to enroll 25 additional patients to provide initial efficacy information in this tumor type.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said data from the Phase III AFFIRM study reported at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Madrid demonstrated that treatment with Tysabri (natalizumab) significantly reduced the proportion of multiple sclerosis patients with worsening cognitive function as measured by the three-second Paced Auditory Serial Addition Test (PASAT 3). More specifically, these monotherapy data showed that Tysabri reduced the risk of sustained cognitive worsening by 43 percent compared to placebo (p=0.013).

• Elusys Therapeutics Inc., of Pine Brook, N.J., said Phase I data reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco demonstrated that Anthim (ETI-204) anthrax antibody therapeutic was safe and well tolerated, with a mean half-life of 16 days. It exhibited a favorable safety risk profile as both a monotherapy and in combination with ciprofloxacin, with no serious adverse events indicating that they can be safely administered together. In a preclinical efficacy trial, there was 100 percent survival in animals that received a single intramuscular dose of Anthim as either a monotherapy or when co-administered with an antibiotic following a lethal anthrax spore challenge, but only 33 percent of animals receiving an antibiotic alone survived to the end of the study.

• EpiCept Corp., of Englewood Cliffs, N.J., said an ongoing analysis of its previously reported Phase III trial of the analgesic lidocaine LidoPAIN SP revealed that the patient's perceived pain intensity score was directly influenced by the amount of lidocaine infiltrated by the surgeon. That is, the greater the amount of lidocaine administered by infiltration, the more difficult it was to show an analgesic effect with the candidate LidoPAIN SP patch.

• Meditor Pharmaceuticals Ltd., of Rehovot, Israel, said a Phase II trial of MTR107 should complete enrollment of 12 end-stage renal disease patients in December.

• Medivation Inc., of San Francisco, got permission from the FDA to begin the company's U.S. Phase I/IIa trial with Dimebon (dimebolin) in patients with Huntington's disease. Medivation expects patient dosing to begin in early October. Earlier this month, the firm reported positive Phase II data with the same compound against Alzheimer's disease. (See BioWorld Today, Sept. 22, 2006.)

• Metabolic Pharmaceuticals Ltd., of Melbourne, Australia, said ethics approval was obtained for the first of two Phase IIa trials on ACV1, for neuropathic pain. Recruitment of 40 patients has commenced. The study will examine the effects of the drug in patients with neuropathic sciatic pain.

• Nitec Pharma AG, of Basel, Switzerland, said it saw positive results in a Phase III clinical trial with Lodotra, a new, modified-release tablet that has been developed to optimize the efficacy of orally administered low-dose prednisone in rheumatoid arthritis. The trial involved 288 patients in 26 centers in Europe.

• NovaDel Pharma Inc., of Flemington, N.J., said it had positive results from a pharmacokinetic study of its improved oral spray formulation of sumatriptan, the active ingredient in London-based GlaxoSmithKline plc's leading migraine remedy, Imitrex. Results demonstrated that sumatriptan spray achieves a statistically significant faster rate of absorption than Imitrex tablets. NovaDel plans to complete the pivotal pharmacokinetic program in 2007.

• Novelos Therapeutics Inc., of Newton, Mass., said the first patient has been enrolled in a hepatitis C trial with NOV-205, the company's second compound. The initial U.S.-based double-blind, placebo-controlled Phase Ib trial will evaluate NOV-205 vs. placebo as monotherapy in 30 chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin.

• QuatRx Pharmaceuticals Inc., of Ann Arbor, Mich., initiated a Phase I study of QRX-431, a compound in development for elevated cholesterol levels and obesity. In primate studies, QRX-431, a selective thyroid beta agonist, lowered LDL, lipoprotein (a) and weight without significantly increasing heart rate, QuatRx said.

• Sonus Pharmaceuticals Inc., of Bothell, Wash., initiated a Phase I study for its second oncology product candidate, Tocosol Camptothecin. Formulated with its proprietary vitamin E-based technology, Tocosol Camptothecin is a conjugate of SN-38. The single-agent Phase I study is expected to enroll up to 61 patients with advanced solid tumors.

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