• Acorda Therapeutics Inc., of Boston, presented data from a Phase III trial of Fampridine-SR in people with multiple sclerosis at the American Academy of Neurology meeting. The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR, a sustained-release tablet, in improving walking ability in people with MS. The trial enrolled 301 individuals ages 18 to 70 with a definite diagnosis of MS and some degree of walking disability. Secondary endpoints for the trial included the Lower Extremity Manual Muscle Test, the Ashworth Score for spasticity and Subject and Clinician Global Impressions. The average increase in walking speed over the treatment period, compared to baseline, was 25.2 percent for the drug-treated Timed Walk Responders vs. 4.7 percent for the placebo group. Statistically significant increases in leg strength, as measured by the Lower Extremity Manual Muscle Test, were seen in both the drug-treated Timed Walk Responders and the drug-treated nonresponders, compared to placebo-treated patients.

• Adventrx Pharmaceuticals Inc., of San Diego, on Wednesday presented results demonstrating synergistic activity against human and avian influenza viruses when the company's broad-spectrum antiviral drug candidate, ANX-201, was combined with oseltamivir phosphate (Tamiflu) in preclinical tests. Thus, ANX-201 dosage could be reduced up to 10-fold against human influenza strains H3N2 and H1N1, and up to 100-fold against avian influenza strain H5N2 when administered in combination with Tamiflu. ANX-201 has shown activity against HIV drug-resistant clinical isolates and its resistance profile of ANX-201 contains mutations that have been shown to resensitize NRTI-resistant virus. In preclinical studies, ANX-201 has shown broad-spectrum antiviral activity against HIV-1, HIV-2, human and avian influenza viruses, and herpes simplex viruses 1 and 2 (HSV-1 and HSV-2). ADVENTRX plans to initiate a Phase I trial of ANX-201 as a component of multidrug therapy for the treatment of HIV during 2007.

• Anadys Pharmaceuticals Inc., of San Diego, presented results from its NS5b HCV program at the 20th International Conference on Antiviral Research in Palm Springs, Calif. Anadys reported optimizing NS5b polymerase inhibitors with nanomolar potency in both biochemical and replicon assays and with promising metabolic properties. The company expects to nominate a new preclinical candidate from the ANA59X subseries of Anadys' AN025-1 program, a series of non-nucleoside NS5B polymerase inhibitors, for the treatment of chronic hepatitis C viral infections.

• Array BioPharma Inc., of Boulder, Colo., initiated a Phase I cancer trial with ARRY-520, a small molecule, kinesin spindle protein inhibitor. In preclinical studies, ARRY-520 caused marked tumor regression often leading to complete, durable responses and outperformed competitor compounds that are currently in the clinic. Earlier this week, Array raised $91 million to support its eight programs in early trials or about to move into the clinic. (See BioWorld Today, May 3, 2007.)

• Biogen Idec, of Cambridge, Mass., and Elan Corp., of Dublin, Ireland, said new data from the TOUCH Prescribing Program and TYGRIS safety study confirm the safety profile from previous clinical studies of Tysabri (natalizumab). The companies also presented data showing that Tysabri has a sustained treatment effect on clinical relapses and the risk of disability progression in multiple sclerosis patients treated for up to three years. As of April 23, there have been no new reports of confirmed cases of progressive multifocal leukoencephalopathy or other serious opportunistic infections. The data were presented at the 59th annual meeting of the American Academy of Neurology in Boston.

• BioMS Medical Corp., of Edmonton, Alberta, completed enrollment in its Phase II clinical trial of MBP8298 for the treatment of relapsing-remitting multiple sclerosis. The double-blind, placebo-controlled trial will last 15 months and be followed by a 12-month open-label extension period. The primary endpoints are safety and efficacy as measured by relapse rate, MRI activity and disease progression. MBP8298, which is designed to induce immune tolerance to a portion of myelin basic protein often attacked in MS, is also being studied in two Phase III trials in secondary progressive multiple sclerosis. (See BioWorld Today, Dec. 9, 2004.)

• Biovitrum AB, of Stockholm, Sweden, initiated a Phase II clinical trial in diabetic neuropathic pain with the A2A agonist BVT.115959. The drug is designed to act peripherally rather than through the brain and is specifically targeted to the lowered pH in inflamed tissues. Data from the 300-patient study are expected in the first half of 2008, at which time Biovitrum said it plans to seek a partner for late-stage development and marketing.

• Cregene Inc., of San Diego, presented positive interim clinical data from a Phase 1 trial of CERE-110, a gene therapy product designed to deliver nerve growth factor for the treatment of Alzheimer's disease. The results indicate that after one year of follow-up of six patients who received CERE-110 in the trial, a single administration of the therapy was well tolerated, and an interim analysis suggested that the therapy had the potential to reduce the rate of cognitive decline and increase brain metabolism. A larger Phase II trial is being planned starting in 2008, and the company said it is discussion potential collaborations. The data were presented at the American Academy of Neurology Meeting in Boston.

• EpiCept Corp., of Tarrytown, N.Y., said it will present new data from two studies of EpiCept NP-1, for managing pain resulting from various peripheral neuropathies, confirming its mechanism of action and showing that it was safe and well tolerated across all age groups studied. Results from a new human pharmacokinetic study of NP-1 to assess the pharmacokinetic parameters and safety and tolerability showed that the highest observed level of amitriptyline at any time point was 5.91 ng/mL. The highest observed level of ketamine was 10.7 ng/mL. These levels are far below any known systemic efficacy level and even further below any known systemic level associated with adverse reactions, the company said. The low systemic levels of amitriptyline and ketamine indicated a local mechanism of action rather than a systemic one. The data were to be presented at the 26th Annual Scientific Meeting of the American Pain Society in Washington.

• Genelabs Technologies Inc., of Redwood City, Calif., presented data on a non-nucleoside hepatitis C virus polymerase inhibitor discovered by the company. The optimized lead that emerged from this approach is known as GL59728. It showed excellent oral bioavailability, exceeding 50 percent in all four species tested, including higher-order species, low clearance and a half-life consistent with once- or twice-daily dosing, the company said. The tissue distribution of GL59728 also appeared favorable. The compound also was tested in combination with other classes of HCV antiviral compounds, including a nucleoside chain terminator, a protease inhibitor and interferon alpha, and showed to be additive in activity with each.