• Altea Therapeutics Corp., of Atlanta, began Phase I trials for AT3022, its fentanyl citrate transdermal patch designed to manage moderate to severe chronic pain. The product uses the company's PassPort Transdermal System, developed to deliver water-soluble small molecules, proteins, carbohydrates and oligonucleotides across the skin. AT3022 is designed to provide a safer and more efficacious alternative to marketed fentanyl patches that only can deliver the highly lipid-soluble base form of fentanyl; they have been associated with safety concerns.

• Antipodean Pharmaceuticals Inc., of San Francisco, began Phase II trials of its lead compound, MitoQ (mitoquinone), in Parkinson's disease patients, in New Zealand and Australia. The product is designed to target mitochondrial dysfunction. The studies will include people who meet Parkinson's diagnosis criteria, but have yet to receive any treatment.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said results of a pilot clinical study of CH-1504 showed no elevation in liver enzymes and a lack of gastrointestinal-related side effects in those treated with CH-1504, suggesting that it might possess an improved safety and tolerance profile compared to methotrexate. The drug also demonstrated efficacy. The data were published in the May 2006 issue of Journal of Rheumatology.

• CV Therapeutics Inc., of Palo Alto, Calif., completed enrollment in the MERLIN TIMI-36 study of Ranexa (ranolazine), with more than 6,500 patients. The company expects top-line data in the first quarter. According to a special protocol assessment agreement with the FDA, if those findings show that Ranexa is not associated with an adverse trend in death or arrhythmia compared to placebo, the study's safety database could support its potential approval as first-line chronic angina therapy, even if the primary endpoint is not met. In addition, if the primary endpoint is met, Ranexa potentially also could be approved for treatment of acute coronary syndromes and secondary prevention. Earlier this year, the product received FDA approval for treating chronic angina, essentially for second-line use. (See BioWorld Today, Jan. 31, 2006.)

• Elite Pharmaceuticals Inc., of Northvale, N.J., initiated a pilot Phase I study of ELI-154, a once-daily oxycodone HCl, to evaluate variables to optimize the formulation. A previous Phase I trial demonstrated proof of concept for ELI-154, a product intended to deliver more consistent levels of the drug to chronic pain patients. Elite expects to enter a Phase II study by the end of 2006.

• Nabi Biopharmaceuticals, of Rockville, Md., started a Phase IIb proof-of-concept study for NicVAX, which is being developed to treat nicotine addiction and prevent smoking relapse. The study will evaluate the effectiveness of an optimized formulation. Results are expected in mid-2007, and Phase III efficacy studies could start in the second half of next year.

• NeuroHealing Pharmaceuticals Inc., of Newton, Mass., said the FDA granted orphan drug status to NH001 for treating patients in a vegetative state or minimally conscious state for up to 12 months following a brain injury (traumatic or spontaneous). NH001 is a dopaminergic agonist being tested in a Phase IIa study to improve the functional outcome of patients following a severe traumatic brain injury.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., said final Phase III results from a second study did not demonstrate a statistically significant improvement of adding Zadaxin to pegylated interferon alpha treatment for hepatitis C virus patients with early cirrhosis of the liver who have failed prior therapy, compared to pegylated interferon alpha alone in sustained virologic response, the trial's primary endpoint. The company's drug generally was well tolerated, with no treatment-related toxicities or side effects, the company said. But the missed data confirm findings from a prior Phase III trial, which also were not statistically significant. Going forward, SciClone's Zadaxin efforts will focus on advanced-staged malignant melanoma. (See BioWorld Today, Dec. 15, 2005.)

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