Raptor Pharma Announces Positive Data On NGX426; Reveals Results From Phase 2b Trial Of DR Cysteamine- Quick Facts

11/23/2009 7:01 AM ET

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(RTTNews) - Raptor Pharmaceutical Corp. (RPTP: News ) announced the presentation of clinical trial data on NGX426, the company's orally administered, non-opioid, AMPA/kainate receptor antagonist, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain, held on November 20-21 in San Francisco.

The results of the study suggested that NGX426 could be effective in a variety of neuropathic pain states, which are caused by damage to or dysfunction of the peripheral or central nervous system rather than stimulation of pain receptors.

The objective of the single center, double-blind, randomized study was to demonstrate that the orally administered prodrug NGX426, maintains the analgesic effect previously shown for the active moiety, tezampanel. Using a cross-over design, a total of 18 study subjects received single doses of 90 mg of NGX426, 150 mg of NGX426 or placebo in each of three treatment periods, the company stated.

In a separate release, Raptor Pharmaceutical revealed results from Phase 2b clinical trial of its proprietary delayed-release cysteamine bitartrate, or DR Cysteamine, in patients with nephropathic cystinosis. The trial evaluated safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in nine cystinosis patients.

The company said that DR Cysteamine demonstrated improved tolerability and the potential to reduce total daily dosage and administration frequency compared to immediate-release cysteamine bitartrate in Phase 2b clinical trial.

The company plans to meet with the Food and Drug Administration and European Medicines Agency to discuss the results of its phase 2b study and its plans for a repeat-dose, pivotal, phase 3 clinical trial in cystinosis patients. Upon receiving FDA and EMEA concurrence, Raptor intends to initiate its phase 3 clinical trial at multiple sites in the US and Europe in the first quarter of 2010.