Pacific Orent Capital Inc.

Pacific Orent Capital Inc.

Message: AlphaRx Provides Corporate and Development Update

AlphaRx Provides Corporate and Development Update

PR Newswire
| 16 Mar 2011 | 07:30 AM ET

HONG KONG, March 16, 2011 /PRNewswire via COMTEX/ -- AlphaRx Inc. (OTCBB: ALRX), today provided an update on its internal product candidates and development plans.

Highlights of the Company's product review and upcoming corporate milestones include: Over the last 12 months we have made significant progress in moving ARX8203 toward clinical application. ARX8203, a novel prodrug of a FDA approved NSAID (non-steroidal, anti-inflammatory drug), has demonstrated excellent safety profile in G.I. toxicity studies. Sufficient amount of ARX8203 is being synthesized for the planned clinical trial. The Company is planning to conduct a POC (Proof of Concept) human trial as soon as practicable, anticipating that the POC human trials will enrol 90 patients in 3 arms (ARX8203 vs. comparator), whereby the primary endpoint will be safety (cumulative incidence of gastric ulcers) as assessed by endoscopy. With an estimated 15 million Americans taking prescription NSAIDs for arthritis, and an estimated 68 million prescriptions a year being written for these products, according to the FDA, the market for NSAIDs is strong. Prolonged use of NSAID's has been associated with a high incidence of gastro-intestinal ulcers. There will be a robust market for new drugs without the serious G.I. side-effects which prolonged use of current NSAID's risk.

AlphaRx has been working diligently with Gaia BioPharma in the GAI-122 stroke program for China. In preparation of a Chinese IND application, the China State FDA requires an additional animal efficacy study that meets the local regulatory requirements. The Company is engaging Beijing Capital Medical University to conduct this study. The Company has been working with a Chinese contract manufacturer in GAI-122 clinical trial material (CTM) production. Pending receiving positive results from the additional animal study, a sufficient amount of CTM could be produced to meet clinical trial needs.

New Message
Please login to post a reply