HONG KONG, March 16 /PRNewswire/ - 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.
About AlphaRx Inc.
AlphaRx is a specialty pharmaceutical company utilizing proprietary drug delivery systems to develop novel formulations of drugs that are insoluble or poorly soluble in water or have yet to be administrable to the human body with an acceptable delivery method. The Company's product candidates address various pharmaceutical markets, including inflammation, CNS and pneumonia.
Forward Looking Statements:
This release contains forward-looking statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and involve risks and uncertainties that may individually or mutually impact the matters herein described, including but not limited to product development and acceptance, manufacturing, competition, regulatory and/or other factors, which are outside the control of the companies.
SOURCE AlphaRx Inc.