AlphaRx Announces Commencement of a Human Clinical Trial of Indoflex -- Indomethacin -- in People's Republic of China -- PRC.Business Editors & Health/Medical Writers BIOWIRE2K RICHMOND HILL, Ontario--(BW HealthWire)--Jan. 3, 2001 AlphaRx Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AHRX) today announced the commencement of a clinical trial of Indoflex(TM) -- Indomethacin indomethacin /in·do·meth·a·cin/ (in?do-meth´ah-sin) a nonsteroidal antiinflammatory drug; used in the treatment of various rheumatic and nonrheumatic inflammatory conditions, dysmenorrhea, and vascular headache. -- for pain management. Based on AlphaRx's BCD (Binary Coded Decimal) The storage of numbers in which each decimal digit is converted into binary and is stored in a single character or byte. For example, a 12-digit number would take 12 bytes. See binary numbers. drug delivery system, Indoflex(TM) is one of the Company's reformulated drugs, designed to be more bioavailable, with faster onset and reduced side effects when compared to original formulations. Indomethacin is a non-steroidal anti-inflammatory (NSAID NSAID: see nonsteroidal anti-inflammatory drug. ) drug. NSAID's reduce inflammation (swelling), pain, and temperature. Indomethacin is used to reduce the pain and swelling associated with osteoarthritis, rheumatoid arthritis, bursitis bursitis (bərsī`təs), acute or chronic inflammation of a bursa, or fluid sac, located close to a joint. In response to irritation or injury the bursa may become inflamed, causing pain, restricting motion, and producing more fluid than can , tendinitis, gout gout, condition that manifests itself as recurrent attacks of acute arthritis, which may become chronic and deforming. It results from deposits of uric acid crystals in connective tissue or joints. , ankylosing spondylitis, as well as headaches. One of the common side effects of NSAID use is stomach irritation. This clinical trial will assess the pharmacokinetics, rate of onset, gastro-intestinal irritation and patient tolerance of Indoflex(TM) compared with conventional Indomethacin formulations on healthy human subjects. Indoflex(TM) complies with the PRC's "4th Category New Drug" status and, as such, only requires successful completion of this pharmacokinetics study for drug approval. Upon successful approval, Indoflex(TM) will receive 7-year marketing exclusivity in China. In 1999, The China State Drug Commission estimated national annual NSAID sales at US$330 million. Worldwide sales of non-steroidal anti-inflammatory drugs Non-steroidal anti-inflammatory drugs (NSAIDs) Aspirin, ibuprofen, naproxen, and many others. Mentioned in: Mastocytosis totaled approximately $6.2 billion in 1999, and are expected to grow at a 4% compound annual growth rate. "We are very pleased with our progress in China. It is consistent with the Company's business strategy utilizing advanced drug delivery technologies to convert old drugs into new opportunities," said Mr. Michael Lee, President of AlphaRx. "We are actively exploring market opportunities in developing Asian, Latin American & Eastern European Countries, where the regulatory approval process provides a rapid time-to-market advantage for our products." For additional information, please visit our web-site at www.AlphaRx.com FORWARD LOOKING STATEMENTS: This release contains forward-looking statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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 Company. |
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