NOVATO, California, November 23 /PRNewswire/ -- Raptor Pharmaceutical Corp. (Raptor or the Company) today 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 led by Mark Wallace, M.D., Professor of Clinical Anesthesiology at the Center for Pain Medicine of the University of California at San Diego, 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 conducted by Dr. Wallace 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. Pain was induced by injecting 250 ug (microgram) of capsaicin under the skin of the forearm at 30 minutes and 120 minutes after dosing.
The 150 mg dose showed statistically significant reductions in spontaneous pain versus placebo after the 30 minute and 120 minute capsaicin injection time points. At the 150 mg dose, reductions in elicited pain were also statistically significant versus placebo. The 90 mg dose of NGX426 showed statistical significance versus placebo after the 30 minute time point on reduction of spontaneous pain, hyperalgesia (increased sensitivity to pain) and allodynia (pain due to a stimulus which does not normally provoke pain). After the 120 minute time point, the 90 mg dose was statistically significant for hyperalgesia and allodynia. NGX426 was well tolerated, all subjects completed the three treatment periods, and the most common adverse events attributed to NGX426 were mild somnolence and dizziness.
Dr. Wallace commented, Human experimental models of pain, such as this used in this study, are emerging as tools to predict efficacy of novel analgesics early in the clinical trial process. These results for NGX426 are exciting because they suggest that this drug could be effective in real-world, clinical pain states. Having worked in both patient care and in the research of state of the art therapies for the management of chronic pain, I'm always excited to see a new potential product deliver encouraging data. These proof-of-concept results support further clinical development for NGX426 as well as its companion drug, tezampanel, as potential non-opioid treatments for pain.
Christopher M. Starr, Ph.D., Chief Executive Officer of Raptor, commented, We are encouraged by these results suggesting that NGX426 could be effective in the treatment of acute pain such as migraine and chronic pain, such as neuropathy. NGX426 has been administered to 182 male and female healthy subjects in single and multiple doses and all doses of NGX426 were well-tolerated with no serious or medically important adverse events reported. We believe the pain indication could benefit from such a safety profile and potential efficacy profile. We plan to continue to explore our options with NGX426 in the treatment of pain, and we are actively looking for partners or collaborators regarding the development of this product candidate.
About Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp. (Raptor) is dedicated to speeding the delivery of new treatment options to patients by working to improve existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise. Raptor focuses on underserved patient populations where it can have the greatest potential impact. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, non-alcoholic steatohepatitis (NASH), Huntington's Disease (HD), aldehyde dehydrogenase (ALDH2) deficiency, and a non-opioid solution designed to potentially treat chronic pain.
Raptor's preclinical programs are based upon bioengineered novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein (RAP) and related proteins that are designed to target cancer, neurodegenerative disorders and infectious diseases.
For additional information, please visit www.raptorpharma.com.
FORWARD LOOKING STATEMENTS
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operation or future financial performance, including, but not limited to the following statements: the potential value of tezampanel and NGX426 in the treatment of migraine, chronic pain, and other diseases; Raptor's ability to spin out or partner the tezampanel and NGX426 pain program; and Raptor's ability to successfully develop any of its product candidates. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results to be materially different from these forward-looking statements. Factors which may significantly change or prevent the Company's forward looking statements from fruition include that Raptor may be unsuccessful in developing any products or acquiring products; that Raptor's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; that Raptor is unable to retain or attract key employees whose knowledge is essential to the development of its products; that unforeseen scientific difficulties develop with the Company's process; that Raptor's patents are not sufficient to protect essential aspects of its technology; that competitors may invent better technology; that Raptor's products may not work as well as hoped or worse, that the Company's products may harm recipients; and that Raptor may not be able to raise sufficient funds for development or working capital. As well, Raptor's products may never develop into useful products and even if they do, they may not be approved for sale to the public. Raptor cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings from time to time with the Securities and Exchange Commission (the SEC), which Raptor strongly urges you to read and consider, including: Raptor's current report on Form 8-K as filed with the SEC on November 17, 2009; ;the joint proxy statement/prospectus on Form S-4 filed with the SEC on August 19, 2009; Raptor's annual report on Form 10-K filed with the SEC on March 27, 2009; and Raptor's quarterly report on Form 10-Q filed with the SEC on August 11, 2009, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Subsequent written and oral forward-looking statements attributable to Raptor or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in Raptor's reports filed with the SEC. Raptor expressly disclaims any intent or obligation to update any forward-looking statements.
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SOURCE: Raptor Pharmaceutical Corp.
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