NOVATO, Calif., Nov. 4 Raptor Pharmaceutical Corp. (Nasdaq: RPTP), today announced that data from a clinical trial of NGX426, the Company's orally administered non-opioid, AMPA/kainate antagonist, will be presented at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain, to be held November 20-21, 2009 in San Francisco.
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Mark Wallace, M.D., Professor of Clinical Anesthesiology at the Center for Pain Medicine of the University of California at San Diego ("UCSD") will present results from a proof of concept clinical trial titled, "NGX426, An Oral AMPA-Kainate Antagonist, is Effective in Human Capsaicin Induced Hyperalgesia Model." NGX426 is a prodrug of Raptor's parenterally administered product candidate tezampanel. When given subcutaneously and intravenously tezampanel demonstrated statistically significant analgesic effect in five Phase II trials. The five trials were completed in acute migraine, nociceptive pain and neuropathic pain models.
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 of capsaicin between layers of skin in the forearm at 30 minutes and 120 minutes after dosing.
Results and details of the study will be presented on November 20, 2009 during Dr. Wallace's presentation.
Raptor's Chief Medical Officer, Patrice Rioux, M.D., Ph.D., said, "Tezampanel and its oral prodrug NGX426 are the first glutamate receptor antagonists to be tested in human pain trials with combined binding activity at the AMPA and kainite receptor subtypes. In particular, this novel, non-opioid mechanism of action is interesting in the context of neuropathic pain where multiple therapies are typically used to manage the condition."
Christopher M. Starr, Ph.D., Chief Executive Officer of Raptor, commented, "We are hopeful that once released this data will further demonstrate the potential value of NGX426 in the treatment of migraine and chronic pain. We plan to continue to explore our options with NGX426 in the treatment of pain, which potentially include spinning-out or partnering this program, to ensure that our shareholders receive the maximum value from this potentially groundbreaking drug."
About Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp. (NASDAQ: RPTP) ("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; Raptor's ability to ensure that its shareholders receive the maximum value from tezampanel and NGX426; that tezampanel and NGX426 can be potentially groundbreaking drugs; 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 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; Raptor's quarterly report on Form 10-Q filed with the SEC on August 11, 2009; Raptor's wholly-owned subsidiary's, Raptor Pharmaceuticals Corp. ("RPC") Registration Statement on Form S-1, as amended, that was declared effective on August 7, 2008; RPC's annual report on Form 10-K filed with the SEC on October 28, 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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