Raptor Pharmaceutical Corp. Announces Positive Data on NGX426 in the Potential Treatment of Neuropathic Pain
By Raptor Pharmaceutical Corp., PRNESunday, November 22, 2009
NOVATO, California, November 23 - Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq: RPTP)
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.
(Logo: www.newscom.com/cgi-bin/prnh/20071022/NYM074LOGO )
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. (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; 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
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.
For more information, please contact: Beal Advisors Georgia Erbez, Business Development +1-925-478-7400 gerbez@bealadvisors.com The Ruth Group Sara Ephraim Pellegrino (investors) +1-646-536-7002 spellegrino@theruthgroup.com Janine McCargo (media) +1-646-536-7033 jmccargo@theruthgroup.com
Beal Advisors, Georgia Erbez, Business Development, +1-925-478-7400, gerbez at bealadvisors.com; or The Ruth Group, Sara Ephraim Pellegrino (investors), +1-646-536-7002, spellegrino at theruthgroup.com, or Janine McCargo (media), +1-646-536-7033, jmccargo at theruthgroup.com
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