NOVATO, California, November 5 /PRNewswire/
- Proof-of-Concept Data at 12th International Conference on the
Mechanisms and Treatment of Neuropathic Pain
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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20071022/NYM074LOGO )
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. (http://www.raptorpharma.com/index.htm)
(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 (http://www.raptorpharma.com/patients-cystinosis.html),
non-alcoholic steatohepatitis ("NASH")
(http://www.raptorpharma.com/patients-nash.html), Huntington's Disease ("HD")
(http://www.raptorpharma.com/dr-cysteamine-huntingtons.html), aldehyde
dehydrogenase ("ALDH2") deficiency
(http://www.raptorpharma.com/convivia.html), and a non-opioid solution
(http://www.raptorpharma.com/tezampanel-migraine.html) 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")
(http://www.raptorpharma.com/science-overview.html) 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.
For more information, please contact:
Karl Cahill, Investor Relations
+1-858-531-6100
kcahill@raptorpharma.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
