Raptor Pharmaceutical Corp. Announces Positive Data on NGX426 in the Potential Treatment of Neuropathic Pain
NOVATO, Calif., Nov. 23 /PRNewswire-FirstCall/ -- 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
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. 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.
Posted: November 2009