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Ed. Note: The following is a press release issued by Pain
Therapeutics, Inc.
April 27, 2004
Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today
announced positive pre-clinical data on a novel treatment for neuropathic
pain. The Company will present its pre-clinical data at the Scientific
Meeting of the American and Canadian Pain Societies on Friday, May 7, 2004
in Vancouver, Canada.
Pain Therapeutics' new data opens up the possibility of using its technology
to treat neuropathic pain, a chronic condition that affects 2 to 3 million
Americans and a new area of focus for the Company.
"We are excited about the possibility of using our novel technology in the
area of neuropathic pain," said Remi Barbier, Pain Therapeutics' president
and chief executive officer. "Moderate-to-severe neuropathic pain is
typically poorly managed by existing drugs, is often under-diagnosed and
affects a large patient population. We believe a novel drug that provides
effective pain relief would bring significant advantages for patients who
endure this chronic condition."
"Neuropathic pain represents a substantial unmet medical need," said Nadav
Friedmann, Ph.D., MD, chief operating officer of Pain Therapeutics. "Opioid
drugs, such as morphine or oxycodone, are generally viewed as ineffective in
relieving chronic pain caused by nerve damage. Our own pre-clinical data
confirms this view. However, new data show that ultra-low-dose naltrexone
co-administered with an opioid drug greatly attenuates neuropathic pain
sensitivity. These pre-clinical data are encouraging, as they may allow us
to develop a novel and effective opioid drug to treat neuropathic pain."
Spending for neuropathic pain is included in the Company's prior financial
guidance for 2004.
Technical Poster Synopsis
"Ultra-low-dose Naltrexone Plus Morphine Blocks Thermal Hyperalgesia and
Attenuates Mechanical Hypersensitivity In A Neuropathic Pain Model"
by Todd W. Vanderah, Ph.D., Assistant Professor of Anesthesiology and
Pharmacology, University of Arizona and Lindsay H. Burns, Ph.D., Director of
Pre-clinical Research at Pain Therapeutics, Inc.
This poster presents the methods and results of a first investigation of an
opium-based drug (morphine) combined with a low-dose opioid antagonist (naltrexone)
in a pre-clinical model of neuropathic pain. In this experiment, a total of
42 rats underwent surgical ligation of spinal nerves (L5 and L6) and were
tested for thermal and tactile hyperalgesia (enhanced sensitivity to pain)
for 7 days following surgery. The 42 rats were divided into 6 treatment
groups: placebo, morphine alone, naltrexone alone and three groups receiving
various morphine/ultra-low-dose naltrexone combinations. Placebo or
naltrexone alone had no effect on hyperalgesia. Morphine alone had a partial
and transient effect on hyperalgesia. All groups receiving
morphine/ultra-low-dose naltrexone combinations, however, showed significant
anti-hyperalgesia compared to morphine alone or placebo for the entire week
of testing (p<0.001). Morphine/ultra-low-dose naltrexone also provided
significant anti-hypersensitivity to tactile stimuli (p<0.001). These
pre-clinical data suggest that neuropathic pain and morphine-induced
hyperalgesia share a common mechanism of action, i.e., excitatory signaling
of opioid receptors. The prolonged anti-hyperalgesic effects demonstrated
here compared to morphine alone suggests an opioid agonist/ultra-low-dose
antagonist combination could be an effective treatment for neuropathic pain.
About Neuropathic Pain
Neuropathic pain is a chronic condition caused by nerve injury. Patients
with neuropathic pain typically develop a painful super-sensitivity (hyperalgesia)
to touch, heat or other stimuli. A number of medical conditions can lead to
neuropathic pain, including diabetic neuropathy, HIV/AIDS neuropathy,
phantom limb pain, spinal cord injury or multiple sclerosis.
At least 1% of the United States population (2-3 million people) suffers
from neuropathic pain. There are few truly effective, well-tolerated drug
therapies to treat neuropathic pain. A variety of classes of drugs, such as
opioids, tricyclic antidepressants or anti-epileptic agents (e.g. gabapentin),
typically offer partial or transient relief from neuropathic pain.
About Pain Therapeutics, Inc.
We are a biopharmaceutical company that develops novel drugs. Our drugs
target severe chronic pain, such as pain associated with osteoarthritis,
low-back pain or irritable bowel syndrome. We have three unique
drugcandidates in clinical development: Oxytrex(TM), Remoxy(TM) and PTI-901.
Our two most advanced drugs, Oxytrex and PTI-901, are in Phase III clinical
trials. Remoxy is in Phase I clinical trials in the United Kingdom. We
believe the target market for our three drug candidates exceeds $3 billion
per year. We currently retain commercial rights to our drug candidates.
Pain Therapeutics is presenting two other technical posters at the American
Pain Society meeting:
"Oxytrex(TM), A Novel Drug, Effectively Treats Chronic Pain Due to
Osteoarthritis," presents the previously announced clinical results of a 360
patient Phase II study;
"Pharmacokinetic Study Supports BID Oral Administration of Oxytrex(TM) in a
Chronic Model of Pain," profiles the bioavailability/pharmacokinetics of
Oxytrex.
All posters will be made available to the general public on April 27, 2004
on Pain Therapeutics' website, http://www.paintrials.com/.
Note Regarding Forward-Looking Statements: This press release contains
forward-looking statements for purposes of the Private Securities Litigation
Reform Act of 1995 (the "Act"). PTI disclaims any intent or obligation to
update these forward-looking statements, and claims the protection of the
Safe Harbor for forward-looking statements contained in the Act. Examples of
such statements include, but are not limited to, the potential use of the
Company's technology to develop treatments for neuropathic pain and the size
of the potential market for treatments for such pain, and the likelihood
that the Company's pre-clinical data will support the development of novel
and effective opioid drugs to treat neuropathic pain. Such statements are
based on management's current expectations, but actual results may differ
materially due to various factors. Such statements involve risks and
uncertainties, including, but not limited to, those risks and uncertainties
relating to difficulties or delays in development, testing, regulatory
approval, production and marketing of the Company's drug candidates,
unexpected adverse side effects or inadequate therapeutic efficacy of the
Company's drug candidates that could slow or prevent clinical development,
product approval or market acceptance (including the risk that current and
past results of
clinical trials are not necessarily indicative of future results of clinical
trials), the uncertainty of patent protection for the Company's intellectual
property or trade secrets, the Company's ability to obtain additional
financing if necessary and unanticipated research and development and other
costs. For further information regarding these and other risks related to
the Company's business, investors should consult the Company's filings with
the Securities and Exchange Commission, including its Form 10-K for the year
ended December 31, 2003 and its subsequent periodic filings.
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