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AllTranz Awarded $4 Million Research Grant by NIH and NIDA

Tue Nov 3, 2009 7:00am EST
Grant Facilitates Development of Novel Transdermal Patch for Treatment of
Cancer, AIDS, and MS Patients and Marijuana Dependence
LEXINGTON, Ky.--(Business Wire)--
AllTranz, Inc., a specialty pharmaceutical company focused on developing drugs
to treat a variety of neurologic and inflammatory disorders, today announced
that it has been awarded a $4 million research grant from the National Institute
on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), to
advance the company`s transdermal tetrahydrocannabinol (THC) patch for the
treatment of marijuana dependence and withdrawal. The grant was awarded through
the American Recovery and Reinvestment Act of 2009 (ARRA) and will directly
support preclinical development and a planned Phase I clinical study. 

"We are pleased to receive this grant from NIDA and are proud that peer review
has recognized the potential of our innovative approach to help people addicted
to marijuana overcome their drug dependence and withdrawal symptoms," said Dr.
Audra Stinchomb, Chief Scientific Officer of AllTranz Inc. "By delivering low,
steady levels of THC using our transdermal patch, patients don`t experience the
euphoria associated with higher levels." 

"NIDA is interested in exploring the role of transdermal THC delivery as an
innovative way to treat marijuana withdrawal symptoms and dependence," said Dr.
Nora Volkow, NIDA`s director. "This is especially relevant to our efforts to
fill a critical gap in available treatments for the many Americans struggling
with marijuana-related disorders and their detrimental medical and social
consequences." 

AllTranz`s patented system presents significant advancements in transdermal drug
delivery. The novel drug delivery technology allows for the non-invasive,
non-oral, controlled delivery of THC. The non-plant based THC patch is designed
to decrease the chance of side effects including drowsiness, dizziness, and the
"high" feeling, as compared to ingesting a capsule, using a spray inhaler, or
smoking marijuana. The patch will reduce dosing frequency and is expected to
improve marijuana withdrawal and addiction symptoms, similar to nicotine patch
treatment for tobacco smoking cessation. 

The patch is initially being developed for marijuana withdrawal and dependence.
Additionally, because of THC`s wide-ranging therapeutic and clinical benefits,
AllTranz is proceeding with development of the patch for other indications,
including cancer chemotherapy nausea and vomiting, AIDS patient appetite
stimulation, and multiple sclerosis (MS) pain. Separate Phase II clinical trials
would be pursued for each indication. 

Following completion of preclinical studies, AllTranz expects to submit an
Investigational New Drug (IND) application and initiate a Phase I clinical trial
to examine the safety of the patch, which will be conducted through the Lifetree
Clinical Research Center for Neuroscience Research, which is recognized as a
therapeutic leader in central nervous system (CNS) and analgesia research. 

About Marijuana Dependence 

Marijuana is the most commonly used illicit drug in the United States. According
to the 2008 National Survey on Drug Use and Health, more than 15 million
Americans (nearly 5% of the U.S. population) age 12 or older used marijuana at
least once in the month prior to being surveyed. More than half of the
individuals addicted to marijuana experience significant withdrawal symptoms if
they try to quit. The withdrawal symptoms contribute to the relapse and
maintenance of marijuana use. Withdrawal symptoms are similar to those
experienced by people who quit cigarettes, cocaine and other drugs. Nearly
two-thirds of marijuana users experience pronounced withdrawal symptoms that can
include anxiety, irritability, depression, mood swings, and sleep problems. 

Marijuana contains more than 400 chemicals, including many of the harmful
substances found in tobacco smoke. Smoking one marijuana cigarette deposits
about four times more tar into the lungs than a filtered tobacco cigarette and
Harvard University researchers report the risk of a heart attack is five times
higher than usual in the hour after smoking marijuana. 

About AllTranz 

AllTranz, Inc. is a privately held specialty pharmaceutical company focused on
developing drugs to treat a variety of neurologic and inflammatory disorders.
The company`s central technology leverages chemical prodrug delivery techniques
developed by its founder and Chief Scientific Officer, Dr. Audra Stinchcomb.
AllTranz has applied its technology in four key areas: prodrug development,
abuse deterrence, unique microneedle formulations, and an internal drug
development program. AllTranz`s strategy is to develop therapeutic products and
form marketing collaborations with industry leaders in order to maximize their
commercial potential. AllTranz`s proprietary technology can be applied to
multiple clinical applications, including but not limited to cancer, AIDS, MS,
marijuana withdrawal and neuropathic pain. For additional information regarding
AllTranz, please visit the company`s website at www.alltranz.com

AllTranz, Inc.
Clint Dederick
Chief Executive Officer
513-252-7894
cdederick@alltranz.com
or
Investor and Media Inquiries:
MD Becker Partners LLC
Janet Dally
Senior Vice President
215-493-5674
janet@mdbpartners.com

Copyright Business Wire 2009



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