Full Press Release Details
Pharmaceuticals, Inc.
Initiates Ketotransdel
3 Clinical Program for Pain
Research Signed as Strategic Partner for the Phase 3 Program
CA - June 16, 2008 -- Transdel Pharmaceuticals, Inc. (OTCBB: TDLP), a specialty
pharmaceutical company developing non-invasive, topically administered
medications, today announced the initiation of its Phase 3 clinical program
Ketotransdel , its novel topical cream based non-steroidal anti-inflammatory
drug ("NSAID") for pain. The Company has engaged Cato Research Ltd., a global
contract research organization ("CRO"), as a strategic partner and as the CRO to
conduct the Phase 3 clinical program.
Company's randomized, double-blind, placebo controlled Phase 3 trial will
evaluate the efficacy and safety of Ketotransdel for the
topical treatment of acute pain from soft tissue injuries. Clinical
sites are planned throughout the United States and potentially other regions,
including Canada. The Company expects that Ketotransdel , if approved by the
U.S. Food and Drug Administration, could become the first topical NSAID cream
product in the United States for acute pain management. The drug could address
what the Company believes is a significant unmet medical need for patients
physicians seeking a potentially safer alternative to existing pain management
approaches, such as oral NSAIDs.
Ketotransdel into Phase 3 clinical studies is a significant milestone for our
Company. Our top priority is to execute our clinical program as planned,"
Juliet Singh, President and Chief Executive Officer of Transdel
Pharmaceuticals."For
conduct of the clinical trial we carefully evaluated only select top level
with extensive experience in the relevant pain area. We selected Cato Research
not only due to their relationship as a strategic partner with us, but because
of their cost efficient approach to the clinical program, expertise in the
space and our direct access to their senior executive management."
our new strategic relationship with Transdel Pharmaceuticals to assist in
advancing this much needed pain drug through the Phase 3 clinical program," said
Dr. Allen Cato, Chief Executive Officer of Cato Research. "We are uniquely
focused on development of pain and topical drugs and we expect to make a
significant contribution in bringing Ketotransdel to the
estimates indicate that the market for NSAIDs and Cox-2 inhibitors exceeds
billion per year and that more than 30 million people worldwide use NSAIDs
daily. Due to the recognition of known risks associated with orally administered
NSAIDs, including cardiovascular, gastrointestinal and other medical
complications, and the decline in the use of Cox-2 inhibitors because of safety
concerns, the Company believes that there is a significant demand for topical
pain management products such as Ketotransdel .
Transdel Pharmaceuticals, Inc.
Pharmaceuticals, Inc. (OTCBB: TDLP) is a specialty pharmaceutical company
developing non-invasive, topically- delivered medications. The Company's
innovative patented proprietary Transdel cream formulation technology is
designed to facilitate the effective penetration of drugs through the tough
barrier to reach the target underlying tissues. In the case of Ketotransdel ,
the Transdel cream allows the active ingredient ketoprofen to reach the target
soft tissue and exert its well-known anti-inflammatory and analgesic effects.
The Company is also investigating other drug candidates and treatments for
transdermal delivery using the patented Transdel platform technology for
products in pain management and other therapeutic areas. For
information, please visit http://www.transdelpharma.com.
Research Ltd. is a global, full-service contract research and development
organization providing strategic and tactical support for clients in the
pharmaceutical, biotechnology, medical device, and medical diagnostic industries
for over 20 years. With a staff of more than 300 employees located in the United
States, Europe, Canada, Israel, and South Africa, Cato Research's services range
from design and management of preclinical and clinical studies to submission
regulatory documents required for marketing approval.
made in this release that are not historical in nature constitute
forward-looking statements within the meaning of the Safe Harbor Provisions
the Private Securities Litigation Reform Act of 1995. Forward-looking statements
can be identified by the use of words such as "expects," plans" "will," "may,"
"anticipates," believes," "should," intends," "estimates," and other words
similar meaning. These statements are subject to risks and uncertainties that
cannot be predicted or quantified and consequently, actual results may differ
materially from those expressed or implied by such forward-looking statements.
Such risks and uncertainties include, without limitation, risks and
uncertainties associated with the uncertainty of future financial results,
additional financing requirements, development of new products, government
approval processes, the impact of competitive products or pricing, and
technological changes. More detailed information about the Company and the
factors that may affect the realization of forward-looking statements is set
forth in the Company's filings with the Securities and Exchange Commission,
including the Company's Annual Report on Form 10-KSB filed with the SEC on
26, 2008. Such documents may be read free of charge on the SEC's web site at
www.sec.gov. All forward-looking statements included in this release are made
of the date of this press release, and the Company assumes no obligation to
update any such forward-looking statements.