SAN DIEGO, April 7 /PRNewswire/ -- Trega Biosciences, Inc. (Nasdaq: TRGA)
today announced that HP 228 was effective in the management of post-surgical
pain as evidenced by the statistically significant reduction of patient
controlled morphine use following hip replacement surgery in a double-blind,
placebo controlled Phase II study. A total of 81 patients in the hip
replacement phase of the dose escalation study received placebo or one of
three doses of HP 228. The two higher doses significantly reduced morphine
consumption compared to placebo.
The study was originally designed to evaluate placebo and five intravenous
HP 228 doses in hip and knee replacement groups. As the study progressed,
preclinical results became available that supported stopping the study at the
lower end of the dose range. At the time the study was terminated, an
insufficient number of knee replacement patients had been enrolled to evaluate
HP 228 in this group of patients. The adverse experience profile in both hip
and knee replacement patients was consistent with events expected following
joint replacement and pain management regimens involving patient controlled
morphine.
"We are encouraged by the preliminary results which suggest HP 228 is
effective in the management of acute post-surgical pain," said Dr. Clifford W.
Colwell, Jr., MD. Dr. Colwell is the Director of the Musculoskeletal Center
of Excellence and Principal Investigator for the study from Scripps Clinic, La
Jolla, California. "The need to improve our current methodologies of managing
surgical pain is compelling. The current mainstay of acute post-surgical pain
management is narcotic analgesics, such as morphine, demerol or dilaudid.
While narcotic analgesics provide excellent pain relief, the issue with
narcotics is that they also generate unfortunate side effects and adverse drug
experiences which may prolong recovery following surgery. These preliminary
results are encouraging to the surgeon to provide quality patient care by
diminishing the level of narcotic usage that patients experience."
"HP 228 is Trega's first drug candidate from the melanocortin research
program to enter clinical trials, and the results of this study confirm our
interest and enthusiasm for this new class of treatments," said Michael G.
Grey, CEO and president of Trega Biosciences.
HP 228 interacts with melanocortin receptors. These receptors may be
associated with a variety of conditions such as inflammatory and metabolic
diseases. It is estimated that over 25 million operations are performed
annually in the United States and most involve some form of pain management.
These estimates include over 600,000 total joint replacements of which 300,000
are hip replacements. With an increase in the aging population, these figures
are expected to rise. Trega plans to seek a corporate partner to undertake
further development of HP 228.
Trega Biosciences is focused on discovering small molecules acting on
melanocortin receptors for the treatment of inflammatory and metabolic
diseases. The Company is also working to accelerate the process of drug
discovery from target identification to clinical candidates by using small
molecule combinatorial chemistry, high throughput screening and predictive
bioinformatics to rapidly create novel drugs having greater chances of
clinical success. In combination with its wholly owned subsidiary, NaviCyte,
Trega offers integrated products and services spanning the drug discovery
process - beginning with synthesizing novel compounds to providing uniquely
qualified drug leads - to the pharmaceutical and biopharmaceutical industries.
Except for the historical information contained herein, the matters
discussed in this news release are forward-looking statements that involve
risks and uncertainties, including whether a corporate partner can be found to
finance HP 228 in further clinical trials, the results of any such trials, any
proposed product can be successfully formulated, scaled-up, developed, and
commercialized, whether regulatory approvals can be obtained, the impact of
competitive products and pricing, whether any corporate collaborations or
alliances will be successful, and other risks detailed from time to time in
Trega's Securities and Exchange Commission filings. These forward-looking
statements represent Trega's judgment as of the date of this release. Actual
results may differ materially from those projected. Trega disclaims, however,
any intent or obligation to update these forward-looking statements.
Trega's releases are on the World Wide Web at http://www.trega.com and
PRNewswire's fax-on-demand service at 1-800-758-5804, extension 374050.
SOURCE Trega Biosciences, Inc.
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Related links:
http://www.trega.com
Company News On-Call:
http://www.prnewswire.com/comp/374050.html or fax,
800-758-5804, ext. 374050
CONTACT:
Gerard A. Wills, Chief Financial Officer,
619-410-6695, or Debra K. Liebert, Sr. Director Corporate
Development, 619-410-6569, of Trega Biosciences
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