LEXINGTON, Mass., Sept. 14 /PRNewswire/ -- Synta Pharmaceuticals, a
biopharmaceutical company focused on discovering, developing, and
commercializing small-molecule drugs to treat serious conditions, announced
today the initiation of a multi-national, multi-center, randomized, placebo-
controlled Phase 2b trial examining the efficacy and safety of STA-5326 in
patients with active Crohn's disease. STA-5326 is the first and only oral,
small-molecule, selective inhibitor of the interleukin (IL)-12 cytokine
family, including IL-12 and IL-23. These cytokines play a central role in
inflammatory diseases such as Crohn's disease and other chronic inflammatory
diseases. The study is designated SCORE (Study in Crohn's disease of the Oral
IL-12/IL-23 inhibitor, STA-5326, for the induction of REsponse and remission).
A companion study will be conducted concurrently to evaluate biological
markers of activity in Crohn's disease.
"The findings from our Phase 2a study suggest that STA-5326 is active and
generally well-tolerated in Crohn's disease patients, and we believe that our
novel approach to this disease could help advance the treatment of the
hundreds of thousands of patients whose disease is not optimally controlled
today," said Matthew L. Sherman, MD, Senior Vice President and Chief Medical
Officer at Synta. "Given that STA-5326 is formulated as a once-daily, oral
therapy, this level of convenience could represent an important clinical
advance for patients suffering from Crohn's disease."
At Digestive Disease Week in May, Synta reported that in a Phase 2a study,
treatment with STA-5326 at daily doses of 35 mg and above demonstrated
clinically meaningful response and disease remission rates in patients with
active Crohn's disease. STA-5326 also showed an acceptable safety profile
with the most common adverse events being dizziness, nausea, headache, and
fatigue.
About STA-5326
STA-5326 is a novel, orally-administered, small-molecule drug candidate
that selectively and potently inhibits the production of the IL-12 family of
proteins, including IL-12 and IL-23. Overproduction of these proteins plays a
central role in chronic inflammatory diseases, including Crohn's disease,
psoriasis and rheumatoid arthritis, causing the body's immune system to
infiltrate and damage tissues and organs. Development in rheumatoid arthritis
is anticipated to commence in late 2005.
About Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease characterized by
inflammation throughout the length of the gastrointestinal, or digestive,
tract. Symptoms can be severe, and include abdominal pain, frequent diarrhea,
and intestinal bleeding. Approximately 500,000 people in the U.S. and over a
million people worldwide are affected by Crohn's disease.
About Synta
Synta Pharmaceuticals Corporation is a biopharmaceutical company focused
on discovering, developing, and commercializing small-molecule drugs to extend
and enhance the lives of patients with severe medical conditions, including
chronic inflammatory disease and cancer. Synta currently has three drug
candidates in human clinical trials, as well as a diverse pipeline of
internally developed discovery programs. For more information, please see
http://www.syntapharma.com.
Contacts:
Synta Pharmaceuticals Corp.
Steven Ertel
(781) 541-7201
sertel@syntapharma.com
GendeLLindheim BioCom Partners (Media)
Stephen Gendel
(212) 918-4650
sgendel@biocompartners.com
SOURCE Synta Pharmaceuticals
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Related links:
http://www.syntapharma.com
CONTACT:
Steven Ertel of Synta Pharmaceuticals Corp.,
+1-781-541-7201, sertel@syntapharma.com; or Stephen Gendel of
GendeLLindheim BioCom Partners, +1-212-918-4650,
sgendel@biocompartners.com
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