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Ocera Therapeutics Receives Orphan Drug Status For AST-120 For Pouchitis
Ocera Therapeutics, Inc., a
privately-held biopharmaceutical company focused on the development and
commercialization of proprietary compounds to treat gastrointestinal and
liver diseases, announced that the U.S. Food and Drug Administration
(FDA) has granted orphan drug designation to AST-120 for the treatment of
Pouchitis.
Ocera will provide an overview of the Company and an update on AST-120
at the 26th Annual JP Morgan Healthcare conference being held at
2:30 pm (PT) at the Westin St. Francis Hotel in San Francisco in the
Elizabethan Room.
"We are pleased by the FDA's decision to grant orphan drug status for
AST-120 in Pouchitis," stated Dr. Laurent Fischer, president and CEO of
Ocera Therapeutics. "This designation, along with the recent positive
results from the exploratory Phase 2 trial for AST-120, allows us to expand
the development of AST-120 for the treatment of Pouchitis, a frequent and
severe complication in patients with a J-Pouch for which there are
currently no drugs approved."
Patients who suffer from ulcerative colitis often require a resection
of the colon and creation of a J-Pouch to reduce the risk of cancer. A
J-Pouch collects stool, but the pouch can become inflamed, resulting in a
condition known as Pouchitis, which is associated with diarrhea, abdominal
cramps, fever and dehydration. AST-120, an oral agent known to adsorb bile
acids and bacterial toxins, as well as to mediate inflammation in the
gastrointestinal tract, is currently being evaluated in a Phase 2 trial in
patients with active Pouchitis.
Less than 100,000 patients in the United States suffer from Pouchitis
which qualifies AST-120 for Orphan Drug status in this condition. Orphan
Drug status was created by the FDA to encourage companies to develop
medicines for the treatment of rare diseases by providing the developer
with market exclusivity of the product for seven years, in addition to
other incentives.
AST-120 was in-licensed from Kureha Corporation, Japan in 2005 and is
currently being studied in a Phase 3 trial in Fistulizing Crohn's disease.
About Ocera Therapeutics, Inc.
Ocera Therapeutics, Inc. is a privately held biopharmaceutical company
focused on the licensing, development and commercialization of proprietary
compounds to treat a broad range of gastrointestinal and liver diseases.
Ocera is based in San Diego and is pursuing the development of AST-120 in
Crohn's disease, Pouchitis and conducting proof of concept trials in other
gastrointestinal and liver diseases including, Hepatic Encephalopathy,
Irritable Bowel Syndrome and Proton Pump Inhibitor-resistant
Gastroesophageal Reflux Disease. Ocera Therapeutics has raised $26.5
million dollars in venture financing from Domain Associates, Sofinnova
Ventures and Thomas, McNerney & Partners. Additional information on the
Company can be found at http://www.oceratherapeutics.com.
For more information on Pouchitis, visit the Crohn's and Colitis
Foundation of America website at http://www.ccfa.org.
Ocera Therapeutics, Inc.
http://www.oceratherapeutics.com
Ocera terapeutice Primeºte Orphan Drug stare pentru AST-120 Pentru Pouchitis - Ocera Therapeutics Receives Orphan Drug Status For AST-120 For Pouchitis - articole medicale engleza - startsanatate