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Intra-Cellular Therapies Enters Phase 3 Development Program

Focus is on ITI-007 for the treatment of bipolar disorder

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Intra-Cellular Therapies Inc., a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, is proceeding with Phase 3 development of ITI-007 for the treatment of depressive episodes associated with bipolar disorder.

The Phase 3 program in bipolar depression consists of two multicenter, randomized, double blind, placebo controlled clinical trials. The first Phase 3 study will evaluate ITI-007 as a monotherapy and the second Phase 3 study will evaluate ITI-007 as an adjunctive therapy with lithium or valproate. The company plans to commence these studies later this year.

“I am pleased with the continued progress of our ITI-007 development programs. The advancement of ITI-007 into Phase 3 development for the treatment of bipolar depression represents a significant milestone in our overall ITI-007 strategy and is an important step in our mission to provide improved treatment options to patients suffering from CNS disorders,” said Sharon Mates, chairman and chief executive officer, Intra-Cellular Therapies. “We look forward to evaluating ITI-007 in bipolar depression, a disorder which exerts a tremendous toll on patients, and for which few treatments options are available.”

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