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TMCNet:  Retrophin to Co-Sponsor Clinical Trial of Intranasal Oxytocin for Schizophrenia

[December 12, 2013]

Retrophin to Co-Sponsor Clinical Trial of Intranasal Oxytocin for Schizophrenia

NEW YORK --(Business Wire)--

Retrophin, Inc. (OTCQB:RTRX) today announced that it has agreed to support the completion of a Phase II clinical trial of oxytocin for the treatment of schizophrenia directed by Dr. David Feifel, Department of Psychiatry, University of California, San Diego. The study will become part of the company's clinical development program for Syntocinon™.

"We look forward to collaborating with Dr. Feifel on this promising study and taking steps toward the development of intranasal Syntocinon," said Martin Shkreli, Founder and Chief Executive Officer of Retrophin. "There has been no new mechanism of action for people suffering from schizophrenia in decades, and doctors tell us that the current treatments often result in non-compliance due to the difficulty in taking the medication."

Under the terms of the agreement, Retrophin will provide continued support and guidance for this study as a named Collaborator. Financial terms of the agreement are not being disclosed.

About the Study

The double-blind, placebo-controlled study, in collaboration with the National Institute of Mental Health, is currently enrolling 143 patients in three arms: 84 IU twice a day for six weeks, 42 IU twice a day for six weeks, and placebo. The primary endpoint of the study is change in total score from baseline to endpoint in the Positive and Negative Syndrome Scale (PANSS). Secondary endpoints include Global Assessment of Functioning (GAF), Clinical Global Impression-Severity of Illness (CGI (News - Alert)-S) and Clinical Global Impression-Global Improvement (CGI-I). Results are expected to e announced during the third quarter of 2014. For more information, please visit http://clinicaltrials.gov/show/NCT01621737.


About Retrophin

Retrophin is a pharmaceutical company focused on the development, acquisition and commercialization of drugs for the treatment of serious, catastrophic or rare diseases for which there are currently no viable options for patients. The Company's pipeline includes compounds for several catastrophic diseases, including Focal Segmental Glomerulosclerosis (FSGS), Pantothenate Kinase-Associated Neurodegeneration (PKAN), Duchenne Muscular Dystrophy and others. Retrophin's lead compound, Sparsentan, formerly known as RE-021, is scheduled to begin enrollment in a potentially pivotal Phase 2 clinical trial for FSGS during 2013. The Company also intends to initiate clinical trials for intranasal oxytocin as a potential treatment for schizophrenia and autism. For additional information, please visit www.retrophin.com.

Forward-Looking Statements

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect the Company's business. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company's filings with the Securities and Exchange Commission.


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