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Trigemina Receives ISP Approval of Clinical Study Protocol for TI-001 Phase 2 Trial
Date:4/8/2013

MORAGA, Calif., April 8, 2013 /PRNewswire/ -- Trigemina, Inc., a biopharmaceutical company focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products, today announced that the Instituto de Salud Publica (ISP) of Chile has approved the Company's protocol for its Phase 2 clinical study of TI-001, intranasal oxytocin, for the treatment of chronic migraine. The TRIG-05 study is expected to begin enrollment in April, 2013, with a primary clinical endpoint of demonstrating efficacy, tolerability and safety of TI-001.

"The ISP acceptance of our study protocol is an important step forward for the clinical development of TI-001 in chronic migraine patients," said Charles Yeomans , Chief Executive Officer of Trigemina. "TI-001 demonstrated strong efficacy in our preclinical and pilot human studies, especially for such a difficult to treat condition as chronic migraine. With approval from the ISP of Chile, we are confident that we will be able to move forward with our business development goals for 2013 as planned."

In preclinical and human pilot studies, treatment with TI-001 has shown promising results for use as a safe and effective therapy for all forms of chronic and subacute head pain. In one study, 64% of chronic migraine patients receiving TI-001 improved from severe to mild/no pain or from moderate to no pain, whereas only 28% of patients receiving placebo reported improvement. Importantly, 29% of patients receiving TI-001 improved to zero pain, compared to none of the placebo treated patients, suggesting strong efficacy for the therapy with little to no side effects and no risk of developing addiction.

"The unique science underlying TI-001's robust efficacy and lack of abuse potential is the relationship shared between pain and oxytocin," stated David C. Yeomans , Ph
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SOURCE Trigemina, Inc.
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