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

.D., Chief Scientist and Founder of Trigemina and Director of Pain Research at Stanford University School of Medicine. "Prolonged pain increases the amount of oxytocin receptors for the drug to work on. Because of this, those with chronic migraines are in an almost constant state of elevated oxytocin receptor numbers on trigeminal neurons. With nasal delivery, TI-001 directly applies oxytocin to the trigeminal neurons and rapidly produces an analgesic effect, but only in the presence of painful inflammation."

The TRIG-05 Phase 2 study is a placebo-controlled, double-blind, randomized-withdrawal and enrollment enriched trial of TI-001 in chronic migraine patients. A total of 96 patients will be enrolled in four trial sites in Chile and another trial site in Argentina to begin in June. The study's primary objective is demonstrating efficacy, tolerability and safety. Additional objectives will include determining the appropriate dose for a future Phase 3 trial and to explore baseline IL-6 plasma levels as a potential biomarker for efficacy response.

About Trigemina

Trigemina is focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products. Trigemina's lead product candidate, TI-001, is a patented new application of oxytocin. TI-001 has shown promising results for use as a safe and effective therapy for all forms of chronic and subacute head pain.

Contact:

The Ruth Group
Aaron Estrada (media)
aestrada@theruthgroup.com  
(646) 536-7028

Trigemina
Charles Yeomans
(925) 377-0664
cyeomans@trigemina.com

 


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SOURCE Trigemina, Inc.
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