SANTIAGO, Chile, June 10, 2013 (GLOBE NEWSWIRE) -- Trigemina, Inc., a biopharmaceutical company focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products, today announced the initiation of their Phase II clinical study investigating the use of TI-001, intranasal oxytocin, for the treatment of chronic migraine. The placebo-controlled, double-blind, randomized-withdrawal and enrollment enriched study, TRIG-05, officially began its enrollment period on May 31, 2013, and is expected to enroll 96 chronic migraine patients at trial sites located in Chile, with additional sites in Argentina expected to join in July. The first patient was enrolled in the study and treated on June 6, 2013.
The primary clinical endpoint of the study is to demonstrate efficacy, tolerability and safety of TI-001, with the secondary goal of determining the best Phase III dosage and exploring interlukin-6 (IL-6) levels as a potential biomarker for predicting efficacy. If approved by the U.S. Food and Drug Administration (FDA), TI-001 could be the first non-invasive treatment approved for chronic migraine, a debilitating condition affecting more than six million Americans.
"There are an estimated six million chronic migraine sufferers in the United States alone," explained David C. Yeomans, Ph.D., Chief Scientist, Founder of Trigemina and Director of Pain Research at Stanford University School of Medicine. "Chronic migraine is a devastating disease where patients have 15 or more excruciating headache days per month. TI-001 has shown promising results in preclinical and preliminary clinical studies as being a safe and effective therapy for chronic migraine, an area where there is only one currently approved treatment. This study is exciting to doctors and patients, not only because this could have a significant impact of the treatment of chronic migraine, but also because, unlike opioids, oxytocin is a safe and natural hormone with a remarkably benign side-effect profile."
"We are pleased with the progress of our lead molecule and its advancement into Phase II following successful preclinical and preliminary clinical studies," said Charles Yeomans, President and Chief Executive Officer of Trigemina. "Our goal is to address one of the most urgent global needs in drug development: an alternative to current opioid pain drugs and a safe and effective, and entirely new, migraine therapeutic."
Trigemina is a privately owned, clinical stage company 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 most forms of chronic or subacute head pain.
For more information, visit the Company's website at www.trigemina.com.