Trigemina Hosts Clinical Investigator Meeting for Chronic Migraine Study
Published: Apr 19, 2013
SANTIAGO, Chile, April 18, 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 Company will be conducting a meeting with clinical investigators in Santiago, Chile, on April 18th, 2013. The meeting will include presentations about the upcoming Phase II clinical study investigating the use of TI-001, intranasal oxytocin, for the treatment of chronic migraine, as well as feature an in-depth discussion on the unique science and mechanism of action behind TI-001. The Company will also use the meeting to train site investigators to ensure consistent patient selection and diagnosis, as well as to discuss strategies for optimal study conduct.
A group of invited key thought leaders and neurologists from leading neurological institutes and headache and pain centers, such as the FLENI Hospital for Neurological Research in Buenos Aires and the Pontifical Catholic University of Chile, will be attending the investigators meeting. Neurologists from the University of Chile, Hospital FUSAT, University of Buenos Aires and Hospital Barros Luco Trudeau will also be in attendance for the meeting.
"It is a great opportunity to meet with such an esteemed group of neurologists and investigators who are enthusiastic about the study and TI-001 in general," commented David C. Yeomans, Ph.D., Chief Scientist and Founder of Trigemina and Director of Pain Research at Stanford University School of Medicine. "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 patients have very few treatment options. This is exciting to doctors and patients, not only because this could have a significant impact of the treatment of chronic migraine, but also because oxytocin is a safe and natural hormone with a remarkably benign side-effect profile."
The placebo-controlled, double-blind, randomized-withdrawal and enrollment enriched Phase II study, TRIG-05, will begin enrollment in April 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 June. 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 for chronic migraine, a debilitating condition affecting more than six million Americans.
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.
The Ruth Group
Aaron Estrada (media)
SOURCE Trigemina, Inc.