BOSTON, June 26, 2013 (GLOBE NEWSWIRE) -- Trigemina, Inc., a biopharmaceutical company focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products, will be presenting clinical data for its leading drug candidate, TI-001, intranasal oxytocin, for the treatment of chronic migraine at the 2013 International Headache Congress (IHC), hosted by the International Headache Society and American Headache Society, June 27th-30th, 2013, in Boston, Massachusetts.
In addition to being a safe and a highly effective treatment for chronic migraine patients, TI-001 demonstrated the importance of the inflammatory cytokine interleukin 6 (IL-6) on the number of oxytocin receptors on trigeminal neurons using the pain neurotransmitter calcitonin gene-related peptide (CGRP). High levels of this cytokine is commonly found in patients with chronic migraine, as well as strongly associated with a number of other chronic head pain conditions.
The presentation, titled, "Therapeutic Effect of Nasal Oxytocin in Chronic Migraine: Dependence on Cytokines", is on a single-dose, placebo-controlled, double-blind, parallel study. Chronic migraine patients were asked to rate their pain, nausea, photophobia and phonophobia on a 4-point scale (severe, moderate, mild or none) prior to and at .5, 1, 2, 4, and 24-hours after dosing. Between two and four hours after dosing, 64% of the patients who received TI-001 reported reduced pain by two categories, compared to only 27% of patients who received a placebo. Meanwhile, those who had taken non-steroidal anti-inflammatory drugs (NSAIDs) 24-hours prior to treatment with TI-001 showed a strong decrease in effect.
"Nearly three times the amount of chronic migraine patients experienced significant relief from their migraine after being given TI-001 compared to those given a placebo," said David C. Yeomans, Ph.D., Chief Scientist and Founder of Trigemina, as well as the Director of Pain Research at Stanford University School of Medicine. "It is also interesting to point out the effect that NSAIDs had on pain relief for patients treated with intranasal oxytocin. Because NSAIDs block the production of IL-6, there is a reduced amount of oxytocin receptors for TI-001 to bind with, making it less effective. This discovery provides valuable insight on the physiology of chronic head pain."
TI-001 is currently being evaluated in a placebo-controlled, double-blind, randomized-withdrawal and enrollment enriched Phase II clinical study, titled TRIG-05, for efficacy, tolerability and safety in patients with chronic migraine. Promising preclinical and human pilot study results suggests TI-001 could be a safe, non-narcotic form of therapy for the effective relief of chronic migraine, a debilitating condition with few treatment options.
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 multiple types of chronic and subacute head pain.
For additional information, please visit www.trigemina.com