Navigation Links
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.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

 


'/>"/>
SOURCE Trigemina, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. UCSB professor receives award for graphene electronics research
2. Watsons Generic Yaz(R) Receives FDA Approval
3. Quanterix Receives Funding From the Department of Homeland Security to Develop Test for Botulinum Toxin
4. Life Technologies Ion Personal Genome Machine Receives San Diegos CONNECT Most Innovative New Product Award
5. MacroGenics Receives Milestone Payment as Part of Its Global DARTâ„¢ Alliance with Boehringer Ingelheim
6. Intimate Bridge 2 Conception, Inc. Receives $4.3M
7. Pacific Meso Center Receives Generous Donation to First Free-Standing Mesothelioma Research Laboratory in Los Angeles
8. BioNeutral Group Receives $400,000 in Equity Financing
9. Amsterdam Molecular Therapeutics Receives US Orphan Designation for Hemophilia B Gene Therapy
10. Arcion Receives Notice of Allowance for US Patent for Novel Topical Lidocaine Formulation for Pain
11. Life Technologies Receives AFNOR Validation for Tests Designed to Detect Listeria Contamination in Food Samples
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... NC (PRWEB) , ... June 27, 2016 , ... ... mission to bring innovative medical technologies, services and solutions to the healthcare market. ... and implementation of various distribution, manufacturing, sales and marketing strategies that are necessary ...
(Date:6/24/2016)... SAN DIEGO , June 24, 2016 /PRNewswire/ ... that more sensitively detects cancers susceptible to PARP ... individual circulating tumor cells (CTCs). The new test ... of HRD-targeted therapeutics in multiple cancer types. ... therapies targeting DNA damage response pathways, including PARP, ...
(Date:6/23/2016)... , June 23, 2016   Boston ... of novel compounds designed to target cancer stemness ... has been granted Orphan Drug Designation from the ... treatment of gastric cancer, including gastroesophageal junction (GEJ) ... inhibitor designed to inhibit cancer stemness pathways by ...
(Date:6/23/2016)... , June 23, 2016  The Prostate Cancer Foundation (PCF) is ... treatments and faster cures for prostate cancer. Members of the Class of 2016 ... countries. Read More About the Class of 2016 PCF ... ... ...
Breaking Biology Technology:
(Date:6/21/2016)... 2016 NuData Security announced today that Randy ... principal product architect and that Jon Cunningham ... development. Both will report directly to Christopher ... reflect NuData,s strategic growth in its product and ... demand and customer focus values. ...
(Date:6/16/2016)... June 16, 2016 The ... expected to reach USD 1.83 billion by 2024, ... Research, Inc. Technological proliferation and increasing demand in ... expected to drive the market growth. ... The development of advanced multimodal techniques for ...
(Date:6/9/2016)...  Perkotek an innovation leader in attendance control systems is proud to announce the ... employers to make sure the right employees are actually signing in, and to even ... ... ... ...
Breaking Biology News(10 mins):