Gamma Therapeutics Awarded Phase II Research Grant
Gamma Therapeutics Awarded Phase II NIH Small Business Innovation Research Grant to Develop GammaCoeur™, a Novel Cardiovascular Disease Risk Test
April 19, 2011–Portland, Oregon-Gamma Therapeutics, Inc., an Oregon biotech venture developing diagnostic test and surgical therapy solutions for the cardiovascular disease (CVD) industry, announced today that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant from the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH),to commercialize its GammaCoeur CVD Risk Assay.
The $1.1 million commercialization grant will allow Gamma Therapeutics to complete development, validation and BETA testing of GammaCoeur; submit its FDA regulatory approval application for a Class II
In Vitro Diagnostic Device and market the product globally when approved. The Company estimates regulatory approval will take up to two years, although it is working toward approval by end of 2012.
GammaCoeur CVD Risk Assay. All Gamma Therapeutic CVD products are based upon a naturally occurring protein in human blood, responsible for the clotting mechanism, called Gamma Prime Fibrinogen. Gamma Prime Fibrinogen has been shown in a host of scientific studies (1,2,3) to be strongly and significantly associated with cardiovascular disease. GammaCoeur addresses the need for a new heart attack and stroke risk biomarker to complement traditional diagnostic tests in use today, such as those to determine cholesterol, triglycerides and glucose levels. Worldwide, millions die each year from fatal heart attacks, many of which were preventable with better predictive data. In 2009 alone, of the 500,000 Americans who died of a heart attack, 50% tested normal for cholesterol, a test considered the gold standard for heart risk assessment.
According to Dr. David H. Farrell, Gamma Therapeutics’ Founder and Chief Science Officer, “Leading cardiovascular disease research institutions, such as the Framingham Heart Study, and others continue to research coronary disease, heart attack, and their causes, with the goal of developing new therapies and preventative care programs to reduce mortality. GammaCoeur, when approved for use, will enhance this effort by giving primary care physicians and cardiologists a better predictive and prognosis tool for assessing patient risk.”
“We completed our Phase I grant milestone for the GammaCoeur CVD Risk Assay, the development of a working prototype in less than six months, and this success and proof of concept supported the NIH’s granting of the Phase II grant monies,” stated David F. Eastman, Gamma Therapeutics’ CEO.
According to Gamma Therapeutic executives, other patented and patent-pending products in the product pipeline include GammaSeal™, a surgical incision sealant, and Gammarin™, an anti-coagulant blood thinner for control of venous thromboembolism (VTE).
About Gamma Therapeutics, Inc.
Gamma Therapeutics is an Oregon “C” corporation and biotechnology venture start-up developing a novel class of diagnostic test and surgical therapy solutions for the cardiovascular disease industry. Gamma Therapeutics’s corporate offices and laboratory are headquartered in the Marquam II Building, 2611 SW Third Avenue, Suite 280N, Portland, Oregon 97201. For more information, go to the Gamma Therapeutics website at: www.gamma-therapeutics.com
David Eastman, CEO
(1) Framingham Heart Study: Lovely et al. ‘ Fibrinogen: Evaluation of a New Assay for Study of Associations with Cardiovascular Disease. Clinical Chemistry 2010; 56: 781-8
(2) Stockholm Coronary Artery Risk Factor Study: Mannila et al. Elevated Plasma Fibrinogen ’ Concentration Increases Risk of Myocardial Infarction: Effects of Genetic Variation in Fibrinogen Genes and Environmental Factors. Journal of Thrombosis and Haemostasis 2007; 5: 766-73
(3) Penn State University CAD Study: Lovely et al. Association of A/’ Fibrinogen Levels and Coronary Artery Disease. Thrombosis and Haemostasis 2002; 88: 26-31
™GammaCoeur, GammaSeal, Gammarin, the products, and Gamma Therapeutics, the company name, letter type and logomark, are trademarks of Gamma Therapeutics, Inc., Portland, Oregon. All Rights Reserved ©Copyright, 2010
Copyright © 2010, Gamma Therapeutics, Inc. All rights reserved.