News
Gamma Therapeutics Awarded U.S. Provisional Patent
May 1, 2012

Gamma Therapeutics Awarded U.S. Provisional Patent for GammaMist Blood Clotting Bypass Device Designed to Address Hemorrhage During Combat Casualty Care.

May 1, 2012–Portland, Oregon-Gamma Therapeutics, an Oregon early-stage biotechnology venture developing solutions for cardiovascular disease risk assessment, surgical therapy and combat casualty care, announced today that the company has been awarded a U.S Provisional Patent (#61/632,696) for its novel human biocompatible GammaMist™ Blood Clotting Bypass Device designed to address warfighter hemorrhage problems and potentially reduce mortality rates during enroute medevac combat casualty care.

Hemorrhage Control #1 Priority of U.S. Military Medicine. Ever since American warfighters took to the first battlefield, U.S. military medicine has sought a solution to save warfighters from dying needlessly due to massively hemorrhaging gunshot wounds and deep penetrating injuries from projectiles, shrapnel and improvised explosive devices. These injuries create large, irregularly-shaped wounds that make adequate compression and hemorrhage control difficult. Although initially stabilized at the point-of-wound with tourniquets, hemostatic dressings and compression devices, as soon as resuscitation procedures, i.e., intravenous (IV) saline, are initiated to raise the patient’s blood pressure and stabilize their medical condition, life-threatening dilutional coagulopathy can occur. In this condition, the body’s natural clotting proteins are consumed by coagulation at the wound site or diluted by IV fluids and the result is new massive hemorrhage and, potentially, death.

GammaMist Blood Clotting Bypass Device Resupplies Clotting Factors. GammaMist uniquely “bypasses” the consumed or diluted clotting proteins by resupplying the blood with new clotting factors, including dry (lyophilized) human thrombin and human fibrinogen. These clotting factors are rehydrated with antimicrobial-infused sterile water under pressure and rapidly “sprayed” over the bleeding injury or wound to rapidly clot the blood and slow bleeding. The handheld, single use, emergency response device
allows medics to control renewed bleeding until the warfighter arrives at definitive trauma care.

GammaMist Mechanism of Action. The mechanism of human blood coagulation comprises two essential steps in the human body: (1) inactive prothrombin is converted into thrombin, and (2) the thrombin acts as an enzyme to convert fibrinogen into fibrin strands that trap platelets, blood cells and plasma to form a clot. In the case of GammaMist, the clots produced by the commercially-produced thrombin and fibrinogen are similar to a plasma clot produced naturally by the body, but may in fact, have a higher tensile strength, since concentrations of commercial fibrinogen are about 20 times higher than in the blood.

According to Dr. David H. Farrell, CSO, “The technology platform for GammaMist, like all Gamma Therapeutics products, is comprised of naturally-occurring proteins in the human body responsible for the clotting mechanism. Through the use of recombinant-protein derived or human plasma-derived proteins in place of artificial materials, such as surgical glues and resins, we can provide human biocompatible products for combat casualty care that further reduce the risk of viral infection, inflammation and other negative adverse reactions.”

Military Medics Require Rapid Response Medical Solutions. During enroute emergency care, time is of the essence and medics need a simple, readily available and rapidly deployable care solution to control massive bleeding and prevent death until the patient is evacuated to definitive trauma care. The fact is, blood management devices designed to control bleeding by quickly closing wounds, externally clotting blood or adding back in clotting factors consumed by coagulation or diluted by conditions of dilutional coagulopathy, simply do not exist today. GammaMist is designed to fill this vital enroute medical care gap.

Gamma Therapeutics hopes to complete prototype development of GammaMist by Fall, 2012 and submit an FDA pre-IDE application for the clotting bypass device by Winter, 2013. Gamma Therapeutics continues to submit extramural medical research grants to various U.S. military medicine scientific research organizations, such as the US Army’s Medical Research and Materiel Command (USAMRMC) and the Henry H. Jackson Foundation for the Advancement of Military Medicine in hopes of receiving
funding for research, development and commercialization,” states David Eastman, chief executive officer.

About Gamma Therapeutics, Inc.
Gamma Therapeutics is an Oregon early stage biotechnology venture developing solutions for cardiovascular disease risk assessment, surgical therapy and combat casualty care and currently is funded with a 3-year, $1.56 M NIH/SBIR grant. Patented and patent-pending products under development include the: GammaCoeur™ CVD Risk Assay, GammaSeal™ Surgical Incision and Wound Closure Sealant, Gammarin™ Anticoagulant Blood Thinner, GammaTF™ Warfighter Hemostatic Dressing and the GammaMist™ Clotting Bypass Device. The company is headquartered at 2611 SW Third Avenue, Suite 280N, Portland, Oregon 97201. For more information, go to:
www.gamma-therapeutics.com
Media Contact: David Eastman, CEO, deastman@gamma-therapeutics.com , 503.222.2313

™GammaSeal, GammaCoeur, Gammarin, GammaMist and GammaTF, the products and brand names, and Gamma
Therapeutics, the name & logomark, are trademarks of Gamma Therapeutics, Inc., Portland, Oregon . All Rights Reserved © 2012



Gamma Therapeutics to Present GammaCoeur CVD Risk Assay
April 17, 2012

Gamma Therapeutics to Present GammaCoeur CVD Risk Assay

Risk Assay at Premier Oak Ridge Conference in San Jose, CA, April 18 & 19.

April 17, 2012–Portland, Oregon-Gamma Therapeutics (GT), an Oregon early-stage biotechnology venture developing solutions for cardiovascular disease (CVD) risk assessment, surgical therapy and combat casualty care, announced today that Dr. David H. Farrell, Chief Scientific Officer, and Dr. Jon Oberdorf, Senior Assay Scientist will present their scientific research and product development of a novel CVD risk assay, branded GammaCoeur,™ at the 44th Annual Oak Ridge Conference in San Jose, California, April 18 & 19, 2012. Oak Ridge is the American Association for Clinical Chemistry’s (AACC) annual forum for pre-commercial, emerging clinical diagnostic technologies and is firmly established as the premier forum for next generation clinical diagnostic developers. Drs. Farrell and Oberdorf will present their abstract titled, “A Fluorescent Microsphere Immunoassay for Gamma Prime (γ’) Fibrinogen as a Novel Risk Assessment Aid for Chronic Inflammation and

Cardiovascular Risk(1).” Gamma Prime Fibrinogen is a minor splice isoform of fibrinogen that constitutes approximately 7% of total fibrinogen, and forms fibrin clots with an altered clot architecture that is resistant to fibrinolysis. Consequently, elevated levels of Gamma Prime Fibrinogen, independent of total fibrinogen, have been strongly correlated in a host of studies(2,3,4) with increased odds of cardiovascular disease, including heart attack and stroke. Although total fibrinogen tests are in use today for assessing cardiac risk, no commercially-available assay for Gamma Prime Fibrinogen exists, making the GammaCoeur CVD Risk Assay the first entry in the fast growing cardiac diagnostic test market.

According to Dr. Farrell, “We believe GammaCoeur one day will become a cardiac biomarker assay of choice for physicians, along with traditional diagnostic tests, to assist them in better predicting cardiac events and implementing preventative care programs to treat patient disease before costly drug regimens and invasive cardiac surgery are required.”

GammaCoeur CVD Risk Diagnostic Assay Platforms. Introduction of GammaCoeur as a microsphere-based immunoassay at the Oak Ridge Conference illustrates one of several diagnostic assay platforms planned for the product. GammaCoeur also is in development on an automated ELISA platform, submitted to the FDA Office of In Vitro Diagnostic Devices and Evaluation (OIVD) as part of the 510 (k) FDA medical device regulatory process and with a projected clearance date of Fall, 2012. Two other planned platforms include an automated turbidimetric assay and lateral flow assay for point-of-care devices.

About Gamma Therapeutics, Inc.

Gamma Therapeutics (GT) is an Oregon early stage biotechnology venture developing solutions for cardiovascular disease risk assessment, surgical therapy and combat casualty care and funded with a 3-year, $1.56 M NIH/SBIRgrant for the development of the GammaCoeur CVD Risk Assay. Patented and patent-pending products under development include the GammaCoeur™ CVD Risk Assay, GammaSeal™ Surgical Incision and Wound Closure Sealant, Gammarin™ Anticoagulant Blood Thinner, GammaTF™ Warfighter Hemostatic Dressing, and GammaMist™ Blood Clotting Bypass Device. The company is headquartered at: 2611 SW Third Avenue, Portland, Oregon 97201. For more information, go to: www.gamma-therapeutics.com


Media Contact:

David Eastman, CEO

deastman@gamma-therapeutics.com

503.222.2313

Oak Ridge Conference Abstract Reference:

  1. A fluorescent microsphere immunoassay for γ‘ fibrinogen as a novel risk assessment aid for chronic inflammation and cardiovascular risk. Oberdorf JA, Alexander, KS, Kazmierczak SC, Farrell DH, Gamma Therapeutics, Inc., Portland, OR, and Oregon Health & Science University, Portland, OR.

Other Noted Study References:

  1. Framingham Heart Study: Lovely et al. γ’ 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 γ’ 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 γA/γ‘ Fibrinogen Levels and Coronary Artery Disease.  Thrombosis and Haemostasis 2002; 88: 26-31


GT Signs Manufacturing Contract with ZEUS Scientific
January 31, 2012

Gamma Therapeutics Signs ELISA Immunoassay Manufacturing
Contract with New Jersey-Based ZEUS Scientific

ZEUS offers a product menu of over 130 FDA cleared immunoassays across three technology platforms

January 31, 2012—Portland, Oregon/Branchburg, New Jersey–
Gamma Therapeutics, Inc., an Oregon early stage biotechnology venture developing cardiovascular disease diagnostic tests, surgical therapy and military medicine solutions, announced today that it has signed a manufacturing contract with New Jersey-based ZEUS Scientific, Inc., one of the world’s leading manufacturers of autoimmune and infectious disease immunoassay kits and products for the clinical diagnostic industry. Initially, ZEUS will manufacture prototype ELISA kits for use in beta testing of Gamma Therapeutics’s GammaCoeur™ Cardiovascular Disease (CVD) Risk Assay currently under product development and in the pre-IDE review process at the FDA’s Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety. Longer term, ZEUS will be the preferred manufacturer for the Company’s assay kit product line. The GammaCoeur assay will be tested at selected beta test sites in the United States starting winter, 2012.

According to Scott J. Tourville, ZEUS Scientific’s President, “ZEUS prides itself on developing innovative and best-in-class products that allow our customers in the global clinical diagnostic market to provide rapid, high quality and accurate testing. We look forward to partnering with Gamma Therapeutics in manufacturing and bringing to market, once cleared by the FDA, a novel cardiac biomarker assay kit to further assist physicians in the testing and prognosis of their at-risk patients.”

First GammaCoeur CVD Risk Assay Planned on ELISA Platform. Mainstream consumer clinical diagnostic laboratories provide testing on a diversity of immunoassay platforms, including enzyme-linked immunosorbent assays (ELISA), microbead turbidimetric and lateral flow, to name a few. Gamma Therapeutics chose the ELISA format because it is the most commonly used assay in clinical diagnostic and research labs. ELISA kits are manufactured and tested on manual, semi-automated and automated platforms. However, automated platforms are more common and the first selected platform for the GammaCoeur assay. Once cleared by the FDA and employed in clinical diagnostic lab tests, the GammaCoeur assay will provide physicians with a cardiac risk score that complements other traditional cardiac biomarkers and will assist them in their prognosis and patient management. New health care reform laws place a higher premium on diagnostic testing and preventative care medicine to avoid costly long term drug treatment regimens and invasive cardiac surgery.  Gamma Therapeutics supports this initiative.

“On behalf of Dr. David H. Farrell, our Founder and Chief Scientific Officer, Gamma Therapeutics looks forward to a long and mutually beneficial relationship with its new manufacturing partner, ZEUS Scientific. One aspect that makes the relationship particularly appealing to the company is the global nature of ZEUS’s business, its vast product portfolio, its distribution network and its long-term experience in bringing highly successful and profitable immunoassays to market, “ commented David F. Eastman, chief executive officer.

About Gamma Therapeutics, Inc.
Gamma Therapeutics is an early stage biotechnology venture developing several patented and patent-pending products including the GammaCoeur™ CVD Risk Assay for diagnostic testing of cardiac at-risk patients; the Gammarin™ Anticoagulant Blood Thinner for control of venous thromboembolism during and after surgery; the GammaSeal™ Surgical Incision and Wound Closure Sealant for trauma surgery, wound repair and tissue regeneration; and, the GammaTF™ Warfighter Hemostatic Dressing for fast clotting of massively bleeding wounds and injuries. All Gamma Therapeutics’s products are based upon human compatible proteins responsible for the clotting mechanism in blood.  Gamma Therapeutics’s corporate offices and laboratory are headquartered at 2611 SW Third Avenue, Suite 280N, Portland, Oregon 97201 USA. For more information visit: www.gamma-therapeutics.com

About ZEUS Scientific
ZEUS Scientific has over 35 years of experience in developing, manufacturing and marketing in vitro diagnostic laboratory tests. No other company offers the breadth and depth of products across both autoimmune disease and infectious serology testing, across three methodologies: IFA, ELISA and multiplex (AtheNA Multi-Lyte®). ZEUS Scientific is based in Branchburg, New Jersey and markets test systems around the globe through an extensive distribution network. ZEUS Scientific complies with the international standard ISO 13485 (2003), Health Canada Medical Device Regulations (SOR/98-282, May 7 1998), the FDA Quality System Regulations (FDA Quality System Regulation, 1996: 21 CFR § 820), and the IVD 98/79/EEC. For more information visit: www.zeusscientific.com.

Media Contact:  deastman@gamma-therapeutics.com, 503.222.2313
™GammaSeal, GammaCoeur, Gammarin, and GammaTF, the products and brands, and Gamma Therapeutics, the company name  and logo, are trademarks of  GammaTherapeutics, Inc., Portland, Oregon. All Rights Reserved ©Copyright, 2012

™ZEUS IFA, ZEUS ELISA and the company name and logo are trademarks of ZEUS Scientific, Inc., Branchburg, New Jersey,  All Rights Reserved © Copyright 2012

®AtheNA Multi-Lyte is a registered trademark of ZEUS Scientific, Inc. Branchburg, NJ



Gamma Therapeutics, One of Oregon’s Leading Early Stage Ventures
October 18, 2011

Gamma Therapeutics Named One of Oregon’s Leading Early Stage Development Ventures by Oregon Entrepreneur and Investment Community

October 18, 2011–Portland, Oregon-Gamma Therapeutics, Inc., an Oregon biotechnology venture developing cardiovascular disease diagnostic tests, surgical therapy and military medicine solutions, announced today that it was named a Finalist in the Oregon Entrepreneur Network’s (OEN) 18th Annual Tom Holce Entrepreneurship Awards honoring venture companies. For the past 18 years, Oregon entrepreneurs, business leaders and the investment community have honored the work of venture start-ups and growth companies by recognizing the work of founders and executives in growing their companies. Tom Holce, a pioneering Oregon technology entrepreneur and business leader believed strongly in the entrepreneurial spirit. Upon his death in 2010, the OEN established the Tom Holce Entrepreneurship Awards, which honor Oregon companies in the categories of Development Stage, Working Capital Stage and Growth Stage. Nine Oregon companies, including Gamma Therapeutics, were awarded entrepreneurship honors in these categories.

According to Brenda Meltebeke, of Portland’s Ater Wynne Law Firm and chair of the 2011 OEN Tom Holce Awards, “It’s been a challenging year for companies given the economy. The finalists for the OEN Tom Holce Entrepreneurship Awards demonstrate the creativity and determination required of businesses to succeed in the face of such odds.”

Gamma Therapeutics Honored as Development Stage Venture. Incorporated in 2009 and launched in 2010 with a $1.5 M National Institutes of Health (NIH) Small Business Innovation Research Grant (SBIR), Gamma Therapeutics’s flagship product, the GammaCoeur™ CVD Risk Assay, is a novel cardiac biomarker that gives physicians a better predictive and prognostic tool for assessing heart attack and stroke risk in their patients. New health care reform laws are placing a higher premium on diagnostic testing and preventative care medicine to avoid costly drug treatment regimens and invasive cardiac surgery.  Gamma Therapeutics supports this initiative. In September, Gamma Therapeutics presented its GammaCoeur Assay to the FDA’s Office of InVitro Diagnostic Devices (OIVD) and, after completion of BETA testing in the Winter, 2012, the company hopes to receive FDA clearance in late 2012 to launch sales of the product to clinical diagnostic laboratories.

“On behalf of Dr. David H. Farrell, our Founder and Chief Scientific Officer, Gamma Therapeutics is honored to be recognized as a fast growing and successful Oregon venture developing innovative products based upon human compatible proteins,“ commented David F. Eastman, chief executive officer. “Dr. Farrell and I are passionate about bringing new medical devices to market that will enhance healthcare delivery and the quality of life for thousands of people who are at risk of cardiac disease or undergoing surgical therapy.”

In addition to the GammaCoeur CVD Risk Assay, Gamma Therapeutics is developing two patented products for surgical therapy applications: GammaSeal™, a high tensile strength, biocompatible surgical  sealant to assist surgeons in trauma surgery, wound repair and tissue regeneration, and; Gammarin™, a short-acting, non-immunogenic, anti-coagulant blood thinner for control of venous thromboembolism during and after surgery. In addition, Gamma Therapeutics is developing GammaTF™, a new patent-pending fast-clotting hemostatic dressing to address warfighter hemorrhaging problems on the battlefield.

About Gamma Therapeutics, Inc.

Gamma Therapeutics is an early stage biotechnology venture developing a novel class of CVD diagnostic risk assays, anticoagulant blood thinners, hemostatic dressings and trauma surgery solutions based upon natural human proteins responsible for the clotting mechanisms in blood.  Gamma Therapeutics’ corporate offices and laboratory are headquartered at 2611 SW Third Avenue, Suite 280N, Portland, Oregon 97201. For more information, go to the website at: www.gamma-therapeutics.com

About Oregon Entrepreneurs Network

Founded in 1991, celebrating 20 years of service to entrepreneurs, the Oregon Entrepreneurs Network (OEN) is a 501c3 non-profit corporation and the largest entrepreneur assistance organization in Oregon and Southwest Washington. OEN fosters the flow of entrepreneurial ideas, services, and capital to entrepreneurs and helps connect emerging Northwest businesses to growth-stimulating expertise and valuable resources.  OEN is a people-oriented network that helps cultivate, nurture and develop emerging businesses and entrepreneurs. OEN offers business education, access to capital networks, support and contacts who can mentor and nurture startup companies’ growth and development. For more information on OEN and its programs visit www.oen.org.

Media Contacts:

David Eastman, CEO
deastman@gamma-therapeutics.com
503.222.2313



Gamma Therapeutics’s Founder Awarded U.S. Patent
July 7, 2011

Gamma Therapeutics’s Founder Awarded U.S. Patent for Novel GammaSeal Surgical Incision and Wound Closure Sealant

July 7, 2011–Portland, Oregon-Gamma Therapeutics, Inc., an Oregon early stage biotechnology venture developing CVD diagnostic tests, surgical therapy and military medicine solutions, announced today that its founder, Dr. David H. Farrell, has been awarded a full U.S Patent (#11/955,080) for its novel GammaSeal™ Surgical Incision and Wound Closure Sealant. GammaSeal is in product development by Gamma Therapeutics under an exclusive license from the Oregon Health & Science University in Portland, Oregon. GammaSeal is comprised of a naturally occurring protein in blood called Gamma Prime Fibrinogen, and when combined with human thrombin is designed to be a more biocompatible, structurally stronger sealant than commercially-available sealants on the market today. After FDA approval, customers for the sealant will include physicians and surgeons in trauma, vascular, organ and cosmetic surgery, emergency response and combat casualty care.

Closure Devices are Problematic. Closure methods in use today employ stitches, staples, bandages and sealants generally made of glues and other artificial adhesives, with the goal of stemming the flow of blood and sealing the incision or wound long enough for natural clotting and tissue regeneration to begin. Affected areas are normally weak for a long period of time, not reaching pre-injury or surgery strength for 6-8 weeks. Some injectable or spray-on-sealants degrade quickly following enzymatic breakdown by the body while others have potentially serious contraindications.

According to Dr. Farrell, Founder and CSO of Gamma Therapeutics, “The stronger fibers and degradation-resistant features of GammaSeal offer a range of benefits that set it apart from other sealants, including a high level of structural strength and the ability to withstand increased blood flows at the wound or surgical site. More importantly, its biocompatibility with the human body allows for strong site integrity, natural healing and regeneration of tissue without the contraindications seen with artificial sealant materials”.

GammaSeal Employs Recombinant Biologic Materials. Like all Gamma Therapeutics’ products, GammaSeal is based upon a natural clotting protein in human blood called Gamma Prime (γ’) Fibrinogen. Gamma Prime Fibrinogen has several biochemical and biophysical properties that distinguish it from more common γA isoform. Clots made from fibrinogen containing gamma prime chains in the presence of factor XIIIa, a key factor in the body’s clotting mechanism, are highly resistant to breakdown. The gamma prime chain contains a binding site for thrombin and the fibers themselves are thinner, but denser and structurally stronger than normal fibrinogen. GammaSeal will be delivered as a medical device, comprised of a two-part syringe applicator employing a recombinant Gamma Prime Fibrinogen sealant and a recombinant human thrombin catalyst, allowing for the sealant to be sprayed or dripped onto trauma wounds, surgical incisions or damaged internal organs for closure, healing and tissue regeneration.

Global Industry Analysts, Inc., (GIA) a life science and biotechnology analyst firm, reports that the global surgical incision closures market is expected to exceed US $7.7 Billion by 2015, driven by the steady rise in surgical procedures, particularly in developing countries. GIA further stated that, “advanced wound closure technologies, which include tissue sealants, hemostats, adhesives and adhesion prevention products are anticipated to generate attractive business opportunities due to enhanced safety provided by these products”.

“Gamma Therapeutics hopes to complete prototype development of GammaSeal over the Summer, 2011, submit a premarket application to the FDA and then begin preclinical testing in the late Fall,” states Chief Executive Officer David Eastman,“GammaSeal already has received early interest from a leading pharmaceutical company, and the U.S. military sees applications for it in combat casualty care when warfighters are transferred to definitive surgical care”.

Other patented and patent-pending products under development at Gamma Therapeutics include: GammaCoeur™, a CVD risk diagnostic assay; Gammarin™, an anti-coagulant blood thinner for control of venous thromboembolism (VTE), and; GammaTF™, a new fast-clotting hemostatic dressing for emergency response.

About Gamma Therapeutics, Inc.

Gamma Therapeutics is an early stage biotechnology venture developing a novel class of CVD diagnostic risk assays, anticoagulant blood thinners, hemostatic dressings and trauma surgery solutions based upon natural human proteins responsible for the clotting mechanisms in blood. Gamma Therapeutics’ corporate offices and laboratory are headquartered at 2611 SW Third Avenue, Suite 280N, Portland, Oregon 97201. For more information, go to the website at: www.gamma-therapeutics.com

Media Contacts:

David Eastman, CEO
deastman@gamma-therapeutics.com
503.222.2313



Copyright © 2010, Gamma Therapeutics, Inc. All rights reserved.