SBIR-STTR Award

Commercial Development of Stabilized Cellular Diagnostics and Therapeutics to Lessen Logistical Burden on the Battlefield
Award last edited on: 7/3/2012

Sponsored Program
STTR
Awarding Agency
DOD : DARPA
Total Award Amount
$848,264
Award Phase
2
Solicitation Topic Code
ST031-001
Principal Investigator
Bob Moore

Company Information

Greystone Pharmaceuticals Inc (AKA: Greystone Medical Group Inc~Dermagenics ~Dermagenics Inc)

3251 Poplar Avenue Suite 200
Memphis, TN 38111

Research Institution

----------

Phase I

Contract Number: ----------
Start Date: ----    Completed: ----
Phase I year
2003
Phase I Amount
$98,294
Blood loss of over 30% is a life-threatening condition. Excessive blood loss results in hemorrhagic shock (HS), which is caused by insufficient blood perfusion to vital organs. As HS persists or as additional blood is lost, vital organs fail and the patient dies. HS causes 20% of all battlefield casualties that could otherwise be saved and, annually, 150,000 civilians in the US die from HS. In life-threatening HS incidents, infusions of whole blood must be administered, often within minutes of injury or the patient will die. An innovative solution for treating HS involves controlling striated muscle blood flow through muscular contractions that decrease the diameter of blood vessels in muscles, which account for 40% of the body's blood. We have developed an HS therapy that causes striated muscle tissue to contract, greatly reducing blood flow in these muscles and thereby increasing blood flow and pressure to vital organs, such as the brain, thereby offsetting multiple organ failure, permanent damage, and death. In preliminary tests, we induced HS in rats by severing their femoral arteries, then we applied our compound. One dose stops bleeding in minutes and extends the life of rats in severe HS from 40-50 minutes to 210+ minutes. Our HS therapy represents a new modality for treating HS and shows promise for both battlefield and civilian trauma situations where blood supplies may be limited or not immediately available. The ability to immediately stop bleeding will save thousands of lives each year, reduce overall demand on blood reserves, provide doctors with more time to operate, and increase the amount of time combat medics and EMTs have to respond to and to transport badly bleeding patients. We intend to seek FDA approval to market our HS therapy as an ethical drug in the US.

Keywords:
Battlefield Trauma, Hemorrhagic Shock, Blood Supply, Phamaceutical, Vasoconstriction, Blood Loss, Fda, Stop Bleeding

Phase II

Contract Number: ----------
Start Date: ----    Completed: ----
Phase II year
2005
Phase II Amount
$749,970
Massive blood loss is the most common cause of death in potentially survivable battlefield casualties, yet no definitive medical innovations have been made for reducing these deaths in the past several decades. It is still highly impractical to carry large volumes of refrigerated blood into battle, and substantial research for developing blood substitutes and extending the durability and portability of whole blood has not yet been successful. A practical means of addressing life-threatening hemorrhaging is still needed. Our objective is to develop and commercialize a novel binary drug therapy that serves as a temporary (3-4 hours), life-saving alternative to volume resuscitation and whole blood transfusions. Phase I proved feasibility using the rat hemorrhagic shock model. In addition to elevating low arterial pressure to vital organs, hypovolemic rats treated with the binary agents exhibited a statistically significant indication that the drug therapy has a potent “insulating” effect in protecting vital organs from the effects of advanced hemorrhagic shock. In Phase II, we will research the binary therapy’s efficacy in a pig hemorrhagic shock model, evaluate vital organ protective properties discovered in Phase I, optimize formulation and dosage, and initiate commercialization via the FDA approval process for an Orphan Drug fast-track designation.

Keywords:
Hemorrhagic Shock. Hypovolemia, Blood,Blood Loss,Wound Resuscitate,Trauma,Bleeding, Transfusion,Bloo