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HLS Potent novel inhibitor of fibrinolytic hemorrhage

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL137514-01
Agency Tracking Number: R43HL137514
Amount: $351,119.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-04-05
Award End Date (Contract End Date): 2018-08-14
Small Business Information
Memphis, TN 38112-5410
United States
DUNS: 803592364
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (901) 921-5569
Business Contact
Phone: (617) 710-3979
Research Institution

This SBIR Application is responsive to NHLBI Small Business Topics of Special Interest
therapeutics that are of high programmatic interest HL
Hemorrhage or bleeding is a serious or fatal complication of surgery Antifibrinolytic agents that inhibit
plasmin mediated fibrinolysis can significantly reduce blood loss emergency reoperation morbidity
and death in patients with severe hemorrhage Antifibrinolytic agents have been reported to have
value in cardiac surgery orthopedic surgery liver transplantation vascular surgery thoracic surgery
gynecological surgery end stage renal disease peripartum bleeding gastrointestinal bleeding
prostate surgery neurosurgery trauma traumatic brain injury intracerebral bleeding and
subarachnoid hemorrhage However current antifibrinolytic agents have properties that limit their
efficacy and may cause serious complications including low potency poor specificity accumulation
in renal disease and penetration of the blood brain barrier and placenta Safer more specific and
potent antifibrinolytic agents may prevent thousands of deaths per year
To address this need Translational Sciences Inc seeks to produce a safe high affinity ultra
specific antifibrinolytic monoclonal antibody as the first new agent to treat severe hemorrhage in
more than years This novel antifibrinolytic acts as a non competitive inhibitor and has greater
specificity and potency than any known agent It blocks fibrinolysis in human plasma with several
thousand fold greater potency than the currently used small molecule antifibrinolytic agents such as
epsilon amino caproic acid EACA or tranexamic acid As a monoclonal antibody this antifibrinolytic
is unlikely to cross the blood brain barrier which avoids the risk of seizures associated with
tranexamic acid Also unlike tranexamic acid or EACA this agent will not significantly cross the
placenta making it a more attractive agent for use in severe pregnancy associated hemorrhage As
a monoclonal antibody this agent will not be excreted by the kidney making it a safer agent than
tranexamic acid or EACA to use in patients that have or are at risk for kidney disease By virtue of its
exquisite potency and specificity this antifibrinolytic agent has extraordinary potential for improving
the treatment of severe and fatal bleeding We project that by comparison to currently available
agents this novel antifibrinolytic will significantly reduce the need for transfusions reoperations and
mortality in bleeding patients without serious adverse events The goal of this Phase I proposal is to
follow FDA guidance to convert this potent monoclonal antibody into a humanized first in class
antifibrinolytic for the treatment of severe human hemorrhage Fibrinolysis contributes to severe and fatal hemorrhage in surgery and many other conditions Current
inhibitors of fibrinolysis are weak and lack specificity which limits their efficacy and causes serious
complications We are developing an ultra specific high potency anti fibrinolytic agent as a more effective
therapy to reduce blood loss and mortality in patients with severe hemorrhage

* Information listed above is at the time of submission. *

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