Time filter

Source Type

GALVESTON, TX, United States

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.00M | Year: 2016

DESCRIPTION provided by applicant With increasing risk of a nuclear accident or detonation there is a critical need to develop effective medicinal countermeasures that can be delivered to victims after an incident to increase survival and prevent long term effects in those that survive Major causes of death following a nuclear incident include acute radiation syndromes ARS that destroy hematopoietic stem cells H ARS gastrointestinal stem cells in the crypts GI ARS or both We have developed a unique regenerative peptide drug TP rusalatide acetate that mitigates effects of radiation by restoring endothelial function and activating stem cells Phase and Phase studies demonstrated that TP significantly increases survival and delays mortality when injected h after lethal doses of gamma radiation In these studies TP increased recovery of bone marrow stem cells and stem cells in intestinal and colonic crypts to maintain GI integrity Our studies also showed that TP systemic injection activates stem cells in the dermis of irradiated animals adjacent to burns and accelerates healing and re epithelization of the burned dermal area These life saving effects of TP therefore appear to be mediated through the protection activation of stem cells or endothelial cells that maintain the stem cell niche Thus in addition to mitigating effects of H ARS and GI ARS TP may have widespread benefit to prevent delayed effects of radiation by stimulating tissue regeneration To obtain FDA andquot animal ruleandapos licensure for TP we will complete steps necessary for approval employing the established regulatory pathway and animal models for H ARS Specific Aims for Phase b are designed to utilize animal studies that will allow us to predict the most efficacious dose of TP to be used in humans following a nuclear incident We will establish optimal TP doses in two strains of mice and conduct GLP PK PD studies in normal and irradiated mice to determine the required systemic bioavailability for maximum efficacy Since most exposed individuals will receive supportive care following exposure we will also determine how supportive care of our animals will affect TP mitigation of radiation induced mortality Although we have information regarding TP effects additional experiments will be used to confirm the key cellular targets and modes of action These studies will include experiments with normal and eNOS mice using established assays to quantify TP effects on hematopoietic cell recovery DNA repair endothelial cell protection and stem cell activation For FDA approval large animal studies predictive of human efficacy must also be completed The large animal andquot gold standardandquot for H ARS drugs is demonstration of increased survival of irradiated non human primates NHP Therefore we will conduct GLP PK PD studies and a pilot efficacy study in NHP using the same formulation and route of administration that will be used in humans Completion of this Phase B project will position TP for pivotal NHP blinded efficacy studies needed for licensure and potential stockpiling of the drug to save thousands of lives in the event of a nuclear disaster PUBLIC HEALTH RELEVANCE We have demonstrated that the regenerative thrombin peptide drug TP significantly increases survival and delays mortality when given as a single injection h after nuclear radiation exposures that cause hematopoietic and gastrointestinal toxicity In these studies TP increases recovery of bone marrow stem cells and stem cells in intestinal and colonic crypts to maintain GI integrity and prevent barrier breakdown that leads to sepsis and death In this project we will conduct studies necessary for FDA approval of TP as a nuclear countermeasure to be used in the event of a nuclear accident or detonation

Chrysalis Biotherapeutics, Inc. | Entity website

The Chrysalin Solution to PreventRadiation Therapy-Induced Tissue Damage Prescriptive Use To Prevent Radiotherapy Damage To Normal Tissue and Allow More Effective Cancer Therapy Almost 70% of all patients with cancer receive radiotherapy alone or in combination with surgery or chemotherapy. The amount of radiation that can be used to control tumor growth, however, is limited by normal tissue damage ...

Chrysalis Biotherapeutics, Inc. | Entity website

ABOUT CHRYSALIS BIOTHERAPEUTICS ChrysalisBioTherapeutics, Inc.is a privately held biopharmaceutical company developing regenerative drugs that mimic the bodys natural signals to activate and protect endothelial progenitor cells and stem cells located within tissues to repair and regenerate tissues damaged by injury, disease, and radiation exposure ...

Chrysalis Biotherapeutics, Inc. | Entity website

The Chrysalin Solution forCardiovascularDisease Cardiovascular disease is the single largest killer of Americans, claiming the lives of almost one million people annually (American Heart Association). Approximately 55% of these deaths are related to coronary heart disease, which includes acute myocardial infarction (heart attack), angina, atherosclerotic cardiovascular disease, and all other forms of chronic ischemic heart disease ...

Chrysalis Biotherapeutics, Inc. | Entity website

Chrysalis BioTherapeutics, Inc. is a privately held biopharmaceutical development company working to save lives and improve lifes quality ...

Discover hidden collaborations