FIBROPLATE INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

ABSTRACTThe threat of radiological and nuclear accidents or attacks demands for effective radiation medical countermeasuresMCMable to mitigate and treat the effects of exposure to ionizing radiationsHematopoietic acute radiation syndromeHRASand cutaneous radiation syndromeCRSpose severelife threatening risks to exposed individualsCurrently no effective radio mitigatorto be administered after radiation exposure but prior to tissue toxicity manifestationor radio therapeuticto be administered after tissue toxicity manifestationhas yet received FDA approvalIntravenous injectable Fibrinogen coated Albumin nano SpheresFASare nanometer sized spheresoriginally developed by Fibroplate to augment hemostatic functions in multiple clinical settingsPreliminary studies conducted on irradiated rodents suggested that FAS administered after ionizing radiation exposure has a unique multi valent radiation MCM potential toiaccelerate healing of ulceratednecrotic tissues arising from CRSchronic woundsiiincrease white blood cells count to counter neutropenia induced by HRASiiiaugment hemostatic functions to mitigate the effects of thrombocytopenia induced by HRASRemarkablythese studies have indicated that FAS might be able to promote mobilization of progenitor cells of various lineagesthis would explain the ability of FAS in increasing white blood cells count and promoting the coordinated developments of multiple tissuesfacilitating chronic wound healingBy taking advantage of this knowledgeFibroplateIncproposes to further investigate the efficacy of FAS as radio therapeutic for radiation skin ulcerRSUarising from CRS in a RSU rat modelif successfulFAS could be administered as a treatment only to the individuals which actually develop ulcers after exposure to high radiation dosesIn case of nuclear emergencyin facthaving a single MCM that is easy to storetransportadminister and effective both before and after the manifestation of toxicity effectswould represent a radiation MCM of tremendous efficacyIn this SBIR Phase I project we aim to accomplish two objectivesdemonstrate the efficacy of FAS as radio therapeutic for RSUFAS will be administered as a treatmenti eafter the ulcer appearsinstead of using it as a mitigation measureto confirm the mobilization of stem cells induced by FASthus allowing to delve deeper into FAS mechanism of actionin view of future IND and FDA submissionThis work will be preparatory of Phase IIwhere a complete preclinical study compliant with FDA animal efficacy rulefor determination of metabolismdose and dose schedulingwill be carried out to obtain IND and FDA licensure for FAS as a unique radio mitigator and radio therapeutic productFibroplate aims to develop FAS as a strategic newmulti valent and easy to use MCMand to target other market segments such as the one of nuclear power plants and radiotherapy patientsdemanding effective MCM to mitigate and treat effects of radiation exposure NARRATIVEThe availability of medical countermeasures able to treat radiation skin ulcers caused by cutaneous radiation syndrome is of extreme importance in case of radiological nuclear emergenciesFibrinogen coated Albumin SpheresFASis a safemulti valentbiological product with long shelf life and ease of administrationFAS can potentially become the first medical countermeasure able to both mitigate and treat multiple radiation syndromes