Allander Biotechnologies — Department of Health and Human Services SBIR Phase II: NIDCR

Description

SUMMARY Chronic skin wounds associated with various diseasese gdiabetesand aberrant healing from acute woundinge ghypertrophic scarringare a major health care burdenThis health burden increases in aging populationsThe cost to treat these conditions exceeds $billion annuallyCurrentlyREGRANEXa cream containing a biologic based on human PDGFPlatelet Derived Growth Factoris the only FDAFood and Drug Administrationapproved biologic to treat diabetic woundsHoweverthe combination of its modest effect on healing and a black box warning added by the FDA for its cancer risk have not translated its drug efficacy to clinical benefitThese facts highlight the sense of urgency for scientific discovery based therapeutic interventionsAllander Biotechnologies is developing proprietary topically applied biologics to promote wound healingDuring the Phase I funding period of this grantwe have tested several biologics and identified our lead biologic to be further developed in this Phase II applicationOur Phase I studies revealed that our biologic has multiple functions needed for wound healingOur Phase II studies will focus on the process of formulation development for our biologic to be used as a topical drugand data production that will lead us to a successful path for filing an Investigational New DrugINDapplication to the FDAWe will perform pre formulation studies for solubility as well as stability of physicochemical characterizations and bioactivities of our drug substanceWe will use data generated from pre formulation studies to guide our formulation prototype developmentWe will produce our biologic at pharmaceutical grade purity and use it as well as the lead formulation sto treat diabetic mouse wounds and pig excisional wounds for efficacy studies to define pharmacodynamicsPDbiomarkers and identify potential acute cutaneous systemic toxicitiesBy the end of this Phase II fundingwe will have stability and physicochemical profiles of our biologicthe lead formulationPD biomarkersand protocolsanalyticalbioassayand toxicologystandardized for generating additional IND data under Good Laboratory Practice conditions NARRATIVE Chronic skin wounds in diabetic patients and the elderlyaffectmillion people in the United StatesThis application aims to develop a novel biologic that can treat chronic and acute skin wounds by topical application to alleviate immediate suffering caused by skin wounds and prevent long term wound related sequelaesuch as permanent tissue organ loss or scarring