Topical proprietary biologic to treat oral mucositis

Summary Oral mucositisa severe oral ulcerationis a common toxic effect of radioor chemoradio therapy and a limiting factor to using the maximum dose of radiation for effective cancer treatmentAt leastand up toof cancer patients treated with standard chemotherapy regimens or upper body radiation develop oral mucositisIntensity modulated RTIMRTlessens chronic side effectsbut not the acute toxicity seen in oral mucosaThe new Stereotactic Body RTSBRTthat directs RT to the tumor mass should reduce oral mucositisbut this will not apply to patients who need chemotherapiestargeted therapiesor conventional RTThe immunotherapy is gaining momentum for cancer therapybut oral mucositis appears to occur more often with immunotherapyTo datePalifermina protein derived from keratinocyte growth factoris the only targeted therapy approved by the Food and Drug AdministrationFDAfor preventing oral mucositis in patients with hematopoietic malignancy followed by bone marrow transplantof the at risk populationbut it has no effect on existing mucositisAllander Biotechnologies has developed a proprietary biologic that shows prophylactic and therapeutic effects on radiation induced oral mucositis in mice upon topical application to oral mucosaOur biologic possesses multiple functions needed for oral mucositis healingIn the Phase I funding period of this grantwe have developed the biologic production system and demonstrated that treating mice with this biologic alleviated radiotherapy induced oral mucositis but did not compromise its killing of adjacent oral cancerIn this Phase II applicationwe will establish the scale up process and quality controls for manufacturing our biologicWe will generate efficacy data to optimize pharmacodynamicsPDbiomarkersWe will generate preliminary toxicity data to design pharmacokineticsPKand toxicology studies required for filing an Investigational New DrugINDapplicationBy the end of Phase II fundingwe will have established manufacturing procedures for our biologic and protocolsanalyticalbioassayPK and toxicologyready for generating additional IND data under Good Laboratory PracticeGLPconditions