DIRECT TO PHASE II SBIR CONCEPT AWARD FOR NOVEL IONTOPHORETIC DRUG DELIVERY DEVICE FOR LOCAL AND EFFECTIVE TREATMENT OF ORAL CANCER

Oral cavity cancer (OCC) remains a life-threatening disease with about 12,000 deaths in the US each year.Surgery provides the best chance of survival but, unfortunately, up to half of OCC patients have recurrenttumors after first line of treatment. These patients suffer from poor quality of life due to needing salvagesurgery that impacts surrounding fragile organs. Furthermore, these patients are often ineligible foradditional systemic chemotherapy due to its toxicity. No effective treatment alternative exists for thesepatients, resulting in a dismal 5-year survival rate of 30%. Focal Medical (FM) has developed a novelmedical drug delivery device that can drive chemotherapy directly into target tumors using a method callediontophoresis. This method of drug delivery can deliver large quantities of chemotherapy directly to thetumor to promote tumor shrinkage and make oral cancer patients eligible for potentially less traumaticsurgical treatments. This work proposes the clinical development of a clinical-grade oral tumor devicethrough IND-enabling nonclinical work and builds upon safety, feasibility, and efficacy results from a pilotstudy that treated spontaneously occurring oral tumors in canines. Success of this work has the potential totransform treatment of OCC patients with recurrent tumors and increase survival rate.