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 recurrent tumors after first line of treatment. These patients suffer from poor quality of life due to needing salvage surgery that impacts surrounding fragile organs. Furthermore, these patients are often ineligible for additional systemic chemotherapy due to its toxicity. No effective treatment alternative exists for these patients, resulting in a dismal 5-year survival rate of 30%. Focal Medical (FM) has developed a novel medical drug delivery device that can drive chemotherapy directly into target tumors using a method called iontophoresis. This method of drug delivery can deliver large quantities of chemotherapy directly to the tumor to promote tumor shrinkage and make oral cancer patients eligible for potentially less traumatic surgical treatments. This work proposes the clinical development of a clinical-grade oral tumor device through IND-enabling nonclinical work and builds upon safety, feasibility, and efficacy results from a pilot study that treated spontaneously occurring oral tumors in canines. Success of this work has the potential to transform treatment of OCC patients with recurrent tumors and increase survival rate. Project Number: 75N91025C00024-0-9999-1 | Fiscal Year: 2025 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: STEPHANIE HAM | Institution: CONTINUITY BIOSCIENCES, LLC, BRADENTON, FL | Award Amount: $2,995,581 | Activity Code: N44 View on NIH RePORTER: https://reporter.nih.gov/project-details/11411015