The Need

Oral cancer affects nearly 50,000 Americans each year and has a five year survival rate of 57%. Often, oral cancer is only discovered when it has metastasized, as it does not present recognizable symptoms, and it has a high risk of producing secondary tumors. Oral squamous cell carcinoma (OSCC), a particularly malignant subset, is one of the most challenging to treat and over 35% of patients with OSCC die from local recurrence.

Treatment of oral cancers typically include chemotherapy and radiation, although some tumors can be surgically excised. Patients with precursor lesions are at high risk for transformation to OSCC and multiple biopsies are required to check patients, resulting in a large economic burden to patients. Following treatment, patients may have disfigurements requiring additional surgery to correct, further exacerbating issues and costs for these diseases.

In order to target these cancers before symptoms arise, physicians have been developing local delivery chemopreventive methods to target clinically evident premalignant lesions. However, some lesions are not easily visualized and current treatment protocols and methods are inefficient for clinically unseen developing premalignant lesions throughout the mouth. Therefore, development of new, efficacious, and well-tolerated chemopreventive is needed for improved outcomes of oral cancer diagnoses and to reduce socioeconomic burdens on patients.

The Technology

Researchers at The Ohio State University, led by Dr. Susan Mallery, have developed novel controlled-release nanoparticles capable of providing on-demand chemopreventive agents to increase the efficiency of the chemopreventive rinse treatments. These agents, derived from black raspberries, a synthetic vitamin A analogue, N-acetylcystein, and an anti-interleukin 6 (IL-6) agent, are loaded onto Janus particles for delivery concurrently. Two of these agents may be utilized at one time, although additional components such as a mucoadhesive or mucous penetration enhancer may also be added. The target for the chemopreventive agents is the epithelia lining of the oral cavity, with broad exposure to the entire area, rather than a targeted delivery. By utilizing Janus nanoparticles loaded with chemopreventive agents, oral lesions will be exposed to the drugs, and therapeutically relevant drugs will be delivered to treatment sites without systemic side effects.

Commercial Applications

• Treatment and prevention of oral squamous cell carcinoma and other oral cancers
• Prevent or treat OSCC progression or recurrence
• Prevent progression of or recurrence of periodontal disease arising from necrotizing tissue, gingivitis, gum recession, and other diseases

Benefits/Advantages

• Dual delivery of two different chemopreventives
• Coverage of the entirety of the mouth more efficiently
• Reduced systemic side effects
• No drug inactivation due to liver metabolism
• Local administration of therapeutic requires a lower dosage

Patent Status

• PCT issued in US and pending in Australia, China, & Europe.