The goal of this SBIR is to create a novel phototherapeutic light delivery device which will advance the standard of care for the prevention and treatment of Oral Mucositis (OM). OM is one of the most common and highly significant toxicities of cancer therapy. Approximately 375,000 patients are affected by OM in the United States each year. OM is an extremely painful condition which breaks down the lining of the mouth and is associated with increased treatment breaks, increased 100-day mortality and a considerable increase in healthcare costs. The standard of care for patients with OM is mainly palliative, aiming to reduce pain, inflammation, and risk of infection. A new and proven approach for treatment and prevention of OM is Photobiomodulation (PBM) Therapy. Specific dosages of red light demonstrate increased production of ATP which protects the mucosa from cell death. Current barriers to the use of PBM Therapy include the cost of laser equipment, labor intensiveness, inter-operator variability, and lack of dose control. As the result of the successful completion of the Phase I grant, Lumitex developed the OralGlo?, a flexible, biocompatible silicone light guide to irradiate OM-susceptible regions of the oral mucosa with therapeutic light. The key innovation is the simultaneous irradiation of the entire oral cavity with minimal clinical supervision while significantly increasing patient comfort. Our light delivery technology can be integrated into a mouthpiece that safely delivers 2-10 J/cm2 of light directly to the oral mucosa in under ten minutes. To complete the preclinical validation of the OraGlo, we created these aims:
Aim 1 : Incorporate design refinements and validate performance. Completion of this aim will result in 32 devices that have +/-20% uniformity to all targeted delivery zones and certification to applicable safety standards.
Aim 2 : Perform a dose- escalation study in vitro to determine the optimal therapeutic dosage range. Successful completion of this aim will result in the determination for the maximum dosage before cell death occurs and determine the dosage for peak cellular response.
Aim 3 : Confirm no tumor progression due to LED PBM therapy in a mouse model. A study of mice implanted with squamous cell carcinomas and undergoing PBM therapy will be conducted. Completion of this aim will result in no statistically significant increase in tumor growth rate associated with our device compared to control. Upon completion of Phase II, we will successfully have refined and validated a phototherapeutic mouthpiece capable of delivering the therapeutic light dosage in an effective, controlled manner. Next steps will be to conduct clinical studies using the OraGlo in Head and Neck cancer patients. The long term goal for the product is to shift the paradigm for OM management from palliative, to treatment and prevention. This technology would be the first PBM product approached for treatment, enabling many new light-based wound healing applications.
In this Phase II SBIR, Lumitex plans to refine and preclinically validate the performance of an intraoral phototherapeutic device for the treatment and prevention of Oral Mucositis. Oral Mucositis is one of the most severe and debilitating side-effects of chemo- and radio-therapy affecting more than 375,000 people annually and can often prevent patients from eating, sleeping, or speaking, thus lowering their quality of life. We expect our non-invasive device can provide a safe, effective and tolerable treatment to eliminate this serious side-effect.
