Non-Invasive Intraoral LED Phototherapy Device for the Prevention and Treatment of Oral Mucositis

Information

  • Research Project
  • 9784787
  • ApplicationId
    9784787
  • Core Project Number
    R44DE026082
  • Full Project Number
    5R44DE026082-03
  • Serial Number
    026082
  • FOA Number
    PA-17-302
  • Sub Project Id
  • Project Start Date
    4/1/2016 - 8 years ago
  • Project End Date
    8/31/2020 - 3 years ago
  • Program Officer Name
    GANNOT, GALLYA
  • Budget Start Date
    9/1/2019 - 4 years ago
  • Budget End Date
    8/31/2020 - 3 years ago
  • Fiscal Year
    2019
  • Support Year
    03
  • Suffix
  • Award Notice Date
    9/16/2019 - 4 years ago
Organizations

Non-Invasive Intraoral LED Phototherapy Device for the Prevention and Treatment of Oral Mucositis

PROJECT SUMMARY/ABSTRACT 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.

IC Name
NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
  • Activity
    R44
  • Administering IC
    DE
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    819095
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    121
  • Ed Inst. Type
  • Funding ICs
    NIDCR:819095\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    LUMITEX, INC.
  • Organization Department
  • Organization DUNS
    108631797
  • Organization City
    STRONGSVILLE
  • Organization State
    OH
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    441361759
  • Organization District
    UNITED STATES