Head and Neck Cancers

Head and neck cancers are those that usually begin in the cells that line the moist, mucosal surfaces inside the head and neck such as the mouth, nose and throat.  In 2018, there will be an estimated 51,540 new cases of cancers of the oropharynx, 13,150 new cases of cancer of the larynx and 17,290 new cases of cancer of the esophagus (1). Based on current data, about 20% of cancers of the esophagus are squamous in histology (2), so that the annual incidence of squamous cell carcinoma of the head and neck (HNSCC) according to this source is 68,148.

Oral mucositis (OM) is the most common side effect of radiation treatment for head and neck cancers and is characterized by painful, ulcerative lesions that occur in the oral cavity and oropharynx within 7-14 days of initiating therapy (3). A common toxicity, OM occurs in >80% of all patients undergoing radiation therapy and/or chemotherapy for HNSCC. The pain from OM can be disabling and prevents patients from eating and drinking normally, and in some cases results in interruptions or discontinuation of anticancer therapy (4). In severe cases, significant additional health care costs (up to $18,000) can be incurred, further burdening the health care system (5).

Use of BIO 300 during radiation therapy for head and neck cancers could help decrease the incidence of mucositis, oral lesions and salivary gland dysfunction, greatly increasing patient quality of life. 

Clinical Program

Planning for a randomized Phase II trial evaluating BIO 300 in head and neck cancers is currently underway.

  1. American Cancer Society. Cancer Facts & Figures 2018. Atlanta: American Cancer Society, 2018.
  2.  Absi A, Adelstein, D.J., Rice, T. Cleveland Clinic, Center for Continuing Education, Esophageal Cancer 2010. Available from: http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/hematology-oncology/esophageal-cancer/.
  3. Lalla RV, Sonis ST, Peterson DE. Management of oral mucositis in patients who have cancer. Dental clinics of North America. 2008;52(1):61-77, viii. Epub 2007/12/25. doi: 10.1016/j.cden.2007.10.002. PubMed PMID: 18154865; PMCID: PMC2266835.
  4. Sonis ST. Oral mucositis in head and neck cancer: risk, biology, and management. Am Soc Clin Oncol Educ Book. 2013;33:e236.
  5. Bonomi M, Batt K. Supportive Management of Mucositis and Metabolic Derangements in Head and Neck Cancer Patients. Cancers. 2015;7(3):1743-57. Epub 2015/09/26. doi: 10.3390/cancers7030862. PubMed PMID: 26404378; PMCID: PMC4586795.