Early Detection of Head and Neck Squamous Cell Carcinoma (HNSCC)
Elizabeth Franzmann, Vinata Lokeshwar, Erika Reategui and Rakesh Sihgal
Problem
There are currently 56 million smokers and 15 million alcohol abusers in the U.S and significantly more worldwide. Early detection of HNSCC can lead to a satisfactory cure while late detection leads to serious surgery, radiation and chemotherapy and potential disfigurement and dysfunction and mortality. The prognosis for stage I and II disease survival is 60-80%. For advanced disease, 50% will relapse in the first year of treatment and then life expectancy is generally 6-7 months.
Solution
This invention is a simple, low cost, saliva based test (ELISA) incorporating a panel of four biomarkers that can detect early stage HNSCC and very early pre-cancerous lesions. At this early stage, the cancer or pre-cancer is treatable or reversible. The complete biomarker panel has 93% sensitivity and 75% specificity.
Competitive Advantage
This early detection panel of biomarkers is simple and low cost, detecting cancer without visual examination of the patient by a primary care provider or dentist.
Applications
This early detection test could be used to test all patients that smoke, use alcohol or have a family history of HNSCC to detect cancer before invasive disease develops. In addition, the test could be used to monitor the results of therapy and watch for recurrence. This test could change the cure rates from 50% to 80% or better if pre-cancerous lesions are detected. This test will be given by practitioners in family medicine, internal medicine, oncology, and dentistry.
Patent Status
U.S. Patent Application US20050214880 A1 entitled "Soluble CD44: A Potential Molecular Marker for Head and Neck Cancer" was published September 29, 2005.
PCT Patent Application counterpart WO2007133725 entitled "Biomarkers for Detection and Diagnosis of Head and Neck Squamous Cell Carcinoma" was published on November 22, 2007.
International Patent Application PCT/US2007/020339 entitled "Hypermethylation of CD44 Promoter in Head and Neck Squamous Cell Carcinoma" filed September 19, 2007.
Licensing Opportunity
We are seeking a collaborative partnership for product development and commercialization of this novel, simple, safe, low cost solution to early detection of head and neck cancer.
About the Inventors
Elizabeth Franzmann, M.D, is an Assistant Professor of Otolaryngology and Board Certified in Otolaryngology. She has a surgical practice and a basic research laboratory and is a recognized expert in biomarkers for head and neck cancer. Dr. Franzmann is a graduate of UCLA Medical School. Vinata Lokeshwar, M.D., is an Associate Professor of Urology and Cell Biology and Anatomy and an internationally recognized expert in tumor biology with special emphasis on mechanisms of tumor proliferation, apoptosis, and metastases and treatment modalities involving matrix molecules. Her laboratory was the first to link HAase to tumor biology, to establish the diagnostic and prognostic potential of HAase in a variety of carcinomas, and also to identify the first tumor-derived HAase.
In 2004-2006, Dr. Lokeshwar served as the Chair of the "International Panel on Cytology and Bladder Tumor Markers," under the project: International Bladder Cancer Consensus, which was supported by several international organizations. She has authored several peer-reviewed and review articles on tumor markers, hyaluronic acid and hyaluronidase. For the last ten years her research on experimental therapeutics related to HAase inhibitors and also tumor markers is funded by grants from the National Institutes of Health.
Selected References
Reategui EP, de Mayolo AA, Das PM, Astor FC, Singal R, Hamilton KL, Goodwin WJ, Carraway KL, Franzmann EJ., Characterization of CD44v3-Containing Isoforms in Head and Neck Cancer, Cancer Biol Ther. 2006 Sep;5(9):1163-8.
Franzmann EJ, Reategui EP, Carraway KL, Hamilton KL, Weed DT, Goodwin WJ., Salivary soluble CD44: a potential molecular marker for head and neck cancer, Cancer Epidemiol Biomarkers Prev. 2005 Mar;14(3):735-9.
Franzmann EJ, Schroeder GL, Goodwin WJ, Weed DT, Fisher P, Lokeshwar VB., Expression of tumor markers hyaluronic acid and hyaluronidase (HYAL1) in head and neck tumors, Int J Cancer. 2003 Sep 1;106(3):438-45.
