LEXINGTON Ky. (January 8 2019) — For the first time in the United States a collaboration between the University of Kentucky and Hospital for Special Surgery has begun a pivotal clinical trial to test the effectiveness of immunotherapy for advanced non-small cell lung cancer (NSCLC) -; the third leading cause of cancer-related death in the United States.
Together with support from Kentuckys Tier 1 Cancer Center the collaboration over the past several years has helped the experimental immunotherapies to turn around tumors lost with chemotherapy.
This collaboration is the first of its kind in the nation. The outcomes are very promising and we are hopeful that these treatments will lead to many more comprehensive clinical trials said John S. Sweeney Jr. MD environmental health director for the U. S. Department of Environmental Health.
The clinical trial will evaluate the effectiveness of multiple immunotherapies currently being used to treat NSCLC patients including cotoxic chemicals and reactive oxygen radicals (ROS) -; toxic reactive molecules that frequently metastasize in NSCLC. By combining research with the University of Kentuckys National Scleroderma Foundation (NSF) Cancer Institute the trial will test the efficacy of a combination of two immunotherapies that have shown promise in both large animal models and human tumor samples.
This infusion of resources from the University of Kentuckys Scleroderma Foundation is expected to promote tumor regression in PRE-clinical mice by among other effects as well as in patients with Scleroderma with symptoms and as a possible facet of aggressive colon cancer.
As part of this trial the experimental immunotherapies are designed to keep cancer-causing pro-mutants alive and provide them with another avenue to grow. However they do so by turning off a subset of tumor-causing proteins that induce angiogenesis the process in which new blood vessels form to nourish and repair damaged tissue. By eliminating this pathway the research allows the cancer cells to die off and stop growing tumors.
The fact that together these trials give rise to large animal models human tumor samples and extensive preclinical animal testing makes this collaboration a truly unique clinical trial said S. Craig Stafford MD medical director of the University of Kentucky Scleroderma Center an adjunct professor in the Department of Medicine Ross Castle Jr. and the state director of the NSF Cancer Center.
Q: Can you tell us more about the collaboration between the University of Kentucky and Hospital for Special Surgery?
A: Together we are ramping up our efforts to train the hospital to conduct the largest-ever .. study of patients needing immunotherapy.
Q: What is this study about and why it took so long to get it started?
A: Research into the use of these kinds of therapies to treat cancers has accelerated in the past few years. Dr. Debra Binders Cancer Research UK Clear Channel Clinical Trial has been underway since 2012 and has confirmed preliminary evidence that immunotherapies such as CAR T-cell therapy which are designed to recognize and kill cancer-causing cells are effective in these cancers. Work on the clinical side of this to date has largely been conducted in the lab places where we are making our own research findings.
Q: How did you find this collaboration?
A: Our study is the first in the United States to look at the effects of immunotherapy in the NSCLC. All of the VA clinics in Kentucky have participated in this study including three of the eight study sites already in operation at the University of Kentucky. The University of Louisville in partnership with Dalton Clinic participated in the clinical trial which is the first use of their well-known CAR T-cell treatment from Kentucky.
Q: Can you tell me the name of this collaboration?
A: This collaboration is our first in the U. S. at both the National Scleroderma Foundation Clinical Trial Center and the UK. Share resources with the National Institute of Allergy and Infectious Disease (NIAID) and the U. S. Centers for Disease Control and Prevention (CDC) as well as the patients.
Q: Tell me about the statistical support you received for this trial.
A: More than 6000 patients were enrolled in the trial. The trials findings were based on drug safety data and positive or negative clinical outcomes as reported by the patients. The research team was also able to operationalize this trial by recruiting IBM Surgical Oncology a separate subsidiary of HP into the platform.
Q: What advice would you give to these patients?
A: This trial is our