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The Spirit of Leonardo Award


The Spirit of Leonardo Award
For Lee B. Riley, MD, PhD
St. Luke’s Hospital & Health Network

Leonardo da Vinci has been described as a man well beyond his time who had a unique way of looking at the world. Historians tell us he had a keen eye and a quick mind which allowed him to make important scientific discoveries. In many ways Dr. Lee Riley and his current research to develop a vaccine to treat malignant tumors is much like Leonardo da Vinci.

Since 2001 Dr. Lee Riley, Surgical Oncologist and Medical Director at St. Luke’s Cancer Center, has been conducting research on a vaccine concept against solid malignant tumors. Effective tumor vaccines require two main components: a specific target (antigen) that distinguishes the tumor from normal cells and a material (adjuvant) that recruits sufficient immunologic help to eradicate the target antigen. Early vaccines against bacterial or viral pathogens were effective in part because the pathogens expressed numerous antigens that easily distinguished them from normal human tissues. In contrast human tumor cells display only a limited number of differences from their normal cellular counterparts. These tumor antigens typically arise from inappropriate expression of normal proteins or from the production of mutated proteins.

In 2002 Dr. Riley successfully completed a small clinical trial to demonstrate the proof of principle for the vaccine. Currently he is conducting two clinical trials to evaluate the safety and effectiveness of the vaccine. The first trial evaluates the safety of granulocyte macrophage colony stimulating factor (GM-CSF) in conjunction with radiofrequency ablation in patients who have metastatic cancer to their liver. The second trial evaluates the safety and effectiveness of radiofrequency ablation with intralesionsal GMCSF followed by high dose intrerleukin-2 in patients with unresectable stage IIIC and IV malignant melanoma.

Early results of both trials indicate that this approach is safe and has produced encouraging results. Next steps include introducing a third trial. This trial is currently undergoing committee review and will evaluate RFA/GMCSF in patients with early, but invasive breast cancer. Presently, RFA is being used to treat breast, lung, liver and renal tumors. Current results suggest that the clinical applications of this approach could have broader applications which will be researched.

Curiosita:
It was because of Dr. Riley’s insatiable quest for knowledge and improvement that he began to search for an effective vaccine against solid malignant tumors. His curiosity led him to begin to research how effective a vaccine would be in treating new and spreading cancers using a patient’s own tumor in conjunction with immune-boosting substances.

Dimostrazione:
The message of yesterday that Dr. Riley knew was that over the last century vaccines have demonstrated that the human immune system can, with appropriate help, protect itself against otherwise lethal pathogens. The truth of today is that extending this phenomenon to generate an effective therapeutic vaccine against neoplastic tissue is a daunting task that is often costly, cumbersome and limited to highly selected patients. The vision of tomorrow that Dr. Riley hopes to bring the world is a safe and effective vaccine that is available for all forms of cancer and all patients in need.

Sensazione:
Through Dr. Riley’s newly formed company, Cancer Immunotherapies LLC, he is actively pursuing patent protection of all his research to date that would assure ownership and future rights of the research. Cancer Immunotherapies’ ultimate goal is to create a worldwide vaccine manufacturing facility located and operated in South Bethlehem. This vision affects our society both personally and professionally.

Sfumato:
The initial challenge Dr. Riley faced when he began developing his vaccine was the huge and highly competitive market that already existed. Major corporations were already developing vaccines and had not experienced success. However, he soon discovered that his late entrance into the field provided several advantages over the competition. Clinical trials that were already being conducted provided an opportunity to test his vaccine on a wide variety of cancer types. This challenge turned into a teaching lesson and provided triumph in testing the vaccine world-wide.

Arte/Scienza
Early on in Dr. Riley’s research he discovered that the advantage of his technology platform was that it uses the patient’s own tumors to create immune responses. This technology can be applied to both primary and metastatic tumors and can be readily applied in developing as well as developed countries. Deciphering this trend in research provided Dr. Riley with the knowledge to make a quantum leap in the way that vaccines will be distributed and used in the future.

Corporalita:
Recently Dr. Riley has received funding for his research through the South Bethlehem Keystone Innovation Zone. Select agency members include: LVEDC, Lehigh University, City of
Bethlehem,Good Shepherd, Lehigh Valley Hospital, Ben Franklin, Wachovia and Northampton County Community College. This partnership seeks to prepare for the future economic development needs of the community with a focus on life sciences and biotechnology.

Connessione:
The ultimate goal of Dr. Riley’s research and his vaccine is to eliminate cancer in our lifetime. It is estimated that over the next decade cancer will surpass cardiovascular disease as the major cause of mortality for Americans. Dr. Riley intends to discover an effective vaccine that will prove this theory wrong. This invention is a positive step in the overall wellness of patients and overall health world wide.

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