Atlantic Health System Cancer Care is the first oncology institution in the world to sign on to, and to enroll the first patient in, a multicenter Phase IIa clinical trial of OBP-301 (Telomelysin®), a virus-based immunotherapy for late-stage melanoma that has not responded to other treatments.
This leading-edge experimental therapy, which is under development by Japanese biotechnology company Oncolys BioPharma, uses the common cold virus to modify a gene that can selectively replicate in, and destroy, cancer cells. The study protocol was approved by the U.S. Food and Drug Administration (FDA) in June.
The clinical trial is being led locally by Eric D. Whitman, MD, FACS, medical director of Atlantic Health System Cancer Care and director of the Carol G. Simon Cancer Center’s Atlantic Melanoma Center at Morristown Medical Center and Overlook Medical Center.
“This targeted immunotherapy holds great promise for improving survival rates in patients with unresectable and metastatic melanoma,” said Dr. Whitman. “We are proud to have been chosen as the first site for this leading edge clinical trial, and happy to be able to offer a wide range of the latest established and experimental treatments to our patients.”
Melanoma, the most serious form of skin cancer, affects more than 50,000 people each year. Although the chances of having melanoma increase with age, the number of cases among young adults is rising every year. Melanoma can have serious health consequences and may even be fatal.
The OBP-301 trial is a multicenter, Phase IIa study to evaluate how melanoma tumors respond to injection of this drug in patients with Stage III and Stage IV melanoma – that is, to determine how much the drug shrinks or destroys tumors after it is injected into them. The study, which will also look at potential side effects, is “open label,” meaning that all participants in the study will receive OBP-301.
OBP-301 is a type of virus known as an adenovirus. Adenoviruses are common in nature and when they multiply in normal human cells they may cause infections that result in symptoms like those of the common cold or the flu. OBP-301 has been genetically changed from the original virus to reproduce in target cancer cells that are emitting a certain signal. As a result of this reproduction, OBP-301 is believed to burst and kill tumor cells.
Study participants will receive multiple injections into their tumors over a period of several weeks. Blood tests will be done to evaluate the level of virus in patients’ systems, and for immune response monitoring. Dr. Whitman and colleagues will also evaluate how long it takes to get a response and how long responses last, as well as overall survival and progression-free survival rates.
In preclinical studies, Oncolys demonstrated OBP-301’s anti-tumor activity in various types of cancer cells. A Phase I clinical trial in the U.S. demonstrated the drug’s safety, and showed that it shrank tumors in a majority of study participants, who had a variety of solid tumors. Additional studies of the drug have been completed, or are underway, in Japan, Korea and Taiwan.
The Atlantic Melanoma Center, a clinical and research center of excellence, is an internationally-recognized program. The center’s multidisciplinary approach – combining the expertise of board-certified surgeons, medical oncologists, pathologists, radiation oncologists and nurses – treats all forms of melanoma, including those in the skin, mucous membranes and eyes. Patients receive the latest medical treatments, and when needed, melanoma surgery is also available.
For more information on the OBP-301 clinical trial or other studies, please call the Atlantic Melanoma Center at 973-971-7111.