NIH Awards $2.3M To Fund Study Of Pancreatic Cancer-Fighting Implant
The National Institute of Health has awarded a $2.3 million grant to CivaTech, developer of an implantable device that provides targeted radiation treatment for cancer patients. CivaTech plans to use the grant to fund a clinical study that will evaluate safety and efficacy of the CivaSheet device in patients with pancreatic cancer.
Treatment of pancreatic cancer is especially complicated because the proximity of the pancreas to other vital organs makes the cancer easy to spread and difficult to target, according to the Pancreatic Cancer Action Network (PCAN). A pancreaticoduodenectomy — more commonly known as the Whipple procedure — is the most common surgical intervention for pancreatic cancer, but even with a successful surgery, chances of cancer recurrence remain very high.
With funds awarded by a Small Business Innovation Research (SBIR) grant from the National Cancer Institute, CivaTech intends to launch a small study of 80 participants who have undergone the Whipple procedure to see if implanting the CivaSheet device during surgery reduces cancer recurrence with fewer side effects than traditional radiation treatments. According to researchers, the study will be completed in two years.
CivaSheet — which received FDA approval in 2014 — is a “membrane-like” brachytherapy device that emits low dose rate (LDR) Palladium 103. The device is customizable to individual patient needs and, by integrating gold shielding, oncologists can direct radiation in planar configuration to target hard-to-treat cancers, such as non-small-cell lung cancer, colorectal cancer, and ocular melanoma. Because the device degrades inside the body, it does not need to be surgically removed.
“We are very excited about the beneficial impact this can have for all the patients who are candidates for this new treatment option,” said CivaTech CEO Suzanne Babcock in 2014. “For the first time, radiation oncologists will have a configurable planar LDR array that is truly customizable to a pecific patient’s condition, allowing clinicians to specify a tailor-made dose distribution that can be unidirectional or bi-directional.”
Joshua Meyer, assistant professor of Radiation Oncology at the Fox Chase Cancer Center in Philadelphia and principal investigator of the upcoming study, commented in a recent press release that the precision targeting offered by the CivaSheet will allow radiation specialists to dial up the dose to levels considered unsafe in less targeted approaches.
“The option to treat patients with a directional radiation implant using the CivaSheet may allow us to increase the safe dose of radiation in this setting, controlling disease that would otherwise come back,” said Meyer.
The American Cancer Society (ACS) estimates that over 53,000 people in the U.S. are diagnosed with pancreatic cancer each year, and the cancer represents seven percent of all cancer-related deaths. In a 2016 report, the ACS predicted that soon pancreatic cancer will surpass breast cancer to become the third leading cause of cancer-related deaths in the U.S.
PCAN is working to increase funding for pancreatic cancer research to $200 million annually and to double survival rates by 2020. “We are at a critical point in history for this disease,” said Julie Fleshman, CEO of PCAN, in a press release. “With more funding, support, and focus, we can expedite progress."