CivaSheet Implantable Radiation Device Brings Rare Good News in Pancreatic Cancer
Positive news about pancreatic cancer is hard to come by. It’s known as aggressive disease that usually leads to poor outcomes.
But CivaTech Oncology, a Research Triangle Park company developing a unique platform of cancer therapy devices, has some good news to share.
A meta-analysis of data comparing outcomes using its CivaSheet implantable radiation device to other treatments shows patients report feeling better, having a high quality of life, reductions in local recurrence within the first six months and cost savings.
“One of the exciting parts is that patients haven’t needed the chemotherapy because they haven’t had a recurrence,” said Suzanne Babcock, CivaTech chair and CEO. “When that happens, they are not impacted in terms of their quality of life.
“A lot of pancreatic cancer patients have trouble eating and digesting food and discomfort related to that. Chemotherapy has its own set of side effects that would be eliminated if they don’t need it.” In addition, Babcock said the analysis shows cost savings of $11,000 per patient.
Pancreatic cancer is notoriously aggressive. Many patients do not experience symptoms or receive a diagnosis until it is at an advanced stage. Fewer than 30% of the 53,000 patients diagnosed annually in the United States receive a diagnosis in time to undergo surgical resection (removal) of the tumor. Even when surgery is an option, time is of the essence to enable follow-up treatment that may prevent local recurrence.
CivaTech, with support from a $250,000 Small Business Research Loan from the North Carolina Biotechnology Center in 2012, has developed a bioabsorbable device to begin delivering a therapeutic dose immediately at the margins of the resection bed by surgeons at the time they remove the tumor. Surgeons custom trim, fit and angle the sheets while in the operating room, to aim the CivaSheet’s radiation exactly where the patient needs it, while protecting other vital organs from exposure. The front side of the sheets have the radiation; the back is lined with gold, which blocks radiation from nearby tissue.
The U.S. Food and Drug Administration approved the CivaSheet for clinical use in 2014, and the first pancreatic cancer patient received implantation of it in 2017.
Though radiation has shown to be effective in treating pancreatic cancer, the traditional method of delivery can cause serious side effects and increase patient suffering. Radiation therapies administered through beams from outside the patient must pass through vital organs to reach the pancreas or the site where a tumor was removed. Thus, the small intestine, stomach, liver or kidneys can be exposed to radiation damage.
A recent development, stereotactic body radiation therapy (SBRT). SBRT is high-dose and finer-beam radiation administered over a span of one to five days, rather than the many weeks of lower-dose traditional external-beam radiation. It’s being used in patients who are not candidates for surgery, to reduce tumor size so some patients can qualify for surgery. It’s also being explored as a post-surgical treatment. It holds the promise of reducing the need for long-term chemotherapy in some patients. However, SBRT is also a form of external-beam radiation and can cause ulcers in the small intestine.
“Even with the SBRT, it gives a radiation dose to the small bowels, the kidneys, the adjacent organs that have already been previously radiated before the patient goes to surgery. So, we have data that show with our product, we give no dose to the kidneys, or the liver or the spinal column and about a third of the dose to the small bowels, which basically means we can give an almost ablative [tissue destroying] dose to the resected tumor bed, controlling the disease locally,” said Kristy Perez, Ph.D., CivaTech’s vice president of clinical programs.
Founded in 2006, CivaTech’s first implantable radiation product, called the CivaString, was approved by the FDA in 2013 for use in prostate cancer. Both CivaString and CivaSheet have FDA clearance to treat cancers of any solid tumor such as prostate, pancreas, sarcoma, head and neck, gynecological, colorectal, breast, brain, etc.
The company is the first therapeutic radiation therapy company licensed as a manufacturer and distributer in North Carolina. Babcock said the company continues to work on new applications and uses for the CivaString and CivaSheet technologies.