CivaSheet Shows Positive Results in Treatment of Soft Tissue Cancer

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The effectiveness of CivaTech Oncology’s implantable radiation device as a treatment for a soft tissue cancer was highlighted recently in an article in the Journal of Surgical Research.

Physicians from four medical centers shared the results from six patients suffering from retroperitoneal sarcoma who received CivaSheet, a new bio-absorbable internal radiation implant. After an average of 16 weeks, the patients experienced no recurrence of cancer, no toxicity, and no reported complications. That’s according to the article entitled “Initial Clinical Experience With Novel Directional Low-Dose Rate Brachytherapy for Retroperitoneal Sarcoma.”

CivaSheet is a thin, flexible polymer membrane containing a radioactive isotope implanted in patients in the operating room immediately following surgery. The isotope, Palladium-103, is on one side of the device and a gold foil barrier is on the other. The active area emits radiation therapy towards the cancer, while the other side blocks radiation from harming healthy tissue.

CivaTech illustration shows implant of CivaSheet.

After the device has delivered its radiation for about three weeks, the isotope naturally decays over a couple of months and no follow-up procedures are needed to remove it, according to CivaTech. The ability to customize the direction in which the radiation is delivered can help oncologists treat a variety of cancers that include soft tissue sarcoma, early stage non-small-cell lung cancer, head and neck cancer, colorectal cancer, ocular melanoma, and skin cancer, the company said in a 2014 press release announcing U.S. Food and Drug Administration clearance of CivaSheet. The product also is being tested for pancreatic cancer.

More than 13,000 new soft tissue sarcomas will be diagnosed and nearly 5,300 people are expected to die from the disease this year, according to the National Cancer Society. Retroperitoneal sarcomas make up approximately 15% of all patients with soft tissue sarcoma. And despite advances in cancer care, the overall five-year survival rate remains at under 65%, according to CivaTech.

“CivaSheet has been effective for our patients as it allows the clinician to personalize therapy to the patient’s anatomy at the time of surgery and to their previous course of treatment to minimize long term radiation side effects,” said Krisha Howell, M.D., clinical director of radiation oncology at Fox Chase Cancer Center in Philadelphia – the site of CivaTech clinical trials. The company said no complications have been reported in nearly 150 patients treated with CivaSheet.

The product was developed with support from the North Carolina Biotechnology Center, which provided CivaTech with a $249,048 Small Business Research Loan in 2012.

The company, founded in 2006, is located in Morrisville.

Bryant Haskins, NCBiotech Writer
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