Novocure™ Announces Opening of Two Pilot Trials to Evaluate the Use of TTFields for Pediatric Gliomas
Trials sponsored by the Pediatric Brain Tumor Consortium and Hackensack University Medical Center now open and recruiting
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ:NVCR) announced today two pilot trials are open and actively recruiting pediatric patients with high grade gliomas to evaluate the safety and feasibility of Tumor Treating Fields (TTFields) in this population. The trials are sponsored by the Pediatric Brain Tumor Consortium and Hackensack University Medical Center.
“Although solid tumor cancers are generally rare in children, brain and spinal cord tumors are the third most common type of childhood cancer,” said Dr. Stewart Goldman, Professor of Pediatrics at the Ann & Robert H. Lurie Children Hospital of Chicago. “In order to make a meaningful impact in the lives of these children, we need ongoing research to test the safety and feasibility of potential treatments. We are pleased to see trials testing TTFields in this underserved population.”
The first trial, sponsored by the Pediatric Brain Tumor Consortium in collaboration with the National Cancer Institute, will study the feasibility of using TTFields for children with recurrent or progressive suptratentorial high-grade glioma and ependymoma. This study will primarily assess patients’ compliance and number of treatment-related toxicities with secondary outcome measures including the response rate and event-free survival. This trial is actively recruiting an estimated 25 patients.
In the second study, the safety, tolerability and preliminary efficacy of TTFields will be tested in pediatric high-grade gliomas in two cohorts. The initial cohort of patients will receive TTFields alone and will consist of children with recurrent high-grade gliomas. The second cohort of patients will receive TTFields in combination with temozolomide and bevacizumab and is open to children with both newly diagnosed and recurrent gliomas. The trial, sponsored by Hackensack University Medical Center, is actively recruiting and is estimated to enroll 12 patients.
For more information on the trial designs, visit clinicaltrials.gov and reference NCT03033992 and NCT03128047. Treatment with TTFields is not approved for the treatment of pediatric gliomas by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for pediatric gliomas has not been established.
Novocure is an oncology company developing a profoundly different cancer treatment utilizing a proprietary therapy called TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.
Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2017, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Media and Investors:
Ashley Cordova, 212-767-7558