Novocure (NASDAQ: NVCR) today announced it has entered into a clinical trial collaboration agreement with GT Medical Technologies, Inc., to develop Tumor Treating Fields (TTFields) together with GT Medical Technologies’ GammaTile Surgically Targeted Radiation Therapy (STaRT) for treatment of recurrent glioblastoma (GBM). Novocure’s TTFields are electric fields that disrupt cancer cell division. GammaTile is an FDA-cleared therapy for the treatment of all types of brain tumors.
“Our collaboration with GT Medical Technologies is an exciting and important opportunity to test the radio-sensitizing effect of Tumor Treating Fields, which will be applied for at least two weeks prior to resection and GammaTile implantation,” said William Doyle, Novocure’s Executive Chairman. “This trial is designed to build additional evidence of the effectiveness of Tumor Treating Fields plus radiation therapy and to explore the potential to further extend survival for recurrent GBM patients.”
Novocure and GT Medical Technologies plan to conduct a phase 2 pilot study to test the effectiveness and safety of neo-adjuvant TTFields followed by resection, GammaTile Therapy, and adjuvant TTFields for recurrent GBM. The study is designed to enroll approximately 55 patients in the United States. Progression free survival (PFS) for the intent-to-treat population is the primary endpoint of the study. Secondary endpoints include overall survival, PFS for per protocol patients, time to progression, six-month survival rate, one-year survival rate, PFS at six months, and safety.
“GT Medical Technologies is enthusiastic about the potential of these combined therapies,” said Matthew E. Likens, President and CEO of GT Medical Technologies. “This trial is a great opportunity to expand care and therapeutic options for recurrent GBM patients. GammaTile delivers 50 percent of the radiation within 10 days of resection, which we believe maximizes patient outcomes while improving local tumor control and access to care. We are pleased to partner with Novocure in this pursuit.”
About Tumor Treating Fields
Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.
When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.
Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.
TTFields is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.
Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields.
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Tumor Treating Fields are electric fields that disrupt cancer cell division. Novocure’s commercialized products are approved for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
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, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com%2Fnovocure.
About GammaTile Therapy
GammaTile is an FDA-cleared Surgically Targeted Radiation Therapy (STaRT) for newly diagnosed malignant and recurrent brain tumors of all histologies, including metastatic brain tumors, high-grade gliomas, and aggressive meningiomas. GammaTile consists of 4 Cesium-131 sources embedded in a bioresorbable collagen matrix. Implanted at the time of brain tumor removal surgery, GammaTile immediately begins targeting any remaining tumor cells to inhibit tumor regrowth. Patients receive a therapeutic dose of radiation while going about their daily lives. There is no need to return to the hospital for ongoing radiation therapy, ensuring treatment compliance and limiting the treatment burden for patients. GammaTile became available to patients in the United States in 2019 and is currently available in 40 top brain tumor centers across the country.
About GT Medical Technologies, Inc.
Driven to overcome the limitations of the current standard of care for brain tumors, a team of brain tumor specialists joined forces and formed GT Medical Technologies with the purpose of improving the lives of patients with brain tumors. GammaTile Therapy received FDA 510(k) regulatory clearance for the treatment of all types of recurrent and newly diagnosed malignant brain tumors. Patients receive GammaTile at the time of their tumor removal surgery which, in contrast to traditional radiation therapy, requires no additional trips to the hospital or clinic for radiation therapy. GammaTile is available in top brain tumor centers across the United States. For more information or to find a GammaTile center near you, visit https%3A%2F%2Fwww.gtmedtech.com%2F and follow @GTMedTech on Twitter and LinkedIn.
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, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers 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, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 25, 2021 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.
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