On May 25, 2021 -Novocure (NASDAQ: NVCR) reported 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) (Press release, NovoCure, MAY 25, 2021, View Source [SID1234580572]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.