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The Israeli with the highest value on the Nasdaq, a pioneer in the war on cancer
The FDA has granted "breakthrough technology" status to a Novocure device for the treatment of liver cancer.
The Israeli company with the highest market value on NASDAQ has developed innovative technology that impairs the process of dividing cancer cells.
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Saturday, 11 September 2021, 09:29 Updated: 09:48
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The FDA has granted "Breakthrough Technology" status to a Novocure liver cancer device (NovoTTF-200T), designed to treat first-line patients with non-operable or metastatic liver cancer, in combination with the tetanus immunotherapy (Atzolizumab, Anti PD-L1) and Avastin ( In Vizizumab).
Nobokior, Israeli company with the highest market capitalization on the Nasdaq, has developed innovative and unique technology named TTFields ((Tumor Treating Fields based on magnetic fields change, which undermine the process of division of cancer cells.
Runway designated a breakthrough technology will allow Lnobokior access and priority processes FDA regulation (while strictly adhering to regulatory procedures)
The FDA decision was based, among other things, on the clinical data from the Phase 2 study (HEPANOVA), which examined the efficacy and safety of TTFields treatment in combination with Surapanib chemotherapy in patients with the disease. Progressive after failure of previous treatment lines.
The results of the second phase study showed a disease control rate that stood at 76% of the patients, while in 9.5% a significant reduction of the tumor was achieved.
Among patients who completed 12 weeks of treatment, the control rate of the disease was 91%, while in 18% a significant reduction in the tumor was achieved.
The approval means that the FDA states that treatment with TTFields has the potential to be more effective than treatment without the technology in this life-threatening disease, and therefore meets the criteria for its definition as a groundbreaking technology.
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Assaf Danziger, CEO of Novocure (Photo: Eldad Refaeli)
Estimated: An investment of $ 100-140 million will be required
"We are pleased with the FDA's decision to grant a groundbreaking treatment to our technology for the treatment of advanced liver cancer," said Assaf Danziger, CEO of Novocure
. We are working closely with international experts in this field to promote clinical study randomized-controlled phase 3, will examine as quickly as possible efficacy in TTFields combined with immunotherapy Tsntrik (Atzolizomab) and Avastin (Boosizomab). "
Liver cancer is the leading cause of cancer deaths Worldwide and is the sixth leading cause of cancer death each year in the US. It is estimated that every year there are 42,000 new cases of liver cancer in the United States, and about 110,000 new cases each year in the rest of the world.
The survival rate in the disease so far is low and stands at less than 20% for five years under treatment.
Existing therapies for patients with advanced disease are systemic treatment with surapnib or navatnib, or combination therapy with atzolizumab (Anti PD-L1) and vasizumab.
A sum of approximately $ 100-140 million will be invested in the development of NovoTTF-200T for liver cancer.
The FDA decision will also affect the possibility and speed of indemnification of the combined treatment by the US CMS, the governmental organization that decides which treatments will be provided as part of Medicare and Mediad, US federal health insurance companies that insure tens of millions of U.S. citizens.
Novokure, the Israeli company with the largest value on the NASDAQ (Photo: ShutterStock)
Affects only the cancer cells
Novocure's technology has already proven its effectiveness in the deadly brain cancer glioblastoma (GBM) and the treatment called Option Approved and is in use and publicly funded in a wide range of countries around the world. The technology has also been proven in a rare tumor of malignant pleural mesothelioma lung cancer with the Option-Loa device, and is currently being tested in a number of other cancers such as ovarian, lung, liver, stomach and pancreatic cancers.
The technology developed by Novocure uses alternating electric fields or TTFields, which disrupt the division of cancer cells. During the development of the cancerous growth, a rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins in the cell are critical to the cell division process, and they make the rapidly dividing cancer cells vulnerable to electrical disturbances.
TTFields has a unique frequency range, between 100 and 500 kHz, which allows the electric fields to penetrate through the cancer cell envelope.
Because healthy cells differ from cancer cells in the rate of division, their geometry, and electrical properties, the frequency of TTFields can be adjusted to specifically affect cancer cells while leaving healthy cells intact.
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