Groundbreaking Israeli cancer treatment gets FDA approval for clinical trials in U.S.
Groundbreaking Israeli cancer treatment gets FDA approval for clinical trials in U.S.
New Phase CEO Ofer Shalev spoke to CTech about their technology which turns advanced cancer into a chronic ailment, extending the lifespans and treating symptoms without any of the side effects associated with other existing treatments
Israeli company New Phase has received FDA approval to begin clinical trials in the U.S. for its groundbreaking cancer treatment solution. "Our vision is to prolong the life of Stage 4 cancer patients and to maintain their quality of life without the side effects of current cancer treatment. We wanted to manage the disease and turn it from a fatal disease to a chronic ailment," Co-Founder and CEO Ofer Shalev said in conversation with CTech.
The new treatment, which has shown success in Phase 1 clinical trials, leverages New Phase’s patented Sarah Nanotechnology System to distinguish between healthy and cancerous cells, ensuring that only cancerous cells are targeted and destroyed. This breakthrough significantly reduces the collateral damage to healthy cells, a common issue with conventional therapies like chemotherapy and radiation.
New Phase’s technology treats metastatic solid tumors through the delivery of thermal energy via “nanoparticles” to malignant cells. The nanoparticles are intravenously administered to the patient, followed by exposure to an alternating magnetic field (AMF) system, developed by New Phase. After accumulation of the nanoparticles at the tumor site, the patient is exposed to a low frequency non-ionizing AMF in an MRI like machine built and patented by New Phase.
The patented technology uses heat or “hyperthermia” to kill cancer cells which are more sensitive to extreme temperatures than non-cancerous cells. “We can control the temperature of the particles in the body while we are radiating the torso with non-ionized radiation. We destroy the cancer cells without causing damage to the normal cells,” says Shalev.
This treatment is unique among existing cancer treatments in a number of ways. There are other cancer treatments which use hyperthermia, but Shalev says that New Phase is the only treatment option that is able to control the temperature which is their patented technology. Additionally, unlike typical radiation which is ionized, leading to the destruction of non-cancerous cells, New Phase’s radiation is non-ionized. Most of the side effects associated with radiation are due to ionization.
Finally, New Phase’s technology is systemic and destroys cancerous cells throughout the body rather than a specific tumor. This is especially important, Shalev says, “because at Stage 4, there are micrometastases as well as tumors, which must be destroyed to slow down the disease.” In other words, it is not sufficient to target the site of the specific tumor because the rate of metastasis is so rapid - the whole body must be treated.
Shalev acknowledges that this is not a cure for cancer, which he doesn’t believe will materialize in the next ten years. Instead, he compares it to treatment of HIV, which was once a fatal illness but today is treated as a chronic condition. “Like HIV treatment we are reducing symptoms and stabilizing the disease.” This treatment would be nothing short of groundbreaking for Stage 4 cancer, allowing patients suffering from the most advanced cancer to extend their lives, manage and reduce their symptoms and not suffer the painful and debilitating side effects associated with other treatments.
New Phase received approval from the Israeli Health Ministry to conduct a clinical trial at Rabin Medical Center where it has so far successfully treated 20 patients with lung, colon, cervical and liver cancer. After receiving FDA approval they plan to begin a clinical trial at a U.S. hospital by the end of the summer, with the goal of completing the trial by the end of 2026. Based on the results, the treatment could be on the market by 2027.
Shalev co-founded New Phase in 2013 alongside Dr. Rafi Hof, who was inspired to develop a better cancer treatment after losing his mother to cancer. New Phases’s Sarah Nanotechnology is named in her honor. The company has 25 employees and is based in Petah Tikvah close to Rabin Medical Center.
They have raised a total of $34 million from some Israeli, but mainly American and Brazilian angel and family office investors. While there has been concern about foreign investment in Israeli ventures since October 7, Shalev says, “There is some impact with the geopolitical situation but once you can demonstrate your resilience, you rise in esteem. Foreign investors highly appreciate Israeli resilience; they’re impressed with our ability to move forward, to not let anything affect our clinical plan.”
Now raising funds for a Round A, Shalev says that, if anything, “We’d be glad to see more Israeli investment. Most Israeli VC’s are interested in digital health and software applications. They’re less interested than the U.S. and Europe.”
