Israelis Invented a New Type of Oncotherapy That Can Destroy Over 70% of Tumours

A new technology developed by the Israeli medical technology company Alpha Tau is currently undergoing clinical trials, during which medical professionals are assessing its effectiveness in treating specific types of cancer, but it already shows enormous potential in combating any solid tumours. If the creators manage to successfully pass all bureaucratic checks, the innovative method, which has been proven to successfully destroy over 70% of malignant formations, will soon be available for use in medical institutions worldwide.

Fifteen years ago, professors Yonah Kaisari and Itzhak Kelson from Tel Aviv University devised a way to use alpha radiation to destroy cancerous tumours. Their proposed approach was undoubtedly revolutionary: alpha particles have such immense power that they can rupture both strands of the DNA of a cancer cell, while unlike other types of radiation, they do not have a detrimental effect on the healthy tissues surrounding the tumour.

Despite this, alpha particles had not been used in the therapy of oncological formations because within the tissues of the human body they can only spread over a very short distance – 50 microns, or 1/20 of a millimeter. Thus, to destroy a tumour the size of, say, five centimeters, hundreds of thousands of sources of alpha radiation with reduced range would be needed – which seems completely impossible to implement.

Professors Kaisari and Kelson discovered that when delivered using a specific isotope of radium, the range of alpha particles increases to three millimeters. This isotope, radium-224, releases atoms that spread within the tumour and then emit their own alpha particles. This approach allows for an increased range of alpha radiation to destroy cancerous tissues.

In 2003, the creators of the technology patented it in collaboration with Tel Aviv University. Since then, numerous studies have been conducted and 12 peer-reviewed scientific articles published. However, due to disputes among all stakeholders regarding intellectual property rights, the general public only learned about the breakthrough methodology in 2015, when Uzi Sofer, who had extensive experience in medical technologies, was brought in to resolve the situation.

Previously, he was one of the founders and served as the CEO of the Israeli company Brainsway, which develops new ways to treat depression, post-traumatic stress disorder, obsessive-compulsive disorder, and other brain diseases and addictions using transcranial magnetic stimulation. Under his leadership, the company's staff grew from two to 70 employees.

To resolve the dispute that arose among all those involved in creating the new technology and ensure its further development, Sofer founded a new company – Alpha Tau (where Tau stands for Tel Aviv University). Over the past year, the startup has raised $29 million for its funding from Shavit Capital, Medison Ventures, and OurCrowd.

Stimulating the Immune System

To date, Alpha Tau is the only company using alpha radiation to destroy solid tumours. Other types of brachytherapy (a form of radiation treatment where a localized source of radiation is placed inside or near a malignant tumour) involve the use of beta or gamma rays. "But they only cause a rupture of one strand of DNA, which allows the cancer cell to subsequently recover," explains Sofer. "Moreover, there is no way to clearly focus their effect, leading to the destruction of healthy tissues and a number of side effects."

When the healthy tissues surrounding the tumour remain unharmed after treatment, the immune system "learns" to recognize and attack a specific type of malignant cells anywhere in the body. This occurs due to the formation of antigens characteristic of a specific type of tumour, which make cancer cells visible and vulnerable to the immune system. As a result, the body independently destroys existing metastases, which are responsible for the death of 85% of cancer patients.

"We are convinced that our technology has enormous therapeutic potential, as it not only destroys tumours but also prevents the spread of cancer cells to other organs," says Sofer.

Clinical Trials

The effectiveness of the new technology, named diffuse alpha-emitting radiation therapy (DaRT), has been tested in thousands of animal trials. The first human trials were conducted in Israel and Italy – researchers studied the ability of the new method to combat squamous cell tumours, characteristic of the skin, head, and neck areas. Studies of its effectiveness in treating other types of skin cancer are planned for 2019 and will take place in medical centers in Israel, Italy, France, New York, and Montreal.

Trials for other forms of oncology are expected to begin within the next 3–6 months in Montreal and New York (pancreatic and skin cancer), Obninsk in Russia (breast cancer), Cambridge in the UK (vulvar cancer), and Israel (prostate cancer). Later, additional studies on more than 20 other types of tumours, including cervical, kidney, and colon tumours, will be conducted in medical institutions in more than 25 countries worldwide.

"Once the DaRT technology is approved by regulatory authorities, we will be able to treat any types of solid tumours, including those forms of cancer where the patient has no other chance of survival," hopes Uzi Sofer. For example, there is currently no treatment for pancreatic cancer, and people typically die within five years after diagnosis. The new technology may change this prognosis.

"In trials on patients with squamous cell cancer, we were able to completely eliminate the tumour in over 70% of subjects; we achieved a reduction in the volume of the neoplasm in 100% of cases," says Sofer. "Encouraged by these promising results, we hope to be able to destroy pancreatic tumours just as effectively, or at least reduce their volume so that they can be surgically removed."

Personal Treatment Kits

Despite the high power of alpha radiation, it is much safer than traditional gamma and beta rays. "As a result, much less radiation is required to achieve the same effect," explains Sofer. "We will be able to deliver treatment kits to hospitals in very ordinary boxes. With them, patients can be treated on an outpatient basis without special radiation protection. A week after therapy, the body eliminates 50% of the received radiation, and after two weeks, there is no trace left."

At the same time, once the treatment kit for DaRT therapy is assembled (for example, a patient with breast cancer may need 12 needle applicators with six seeds in each), it must be sent to the medical facility as quickly as possible. "If for some reason the patient does not show up on time, the entire kit will have to be thrown away the next day," explains Sofer.

Due to the rapid alpha decay, Alpha Tau is forced to build its production facilities near major medical institutions. Its first facility is already operating in Israel. Recently, the company received permission to build a second production facility in Massachusetts. A third will appear in Japan, and a fourth in Europe.

Currently, Alpha Tau's staff in Israel consists of 26 employees, including the professors who invented the basic technology. After the completion of clinical trials, Sofer hopes that the DaRT method will be approved for use in the European Union by 2020, and by 2022 in America and Japan. "We are already saving lives during the trials," he says. "It is amazing to see how patients who were previously told by doctors that they had only weeks to live, after treatment with our technology under local anesthesia, are completely rid of the tumour within two months. I have been working in this field for quite some time, but seeing such results is the best thing that can happen."