New hyperthermic treatment offers hope for stage 4 metastatic cancer

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It is one of the most heartbreaking moments in medicine and in life. The doctor informs a patient that his stage 4 cancer has metastasized all over his body and there is nothing more he can do except write a referral for palliative care.

What if there was a way to cut those stage 4 tumors in half? It wouldn’t make the cancer go away, but it would turn it from a likely death sentence into a “chronic disease” requiring treatment every few months.

That’s what New Phase, based in Petah Tikva, hopes to do by applying electromagnetic hyperthermia to treat inoperable tumors. Hyperthermia is when the body heats up.

It has been known for some time that cancer cells do not like heat. They die when the temperature reaches around 45 degrees Celsius (114 Fahrenheit). Non-cancerous cells, on the other hand, can survive temperatures up to 55C/131F.

This is because tumor cells have a disorganized vascular structure which, unlike normal cells, has difficulty dissipating heat.

New Phase injects iron oxide nanoparticles specially created by IV. The nanoparticles are embedded in a phase-change material (which releases or absorbs energy to provide heat or cooling) and coated with polyethylene glycol (a petroleum-derived compound).

Ofer Shalev, co-founder and CEO of New Phase. Photo courtesy of New Phase

They locate tumors through a process known as EPR – “enhanced permeability and retention”, says Ofer Shalev, who co-founded New Phase with Dr Rafi Hof.

“The tumor cells feed on the blood capillaries, where there is a lot of leakage,” Shalev told ISRAEL21c. “We use it to ‘leak’ into cancer cells. This is the permeability of the EPR.

Selective destruction

Four hours after receiving the nanoparticle injection, the patient lies on a bed inside an RF machine that uses an electromagnetic induction system to generate non-ionizing radiation.

This radiation heats the nanoparticles to a maximum of 50 degrees Celsius by altering the polarity of their iron oxide core. Patients undergoing New Phase treatment wear a special blanket to cool off.

The patient lies on a bed inside an RF machine for electromagnetic treatment. Photo courtesy of New Phase

Stage 4 metastasized cancer is particularly insidious because many of the “micro-metastases” cannot be identified, even under a microscope. This makes surgical removal of these types of tumors impossible. But New Phase nanoparticles can find them.

And even if not all of the tumors are destroyed, the treatment transforms a stage 4 cancer into something closer to stage 2 – for which many other treatment options are available.

“Even reducing a cancerous mass by 30% to 50% is a huge achievement,” Shalev points out.

If certain nanoparticles enter healthy cells, these cells can survive. “This is how we selectively destroy only cancer cells,” Shalev explains.

When there’s nothing else to offer

Why not use New Phase’s technology for the early stages of cancer?

“We can,” says Shalev, “but we wanted to start with stage 4 cancers, where there’s nothing else to offer. In Israel, 11,000 patients die of cancer each year. In the United States, it’s more than 600,000 – and the number is growing by 5,000 people a year. So even treating only this subset of patients is a lot of work.

Shalev and his partner previously worked together at ReDent-Nova, which develops dental devices and instruments to treat root canals. They named New Phase’s technology “Sarah” after Hof’s mother, who died of lung cancer.

“We want patients to survive until [a ripe old] age and die for reasons other than cancer,” says Shalev.

New Phase has so far been tested in mice, pigs and rabbits and “a few human patients” at a hospital in Nahariya, northern Israel. These phase I clinical studies started with a fairly low dose.

“With each cohort, we will add more and more doses,” says Shalev.

Efficacy results are not yet known. “But we know from the MRIs that the nanoparticles hit their targets,” Shalev says.

Systematic approach

The nanoparticles are developed by New Phase in a “clean room” near Karmiel. The laboratory is run by three female Druze chemists from a nearby village.

New Phase isn’t the only company using hyperthermia to kill cancer cells. “But we are the only ones using it for systemic treatment,” Shalev told ISRAEL21c.

“Others inject nanoparticles into a specific tumor to treat it locally. It does not matter where the micro-metastases are. They will retain our nanoparticles and later be destroyed by hyperthermia.

Another Israeli startup, AlphaTau, uses alpha radiation to kill tumors. This approach is also very local, targeting specific tumours.

The New Phase nanoparticle treatment won’t be available until at least late 2024 or early 2025. That’s how long it takes to complete all the clinical studies.

But the good news is that the approval process will be faster than if it were a drug, as the US Food and Drug Administration has agreed to categorize New Phase’s treatment as a Class 3 medical device.

Multicultural team

New Phase’s Scientific Advisory Board includes Professor Dan Peer, Director of the Precision Nanomedicine Laboratory at Tel Aviv University; Dr. Glenwood Goss, Chair of the Thoracic Oncology Site Committee and Professor of Medicine at the University of Ottawa; and Dr. Arnold Cyjon, former deputy director of oncology at Shamir Medical Center in Israel.

In late 2021, the company added Professor Zeev Rotstein, former head of Hadassah and Sheba Medical Centers in Jerusalem and Tel Aviv, respectively. Rotstein is an active adviser and has good relationships with American hospitals, Shalev notes.

Founded in 2013, New Phase has raised $25 million to date (largely from the family office of serial entrepreneur Aharon Lukach) and employs a multidisciplinary team of 30 engineers, biologists and chemists.

Shalev is proud that the company is made up of 50-50 men and women. Getting started in the NextGen Technologies incubator in Nazareth also means the company employs both Jewish and Arab Israelis.

New Phase’s technology will, in part, allow patients suffering from solid tumor cancers to “catch up” with their blood cancer counterparts, where immunotherapy has already turned many conditions, such as lymphoma, into “chronic cancers.” “.

For more information on the new phase, click here

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