Brain game changer presentation -israeli leadership in cns ilsi iata biomed ...
Aa alpha tau medical globes uzi sofer howard sterling english and hebrew 12 23-16
1. Alpha Tau Medical, an Israeli company, found a way
for the first time to destroy all human tumors, using
Alpha Particles,without any side effects.
FROM GLOBES NEWSPAPER, THE WALL STREET JOURNAL OF ISRAEL
12.20.2016, 15:06 Gali Weinreb
"When I retired from managing Brainsway as CEO, I had no interest in entering a
new administrative postimmediately," says Uzi Sofer. "But one day, Howard
Sterling, investment banker, a man no one can refuse, called and told me he had a
mission for me," The mission Sofer received from Sterling was to save a company
called Althera Medical, an Israeli company headquartered in New York,
established on the basis of invention and research work of Prof. Yitzhak Kelson, an
eminent physics professor, and Prof. Yonah Kesari, an eminent biology professor
at Tel Aviv University. They have developed a new method to treat cancer using
the powerful radiation from alpha particles, the radioactive nuclei of helium, but
for various reasons the company, Althera, failed to take off.
Uzi Sofer did not come from Althera, but was most famous as CEO of Jerusalem’s
Brainsway the successfuldeveloper of a patented magnetic helmet for treatment of
depression and other neurological conditions. Sofer brought the idea of a super
helmet from a great Israeli scientific achievement to a marketed productapproved
all over the world. After the first phase of introducing the productto the United
States, Uzi Sofer felt exhausted its role, and the Board was looking for another
CEO. Todaythe company is traded on the Tel Aviv at a value of hundreds of
millions of shekels (worth actually fell after two years without Uzi).
Althera Medical just needed somebody, like Uzi who has taken a medical product
from conception, all the way, as he had done with Brainsway.
2. Althera Medical worked more than a decade trying to move from science t product
and regulatory approvals. But Althera had many mutual lawsuits over intellectual
property between Althera and Tel Aviv University. In addition, a series of internal
conflicts among the more than 70 shareholders and various debtholders led to a
halt the company's operations. In fact, from 2011, the company was paralyzed from
a business viewpoint. However, during this time the scientists ProfessorKelson
and ProfessorKesari continued to develop the technology of effective cancer
technology with no bad side effects in animals.
In 2014 the lawsuit over the patents with the University ended. The intellectual
property was taken over by Althera, and the University had partial ownership in
Althera and an Althera promise to royalties to the University. Althera Medical
could theoretically have continued to mature as to animal trials, but the
shareholders’ conflicts continued to simmer. Sofer said, "Howard told me - only
you can make peace between all these factors and you must to save perhaps
millions of people from dying of cancer."
Due to the commitment he felt for Sterling and the uniquely better cancer therapy,
Sofer decided to take on the task, at first unofficially and then officially. He began
to run between shareholders and debt holders and to speak to their hearts where he
showed them a simple message: if there is no agreement, there is nothing to fight
over. If they all agree, the technology would go forward and they could make a lot
of money. In the end, all the Althera stakeholders agreed to allow the transfer of
the intellectual property of Althera Medical new Israeli company, Alpha Tau
Medical. The agreement provided certain holdings in the new company for the
Althera shareholders and creditors. The transaction was closed in April 2016, and
Alpha Tau Medical became strongly operational under Sofer.
Marie Curie's radiation
Sofer said: "In 1898 Marie Curie discovered radium, a substanceemits alpha
particles radiation, and Curie, even then believed, that this radiation can aid in
cancer healing. Alpha Particles are ideal for the treatment of cancer. They are
heavy particles that hit the powerfully destroy tumor cells but do not pass into the
3. normal tissue surrounding the tumor or the systemic blood vessels in the rest of the
body. That is why there are no side effects.
Alpha particles can travel only about 1-2 microns, millions of a centimeter, in
tissue. This is advantageous because the damage it performs is very focused in one
place, only in the tumor. But this is also was a disadvantage, because it was clear,
to all scientists before ProfessorKelson did the impossible, that the alpha particles
could not travel far enough to move around and damage a whole cancer tumor.
Even if brought to the alpha particle radiation source very close to the tumor, the
alpha particles could hit only on the margins of the tumor, and not penetrate, kill,
the whole tumor.
ProfessorKelson had developed isotopes of Thorium, Radium and Radon which
disintegrate and emit energetic alpha particles with their strong radiation. Kelson
found a unique and patented way by making the emitting isotopes into
nanoparticles to get the isotope particles to move around the tumor. It is like the
recoil that moves a big rifle when a small bullet is energetically fired. Treatment of
tumors involves inserting isotope-energetically-emitting alpha particles in the
tumor, it is called intra-tumoral therapy. The number of isotopenano-particles
inserted in the tumor are in accordancewith the tumor size, type and location, so
that the fields of alpha particles’ radiation cover the entire tumor and lead to the
tumors complete destruction.
Treatment creates a uniform and extensive damage increase, but not the
surrounding tissue. No other cancer therapy, chemotherapy or radiation today is
known that does not have, usually severe, side effects.
The alpha particle medicine was tested in many different types of cancer, human
and others, in over 6,000 animals and it significantly contributed to the elimination
of a large variety of solid tumors, with minimal or no side effects. The productcan
be treated through repeated treatments or combined it with existing therapies,
including chemo and immune therapies.
4. Alpha Tau Medical decided not to concentrate on one cancer, and decided to look
at the experimental feasibility of treating various types of cancers in humans in
parallel (like Sofer did trials on many human neurological conditions at
Brainsway). In a Tel Aviv University physics building, Alpha Tau established a
unique super-clean) so no environmental impact) nuclear manufacturing laboratory
to producea sufficient quantity of alpha particle radiation sources for the several
human clinical trials. Human cancers where Alpha Tau is expected to be active in
the first phase are: head and neck cancer, skin cancer, prostate cancer, melanoma
of the eye, cervical cancer and rectal cancer. The studies are focused on patients
with cancer that conventional treatments are limited in their effectiveness (difficult
area to treat with external radiation, widespread metastases).
USA major clinical trial
One of the challenges of society in the future, if and when the Alpha Tau medicine
device is approved, will provide appropriate resources for growing specific and
individual patient treatment protocols, and taking into accountthe short shelf life
of the radioactive source. Sofer is confident that the challenges can be overcome
by, for example, putting the relatively small, relatively inexpensive, alpha particle
manufacturing facilities near major hospital centers all over the world.
Sofer "In April this year we did closing of transactions which compromised the
shareholders and debt holders and led to the establishment of Alpha Tau Medical.
Since then we have achieved many amazing and significant milestones, including
the establishment of the laboratory at the university and recruiting great
management and key-opinion-leader doctors. Apart from the scientists who
founded the company and me, we've enlisted Prof. Rafael Catane as medical
director, Amnon Gat, as head of marketing, and Dr. Morry Blomfeld, Meir
Jacobsonand of coursethe Howard Sterling as board members. Also we have
began patient recruitment in skin cancer and head and neck cancer at Beilinson
Medical center in Israel. We also received permission to begin a similar study in
Italy and we are working to obtain approvals for additional indications for further
studies in Germany and France. "