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'Angry' Cell Treatment Harnesses Power Of Immune System To Destroy Cancer Cells
An Israeli biopharmaceutical start-up is developing a treatment for cancer
patients designed to harness the power of the patient's immune system in
order to destroy cancer cells in the body.
The potentially revolutionary immunotherapy drug, developed by Shoham-based
company Immunovative Therapies, incorporates living immune cells as the
active ingredient in the treatment, stimulating the body's own immune system
to fight the tumor. The drug, AlloStim, has already been successfully tested
in animal trials, and Phase I/II clinical trials on patients with advanced
blood cancer will begin at the end of this year, or the start of 2008.
Cancer is a growing problem worldwide. Over recent decades, the incidence of
cancer has escalated dramatically, now striking nearly one in two men, and
more than one in three women. In the US alone, 1.2 million people are
diagnosed with cancer every year, and half of them die as a result of the
disease. The National Cancer Institute estimates that the number of cancer
cases will increase further as the population ages.
"The battle against cancer is a battle we are losing," admits Michael
Har-Noy, founder and CEO of Immunovative Therapies. But he hopes to be part
of the change in the battle techniques being employed by doctors.
Despite dramatic advances in medicine, conventional cancer therapies -
surgery, radiation and chemotherapy - remain much the same today as they
have for decades. All three are drastic treatments, and both radiation and
chemotherapy affect normal cells causing severe side effects. The major
limitation of these therapies is their inability to eliminate the last tumor
cell. Any remaining cells proliferate and cause a relapse. These new cells
are often resistant to chemotherapy/radiation treatments, leaving the
patient with what can be an untreatable disease.
Immunotherapy is a new form of treatment that researchers have been
investigating for the last two decades. It uses the human immune system to
seek out and destroy cancer cells wherever they reside in the body.
Initially this field of medicine was considered one of the most promising
potential treatments for cancer because it seemed to offer up the hope of
getting rid of every single tumor cell. Animal trials went well, but when
the new treatments reached human trials they inevitably failed.
"The problem was that it was easier to train a mouse's immune system to
fight a tumor, than to train the human immune system," Har-Noy told
ISRAEL21c. "Tumors in humans seem to have evolved a very sophisticated
mechanism to avoid an immune attack."
With this in mind Har-Noy, who had been working in the field of
immunotherapy in California for over 20 years, decided to try an alternative
approach. He began researching bone marrow transplants (BMT), the one area
of medicine where it has been proven that the immune system can cure
patients of cancer.
With BMT, which is used to treat blood cancer, immune T-cells from a
tissue-matched donor are transplanted into the patient. These transplanted
immune cells kill the tumor cells, overcoming the tumor's immunoavoidance
mechanisms, in what is known as the 'graft vs. tumor' effect. The result is
the complete eradication of cancer, even in cases where patients had large
tumors that were unresponsive to other cancer treatments.
While this can cure the patient, in 50% of cases, the new immune cells cause
a serious and sometimes fatal side effect known as graft vs. host disease
(GVHD), when the transplanted immune cells recognize both normal and tumor
cells as foreign and mount attacks against both indiscriminately.
Har-Noy began looking for a treatment that would create the same anti-tumor
effect of the BMT, without any of the toxic side effects. After three years
of development, this is exactly what Immunovative believes it has achieved.
The company's new treatment, which can be used for virtually any type of
cancer, works in two ways, firstly - like BMT - it disables the ability of
the tumor to fight the immune response, and secondly it trains the patient's
immune system to kill the cancer cells wherever it finds them.
The company takes T-cells from a normal donor and produces them ex-vivo in a
nine-day proprietary culture process in a bioreactor. There is no need to
match the donor to the recipient as required in BMT procedures. The AlloStim
product is an intentional mismatch to the recipient. In the bioreactor the
cells are activated with monoclonal antibody-coated particles that are
removed before they are given to the patient.
"We provoke these cells, so that they become very 'angry' immune cells that
are highly stimulated," explains Har-Noy. "Then we infuse them into the
patient. The patient's immune system sees these new 'angry' cells as a great
danger to the body, and rallies to the defense to eliminate the threat,
releasing an array of inflammatory cytokines, in what is a bit like the
fight or flight response of adrenaline."
These inflammatory cytokines, which remain in the body for between 24-36
hours, shut down the ability of the tumor to avoid an immune attack and at
the same time enable immune-mediated killing of tumors spread throughout the
body.
In the wake of this treatment, even if cancer cells recur in the body, the
immune system can destroy them and does so automatically in much the same
way that vaccines work. If a patient is treated for breast cancer, for
example, and breast cancer cells begin to grow again after a few years, the
immune system destroys them immediately. If the patient develops an
alternative type of cancer, such as lung cancer, however, the AlloStim
treatment will have to be repeated for that new type of cancer.
Patients who undergo the AlloStim treatment are not expected to suffer any
side effects due to what the company calls the 'Mirror Effect'. The T-cells
infused into a patient do not attack the patient's immune system, but
stimulate it to attack the tumor. This is known as the host vs tumor (HVT)
effect, and is the mirror image of the GVT effect. Unlike the GVH effect, it
is not toxic, representing a new concept in the treatment of cancer.
"We'll know for sure when we treat patients, but we aren't anticipating any
kind of toxic response," says Har-Noy.
The three-year-old company, which works from labs at Hadassah-Hebrew
University Medical Center and Tel-Aviv Sourasky Medical Center, has already
carried out successful animal trials on mice. "We were able to show that we
could cure many types of tumors located throughout the bodies of the mice. A
high percentage of the mice were cured without the GVHD side effect," says
Har-Noy.
While animal trials were also successful in immunotherapy treatments that
later proved unsuccessful in humans, Har-Noy believes this is different. "We
reverse engineered a new response that works in humans and just tested the
principle on mice," he explains.
The next stage is clinical trials on humans. Phase I/II clinical trials at
Hadassah are expected to begin at the end of this year and will test both
toxicity and efficacy at the same time. "We will be dealing with patients
who suffer from incurable cancers and will be monitoring the response of the
tumors to see what response the drug has," says Har-Noy.
Initially the company plans to focus on patients with advanced blood
cancer - diseases like Chronic Lymphocytic Leukemia (CLL), non-Hodgkin's
Lymphoma and Multiple Myeloma. Additional studies for advanced cancers that
have metastasized to the liver, lungs, or bone, and advanced prostrate
cancer are also planned for mid-2008.
The company has focused on CLL because currently there is only one approved
drug to treat this disease, Campath by Ilex, and the FDA will fast-track any
promising drug in this field, bringing it through testing and out to market
in just 18 months.
Immunovative, which is just a small start-up with five members of staff,
needs this quick approval. It will enable the company to reduce the size of
its clinical studies, and cut down the length of approval time it needs to
test the drug on other types of cancer. Fast track approval also brings
other benefits. When Campath was approved in 2005, Ilex was acquired by
Gensyme for $1 billion.
In the first trial, the company plans to test 25 patients over a period of
about six months. If the clinical trials go well, they will be expanded to
the US.
"We can't wait to see how it really works in patients," says Har-Noy
enthusiastically. "It has such huge potential. Our collaborators at Hadassah
also want to bring it to patients as soon as possible."
Har-Noy founded Immunovative at the Misgav incubator in May 2004 when he
emigrated from San Diego specifically to set up the company. Har-Noy had
previously set up two other companies specializing in developing cell-based
immunotherapies, Medcell and Biovest International, which is still
operating.
"I was involved in a lot of things that didn't work," Har-Noy admits. "It
was this history of failure that helped me come up with this idea. We know
that immunotherapy can work. In 4-5% of patients it works dramatically. I
realized that the problem in the past was that scientists were developing
elegant solutions to the wrong problems. They assumed the immune system is
weak, and worked to boost it, while in most cancer patients it is strong,
and the problem lies with the tumor instead."
Because of the lack of credibility in this field, it was difficult for
Har-Noy to get funding in the US for what was then just a theoretical idea.
When he was offered a grant of $300,000 by the Office of the Chief Scientist
he jumped at the opportunity.
Immunovative left the incubator in May 2006 and raised $1.2 million from
angel investors. The company is now in the midst of another fundraising
round of $1m., which it plans to use to support the clinical trial program
and set up a manufacturing facility in Israel.
If the clinical trials go well, Immunovative will be in from the cold, and
so potentially will the field of immunotherapy. "The real launch for us will
after our trials in Hadassah," says Har-Noy. "The VCs and pharmaceutical
companies have been so burned in the past that they won't even talk to us
until we bring them human data."
Har-Noy is optimistic. "Our approach is unique. This is potentially a major
breakthrough that could change the paradigm of how we treat cancer. In the
early stages, we might well compete with chemotherapy. In addition, this
treatment could also work in other diseases as well. In animal models we
were able to show that our drug protected mice from malaria, infections in
the brain, and Lupus, so it may well have implications even broader than
cancer."
A seasoned veteran, however, Har-Noy is not about to get carried away.
"Every scientist believes their treatment is going to bring a Eureka moment,
but I've had enough failures to be a little more humble. At Immunovative we
have set in place a system to monitor patients at every step of the
treatment. If it doesn't work, we will know where it gets stuck, and this
data will be vital to understanding what interventions are necessary to make
it work. If we know what the problem is we can develop a solution.
Hopefully, however, we won't need to."
By Nicky Blackburn
http://www.immunovative.co.il
View drug information on Campath.
"Suparat" de celule de tratament Hamuri putere de sistem imunitar pentru a distruge celulele canceroase - 'Angry' Cell Treatment Harnesses Power Of Immune System To Destroy Cancer Cells - articole medicale engleza - startsanatate