[acb-diabetics] FW: [leadership] groundbreaking insulin pill nearing market
Shirley Roberts
n8lx at earthlink.net
Thu Feb 14 21:58:03 EST 2013
Shirley Roberts
n8lx at earthlink.net
-----Original Message-----
From: A.C.McGhee <miscwell at atlanticbb.net>
Sent: Thursday, February 14, 2013 7:51 AM
To: leadership at acb.org
Subject: [leadership] groundbreaking insulin pill nearing market
Groundbreaking insulin pill nearing market
Groundbreaking
insulin
pill
nearing
market
For 100 years, scientists searched for a way to deliver insulin
orally
instead of by injection. Now an Israeli team claims it's found
the solution.
Phase
2 clinical trials are coming.
By
Abigail Klein Leichman
February
12,
2013,
No
Comments
Swallowing a pill is much more palatable for diabetics than
getting an
injection. Photo via Shutterstock Swallowing a pill is much more
palatable
for diabetics than getting an injection. Photo via Shutterstock*
Jerusalem's
is one step closer to putting a groundbreaking oral insulin
capsule on the
market for people with Type 2 diabetes. The company is about to
begin Phase
2 clinical trials on 147 people at about a dozen medical centers
in the
United States.
CEO Nadav Kidron tells ISRAEL21c that the company's flagship
product could
revolutionize the , which now affects more than 371 million
people worldwide
and is the seventh leading cause of death in the United States.
Most cases
are Type 2, where the body does not use the hormone insulin
effectively to
metabolize sugars.
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Local relevancy? Send this article to your local press The
current method of
self-injecting insulin is unpleasant and also carries the
constant risk of
infection. A capsule taken by mouth would be more convenient and
also more
natural, as it would mimic insulin's normal route in the body.
But until now nobody had found a way to orally deliver
large-molecule
polypeptides such as insulin and vaccines.
Israel is a major center for
, and in fact the technology underlying Oramed is based on 25
years of
research at Hadassah University Medical Center in Jerusalem by
scientists
including Kidron's mother, Dr. Miriam Kidron.
"After the breakthrough, we sat and talked about how it could
help millions,
but to do that you need to establish a company and get it
financed," Kidron
relates. "I'm a lawyer with an MBA, so I started the company and
raised the
money nearly eight years ago." The elder Kidron is chief medical
and
technology officer of the publicly owned Oramed, and Hadassah is
a
stakeholder.
"When they initiated this project almost 30 years ago at
Hadassah, trying to
get insulin delivered orally looked almost impossible," says
Kidron. "Today
it's just a matter of time till it's on the market."
Insulin capsule can slow the progression of diabetes Kidron
explains that
Oramed's management decided to focus solely on insulin not only
because of
the founding scientists' expertise in diabetes research, but also
because
insulin levels are quite easy to measure in the blood.
And from a business standpoint, diabetes represents a giant
market. Some
$471 billion was spent worldwide last year to treat diabetes, and
the
International Diabetes Foundation estimates that by 2030, some
552 million
people in the world will be diagnosed with the disease.
Most importantly, says Kidron, Oramed's insulin capsule could
slow the
progression of Type 2 diabetes, which has three classic phases.
The first phase can be addressed through and exercise, while the
next phase
requires oral medications that boost the body's own insulin
production. In
the third phase, when the insulin-producing pancreas cannot
continue
producing the hormone, a patient becomes insulin-dependent.
"We wanted to do more than just replace injections - we wanted to
provide an
alternative oral medication as an earlier treatment that can
extend the
second phase and prevent patients from becoming insulin
dependent," says
Kidron.
"That's the revolution."
Nadav Kidron, CEO of Oramed Pharmaceuticals By offering a better
solution in
the second phase of the disease, Oramed could assure that people
with Type 2
diabetes avoid further complications of the disease, while
benefiting from a
less painful, more convenient and more affordable treatment.
Other diabetes meds in the pipeline
Because Type 2 diabetes often results from excess body weight,
Oramed is
also developing an oral capsule containing the hormone exenatide,
which
helps balance
and controls appetite. Exenatide can be given by injection but
it tends to
make people nauseous. The oral preparation would reduce that
side effect and
open it up to a much larger market.
"This is a very potent drug in the world of diabetes. We are now
doing
trials at Hadassah, and probably toward the end of the first
quarter of 2013
we should have results," says Kidron. "If it's successful, we
will then file
for FDA approval."
Oramed has a third product in the pipeline that combines oral
insulin and
oral exenatide. Preliminary results of this therapy were
presented at the
meeting of the American Diabetes Association last June,
demonstrating a
greater positive effect when the two products were given in
tandem.
"We saw that one plus one equals three when people take these
together,"
says Kidron, "and giving them together is better than giving them
separately. So it's another breakthrough not just in delivery
but in
combining these products." Human trials have yet to begin but
results in
animal models are promising.
Though the company employs just 11 people, Oramed is backed by a
scientific
advisory board that includes top diabetes researchers. It
includes, among
others, Nobel Prize laureate Dr. Avram Hershko; Dr. Michael
Berelowitz,
former senior vice president of Pfizer; Gerald Ostrov, former CEO
of Bausch
& Lomb and former senior executive of Johnson & Johnson; and
Prof. Derek
LeRoith, chief of endocrinology, diabetes and bone disease at the
Mount
Sinai School of Medicine
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