Cellceutix Comments on New York Times Article Heralding p53 Drugs as the New Age in Cancer Research
December 24 2012 - 7:00AM
Marketwired
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical
stage biopharmaceutical company focused on discovering small
molecule drugs to treat unmet medical conditions, including
drug-resistant cancers and autoimmune diseases, today provides
commentary on a front page New York Times article published
December 23, 2012 titled, "Genetic Gamble; New Approaches to
Fighting Cancer."
The article, authored by Gina Kolata, discusses a seismic change
in the direction that cancer research may undergo. Major
pharmaceutical companies are striving to conduct clinical trials
testing their drug candidates against a wide range of cancers,
regardless of the tumor's origin. More succinctly, the article
focuses on the key protein p53, often referred to as the "Guardian
Angel Gene," and initiatives by Merck & Co., Roche Holding
Ltd., and Sanofi SA in "racing to develop their own versions of a
drug they hope will restore a mechanism that normally makes badly
damaged cells self-destruct and could potentially be used against
half of all cancers."
"I am pleased to see such a high profile article being written
on the game changing impact that a p53 drug can have on treating
cancers," said Leo Ehrlich, Chief Executive Officer of Cellceutix.
"While I am disappointed that Cellceutix was not mentioned in the
article, I understand that the article was likely written before
Cellceutix's clinical trials began. The facts are while other
compounds mentioned are not yet in clinical trials, or ready for
clinical trials, our flagship p53 compound, Kevetrin is currently
in phase 1 trials ongoing at Harvard's Dana-Farber Cancer Institute
and Beth Israel Deaconess Medical Center. I believe that a
discerning examination of the article and publicly available
information shows that we are not only ahead of these larger
companies, but we have a better mechanism which is more likely to
function against most cancers. Our research to date shows that
Kevetrin affects both wild and mutant types of p53, a claim that to
the best of our understanding, the other companies cannot make. It
is true that Roche has had Nutlins in clinical trials for years,
but has faced ongoing challenges. Our data shows that Kevetrin is
non-genotoxic, meaning that it does not damage surrounding normal
DNA."
"As we stated in a press release on April 25, 2011 discussing
our poster presentation at last year's annual meeting of the
American Association for Cancer Research, Kevetrin was a standout
then amongst any other p53 drug in development," added Dr. Krishna
Menon, Chief Scientific Officer of Cellceutix. "Nothing has
fundamentally changed since that day. In fact, the additional
laboratory data that we have collected on Kevetrin, reinforces the
novel drug's ability to re-activate p53 to its role as a potent
anti-proliferative and pro-apoptotic protein and holds a great deal
of promise as a new therapeutic for treating cancer including some
of the most difficult to treat types of the disease. The New York
Times may have overlooked Cellceutix and Kevetrin, but the
organizations that are contacting us to host and sponsor clinical
trials certainly have not."
About Kevetrin™ As a completely new class of chemistry in
medicine, Kevetrin™ has significant potential to be a major
breakthrough in the treatment of solid tumors. Mechanism of action
studies showed Kevetrin's unique ability to affect both wild and
mutant types of p53 (often referred to as the "Guardian Angel Gene"
or the "Guardian Angel of the Human Genome") and that Kevetrin
strongly induced apoptosis (cell death), characterized by
activation of Caspase 3 and cleavage of PARP. Activation of p53
also induced apoptosis by inducing the expression of p53 target
gene PUMA. p53 is an important tumor suppressor that acts to
restrict proliferation by inducing cell cycle checkpoints,
apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited
in its anti-tumor activities by mutations in the protein itself.
Currently, there are greater than 10 million people with tumors
that contain inactivated p53, while a similar number have tumors in
which the p53 pathway is partially abrogated by inactivation of
other signaling components. This has left cancer researchers with
the grand challenge of searching for therapies that could restore
the protein's protective function, which Kevetrin appears to be
doing the majority of the time.
The clinical trial titled, "A Phase 1, Open-Label,
Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study
of Kevetrin (Thioureidobutyronitrile) Administered Intravenously,
in Patients With Advanced Solid Tumors," is available at:
http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
About Cellceutix Headquartered in Beverly, Massachusetts,
Cellceutix is a publicly traded company under the symbol "CTIX". It
is an emerging bio-pharmaceutical company focused on the
development of its pipeline of compounds targeting areas of unmet
medical need. Our flagship compound, Kevetrin™, is an anti-cancer
drug which has demonstrated the ability in pre-clinical studies to
regulate the p53 pathway and attack cancers which have proven
resistant to today's cancer therapies (drug-resistant cancers).
Cellceutix also owns the rights to seven other drug compounds,
including KM-133, which is in development for psoriasis, and KM-391
for the treatment of the core symptoms of autism. More information
is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not
strictly historical, including statements as to revenue
projections, business strategy, outlook, objectives, future
milestones, plans, intentions, goals, future financial conditions,
future collaboration agreements, the success of the Company's
development, events conditioned on stockholder or other approval,
or otherwise as to future events, such statements are
forward-looking, and are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
The forward-looking statements contained in this release are
subject to certain risks and uncertainties that could cause actual
results to differ materially from the statements made. Factors that
may impact Cellceutix's success are more fully disclosed in
Cellceutix's most recent public filings with the U.S. Securities
and Exchange Commission.
INVESTOR AND MEDIA CONTACT: Cellceutix Corp. Leo Ehrlich (978)
236-8717 Email Contact
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