Cellceutix Comments on New York Times Article Heralding p53 Drugs as the New Age
in Cancer Research
BEVERLY, MA, Dec 24, 2012 (MARKETWIRE via COMTEX) -- Cellceutix Corporation
(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(TM) As a completely new class of chemistry in medicine,
Kevetrin(TM) 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: clinicaltrials.gov
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(TM), 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
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
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