Cellceutix Files Amended IND With FDA for Its Novel p53 "Guardian Angel" Anti-Cancer Drug
May 21 2012 - 9:10AM
Marketwired
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a
biopharmaceutical company developing a novel drug to treat cancers
and cancers which have proven resistant to today's cancer therapies
(drug-resistant cancers), is pleased to announce that its amended
Investigational New Drug ("IND") application for Kevetrin™ has been
submitted to the U.S. Food and Drug Administration ("FDA") today.
As previously disclosed, the planned Phase 1 clinical trial for
this pioneering drug is to take place at the Harvard Cancer Center
in Boston.
Per standard protocol, the FDA now has 30 calendar days to
review and present any questions related to the IND before the
Company can initiate the commencement of the clinical trial. The
clinical trial will test Kevetrin against a variety of cancer types
in patients with advanced-stage cancers. Primary endpoints for the
study will be safety and tolerable dosing levels for a future Phase
2 clinical trial.
Cellceutix consultant Dr. Sylvia Holden commented, "I have been
researching new drugs for nearly 30 years. Cellceutix is now a true
pioneer in oncology discovery with this very special compound,
Kevetrin. The Mechanism of Action of Kevetrin™, impacting both wild
and mutant types of p53 to induce apoptosis and cell cycle arrest
through multiple pathways while being well-tolerated, is what sets
it apart from other chemotherapies today. Rather than being a
traditional drug that targets and attempts to seek and destroy
cancer cells independently, Kevetrin™ revitalizes p53 so that the
body's natural defense system eliminates the tumor on its own. As a
stand-alone or combination front-line therapy, the magnitude of the
potential of Kevetrin™ is simply unparalleled by anything that I
have ever seen in the laboratory before."
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix
commented, "I will be attending the American Society of Clinical
Oncology ("ASCO") Meeting in June to continue discussions regarding
Kevetrin™. We anticipate that next year we will be presenting data
from this year's planned clinical trials."
About Dr. Sylvia Holden Dr. Holden
received her PhD from Boston University followed by an NIH-funded
post-doctoral fellowship at Dana-Farber Cancer Institute in the
Division of Cancer Pharmacology headed by chemotherapy pioneer and
Cellceutix Scientific Advisor Dr. Emil Frei III. Before joining
Cellceutix, Dr. Holden was the Director of Pharmacology at EMD
Serono in Billerica, MA (Merck KGaA) and Director of Tumor Biology
at Shionogi BioResearch Corp., in Lexington, MA (presently Synta
Pharmaceuticals). She was awarded 5 US patents and has published
over 100 publications in peer-reviewed journals, including 12
first-authored papers and publications in Science and Nature
Medicine.
About Kevetrin™ As a completely new class
of chemistry, 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, 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.
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.
Cellceutix Corp. Leo Ehrlich (978) 236-8717
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