Cellceutix Approved by FDA to Proceed With Clinical Trials on Novel Cancer Drug
June 22 2012 - 8:13AM
Marketwired
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a
biopharmaceutical company focused on discovering small molecule
drugs to treat unmet medical conditions, including drug-resistant
cancers and autoimmune diseases, is pleased to announce that the
U.S. Food and Drug Administration ("FDA") has completed the review
of the Company's Investigational New Drug (IND) application for
Kevetrin™, the Cellcetix's novel anti-cancer compound, and has
yesterday informed Cellceutix that "we have completed the review of
your submission, and have concluded that you may proceed with the
proposed study."
As previously disclosed, the Phase 1 clinical trials are slated
to be conducted at Harvard Cancer Center's Dana-Farber Cancer
Institute and partner Beth Israel Deaconess Medical Center.
Additionally, the Company has received notification yesterday
from both the Institutional Review Board and the Scientific Review
Committee at the hospital that the protocol for the clinical trial
has been approved.
Further details on the commencement of the clinical trials will
be provided to shareholders next week.
To learn more about Kevetrin™ and the potent anti-cancer
activity that it has demonstrated across multiple cancer lines,
please visit:
http://www.cellceutix.com/product-candidates/kevetrin-our-lead-compound.html
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.
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 Email Contact
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