Cellceutix Announces Kevetrin Dosing Levels Increased as Clinical Trials Advance
BEVERLY, MA, Dec 14, 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, announces today that clinical
trials being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess
Medical Center for the Company's flagship anti-cancer drug Kevetrin(TM), have
advanced to the next cohort. In addition to patients in the first cohort now
receiving their second cycle of dosing, the Institutional Review Board ("IRB")
and Safety Committee have approved escalated dosing levels for the second cohort.
The Company has been advised that the second cohort will begin dosing during the
week beginning December 16.
"We are very encouraged with the way the Kevetrin trials are progressing," said
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "At this time, we are
eagerly awaiting the pharmacokinetics analysis of the first dosing."
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.
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
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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