Cellceutix Reports on Kevetrin Clinical Trials and Prurisol Manufacturing
February 25 2013 - 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, is pleased to
provide shareholders an update on Kevetrin™, the Company's novel
drug in development for multi-drug resistant cancers, and
Prurisol™, the Company's anti-psoriasis drug in development set to
commence mid-stage clinical trials.
The Phase 1 clinical trial of Kevetrin targeting solid tumors at
Dana-Farber Cancer Center and Beth Israel Deaconess Medical Center
is progressing as expected with the next cohort to begin treatment
at escalated dosing levels. Studies evaluating the p21 biomarker
will soon begin and the first data report is expected in
mid-March.
"We are excited by the advancement of the clinical trials of
Kevetrin as we move toward finding the MTD (maximum tolerated
dose)," said Dr. Krishna Menon, Chief Scientific Officer of
Cellceutix. "While we are still early in the trials, we are eager
to receive information on the p21 biomarker as it could represent a
major breakthrough in cancer research. There has been no shortage
of commentary and discussions in the scientific community recently
about the latest initiatives of the U.S. Food and Drug
Administration to further expedite novel drugs to market for areas
of great unmet medical need. Obviously, we will be exploring this
option for Kevetrin, however an application for this type of rapid
movement through the regulatory process can only be made after the
completion of the phase 1 clinical study."
Regarding Prurisol, Dr. Menon and Cellceutix Chief Executive
Officer Leo Ehrlich have recently returned from meetings with Dr.
Reddy's Laboratories Ltd., ("Dr. Reddy's"), a New York Stock
Exchange listed company, at Dr. Reddy's state-of-the-art
manufacturing facility and headquarters in Hyderabad, India.
Dr. Reddy's has completed the process development of Prurisol
and is now in the formulation stage for the manufacturing of
Prurisol for the upcoming clinical trials in Europe planned for the
second quarter of 2013.
"At our meetings with Dr. Reddy's, we met with over twenty
scientists working on the Prurisol project. I was very impressed
with the comprehensive scientific team that they have dedicated to
our project," said Leo Ehrlich. "While they had already informed us
that they had reduced the number of manufacturing steps, Dr.
Reddy's has now advised that they have further condensed the
process, which is delivering much higher yields than originally
anticipated that ultimately will save us valuable time and money in
the production of Prurisol."
The Company is pleased to report that the recently filed
registration statement with the Security and Exchange Commission is
now effective, thus concluding the imposed "quiet period."
Additional updates on the planned studies testing Kevetrin
against Acute Myelogenous Leukemia at the University of Bologna as
well as other corporate developments relating to research on
Kevetrin at a world-renowned cancer center in the Southwest United
States are forthcoming shortly.
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.
Further information on 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.
Cellceutix Corp. Leo Ehrlich (978) 236-8717
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