Cellceutix Novel Anti-Cancer Drug Kevetrin(TM) Receives IRB and SRC Approvals for Clinical Trials at Harvard's Dana-Farber Ca...
June 26 2012 - 7:00AM
Marketwired
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a
biopharmaceutical company focused on discovering small molecule
drugs to treat unmet medical conditions, is pleased to follow-up on
its press release from Friday, June 22, 2012 in which the Company
announced that the U.S. Food and Drug Administration ("FDA") has
approved the Investigational New Drug (IND) application for
Kevetrin™, Cellceutix's novel anti-cancer compound. The Phase 1
trials are to be conducted at Harvard Cancer Center's Dana-Farber
Cancer Institute and partner Beth Israel Deaconess Medical Center.
The Company received notification of clearance to proceed with
the clinical trials from the FDA as well as notification of
approval of the protocol from both the Institutional Review Board
("IRB") and the Scientific Review Committee ("SRC") throughout the
day on Thursday, June 21, 2012.
The trial, titled, "A Phase I, Open-Label, Dose-Escalation,
Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin
(thioureidobutyronitrile) Administered Intravenously in Patients
with Advanced Solid Tumors," will be conducted for the
determination of the pharmacokinetics, pharmacodynamics, tolerance,
safety, and maximum tolerated dose in patients with the diagnosis
of refractory solid tumors. Approximately 40 patients will be
enrolled in the dose escalation portion of study. In addition, once
the MTD has been established, up to 12 additional patients may be
enrolled at the MTD dose level to further evaluate this dosage
safety and pharmacodynamics.
The Principal Investigator for the trial is Geoffrey Shapiro,
MD, PhD, Director, Early Drug Development Center and Associate
Professor of Medicine, Harvard Medical School.
The primary objectives are the following:
- To determine the maximum tolerated dose (MTD) of Kevetrin.
- To determine the dose limiting toxicities (DLT) of
Kevetrin.
- To establish a safe dose level of Kevetrin that can be used for
future studies.
The secondary objectives are to determine the following:
- The pharmacokinetics of Kevetrin in humans.
- Observe for evidence of antitumor activity following
administration of Kevetrin.
- If there is a pharmacodynamic relationship between the plasma
concentrations of Kevetrin and a clinical/cellular effect.
- If Kevetrin induces changes in the biomarker p21 in peripheral
blood lymphocytes.
"In many, if not the majority, of instances, approval from the
IRB and SRC can take months to receive. For us to be notified the
same day as the FDA clearance that the protocol has been approved
by the hospital is extremely rare and I believe that shows the
commitment to commence the human trials as quickly as possible,"
commented Dr. Krishna Menon, Chief Scientific Officer at
Cellceutix. "Everything is coming together very nicely and we will
now be meeting with the host hospitals regarding the scheduling of
patient enrollment and the first doses of Kevetrin™ to be
administered."
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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