Cellceutix Completes Successful Pre-IND Meeting With FDA for Cancer Drug
Company Has Remaining Pre-IND Animal Studies on Kevetrin(TM) Underway
BEVERLY, MA--(Marketwire - February 16, 2010) - Cellceutix Corporation (OTCBB: CTIX), a
bio-pharmaceutical company that develops small molecules to treat cancer
and inflammatory disease, today announced that is has completed a
successful pre-Investigational New Drug exemption (pre-IND) meeting with
the U.S. Food and Drug Administration (FDA) for its lead compound,
Kevetrin, which is being developed to treat drug resistant cancers. The
Company has the remaining pre-IND animal studies for Kevetrin underway.
These studies consist of intermediate-term toxicity studies in two species
and safety pharmacology studies in the cardiovascular, central nervous
system and respiratory areas.
In animal studies, Kevetrin was found to significantly delay tumor growth
in two multi-drug resistant lung cancer cell lines. In two experiments
with the NCI-H1975 cell line, Kevetrin showed an average tumor growth delay
of 149% compared to controls, while paclitaxel delayed tumor growth an
average of 72%. The delay in Kevetrin treated animals was significantly
greater than in the animals treated with paclitaxel (p < 0.01). In two
experiments with the A549 cell line, Kevetrin showed an average tumor
growth delay of 72% compared to controls while paclitaxel showed an average
tumor growth delay of 6%. Again, the delay in Kevetrin treated animals was
significantly greater than in the animals treated with paclitaxel (p <
0.01). Kevetrin has also shown promising results in animal studies of
resistant breast and colon cancer.
"FDA provided some very helpful comments on our study protocols," said
George Evans, CEO of Cellceutix. "We have incorporated their comments and
now have the remaining studies underway, after which we will be able to go
forward with our IND filing. This would be a very significant milestone
for Cellceutix."
An audio link discussing this event is at:
http://www.cellceutix.com/news/press-release-audio-2-16-2010.html
About Cellceutix
Cellceutix Corporation is a preclinical cancer and anti-inflammatory drug
developer. Cellceutix owns the rights to seven drug compounds, including
Kevetrin, which it is developing as a treatment for certain cancers, and
KM-133, which it is developing for the treatment of psoriasis. More
information is available on the Cellceutix web site at www.cellceutix.com.
This Press Release contains forward-looking statements that are based on
our current expectations, beliefs and assumptions about the industry and
markets in which Cellceutix Corporation operates. Such forward-looking
statements involve known and unknown risks, uncertainties, and other
factors that may cause Cellceutix's actual results to be materially
different from any future results expressed or implied by these
statements. Actual results may differ materially from what is expressed in
these statements, and no assurance can be given that Cellceutix can
successfully implement its core business strategy and improve future
earnings.
The factors that may cause Cellceutix's actual results to differ from its
forward-looking statements include: Cellceutix's current critical need for
additional cash to sustain existing operations and meet ongoing existing
obligations and capital requirements; Cellceutix's ability to implement its
new product development and commercialization, enter into clinical trials,
expand the intellectual property portfolio, and receive regulatory
approvals in a timely and cost-effective manner. All forward-looking
statements are also expressly qualified in their entirety by the cautionary
statements included in Cellceutix's SEC filings, including its quarterly
reports on Form 10-Q and its annual report on Form 10-K.
Kevetrin has not been studied in humans at this time. The Company's
positive results in animal studies do not necessarily guarantee success in
humans, though they may form the basis for beginning Phase 1 trials.
Contact Information: Contact:
Cellceutix Corp.
Leo Ehrlich
(978) 633-3623