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Cellceutix Completes Successful Pre-IND Meeting With FDA for Cancer Drug


2/16/2010 11:18:11 AM

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:
Cellceutix Corp.
Leo Ehrlich
(978) 633-3623
Email Contact



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