SOURCE: Cellceutix

September 28, 2010 09:06 ET

Cellceutix Nearing Completion of Toxicity Studies for Its Cancer Compound for the Treatment of Resistant Lung and Breast Cancers

Company Begins Discussions With One of the World's Leading Cancer Centers for the Expected Phase 1 Trials

BEVERLY, MA--(Marketwire - September 28, 2010) -  Cellceutix Corporation (PINKSHEETS: CTIX) today announced that it has completed its first species toxicity study under the conditions prescribed by United States Food and Drug Administration (FDA) Good Laboratory Practices regulations. This study is required for an Investigational New Drug (IND) filing. In the study, rats were administered five doses of Kevetrin ™ weekly over a 29 day period. Three groups of 20 animals were administered 60 mg/kg, 90 mg/kg and 120 mg/kg respectively while a fourth group acted as controls. There was a 14 day recovery period after the dosing. Parameters measured were hematology, clinical chemistries, weight change, food consumption, survival, and pathology.

"We are now completing a similar study in the second tier of animals as required by the FDA," said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "At Cellceutix we are very excited about the progression of Kevetrin as we are right on course with our business plan to develop it as a treatment for cancers that are resistant to standard therapies."

In animal studies, Kevetrin was found to significantly delay tumor growth in multi-drug resistant lung, breast and colon cancer cell lines. In data presented in April, 2010 at the American Association for Cancer Research, the efficacy of Kevetrin in a mouse model of drug resistant lung cancer was shown to increase with increasing dose. The data presented at the AACR also show that the administration of a second cycle of therapy with Kevetrin in the same animal model continues to delay tumor growth without the development of resistance.

"The toxicity studies are on the critical path for our IND filing," said George Evans, CEO of Cellceutix. "The final FDA required studies necessary to begin human trials are near completion, after which we will be able to file our IND. The Company has begun discussions with clinical investigators at one of the world's leading cancer centers for the expected Phase 1 trials."

About Cellceutix

Cellceutix Corporation is a preclinical cancer and anti-inflammatory drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, and KM-391, which it is developing for the treatment of autism. 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 and KM-391 have 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
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