BEVERLY, MA--(Marketwire - July 07, 2010) - Cellceutix Corporation (OTCBB: CTIX) today announced that it has completed all three animal safety pharmacology studies for its cancer compound, Kevetrin™, that are required by the U. S. Food and Drug Administration prior to filing an IND. These studies involve assessments of the impact of the administration of a compound on the respiratory, cardiovascular, and central nervous systems of test animals.
Dr. Krishna Menon, Chief Scientific Officer of Cellceutix commenting on the results, stated, "Previous required testing on the respiratory and central nervous systems showed no significant neuropharmacological or biologically relevant effects. This set of cardiovascular testing coincided with those results with no significant effects at low, medium or high dosage levels. While there was a transient increase in heart rate at extreme dosage levels, we do not believe it will be of any significance going forward as even the highest dosages had no toxicological effects on ECG or cardiac rhythm." Dr. Menon continued, "The completion of animal safety pharmacology studies presents a big milestone for Cellceutix. The remaining toxicology data necessary for preparing our IND should be received by late July."
Multi-drug resistance, the principal mechanism by which many carcinoma strains develop resistance to chemotherapy drugs, is one of the primary reasons for ineffectiveness of standard cancer therapies on the market today. Treatments that were once effective at destroying cancer cells are being rendered ineffective due to specific strains of cancer cells that have modified their compositions to be resistant to today's chemotherapy treatments. Kevetrin, a completely novel compound, is being developed as a possible solution for several strains of lung, breast and colon cancers that have been proving themselves resistant to the chemotherapy drugs presently available.
"The completion of these studies is a giant step forward," said Leo Ehrlich, CFO of Cellceutix. "We are excited to have advanced Kevetrin so far so fast while also developing our other compounds, especially KM-391 for autism. In the last few weeks, we have been visited by a major financial institution wanting to learn more about Cellceutix, as well as meeting with one of the world's largest Pharmas who too wished to learn more about Cellceutix. We are excited that we are now attracting industry attention. I believe this is the start of an exciting time for our Cellceutix team and shareholders."
Cellceutix Corporation is a preclinical cancer, autism 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.