With Contracts and IND Application in Hand, Cellceutix Nears Clinical Trials for New Cancer Drug
Published: Aug 01, 2011
BEVERLY, MA--(Marketwire - August 01, 2011) - Cellceutix Corporation (OTCQB: CTIX) (PINKSHEETS: CTIX), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, would like to update shareholders on recent developments regarding the impending clinical trials for Kevetrin™, the Company's novel anti-cancer compound. The contracts for the clinical trials to be hosted by a world- renown cancer center have been received and reviewed, and are slated to be back at the clinical site by the end of the week. The 3,000-page Investigational New Drug (IND) application has been reviewed and is ready for printing and binding. Stability testing has been completed for the manufactured materials in dose form and are now in hand for the commencement of clinical trials.
"It's been a long road, but the light at the end of the tunnel is now bright," commented Cellceutix CEO Leo Ehrlich. "As CEO and a significant investor in Cellceutix, I can't possibly express how pleased I am with our position at this moment as we seek to make our mark on the future of cancer therapies. We are ready."
Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, KM-133, for the treatment of psoriasis, and KM-391, 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, KM133, 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.