SOURCE: Cellceutix

September 26, 2011 06:30 ET

Cellceutix to Pursue 505(b)(2) Clinical Process for Psoriasis Drug

Company Releases Pictures of Mice Studies Showing Dramatic Response to Drug

BEVERLY, MA--(Marketwire - Sep 26, 2011) - Cellceutix Corporation (OTCQB: CTIX) (PINKSHEETS: CTIX) (the "Company"), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, today released pictures of its mice study with KM-133, the Company's small molecule acting on the principles of immune stimulation and PRINS reduction as a new treatment for psoriasis. The pictures are available for viewing at http://www.cellceutix.com/product-candidates/km-133---psoriasis-compound.html. The pictures show a dramatic response to treatment with KM-133. In the studies 100% of the mice responded to the treatment.

The Company also reported that it has engaged its FDA consultant for the purpose of preparing a regulatory pathway with the U.S. Food and Drug Administration ("FDA") pursuant to Section 505(b)(2) for KM-133, as a new treatment for psoriasis.

Given the fact that the active moiety of KM-133 is an already FDA-approved product, Cellceutix believes that it will be eligible for a 505(b)(2) regulatory pathway, which permits compounds in development to be taken into advanced stages of clinical trials based upon bioequivalence from previously reported filings; saving time and money in the development process.

Research of a human xenograft animal model of psoriasis conducted by Cellceutix on KM-133 measuring it against methotrexate, a commonly used drug today in the treatment of psoriasis, showed a faster reduction of lesion appearance (84% versus 63%), a greater reduction in serum PRINS (96 versus 48%) and a significant reduction in serum IL-20 (87% versus 46%) in models treated with KM-133 as compared to methotrexate. More importantly, psoriasis lesions showed no reoccurrence in models treated with KM-133 throughout the 180-day study whereas psoriasis lesions reappeared in those treated with methotrexate in 61 days.

"Now that we have Kevetrin™ firmly on course for human trials, we can dedicate resources towards other drugs in our pipeline," commented Cellceutix CEO Leo Ehrlich. "The psoriasis market is a multi-billion dollar opportunity in which we feel we have a competitive edge based upon our pre-clinical data of KM-133 outperforming today's standards of treatment. The results on the mice were beyond our most optimistic expectations. Most importantly the study used a 'human xenograft" animal model of psoriasis. We have signed confidential agreements with some large pharmas who have already shown interest in KM-133. Our belief is that based on the chemistry of KM-133, it meets the eligibility for 505(b)(2) clearance which means that we could have two extremely promising drugs in clinical trials in 2012, with KM-133 potentially being in Phase II/III trials. I am excited about all of the developments happening at Cellceutix and look forward to providing shareholders with frequent updates over the coming weeks."

About Cellceutix
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, KM-133, 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) 236-8717
    Email Contact