SOURCE: Cellceutix

May 22, 2015 07:00 ET

IRB Approves Additional Enrollment in Cellceutix's Clinical Trial of New Cancer Drug Candidate for Solid Tumors

Company to Seek FDA Guidance to Pursue Phase 2/3 Trial of Kevetrin

BEVERLY, MA--(Marketwired - May 22, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the Institutional Review Board ("IRB") overseeing the Company's Phase 1 clinical trial of Kevetrin for the treatment of advanced solid tumors being conducted at Harvard University's Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center has approved the amended protocol to allow additional patient enrollment to the study. 

The original protocol for the trial specified 40 patients to be enrolled. Due to maximum tolerated dose ("MTD") not yet being identified and data indicating that the effect of Kevetrin on p53, a key tumor suppressor protein often referred to as the "Guardian of the Genome," is dose dependent as expected, Cellceutix requested an amendment to the protocol to continue to evaluate administration of Kevetrin at higher doses. The trial is currently in its eleventh cohort, with one patient (the 40th in the trial) having received two infusions of Kevetrin at 750 mg/m2. The Company has been advised that screening of additional patients is underway and they are expected to be enrolled into the study.

"We interpret the IRB approval as a strong vote of confidence as to the safety and potential impact of Kevetrin to deliver a meaningful effect on p53, a protein that researchers have been trying for decades to safely revitalize to unlock better clinical outcomes in the millions of cancer patients where the p53 pathway is damaged," commented Leo Ehrlich, Chief Executive Officer of Cellceutix. "We could have concluded the trial with the completion of the target enrollment, but we have a novel drug delivering compelling data that we want to push to the limit to best direct the scope of future studies. With regards to cancer, the U.S. Food and Drug Administration is doing a tremendous job with initiatives, programs, and support of trial designs to expedite the development of safe and effective new cancer treatments to get them to patients that so desperately need them. Effectively, this is blurring the lines of traditional clinical trial phases such as 1, 2 and 3 for promising new therapies, and we believe Kevetrin fits that mold as an activator of p53. We are privileged to have the experts at Dana-Farber, Beth Israel Deaconess, and partners conducting the research that is helping us chart a course to try and capitalize on this shifting regulatory trend by meticulously defining which cancer tumor types may be most beneficially impacted by Kevetrin."

With 40 patients enrolled, Cellceutix feels that it has more than ample data supporting the safety of Kevetrin as well as evidence of possible therapeutic benefits. As such, the Company is moving forward with confidence in preparing documentation for a meeting with the Food and Drug Administration seeking to initiate a Phase 2/3 trial of Kevetrin against a specific type of cancer.

Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.VNkn7FY9.dpbs

About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix will soon begin a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.

Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

Contact Information

  • INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
    Email Contact