SOURCE: Cellceutix

March 24, 2015 08:28 ET

Tenth Cohort Completed in Cellceutix Clinical Trial of Anti-Cancer Drug Kevetrin, No Adverse Events Reported

BEVERLY, MA--(Marketwired - Mar 24, 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 tenth cohort in the Company's Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center has been completed. Patients in the tenth cohort were treated with 450 mg/m2 of Kevetrin with no adverse events reported.

Cellceutix has been advised that the tenth cohort is being included in the latest testing for the effect of Kevetrin on the biomarker p21, a key downstream protein and proxy for reactivation of the tumor suppressor protein p53. The data on p21 are expected to be received in mid-April.

Cellceutix had several options on the table moving forward with the trial. After meeting with the trial's Principal Investigator and Cellceutix consultants, the Company has decided to take dosing even higher due to the wide bandwidth of Kevetrin and enroll an eleventh cohort. The Safety Committee will meet in the coming weeks to determine the new dosing level, which, theoretically, could be increased up to 100 percent in a bid to define the maximum tolerated dose of Kevetrin.

"This is great news that the tenth cohort has been completed, once again demonstrating the safety of Kevetrin. Our team is excited by the fact that no dose limiting toxicity (DLT) has been seen even at these higher levels, as DLT has historically been a significant hurdle for any biotech targeting p53. As such, we're going to continue to push our novel drug as far as possible for maximum therapeutic effect and to collect the most robust data set possible," commented Dr. James Alexander, Chief Operating Officer at Cellceutix. "We have seen some encouraging data in different types of cancer to date and the eleventh cohort gives us the opportunity to add to our knowledge base in preparation for future clinical studies."

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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.

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