Cellceutix Advancing Treatment for Hidradenitis Suppurativa, Pre-IND Meeting Request to Food and Drug Administration - Seite 2

With respect to the Phase 1 clinical trial of Kevetrin for solid tumors being conducted at Harvard's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, the third and final patient in the tenth cohort is now enrolled and being treated with 450 mg/m2. Two patients have completed the dosing protocol with no serious adverse events reported to date. Further, samples have been taken from these subjects and sent to the laboratory for analysis of increased levels of the protein p21, a key biomarker for activity of p53, a protein often referred to as the "Guardian Angel of the Human Genome" because of its role as a master cell regulator and tumor suppressor.

"We are exhilarated for our company and shareholders as the ball is now rolling with respect to our move to Nasdaq. Our team is eagerly putting together the requested information to respond as quickly as possible," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "As far as the Kevetrin trial, we believed that the severe weather conditions recently in the Boston area would have a more profound impact on treating patients. We are very happy to be advised that two patients have completed the treatment per protocol and the final patient in the cohort has been enrolled. We are aiming for a major breakthrough to treat certain types of cancer and greatly look forward to data on the p21 biomarker for patients treated at these higher dosing levels, which we are hopeful will support earlier data from the trial showing that increasing levels of p21 are dose dependent."

Elsewhere in the pipeline, Cellceutix is also now engaged in scaling up the manufacturing of its lead Gram-negative compound for treating Klebsiella species and Escherichia coli (E. coli). Grant money studies are ongoing and data is expected in approximately one month, which will be used for planning clinical research. To expedite the Company's Gram-negative program, Cellceutix is improving the manufacturing process of this very unique HDP mimetic.

Cellceutix intends to provide shareholders with a comprehensive update on all clinical trials and development of compounds in the pipeline following the end of the quarter.

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

About Cellceutix: