Enrollment in Phase 2b Trial of Novel Antibiotic Brilacidin Approximately 70% Complete
BEVERLY, MA–(Marketwired –June 16, 2014)- Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to report that the safety committee overseeing the Phase 1 clinical trial evaluating Cellceutix’s lead anti-cancer drug Kevetrin for solid tumors being conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center has approved dosing for the eighth cohort. The dosing was been increased approximately 33 percent from the seventh cohort to 215 mg/m2. Enrollment for the eighth cohort is expected to commence shortly.
Cellceutix would also like to inform shareholders that enrollment in the Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) is approximately 70 percent complete. To date, no drug-related serious adverse events have been reported.
The Company has been advised that the Brilacidin safety committee meeting is scheduled for the end of June. Cellceutix anticipates providing shareholders with an update on data from the trial and any commentary from the safety committee in the first half of July.
Cellceutix is delighted by the recent release of the final rule by the U.S. Food and Drug Administration list of qualifying pathogens under the Generating Antibiotic Incentives Now (GAIN) Act. The list is advantageous to our Company’s robust portfolio of defensin mimetics, as the list contains many of the pathogens we are working on. We expect to benefit from the regulatory framework of the GAIN Act to expedite development. Interested parties are encouraged to read the Federal Register to learn more about the final rule list by the U.S. Food and Drug Administration at: http://www.gpo.gov/fdsys/pkg/FR-2014-06-05/pdf/2014-13023.pdf
Additionally, Cellceutix has been informed that the U.S. Patent and Trademark Office has issued a Notice of Allowance for the U.S. Patent Application No. 13/730247 “Carbocyclic Nucleosides And Their Pharmaceutical Use And Composition” with claims covering Cellceutix’s compound Prurisol. Cellceutix announced on June 2, 2014 that it has completed enrollment in a Phase 1 crossover study of Prurisol as a new drug candidate for the treatment of psoriasis and that lab results, pharmacokinetic studies, and analysis is expected to take approximately two months.