BEVERLY, MA--(Marketwired - February 16, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce the successful completion of its Phase 1 trial of Kevetrin in patients with advanced solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center.
The open-label, dose escalation study met Cellceutix's objectives by demonstrating the safety and tolerability of Kevetrin, while providing key information on the pharmacokinetics of Kevetrin. These data are being utilized in designing a Phase 2 study, which will evaluate Kevetrin as a component of combination therapy in the treatment of ovarian cancer. As disclosed on February 10, 2016, the U.S. Food and Drug Administration (FDA) informed Cellceutix that increasing the frequency of Kevetrin dosing from once weekly to three times weekly would be acceptable based upon the data from the Phase 1 study. We look forward to these future trials and are hopeful that Kevetrin will develop into one of the great cancer treatment drugs.
Cellceutix is developing Kevetrin under an Orphan Drug designation for ovarian cancer from the FDA.
Cellceutix would like to thank all the staff at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center for their tireless work and valuable insight throughout the clinical trial, especially the trial's Principal Investigator, Dr. Geoffrey Shapiro. The trial was a success and we appreciate the opportunities recently afforded to us to further expand enrollment for the purpose of excellent research on Kevetrin for better patient care.
Cellceutix is now informing clinicaltrials.gov that the trial is no longer active and expects the website to be updated soon to reflect the trial as completed.
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 multiple diseases. 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 concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its application for a Phase 2 study. 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 is in 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 is in 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.