Cellceutix Announces Database Lock in Phase 1 Trial of Kevetrin, a Promising New Cancer Treatment That Activates p53

BEVERLY, MA--(Marketwired - June 06, 2016) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce that the study database from the Phase 1 trial of Kevetrin (thioureidobutyronitrile) for advanced solid tumors will be "soft locked" this week. These locked results are the final protocol requirement for the study of Kevetrin in its next clinical trial and will be added to the already prepared documentation for submission to the U.S. Food and Drug Administration ("FDA") in support of the planned Phase 1b/2 trial of Kevetrin in ovarian cancer patients with resistance to platinum-based therapies. Cellceutix is developing Kevetrin under an Orphan Drug designation from the FDA.

The first-in-human clinical trial evaluating the safety and pharmacokinetics of Kevetrin was conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The study enrolled a total of 48 patients, who had failed previous therapies, with various types of advanced solid tumors, including 11 patients with advanced ovarian cancer. A dose-escalation design was used with patients enrolled in 11 cohorts with the maximum dose administered at 750 mg/m2. Kevetrin was shown to be safe and well-tolerated, with no dose-limiting toxicities occurring among patients who received even the highest dose of Kevetrin.

Kevetrin has a unique multimodal mechanism of action. The drug enhances the activity of p53, a key tumor suppressor protein often referred to as the "Guardian Angel" gene, in both wild type and mutant p53-expressing tumors. In the majority of advanced ovarian cancer patients, p53 is inactive because of genetic mutations. In the completed trial, the hospital measured p53 activity by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. Samples were collected from patients at 7 and 24 hours after the initiation of the first Kevetrin infusion.

Preliminary data has been very encouraging. As previously released, regardless of tumor type, a total of 27 of 40 evaluable patients (67.5%) had an increase in p21 expression relative to pre-treatment levels. For patients with the greatest increases at either 7 hours or 24 hours, the mean percent increase at 7 hours (10 patients) was 38.5% (median 22%) and at 24 hours (17 patients) the mean percent increase was 24.5% (median 17%). For those patients who received Kevetrin at doses of ≤ 165 mg/m2, the mean percent increase was 21.7% (n=11). And for patients who received Kevetrin at doses ranging from 215 mg/m2 to 750 mg/m2, the mean percent increase was 35.2% (n=17). Concerning ovarian cancer in particular, analyses showed increased p21 expression in 8 of 11 (73%) patients.