Assay Results from Cellceutix Phase 1 Clinical Trial of Kevetrin for Cancer Show Increased p21 Expression in 67.5% of Evaluable Patients

BEVERLY, MA–(Marketwired – February 22, 2016) Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to release the latest p21 data from the recently completed Phase 1 trial of Kevetrin for patients with advanced solid tumors.

Cancer is an extremely complex disease, with many different types falling under a general category.  For instance, there are dozens of types of ovarian cancer, categorized by the type of cell from which they originate. While many are treated in the same manner, scientists are working to try and determine if certain types, such as epithelial, need to be treated differently than others, such as the serous type.  These differences can be culprits in the failure of many experimental drugs to have efficacious results in clinical trials, which once looked promising in the laboratory.  In Cellceutix’s view, the best likelihood for success with a new drug is for it to identify and target a common factor across the different tumor variations.  In our planned clinical trial for treating ovarian cancer, the commonality that Kevetrin is being developed to target is the key tumor suppressor p53, a protein that is typically damaged or dormant in ovarian cancer, as well as cancers of different origins.

The Phase 1 study, conducted at Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center, evaluated not only the safety and pharmacokinetics of Kevetrin, but also assessed changes in p21 expression in peripheral blood monocytes as a measure of p53 activation resulting from Kevetrin treatment.  Expression of p21, a potent cyclin-dependent kinase inhibitor, is tightly controlled by the tumor suppressor protein p53, also known as the “Guardian Angel of the Human Genome.”

A total of 48 patients in the study received Kevetrin and final p21 expression data are now available for 40 patients; samples could not be analyzed for 8 patients.  Samples were collected at 7 and 24 hours after the initiation of the first Kevetrin infusion. Regardless of tumor type a total of 27 of the 40 patients (67.5%) had increases in p21 expression relative to pre-treatment levels. For the 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).

These data confirm the ability of Kevetrin to activate p53, as shown in a majority of the patients in this study. In addition, the detection of p21 expression at 24 hours after Kevetrin administration, coupled with the known short half-life of Kevetrin in plasma, is consistent with an intracellular site of action of Kevetrin.  Finally, the suggestion of a dose-response in p21 expression with higher Kevetrin doses will be further evaluated in the planned clinical study in patients with ovarian carcinoma.

“In past releases, we have discussed disease stabilization and reduction of cancerous lesions in some patients treated with Kevetrin,” said Leo Ehrlich, Chief Executive Officer at Cellceutix. “Now, this new p21 data only reinforces our high expectations for and confidence in Kevetrin, specifically, its potential to treat patients across a broad spectrum of cancer types and even those in late stages with refractory tumors. It is exciting to see our early clinical work in the lab translating to the bedside.”