Cellceutix’s Clinical Trial of Anti-Cancer Agent Kevetrin Meeting its Goals, Approaching End of Trial

BEVERLY, MA–(Marketwired – August 20, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today discussed the Phase 1 clinical trial of Kevetrin in patients with advanced solid tumors. The trial was designed to determine the safety profile of escalating single intravenous doses of Kevetrin. A secondary objective was to assess any preliminary evidence of anti-tumor activity. The trial inclusion limits patients to “Pathologically confirmed solid tumor, locally advanced / metastatic, refractory after standard therapy, or for which no effective curative or surgical treatment options are available.”

The trial has accomplished many of its goals and will be concluded shortly. Over 40 patients have been enrolled, providing ample data to confirm the safety of Kevetrin. Kevetrin has been well tolerated and the pharmacokinetic profile was dose dependent and predictable. Importantly, Cellceutix believes that p53 activation has been shown, as measured by p21 expression in peripheral blood samples. To that point, Cellceutix would like to share an excerpt from Company’s annual report to the U.S. Food and Drug Administration concerning the Phase 1 trial.

“Of 40 subjects enrolled to date, 31 were evaluable for changes in p21 biomarker (pre-dose and at least 1 time point post-dose blood sample obtained after first dose of Kevetrin). Of the 31 evaluable subjects, 68% had an increase in p21 expression in a range of 3% to 205% and 48% had an increase in p21 expression of ≥ 10%, considered a meaningful increase.

Of the 15 evaluable subjects with gynecological cancers, p21 expression increased in 11 (73%) subjects. Also, p21 expression increased in both of the two subjects with prostate cancer.”

These results support the concept that Kevetrin activates p53 by inducing p21 gene expression.

Although the goal of a Phase 1 trial is to evaluate the safety profile of a drug candidate, Cellceutix is optimistic about the potential effects of Kevetrin as evidenced by disease stabilization in several patients. This information has been presented to peers, such as at the latest American Society of Clinical Oncology meeting, and is publicly available on the Cellceutix website. Final data for the safety observations in patients receiving Kevetrin as well as tumor response information will be presented after the completion of the study. We recommend that shareholders and other interested parties review ASCO presentations and reports by the Company.

The Company’s previously reported mechanism of action (MOA) of Kevetrin strongly suggests that Kevetrin has great potential to enhance chemosensitivity. Multiple reports from different laboratories have shown that drugs modulating any of these: p531, HDAC2, c-MYC3(p53:Clin. Can. Research 2009 15, 6495-502; HDAC: Cancer Sci 2008 99, 378-84; c-Myc: Biomed Pharmacother 2015 73, 123-128) has shown enhanced sensitivity to chemotherapeutic drugs. p53 is major determinant of chemosensitivity in humans while mutant p53 proteins can induce drug resistance. Since Kevetrin modulates all of the above molecules, laboratory studies tested the sensitizing ability in mutant p53 cells and tumors which are refractory to chemotherapeutic agents. The combination of Kevetrin with chemotherapy drugs resulted in synergistic apoptosis at a much lower concentrations than with each agent individually. Thus, Kevetrin holds promise to maximize tumor cell killing when used in combination therapies. Laboratory studies conducted by Cellceutix and at leading institutions on the effects of Kevetrin in combination with approved cancer drugs, including studies against renal cancer, pancreatic cancer, ovarian cancer, glioblastoma and acute myeloid leukemia, have delivered promising data supporting the ability of Kevetrin to enhance chemosensitivity.

Additionally, research indicates that Kevetrin is not likely to alter hematological parameters, which would give Cellceutix the opportunity to combine an immunotherapy with Kevetrin for its maximum outcome. In this approach, Cellceutix believes Kevetrin can provide a significant advantage over other drugs in immuno-oncology combination studies.

The clinical data on Kevetrin, with consideration to extensive laboratory studies by Cellceutix and independent institutions, leaves the Company with many potential channels for mid-stage studies of Kevetrin as a monotherapy, combination therapy, or both. Presently, the Company is drafting a study protocol for a Phase 2/3 clinical trial on ovarian cancers.

“The information we have received on Kevetrin is exceptional, especially when viewed with the understanding that Kevetrin is being evaluated in cancer patients with no effective curative or surgical treatment options. The MOA and safety profile will allow us to explore dosing multiple times weekly and combination studies unlike many other drugs, while adding to our optimism that Kevetrin can be a first-in-class drug,” said Leo Ehrlich, Chief Executive Officer. “We have a portfolio of excellent and very valuable compounds. In addition to advancing Kevetrin, the designing of the Phase 3 ABSSSI trial of Brilacidin is ongoing and our Phase 2 trial of Brilacidin-OM for oral mucositis is already enrolling at four clinical sites and we expect to begin recruitment at a fifth site next week. With the recent commencement of our Phase 2 trial of Prurisol for psoriasis, we are operating on all cylinders as we move forward toward our goals of developing best in class FDA approved drugs.”