Cellceutix AACR Poster Presents Data Supporting Kevetrin Modulation of p53 in Multiple Human Ovarian Cancer Cell-lines and Corresponding Xenograft Tumors

BEVERLY, Mass., April 03, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), is pleased to share further data supporting the p53 mechanism of action of Kevetrin in Ovarian Cancer (OC) at the American Association of Cancer Research (AACR) Annual Meeting.

- Poster title: “Kevetrin induces p53-dependent and independent cell cycle arrest and apoptosis in ovarian cancer cell-lines representing heterogeneous histologies”

- Presentation time: At the AACR Annual Meeting, from 8am to 12pm, Tuesday, April 4, 2017 in Washington, D.C.

Previously, data have been presented from cell studies showing that Kevetrin stabilized wild type p53 and induced transcriptional targets in human lung carcinoma. The current poster presentation includes key findings from studies that we have performed to validate Kevetrin as a potential treatment for OC with varied p53 status. Endometrioid carcinoma (A2780, wt p53), high-grade serous (OVCAR-3, mutant p53; OV-90, mutant p53) and atypical non-serous clear cell (SKOV-3, partially deleted p53) OC cell-lines and tumors were treated with Kevetrin in these studies.

Key findings presented include: transcriptomic analyses, demonstrating Kevetrin modulation of p53 signaling pathways; and induction of cell cycle arrest and apoptosis in Ovarian Cancer cell-lines and in xenograft tumors.

In a completed Phase 1 clinical trial, Kevetrin was well-tolerated with minimal adverse effects. A Phase 2a clinical trial in Ovarian Cancer is currently underway in which similar analyses of pathway modulations by Kevetrin are being explored directly using tumor biopsies before and after treatment.

On April 4, the scientific poster will be available for download on the Events and Presentations section of the Cellceutix company website, linked to below:

http://www.cellceutix.com/new-events-and-presentations/

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About Kevetrin

Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. Cellceutix has initiated a Phase 2a trial of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent Kevetrin administration (3 times per week), escalating to higher dosing in the second cohort, and after trial completion will receive standard of care treatment. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.

Learn more here:
http://www.cellceutix.com/kevetrin-1/

About Ovarian Cancer

Ovarian cancer is a common type of cancer that commonly begins in women’s ovaries. Malignant ovarian tumor cells metastasize either directly through the organs of the pelvis region, or through the bloodstream, or the lymphatic system. The causes of ovarian cancer are still not known, though women over the age of 63 represent more than 50 percent of newly diagnosed cases, with the cancer more frequently found in white women than other ethnicities. Ovarian cancer ranks fifth in cancer deaths among women worldwide. It is estimated that in 2016, in the United States, over 22,000 women will be diagnosed with ovarian cancer, with approximately 14,000 women dying from the disease. A $1.6 billion market, current treatment is often limited to surgery and chemotherapy and there is no cure.

More information can be found at:
https://seer.cancer.gov/statfacts/html/ovary.html

About Cellceutix Phase 2a Ovarian Cancer Trial Design

CTIX-KEV-201 is an open-label, Phase 2a study evaluating the safety, tolerability, and pharmacokinetics of Kevetrin as well as changes in select biomarkers and objective tumor response when administered to patients with platinum-resistant/refractory ovarian cancer. The clinical trial comprises two different short-term treatment regimens and will enroll an estimated 10 patients. Primary outcome measures include the incidence of Treatment-Emergent Adverse Events (TEAEs) and changes in pre-specified biomarkers (via tumor biopsy, examination of ascites fluid and peripheral blood), pre-treatment and post-treatment, at 3 weeks. Secondary outcome measures include objective tumor response, per Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) and plasma concentrations of Kevetrin.

For more information on the CTIX-KEV-201 Phase 2a study, please visit:
https://clinicaltrials.gov/ct2/show/NCT03042702

About Cellceutix

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 first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix's psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced 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 (a defensin mimetic compound) for the prevention of oral mucositis in patients with head and neck cancer. Interim analysis has shown Brilacidin-OM to have a high potential for prevention of severe oral mucositis. Clinical results are consistent with those seen in an animal model in which the occurrence of severe ulcerative oral mucositis was reduced by more than 94% compared to placebo. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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"). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).  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 at www.cellceutix.com.

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INVESTOR AND MEDIA CONTACT
                    
                    Cellceutix Corporation
                    Leo Ehrlich
                    info@cellceutix.com