Cellceutix Announces Initiation of Main Clinical Site for Phase 2a Trial of p53 Drug Candidate Kevetrin in the Treatment of Platinum-Resistant/Refractory Ovarian Cancer

BEVERLY, Mass., February 10, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to inform shareholders that the Company has initiated its main clinical site for the start of its Phase 2a clinical trial of the p53 drug candidate Kevetrin in the treatment of platinum-resistant/refractory ovarian cancer.

This small mid-stage study being conducted at a Texas cancer center is designed to evaluate Kevetrin for safety and tolerability, as well as assess changes in select biomarkers and objective tumor response. Cellceutix believes that this clinical trial, using IV dosing, will directly inform how Kevetrin modulates the p53 signaling pathway—one of the key questions asked by multiple pharmaceutical companies we are engaged with under Confidential Disclosure Agreements. Furthermore, as the Company has recently achieved 79 percent bioavailability of Kevetrin by oral administration in animal testing, Cellceutix anticipates being able to subsequently switch to oral dosing in future clinical trials, resulting in more frequent and convenient drug delivery. Bridging toxicology studies are now underway to enable this transition to oral dosing of patients.

Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix, said, “In this trial, we will be using sophisticated molecular mapping technology to analyze ovarian cancer tissue samples removed from study participants. Such data, complementing that already generated by testing discrete ovarian cancer cell-lines, will anchor our understanding of Kevetrin’s multimodal mechanism of action, providing a more complete understanding of its full potential as a novel cancer treatment.”

“For Cellceutix, there is a lot of activity going on in Texas. Elsewhere, when we mentioned the bioavailability achieved in oral Kevetrin to scientists at our previous Phase 1 clinical site, they commented that it could represent a significant improvement to lengthy or frequent intravenous infusions and urged us to select them as a site for future Kevetrin trials. That is very encouraging, as they are some of the most respected and experienced investigators in the world,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “The Company is taking a major step not only toward developing a potent new cancer drug, but one that may become the first ever shown to safely modulate p53, with the added benefit of oral delivery.”


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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 is initiating a Phase 2a trial of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent dosing (3 times per week) at higher levels and then 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.

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About Ovarian Cancer

Ovarian cancer is a common type of cancer that 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.

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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.

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