BEVERLY, Mass., Dec. 15, 2016 (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 announce today the selection of Contract Research Organizations (CROs) to initiate additional nonclinical studies to support the potential transition to oral dosing of Kevetrin for ovarian cancer. Cellceutix continues to build upon the successful Phase 1 trial evaluating Kevetrin in treating advanced solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. Kevetrin, in IV form, was shown to safely modulate, in a non-genotoxic manner, the key tumor suppressor protein p53 as measured through increased expression of p21, a key downstream biomarker of p53. Cellceutix is advancing Kevetrin under an Orphan Drug designation from the Food and Drug Administration (FDA) for the treatment of ovarian cancer, which would qualify it for developmental incentives and a potential additional seven years of market exclusivity upon drug approval.
Due to Kevetrin’s solid pharmacokinetic profile showing a short half-life that results in the drug exiting the human body in approximately 8 to 10 hours, the drug candidate appears ideal for administration on a daily basis. In order to best accommodate frequent dosing, Cellceutix is working to develop an oral formulation of Kevetrin. There are currently no approved drugs acting through modulation of p53 for treating cancer, much less in pill form. Based upon discussions with advisors and others with deep experience in this area, Cellceutix believes that an oral formulation of such a drug would command strong interest from large pharma, potential resulting in a development partnership or investment.
To assess Kevetrin’s bioavailability, groups of mice were administered Kevetrin either intravenously or orally. At several different time points, blood samples were taken and then analyzed for concentrations of Kevetrin in the plasma using LC-MS/MS methodology. Results of these analyses demonstrated highly encouraging bioavailability via the oral route. Further studies in a mouse model, in which human ovarian cancer cell line OV90 was examined, showed both intraperitoneal and oral Kevetrin administration were successful in prolonging survival. On the basis of these results, Cellceutix has now selected CROs to perform the additional nonclinical studies, including necessary bridging toxicology, required to support clinical dosing of Kevetrin via the oral route. Additional laboratory research is underway to further expand these findings.
The next step after obtaining the results of the supportive nonclinical studies will be to engage with FDA pertaining to initiating a Phase 1 oral Kevetrin safety and toleration study in healthy volunteers as Kevetrin is non-cytotoxic. As is often the case with this type of study, Cellceutix anticipates that this type of trial could be completed in an expeditious fashion. The aim is to subsequently enable convenient therapeutic dosing in the ovarian cancer population.
“We very much look forward to being able to dose Kevetrin in oral form as it will make possible a frequency of daily dosing, multiple times per day. This should provide a way for patients to garner the full benefit of the therapy in a way that simply would not be practical by intravenous infusion,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix.
Leo Ehrlich, Chief Executive Officer at Cellceutix commented, “An effective and safe p53-modulating anti-cancer drug has blockbuster potential. The possibility of formulating Kevetrin in a pill form where patients could conveniently be dosed frequently, possibly twice a day, has us extremely excited, as it could one day position Kevetrin as a go-to cancer treatment. I think based on all the studies to date, we are on our way to accomplishing this and it will have a life-altering effect on countless patients.”
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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 will be initiating a Phase 2a trial of Kevetrin in platinum-resistant 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.
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. More information can be found at: https://seer.cancer.gov/statfacts/html/ovary.html
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 is preparing for 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 for the prevention of oral mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis 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 Infections, 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 cohort 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 on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
CONTACT: INVESTOR AND MEDIA CONTACT: Cellceutix Corporation Leo Ehrlich info@cellceutix.com
