SOURCE: Cellceutix

Cellceutix

March 31, 2016 09:00 ET

Cellceutix Successfully Completes In Vitro Study in Support of Planned Phase 2 Trial of Kevetrin for Ovarian Cancer

Research on CYP450 Shows No Concerns for Adverse Drug-Drug Interactions in Combination Therapy

BEVERLY, MA--(Marketwired - March 31, 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 announce that the latest laboratory research on the Company's anti-cancer drug Kevetrin showed that Kevetrin did not inhibit or induce cytochrome P450 enzymes in vitro. Based upon the documented relationship of P450 and certain potential drug-drug interactions, this positive data is central to the planned Phase 2 clinical trial where Kevetrin will be used in a combination therapy for the treatment of ovarian cancer.

The testing was performed at the request of the U.S. Food and Drug Administration ("FDA") during Cellceutix's recent meeting with the FDA pertaining to the planned Phase 2 trial. Per standard protocol, the FDA requires specific studies in an attempt to preempt possible drug interaction complications during human trials. The requisite in vitro testing met Cellceutix's expectations in demonstrating that Kevetrin can be combined with another anti-cancer drug without any concerns of adverse drug-drug interactions.

Enzymes produced by cytochrome P450 genes are involved in the synthesis and metabolism of molecules within cells. Cytochrome P450 enzymes (CYP450), found primarily in liver cells, account for 70 to 80% of enzymes involved in drug metabolism (US National Library of Medicine, 2016). There are more than 50 enzymes, but only six metabolize 90% of drugs, especially CYP3A4 and CYP2D6 (Lynch and Price 2007).

Many drugs are metabolized through the CYP450 enzyme system, which can be inhibited or induced by other molecules, such as anti-cancer drugs, grapefruit juice or tobacco. It is important to know if a molecule inhibits or induces these enzymes, especially when used in combination with other drugs, since there is a potential for drug-drug interaction that can cause unexpected adverse events or inactivity (Ogu and Maxa 2000).

Kevetrin, under development as an anti-cancer agent as monotherapy or in combination with chemotherapeutic agents, was assessed for its ability to inhibit or induce P450 enzyme activity.

For assessment of inhibition of CYP450, Kevetrin, at concentrations up to 100 μg/mL, were incubated with human liver microsomes and enzyme-specific substrates at 37°C. The following CYP450 isozymes were evaluated: 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4. Kevetrin showed little to no inhibition and no time dependent inhibition (TDI) effect on any of the seven isozymes tested, whereas the positive controls showed inhibition of the isozymes in the same system, as expected.

For assessment of induction of CYP450, Kevetrin, at 10 and 100 μM, and positive inducers were incubated with primary human liver cells at 37°C for 48 hours. The following CYP450 isozymes were evaluated: 1A2, 2B6, 2C9, 3A4. Enzyme-specific substrates were added, incubated for one hour then metabolites were measured. Kevetrin did not induce any of the four CYP isozymes tested, whereas the positive controls did show induction in the same system, as expected.

Given the lack of inhibition or induction of CYP450, the study met the requirements of the FDA and it is expected that the development of Kevetrin in human clinical trials may proceed in combination with certain other chemotherapeutic agents without concern for potential drug-drug interactions. Cellceutix is currently finalizing the documentation for submission to the FDA.

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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 compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer 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 anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. 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). 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 that 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.

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