BEVERLY, MA--(Marketwired - July 07, 2016) - Cellceutix Corporation, (
"As I become even more familiar with the Cellceutix staff and pipeline, I continue to see a great deal of value and potential in our three lead compounds: Kevetrin, Brilacidin and Prurisol," commented Dr. Bertolino. "I am working full-time with our team to define succinct clinical development strategies to advance these programs in a manner proven successful in my previous pharmaceutical experiences. My current emphasis is centered on efficient drug development and recruiting additional leading industry veterans for our staff and advisory board to assist in these matters. I believe this will translate into sustainable value for our company."
Since successfully completing the initial Phase 2 trial of oral Prurisol for mild to moderate plaque psoriasis, the Company has fielded inquiries from many interested parties about the compound and has evaluated several options for the next stage of development. After a detailed analysis, the data clearly show that the most robust response to Prurisol was in patients with moderate psoriasis in the trial's highest dosing arm (200mg), with no serious adverse events reported. Benefits were apparent by two weeks and showed further improvement by the end of the study at 12 weeks.
Cellceutix has begun preparing for a Phase 2b trial of Prurisol for patients with moderate to severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses. The Company intends to increase the dosing beyond 200mg and evaluate patients using the Psoriasis Area and Severity Index (PASI) scoring method, which will enable better comparison to approved psoriasis drugs, including apremilast and biologics. In addition to evaluating efficacy in moderate to severe psoriasis, multiple secondary endpoints will be studied to provide insights regarding additional potential benefits of Prurisol compared to approved therapies. Our expectations are to initiate the trial late in the third quarter or early in the fourth quarter with top-line results in the second quarter of 2017.
"There is a significant opportunity in successfully developing a potent oral drug for chronic psoriasis. The spectrum of current treatment options spans multiple injectable biologics, oral apremilast, and a variety of topical creams," said Dr. Bertolino. "A new oral drug that delivers substantial efficacy should command considerable market value and further attract the attention of pharmas looking to expand their dermatology offerings. I believe that Prurisol has that potential and that a refined second successful Phase 2 trial would further anchor the value that we already appreciate."
"As we further define plans in the coming weeks for the development of Brilacidin and Kevetrin, we intend to also provide shareholders with additional updates on our clinical and pre-clinical program strategies," concluded Dr. Bertolino.
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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 application 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 anti-psoriasis drug Prurisol completed a Phase 2 trial and is now setting up a Phase 2b study. 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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