SOURCE: Cellceutix

October 31, 2014 07:00 ET

Cellceutix's New Chief Operating Officer Dr. James Alexander Addresses Shareholders

BEVERLY, MA--(Marketwired - Oct 31, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antibiotic applications, is pleased to provide a strategic and operations update to shareholders from the Company's newly appointed Chief Operating Officer, Dr. James Alexander. Cellceutix disclosed in an 8-K filing with the U.S. Securities and Exchange Commission (SEC) on October 24, 2014 that the Board of Directors approved the appointment of Dr. Alexander as COO, effective October 27, 2014.

Dr. Alexander, who is board certified in both internal medicine and infectious diseases, has held clinical development and pharmacovigilance positions with SmithKline Beecham, Glaxo, GlaxoWellcome and BioCryst. His efforts have supported the approval of drugs for treatment of bacterial and viral infections, asthma, COPD, and migraine. He has served as a medical consultant to Cellceutix since 2012.

Dr. Alexander said: "To begin, I'd like to thank shareholders for the warm reception that I have received since people learned of my appointment at Cellceutix through the regulatory filing. If there is a theme to the questions I have been asked about my new position, that theme is 'Why did you decide to join Cellceutix now?' I'd like to take a moment to publicly address this question.

"Cellceutix is no longer the nascent biotech that I was first introduced to a couple of years ago. The Company has grown into a formidable firm with the makings of what I believe can be a tremendous pharma success story because of its leadership, its scientists and an extremely promising pipeline. Mr. Ehrlich believed that the timing was right to add to the management team to most efficiently manage a rapidly growing list of drugs in development. I am thrilled to have been offered the position of COO and the challenge to enhance and accelerate the development of the drugs in the Cellceutix pipeline.

"I have been involved in the clinical development of Kevetrin for several years and am excited to continue my involvement with the ongoing trial for patients with refractory solid tumors. I look forward to helping analyze the early data to define parameters for a mid-stage trial, or perhaps two trials depending on the results, looking at specific tumor types. I believe the safety profile of Kevetrin has been very well evaluated in the current trial and is reassuring when Kevetrin is used a single agent and potentially in combination with other therapy.

"My extensive background in development of compounds for infectious diseases has spurred my excitement about Brilacidin and the whole defensin-mimetic franchise of Cellceutix; I have never seen anything similar. When Cellceutix acquired these novel assets at such a low price last year I had hoped that there might be a larger role for me at Cellcelutix eventually. That has indeed happened and at a time when we now have positive top-line data from the Phase 2b trial in Acute Bacterial Skin and Skin Structure Infections showing that a one-day treatment with Brilacidin -- a single dose -- produces results comparable to 7 days of daptomycin treatment. What I see -- and what I think many people still don't fully grasp -- is that Brilacidin is not just a potential blockbuster for the indication of ABSSSI, including infections caused by MRSA, but this trial provides proof-of-efficacy data for defensin-mimetics as a novel class of antimicrobials that may be used to treat a broad array of diseases and conditions with a very limited chance for drug resistance to develop. I don't believe the potential efficacy of defenisin-mimetics was ever questioned by the scientific community, it was rather whether there would be any safety concerns. The results of this completed Phase 2b study provide reassuring top-line safety data for Brilacidin. We plan to leverage the clinical data we now have for Brilacidin to move quickly into mid-stage trials, while concurrently seeking every expedited pathway of the Food and Drug Administration available. Brilacidin for oral mucositis is next in line, taking into account its anti-inflammatory and immunomodulatory activity, with diabetic foot infections and ocular and otic conditions next on the clinical docket for us. Moving forward, we are planning IND filings for defensin-mimetics with antifungal activity as well as activity against resistant Gram negative pathogens.

"With these things in mind, we think our shareholders will be pleased to know that we have filed an S-3 with the SEC to solidify our financial position for the years to come. Simply, we have plenty of cash on hand and available to us for our planned laboratory and clinical studies, but a shelf registration with a few year term affords us the opportunity to explore other future considerations that are immediately accretive to our corporate value, whether it is additional clinical trials or an acquisition. We're under no pressure to ever exercise the registration, but it is a prudent financial move to have additional cash available to us should a unique opportunity arise.

"I've never known Cellceutix to take its foot off the gas pedal or fail to execute on its business plan. My addition to the team is intended to complement and support this approach and continue to grow shareholder value in a bid to have at least five different clinical trials in progress in 2015, a goal I believe we will attain."

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 oncology, dermatology and antibiotic applications. 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 is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. 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 will soon begin a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data has shown a single dose of Brilacidin to deliver statistically comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for 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

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.

Contact Information

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    Cellceutix Corporation
    Leo Ehrlich
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