BEVERLY, MA--(Marketwired - September 16, 2016) - Cellceutix Corporation, (OTC: CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, antibiotic, and anti-inflammatory applications, is pleased to announce today the appointment of LaVonne Lang, DrPH, to the role of Vice President, Regulatory Affairs.
Dr. Lang has over twenty-five years of experience in a variety of specialty roles with a focus in several different therapeutic areas in pharmaceutical development. Dr. Lang received a BSN, a MPH (Environmental and Industrial Health: sub-specialty in Toxicology), and a DrPH (Health Management and Policy) from The University of Michigan. She served as study coordinator at the University of Michigan Hospital, overseeing clinical trial research in Pediatric Endocrinology. Upon joining Warner-Lambert Parke-Davis, her work included study director and writer in Pathology and Experimental Toxicology as well as Clinical Communications. As Director of Regulatory Affairs at Parke-Davis/Pfizer, she was therapeutic area lead in gene therapy and dermatology.
For the last seven years, Dr. Lang has been a consultant, providing FDA liaison support and serving as head of regulatory for companies focusing on a variety of therapeutic areas, including cardiovascular, metabolic, and inflammatory disease.
She joins an expanding senior management team at Cellceutix, further complementing the recent hiring of pharmaceutical executive, Arthur P. Bertolino, MD, PhD, MBA, as President and Chief Medical Officer, and Jane Harness, MS, MP, as VP, Clinical Sciences and Portfolio Management.
"I am excited to join Cellceutix," commented Dr. Lang, "and work with this team of professionals to help advance investigational products toward FDA approval in areas that could have a positive impact on the public's health."
"LaVonne is a fantastic addition to our team," said Dr. Bertolino. "With our lead drug candidates approaching pivotal, later-stage FDA trials, LaVonne's leadership in regulatory affairs will be of paramount importance as we continue to work closely with our research partners and the FDA towards further validating our drug candidates. The professional relationships that she has built over the years at the FDA, coupled with her extensive clinical and regulatory knowledge, should help ensure that lines of communication with the agency remain open and productive."
Leo Ehrlich, Chief Executive Officer of Cellceutix added, "The strengthening of our senior management team by adding proven industry veterans will help us execute more expediently all of our business objectives."
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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 plans 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 Cellceutix 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 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.