Cellceutix to Pursue Significant Conjuctivitis and Kerititis Ocular Markets With Novel Antibiotic Brilacidin
Marketwired
BEVERLY, MA--(Marketwired - Nov 4, 2013) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to inform shareholders that the Company is conducting experiments on Brilacidin™, its lead antibiotic compound, for ophthalmic infections, including keratitis and conjunctivitis. Cellceutix estimates the market potential for these indications well in excess of $1 billion and has its antibiotic team expanding upon the significant amount of preclinical research that has been conducted on Brilacidin for these conditions.
Prior to the Cellceutix acquisition of PolyMedix in September, lab studies conducted at the Charles T. Campbell Ophthalmic Microbiology Laboratory at the University of Pittsburgh demonstrated the safety, tolerability and broad activity of Brilacidin against clinically important Gram-positive and Gram-negative pathogens, including drug-sensitive and drug-resistant clinical isolate strains of ocular infections.
Pharmacokinetic studies were conducted at Iris Pharma, a Contract Research Organization based in France, showing that Brilacidin has a high residence time on the surface of the eye with negligible systemic exposure. This indicates that effective therapeutic concentrations of Brilacidin can be maintained in the eye with infrequent treatments.
As a defensin-mimetic, Brilacidin is a completely novel class of antibiotics and a platform for a broad spectrum of indications in an area of urgent need for new drugs. Topical ophthalmic anti-infective drugs that are used today for keratitis and conjunctivitis have serious limitations due to bacterial resistance and serious side effects. For example, although exclusive of topical uses of fluoroquinolones for eye and ear infections, the U.S. Food and Drug Administration in August required that drug labels and Medication Guides for all systemic fluoroquinolone antibacterial drugs be updated to describe the potential serious side effect of peripheral neuropathy.
"The Brilacidin ocular data is highly exciting. Our new research program focusing on ocular drugs is the next step in expanded uses of Brilacidin that we believe will develop into a blockbuster antibiotic drug franchise," said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "We have a litany of clinical and preclinical data on Brilacidin. Our research staff is currently growing epithelial cells for testing so that we can formulate Brilacidin as a topical solution with efficient penetration of the epithelium to maximize clinical results."
"We are going to continue aggressively moving forward with Brilacidin as the current biotechnology environment is desperate for new therapeutics," added Leo Ehrlich, Chief Executive Officer at Cellceutix. "Reuters reported only yesterday that Swiss drugmaker Roche is poised to get back into antibiotics because of a novel drug that they want to develop to tackle drug-resistant bacteria. Simply, a novel drug has phenomenal sales potential. Johnson & Johnson's Levaquin was generating $1.3 billion in sales before it came off patent. Cubist's Daptomycin for ABSSSI only comprised 8 percent of total doses, yet controlled approximately 82 percent of total sales in that market. The majority of approved antibiotics today are legacy drugs or variations of them for which resistance is constantly evolving. Our plan is to establish Brilacidin as the next generation antibiotic. It has opened a door to a multi-billion-dollar pathway and we are not just looking at it, we are part way through it and moving as quickly as possible to establish a leadership position."
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 is planning 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 is being readied for a Phase 2/3 clinical trial at sites in the U.S. and Europe. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, is set to begin a Phase 2b trial in the first half of 2014 for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy for multi-drug resistant bacteria or a dosing regimen that is shorter than currently marketed antibiotics. 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.
