BEVERLY, MA--(Marketwired - March 05, 2014) - 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 several preclinical investigations are underway with several lead compounds in animal models of Gram-negative bacterial infections. The Company is focusing this research on some of the most difficult to treat multi-drug resistant or "pandrug-resistant" bacterium where there is a significant and growing medical need for new therapies.
One set of studies are being done with systemically-administered compounds in tissue infection models with multi-drug resistant Klebsiella pneumoniae. Specific drug-resistant strains of Klebsiella bacteria have rendered today's approved antibiotics completely ineffective, including carbapenems, the last line of defense for Gram-negative drug-resistant bacteria.
A second set of studies is being conducted with topically-administered compounds in models of superficial and deep tissue wounds, such as those encountered on the battlefield. Infecting organisms include multi-drug resistant Pseudomonas aeruginosa and Acinetobacter baumannii. Acinetobacter is an example of long-known bacteria that has now mutated into thousands of resilient strains that thrive in jagged combat wounds, with many resistant to even the most powerful antibiotic treatments available today.
The lead Cellceutix compounds in both sets of studies are small mimics of the host defense proteins that have been discovered to be potently active against these challenging pathogens. The studies are being conducted at a university laboratory.
"Gram-negative infections represent a growing and significant medical need. The organisms included in these studies represent some of the most difficult-to-treat pathogens due to their resistance to available antibiotics," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "The $560-million agreement between Roche and Polyphor in November for a Phase 2 drug and $191 million-plus deal with Discuva the other week for a technology to discover new therapies highlights just how valuable a new multi-drug resistant Gram-negative antibiotic is today."
Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Cellceutix is pleased to report that all four U.S. sites in its phase 2b Acute Bacterial Skin and Skin Structure Infection (ABSSSI) clinical trial are now screening and enrolling patients.
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 clinical trials 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, has begun a Phase 2b trial in February 2014 for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics 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 www.cellceutix.com
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.