BEVERLY, MA--(Marketwired - April 14, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to report favorable results in a recently completed preclinical study evaluating its novel antibiotic compounds against specific strains of multi-drug resistant Klebsiella pneumoniae. The research, which is government funded through existing grants to research institutions, is being conducted at a major university in Texas.
In a thigh burden study of a multi-drug resistant strain of Klebsiella pneumoniae in a mouse model, Cellceutix's defensin mimetic compound CTIX1278, was efficacious as compared to a carbapenem antibiotic that is widely used as a last line of defense against drug-resistant, Gram-negative bacteria, including Klebsiella pneumoniae. A second study is now being conducted at multiple dosing levels with various infusion parameters with the goal of increasing efficacy and further defining a treatment protocol for the compound.
"This is highly encouraging early data of CTIX1278 as it is the first example of efficacy in vivo with one of our defensin mimetic compounds versus Klebsiella pneumoniae," comments Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "A Gram-negative bacteria, Klebsiella pneumoniae is one of the world's most dangerous superbugs; strains of this bacteria are rapidly emerging that are resistant to virtually every antibiotic available today. The world is staring down the barrel at a growing number of bacteria that can't be killed by available drugs and the last line of defense is wearing thin. We are very pleased with this latest study providing another piece of evidence that our defensin mimetics have the potential to introduce the first new class of antibiotic drugs in more than two decades to combat the growing problem of antibiotic resistance."
As it conducts the second study for Klebsiella pneumoniae, the university is awaiting additional materials to begin in vivo research in models of superficial and deep tissue wounds. In these studies, infecting organisms include Gram-negative multi-drug resistant Pseudomonas aeruginosa and Acinetobacter baumannii. This research is also being funded through existing government grants.
Separately, the Company is pleased to inform shareholders that to date: a) the Phase 2b trial of its defensin mimetic compound, Brilacidin™, for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) is progressing with approximately 30% patient enrollment completed with no drug-related serious adverse events (SAE); b) the Phase 1 trial of Kevetrin for solid tumors is progressing with no SAE events presently in the seventh cohort of the trial; c) and patient screening is ongoing in the Phase 1 trial of Prurisol for psoriasis.
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 presently in a bioequivalence crossover clinical trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, is in a Phase 2b trial 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.