INNOVATION PHARMACEUTICALS INC.
BEVERLY, MA--(Marketwired - Jan 22, 2015) - Cellceutix Corporation (
"We worked with the FDA in designing the recent phase 2b study," said Dr. Jorgensen. "As predicted, a lower total dose of Brilacidin, given as a single-dose regimen, was well tolerated and efficacy was comparable to that of the 7-day regimen of the active control, daptomycin."
"It's important to note that a single-dose regimen has benefits beyond safety and efficacy," Dr. Jorgensen added. "It can maximize patient compliance and thereby reduce the potential for the development of antibiotic resistance. Of course, Brilacidin's unique mechanism of action to penetrate the bacterial cell wall to eradicate bacteria is another reason why resistance is unlikely to develop. Further, Brilacidin has anti-inflammatory and anti-biofilm properties. When considering all these factors, Brilacidin has the potential to transform the way we treat infectious diseases."
In addition to the clinical data from the ABSSSI trial, Cellceutix will also present important preclinical data. The abstract entitled Synthetic Novel Host Defense Protein Mimetics for the Treatment of Gram-Negative Bacterial Infections has been accepted for oral presentation in the session entitled Drug Discovery. "This is an opportunity for experts to hear about the other promising defensin-mimetics -- not just Brilacidin," said Dr. Jorgensen. "These compounds have potential to treat serious Gram-negative infections, including those identified by CDC as 'antibiotic resistance threats.' "
The final presentation, a poster entitled Brilacidin, Host Defense Peptide Mimetic, One of a New Class of Immunomodulatory Agents that can Target Multiple Disease Indications, will be given in the category of New Antimicrobials. "This is an important poster, as it highlights the immunomodulatory properties of Brilacidin, in addition to its antimicrobial properties," Dr. Jorgensen added. "These animal data support the use of topical Brilacidin in humans to prevent or ameliorate oral mucositis, a painful condition in cancer patients undergoing chemoradiation therapy. A phase 2 clinical trial is about to begin."
Dr. Jorgensen concluded, "There is an urgent need for new classes of antibiotics that are effective in this era of increasing drug resistance. We believe our defensin-mimetics, including Brilacidin, can address this need and that these compounds will also play an important role in the management of inflammatory diseases of the skin and mucous membranes. The laboratory and clinical data we have collected to date support the exciting promise of this class of compounds. We look forward to sharing these data at the ECCMID meeting."
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 antimicrobial 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 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 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 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.
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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.
