BEVERLY, MA--(Marketwired - Jan 21, 2014) - Cellceutix Corporation (
Entering the conference, the Company believed that Brilacidin for a single indication such as Acute Bacterial Skin and Skin Structure Infections (ABSSSI) would conservatively have a market potential slightly above $100 million annually should it eventually garner U.S. Food and Drug Administration approval. Following a week of meeting with other biotechnology companies, investment bankers and analysts, the Company realized that it was significantly undervaluing its estimation of the potential value of Brilacidin for ABSSSI. Several factors influenced the determination, including the dire need for new antibiotics that have not yet developed resistance and are less likely to develop resistance, recent changes in reimbursement policies and an ongoing shift to encourage cost-effective therapies, which is supportive of single-dose treatments, such as two of the dosing regimens in the upcoming Phase 2b trial of Brilacidin. The Company sees reduced reimbursement for the other competing drugs for ABSSSI that have already developed resistance and a higher reimbursement for a drug like Brilacidin, which is needed for patients who have resistance to existing antibiotics. Further, reimbursement is expected to be higher for drugs that prevent serious illness or death and for those where there is no alternative treatment.
As announced on January 15, the Company has received Institutional Review Board approval for a U.S.-based phase 2b clinical trial in ABSSSI. In this 200-patient study, three Brilacidin dosing regimens (two single-dose regimens and one 3-day regimen) will be compared to a standard seven-day regimen of daptomycin. Enrollment is expected to begin shortly.
During meetings at the Biotech Showcase conference, the Company became aware that others in the industry had no knowledge of the posters presented on Brilacidin at the 23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2013 held April 27-30, 2013 in Berlin, Germany. Due to the early April 2013 bankruptcy filings of PolyMedix, the owner of Brilacidin before Cellceutix acquired substantially all of the PolyMedix assets in September, the poster was presented at the conference by the Pharmacokinetic/Pharmacodynamic researchers from the Phase 2a clinical trial of Brilacidin for ABSSSI and was only seen by few.
The posters are a summary of all the data from the earlier clinical trial and an analysis by renowned experts showing the potential of Brilacidin to be efficacious in destroying bacteria as a single dose therapy. It was this data that was reviewed with the U.S. Food and Drug Administration ("FDA") to support that Brilacidin could potentially be effective as a single dose and without serious adverse events, leading to the recommendation to proceed with a Phase 2b clinical trial with lower dosing regimens.
The three posters from the conference are now available on the Cellceutix website at www.Cellceutix.com/events.
Brilacidin is in a class of by itself, having anti-microbial, anti-biofilm and anti-inflammatory properties. In extensive preclinical testing, Brilacidin has shown to not develop any drug resistance due to its rapid bactericidal implications. The Company is now in development programs evaluating oral, intravenous and topical formulations of Brilacidin for treatment of Oral Mucositis, Keratitis, Conjunctivitis, Otitis and other infectious conditions and diseases.
"The posters were such an important part of our due diligence in purchasing this asset, yet hardly anyone knew of their existence," commented Leo Ehrlich, Chief Executive Officer of Cellceutix. "This sheds a whole new light on Brilacidin for people that weren't aware of the compelling power of the defensin-mimetic platform. Following many discussions, we believe that we are addressing market sizes in the billions of dollars annually given the expansiveness of indications that Brilacidin could potentially provide a substantial benefit over approved drugs today. If Brilacidin is clinically proven to be efficacious as we believe it is, we would expect to attain a significant share of those markets."
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 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, is set to begin a Phase 2b trial in January 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
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.
Contact Information:
Contact:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717