Cellceutix Enrolls First Patients in Phase 2b ABSSSI Clinical Trial
BEVERLY, MA—February 26, 2014 - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the first patients have been enrolled and treated in the Company’s Phase 2b clinical trial of Brilacidin in patients with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).
The trial compares three different dosing regimens of Brilacidin (two single-dose regimens and one 3-day regimen) to a standard 7-day regimen of daptomycin, a drug marketed in the United States by Cubist Pharmaceuticals under the brand name Cubicin. This is an important milestone for the Company as there are currently no Food and Drug Administration-approved drugs that have a dosing regimen of less than seven days in duration. The data from this trial, if positive, will be used for dose selection in an upcoming Phase 3 program.
Brilacidin is the lead compound in a novel class of immunomodulatory antimicrobials known as defensin-mimetics. Similar to the body's innate immune system, these compounds are also active on the surface of skin and mucous membranes. This unique class of antimicrobial chemistry presents numerous other drug development opportunities for Cellceutix, such as treatment of bacterial infections of the eye and ear, as well as the prevention and treatment of oral mucositis in cancer patients.
“We are very pleased that clinical trials of Brilacidin for ABSSSI are underway,” commented Leo Ehrlich, Chief Executive Officer of Cellceutix. “Patients are now being treated with Brilacidin at one clinical site and we anticipate that all four U.S. sites in the trial will be up and running within one week. As the trial progresses, we expect that approximately 40 patients will be enrolled each month in the 200-patient study.”
Interested parties are encouraged to follow the progression of the clinical trial on the Food and Drug Administration website at http://www.clinicaltrials.gov/ct2/show/NCT020...amp;rank=2 , which is expected to be updated to its current status in a matter of days.
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 currently 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
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:
Contact:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
info@cellceutix.com
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