Cellceutix Submits Application for IRB Review to Commence Phase 2b Clinical Trial of Novel Antibiotic Brilacidin
December 16 2013 - 7:00AM
Marketwired
Cellceutix Submits Application for IRB Review to Commence Phase 2b
Clinical Trial of Novel Antibiotic Brilacidin
BEVERLY, MA--(Marketwired - Dec 16, 2013) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company"), a clinical stage
biopharmaceutical company developing innovative therapies in
oncology, dermatology, and antibiotic applications, is pleased to
announce that it has submitted the application to the Institutional
Review Board ("IRB") responsible for the Company's planned Phase 2b
clinical trial of its novel antibiotic Brilacidin as a drug
candidate for Acute Bacterial Skin and Skin Structure Infections
("ABSSSI").
The protocol for the clinical trial was constructed following
the successful completion of a Phase 2a clinical trial of
Brilacidin for ABSSSI. The Company anticipates that the trials will
commence on schedule in just a few weeks, in January 2014. The
clinical trial information will soon be updated on
www.clinicaltrials.gov
Cellceutix is particularly excited about the timing of its
recent acquisition of novel antibiotic and antifungal compounds
because of the introduction last week of the ADAPT (Antibiotic
Development to Advance Patient Treatment) Act of 2013 by the House
of Representatives to expedite development of new antibiotics and
antifungal drug candidates. The bill builds upon the GAIN
(Generating Antibiotic Incentives Now) Act that was passed in 2012
to provide incentives, such as extended periods of exclusivity and
smaller patient populations for clinical trials, for new
antibiotics that target areas of great unmet medical need. The FDA
is demonstrating its commitment to find solutions to the growing
problem of bacteria infections. Cellceutix feels its drug
candidates are prime candidates to benefit from these government
initiatives.
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 for multi-drug resistant
bacteria or a dosing regimen that is shorter than currently
marketed antibiotics. 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: INVESTOR AND MEDIA CONTACT: Cellceutix Corp. Leo
Ehrlich (978) 236-8717 Email
Contact
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