Cellceutix Reports 20 Percent Enrollment Completed in Phase 2b Trial of Brilacidin as Short-Course Therapy for ABSSSI
March 31 2014 - 09:25AM
Marketwired
Cellceutix Reports 20 Percent Enrollment Completed in Phase 2b
Trial of Brilacidin as Short-Course Therapy for ABSSSI
BEVERLY, MA--(Marketwired - Mar 31, 2014) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company"), a clinical stage
biopharmaceutical company developing innovative therapies in
oncology, dermatology, and antibiotic applications, is pleased to
provide shareholders an update on the status of the Company's
clinical trial of its novel antibiotic Brilacidin as a treatment
for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
One month into the study, the trial has completed enrollment of
approximately 20 percent of the total patients scheduled in the
protocol.
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.
"The shortest dosing regimen of any antibiotic treatment for
ABSSSI approved by the U.S. Food and Drug Administration is seven
days," commented Leo Ehrlich, Chief Executive Officer at
Cellceutix. "We believe that among comparably priced drugs that are
safe and effective, the shortest course regimen will take over the
market. We are pleased that the trial of our one- and three-day
Brilacidin treatment is on schedule to date and we anticipate
enrollment to be 50 percent complete in another six weeks."
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
presently in a bioequivalence crossover clinical trial in Miami,
FL. 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.
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.
INVESTOR AND MEDIA CONTACT: Cellceutix Corporation Leo Ehrlich
(978) 236-8717 Email Contact
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