Cellceutix Files With FDA for Phase 2b Clinical Trial of Novel Antibiotic Brilacidin; Enrollment of Patients Expected to Star...
February 03 2014 - 7:00AM
Marketwired
Cellceutix Files With FDA for Phase 2b Clinical Trial of Novel
Antibiotic Brilacidin; Enrollment of Patients Expected to Start
Mid-February
BEVERLY, MA--(Marketwired - Feb 3, 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 protocol for the Phase 2b trial of Brilacidin,
Cellceutix's lead compound in a novel class of synthetic
immunomodulatory antimicrobials known as defensin-mimetics, was
sent to the U.S. Food and Drug Administration.
Also, the Company's submission to ClinicalTrials.gov for this
upcoming Phase 2b clinical trial of Brilacidin for Acute Bacterial
Skin and Skin Structure Infections (ABSSSI) has been
accepted. Cellceutix has been advised that the Brilacidin for
ABSSSI trial will appear on www.ClinicalTrials.gov within two
business days.
Cellceutix anticipates that trial recruitment of patients will
begin mid-February.
The Phase 2b clinical trial will be evaluating Brilacidin as
compared to the FDA-approved drug daptomycin in patients with
ABSSSI caused by S. aureus and Strep pyogenes. Brilacidin will
be administered in one-day and three-day dosing regimens, dosing
schedules that are shorter than those of currently marketed
antibiotics.
"We are within a few weeks of a milestone moment for our Company
with the commencement of the Brilacidin trial for ABSSSI," comments
Leo Ehrlich, Chief Executive Officer at Cellceutix. "We have
made it very clear that we have high expectations for Brilacidin
ever since we acquired it in September. I am very proud of the
commitment and efficiency of our team, which in less than five
months, completed requisite lab work and regulatory filings to have
this important clinical trial ready to begin. With optimized
dosing, we believe that Brilacidin can represent a major
breakthrough in the field of antibiotics. "
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 February 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: INVESTOR AND MEDIA CONTACT: Cellceutix Corp. Leo
Ehrlich (978) 236-8717 Email Contact
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