Cellceutix Enrolls First Patients in Phase 2b ABSSSI Clinical Trial
February 26 2014 - 6:00AM
Marketwired
Cellceutix Enrolls First Patients in Phase 2b ABSSSI Clinical Trial
BEVERLY, MA--(Marketwired - Feb 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 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/NCT02052388?term=ctix&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
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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