Cellceutix to Initiate Psoriasis Clinical Trial
March 21 2014 - 6:00AM
Marketwired
Cellceutix to Initiate Psoriasis Clinical Trial
Company Conducting Three Clinical Trials for Three Separate
Areas of Unmet Medical Need
BEVERLY, MA--(Marketwired - Mar 21, 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 U.S. Food and Drug Administration's ("FDA") 30-day waiting
period pertaining to the Company's Investigational New Drug
Application ("IND") for Prurisol™ has now passed. Cellceutix is
moving towards the commencement of clinical trials of Prurisol™ as
a new drug candidate for the treatment of psoriasis.
"This is another significant moment for our Company as we bring
our third compound into clinical trials," commented Leo Ehrlich,
Chief Executive Officer at Cellceutix. "A steady stream of
developments has led to a great start to 2014 for our Company. We
initiated a multi-center Phase 2b trial of our novel antibiotic
Brilacidin. The Phase 1 trial of our novel anti-cancer compound
Kevetrin™ is in the seventh cohort and now Prurisol™ is set to
enter human trials, positioning us with three clinical drug
candidates targeting three different areas of unmet medical
need."
"I am also excited about the laboratory research that is being
conducted on Brilacidin for a wide range of indications," added Mr.
Ehrlich. "We are nearing completion of IND-enabling studies of
Brilacidin-OM for oral mucositis. Other pre-clinical studies of
Brilacidin are ongoing for otitis and ophthalmic infections.
Separately, in our recent acquisition of assets we acquired a
library of compounds that have shown promise for Gram-negative
bacterial infections. These compounds have been sent to a
university laboratory in Texas for further testing. We are actively
developing other acquired compounds for anti-fungal treatments. In
short, while we are very pleased with the clinical development to
date, we feel that there are many other areas of tremendous
opportunity for our pipeline and intend to relentlessly research
them to define future clinical trials."
Cellceutix is developing Prurisol under FDA guidance that a
505(b)(2) designation is an appropriate development pathway. The
initial clinical research will be a brief Bioequivalence crossover
study expected to last approximately 45 days with the primary
endpoint of demonstration that Prurisol converts to abacavir in
humans, as it has been shown to do in animal models. Upon
successful completion of the crossover trial, the Company will
initiate a larger Phase 2/3 clinical trial under a 505(b)(2)
designation, which would permit Prurisol to move to advanced trials
because the active moiety of Prurisol is that of a drug already
approved by the FDA.
Cellceutix management previously submitted to the FDA an
application for an Orphan Drug designation for Brilacidin-OM for
the prevention of oral mucositis in head and neck cancer patients.
After reviewing the extensive data supplied with the application,
the FDA advised the Company that the data would indicate that
Brilacidin-OM could treat a patient population that is actually too
large for an Orphan Drug designation. Although the Company is glad
that the market is potentially much larger than initially thought,
meaning that Brilacidin-OM would be beneficial to so many more
people suffering from this terrible disease, Cellceutix management
is evaluating all scenarios. The Company may narrow the focus of
the application and continue the dialogue with the FDA going
forward or pursue the larger market. The Company believes either
option presents the potential to capture significant market share
with the introduction of a new therapy for oral mucositis.
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 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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