Cellceutix Plans for Entry in Diabetic Foot Wound and Ulcer Market
May 19 2014 - 7:00AM
Marketwired
Cellceutix Plans for Entry in Diabetic Foot Wound and Ulcer Market
Cellceutix Study Shows Brilacidin to Expedite Healing in Animal
Model of Diabetic Foot Wounds
BEVERLY, MA--(Marketwired - May 19, 2014) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company"), a clinical stage
biopharmaceutical company developing innovative therapies in
oncology, dermatology, and antibiotic applications, is pleased to
report that its lead antibiotic, Brilacidin™, demonstrated visually
convincing wound healing properties in a recently completed
experiment in a diabetic rat model.
As a small molecule mimetic of human host defense proteins,
brilacidin has demonstrated antibacterial and tissue healing
properties on barrier surfaces, such as skin and mucous membranes.
Results from the diabetic rat study are consistent with these
properties.
In the study, diabetic rats with similar non-infected diabetic
wounds were treated with Brilacidin for five days and compared to
an untreated control. By visual inspection, the brilacidin-treated
animals experienced a more rapid and complete reduction in the area
of the wound. Additional experiments are now scheduled in infected
diabetic wound models. Afterwards, the Company anticipates entering
the necessary clinical trials.
The accompanying image is from the research showing the
improvement in wound healing in a diabetic rat model following five
days of treatment with Brilacidin:
http://media.marketwire.com/attachments/201405/75445_brilacidin.jpg
"We already know that Brilacidin has strong anti-infective
properties, so the trial was designed to validate our contention
that the drug also expedites the healing process in wounds that are
free of infection; a powerful one-two punch in the treatment of
diabetic foot wounds, regardless of infection," commented Dr.
Krishna Menon, Chief Scientific Officer at Cellceutix. "Through the
combination of our internal research and the ongoing Phase 2b
clinical trial of Brilacidin for ABSSSI, we are rapidly growing a
large body of evidence demonstrating the potential clinical
benefits of Brilacidin across a broad spectrum of indications of
great unmet medical need. Last week, we moved one step closer
to the initiation of a Phase 2 clinical trial of Brilacidin for
oral mucositis through the receipt of the draft GLP toxicology
report. We expect the final report within the next few weeks,
at which time we will add it to the Investigational New Drug
application for submission to the U.S. Food and Drug
Administration."
Because of compromised peripheral nerves and blood vessels,
diabetic foot wounds readily become a chronic condition and
represent a leading cause of hospitalization and amputation for the
approximately 26 million people living with diabetes in the United
States. Most of these wounds, at one time or another, get
infected. According to the American Podiatric Medical Association,
a chronic diabetic foot wound occurs in approximately 15 percent of
people with diabetes. Of those patients, up to 18 - 24 percent
will require an amputation. Cellceutix believes the market size for
an effective treatment is significantly larger than the ABSSSI
market that alone is greater than a billion dollars in the U.S.,
thus the Company is targeting a potential multibillion-dollar
worldwide market.
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. 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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