Cellceutix Sees Increased Valuation Potential for Its Novel Antibiotic Brilacidin
January 21 2014 - 6:00AM
Marketwired
Cellceutix Sees Increased Valuation Potential for Its Novel
Antibiotic Brilacidin
ECCMID Poster Now Available on Cellceutix Website
BEVERLY, MA--(Marketwired - Jan 21, 2014) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company"), a clinical stage
biopharmaceutical company developing innovative therapies in
oncology, dermatology, and antibiotic applications, is pleased to
inform shareholders of an extremely productive Biotech Showcase
2014 conference, notably the Company's increased optimism regarding
the potential value of Brilacidin, the first drug candidate from
the Company's franchise antibiotic platform that has the potential
to treat many indications of great unmet medical need.
Entering the conference, the Company believed that Brilacidin
for a single indication such as Acute Bacterial Skin and Skin
Structure Infections (ABSSSI) would conservatively have a market
potential slightly above $100 million annually should it eventually
garner U.S. Food and Drug Administration approval. Following a week
of meeting with other biotechnology companies, investment bankers
and analysts, the Company realized that it was significantly
undervaluing its estimation of the potential value of Brilacidin
for ABSSSI. Several factors influenced the determination, including
the dire need for new antibiotics that have not yet developed
resistance and are less likely to develop resistance, recent
changes in reimbursement policies and an ongoing shift to encourage
cost-effective therapies, which is supportive of single-dose
treatments, such as two of the dosing regimens in the upcoming
Phase 2b trial of Brilacidin. The Company sees reduced
reimbursement for the other competing drugs for ABSSSI that have
already developed resistance and a higher reimbursement for a drug
like Brilacidin, which is needed for patients who have resistance
to existing antibiotics. Further, reimbursement is expected to be
higher for drugs that prevent serious illness or death and for
those where there is no alternative treatment.
As announced on January 15, the Company has received
Institutional Review Board approval for a U.S.-based phase 2b
clinical trial in ABSSSI. In this 200-patient study, three
Brilacidin dosing regimens (two single-dose regimens and one 3-day
regimen) will be compared to a standard seven-day regimen of
daptomycin. Enrollment is expected to begin shortly.
During meetings at the Biotech Showcase conference, the Company
became aware that others in the industry had no knowledge of the
posters presented on Brilacidin at the 23rd European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID) 2013 held
April 27-30, 2013 in Berlin, Germany. Due to the early April 2013
bankruptcy filings of PolyMedix, the owner of Brilacidin before
Cellceutix acquired substantially all of the PolyMedix assets in
September, the poster was presented at the conference by the
Pharmacokinetic/Pharmacodynamic researchers from the Phase 2a
clinical trial of Brilacidin for ABSSSI and was only seen by
few.
The posters are a summary of all the data from the earlier
clinical trial and an analysis by renowned experts showing the
potential of Brilacidin to be efficacious in destroying bacteria as
a single dose therapy. It was this data that was reviewed with the
U.S. Food and Drug Administration ("FDA") to support that
Brilacidin could potentially be effective as a single dose and
without serious adverse events, leading to the recommendation to
proceed with a Phase 2b clinical trial with lower dosing
regimens.
The three posters from the conference are now available on the
Cellceutix website at www.Cellceutix.com/events.
Brilacidin is in a class of by itself, having anti-microbial,
anti-biofilm and anti-inflammatory properties. In extensive
preclinical testing, Brilacidin has shown to not develop any drug
resistance due to its rapid bactericidal implications. The Company
is now in development programs evaluating oral, intravenous and
topical formulations of Brilacidin for treatment of Oral Mucositis,
Keratitis, Conjunctivitis, Otitis and other infectious conditions
and diseases.
"The posters were such an important part of our due diligence in
purchasing this asset, yet hardly anyone knew of their existence,"
commented Leo Ehrlich, Chief Executive Officer of Cellceutix. "This
sheds a whole new light on Brilacidin for people that weren't aware
of the compelling power of the defensin-mimetic platform. Following
many discussions, we believe that we are addressing market sizes in
the billions of dollars annually given the expansiveness of
indications that Brilacidin could potentially provide a substantial
benefit over approved drugs today. If Brilacidin is clinically
proven to be efficacious as we believe it is, we would expect to
attain a significant share of those markets."
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 January 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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