Cellceutix Prepares for Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis

Cellceutix Prepares for Phase 2 Clinical Trial of Brilacidin-OM for Oral 
Mucositis 
BEVERLY, MA -- (Marketwired) -- 08/11/14 --  Cellceutix Corporation
(OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical
company developing innovative therapies in oncology, dermatology, and
antibiotic applications, is pleased to announce that the Company has
just received the final toxicology report for Brilacidin-OM.
Cellceutix is developing Brilacidin-OM as a new treatment for oral
mucositis, a common and often debilitating inflammation and
ulceration that occurs in the mouth as a side effect of certain
cancer treatments, including chemotherapy and radiation therapy. 
Cellceutix is reviewing the report, which will be added to finalize
the already prepared Investigational New Drug (IND) application for
submission to the U.S. Food and Drug Administration seeking approval
to commence a Phase 2 clinical trial of Brilacidin-OM as soon as
possible. 
"The past week was full of great news for us; that enrollment for the
Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin
Structure Infections will be completed this month, the statistical
data on our anti-psoriasis drug Prurisol showed that it attained its
primary endpoint in a Phase 1 trial, and now the data to complete the
IND for Brilacidin-OM. We look forward to the IND submission in a bid
to fill an area of great unmet medical need to the nearly half a
million patients that suffer the painful effects of oral mucositis
every year," commented Leo Ehrlich, Chief Executive Officer of
Cellceutix.  
Mr. Ehrlich added, "On a broader perspective, the question has been
posed to me about what last week's FDA approval of The Medicines
Company's oritavancin, a one-time treatment for ABSSSI, means to
Brilacidin. First, we congratulate The Medicines Company on their
approval. Candidly, we do not view oritavancin as a potential
competitor to our Brilacidin because of several key differentiators,
namely pharmacokinetic profiles and subsequent implications.
Ortavancin is a lipoglycopeptide, the same class of drug as Durata
Pharmaceutical's Dalvance(R) (Dalbavancin), and both drugs have a
very long half-life of approximately one to two weeks. This means
that the drug remains in a patient's system for a considerable period
following dosing, which has the potential for contraindication with
other medicines and questions concerning metabolism and drug
resistance. Brilacidin, a new class of drug, has a half-life of only
13 to 16 hours, a time frame that we believe is ideal for a one-time
treatment, while greatly decreasing the chance of resistance
developing. Further, Brilacidin in its clinical trials is being
tested compared to daptomycin, a superior drug to vancomycin, which
was the comparator arm in the pivotal trials of ortavancin and
Dalvance. Overall, in addition to the direct comparison with ABSSSI,
we look at our asset as offering much more potential as an
antibiotic, especially with room temperature formulations paving the
way for possibly treating a wide range of other indications, such as
diabetic foot ulcer infections, ophthalmic infections and otitis
media. ABSSSI alone is more than a billion-dollar market and growing,
and there is room for everyone with the best drug taking the lion's
share of dollar sales. So while we applaud a new therapeutic option
for patients, we are not concerned about the approval of ortavancin." 
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 has recently
completed 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
info@cellceutix.com 
 
 
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