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Cellceutix Identifies Drug Candidates for Gram-Negative and Candida Fungal Infections

Cellceutix Identifies Drug Candidates for Gram-Negative and Candida Fungal 
Infections 
Company Completing IND Application to Commence Clinical Trial of New
Psoriasis Drug Prurisol 
BEVERLY, MA -- (Marketwired) -- 11/18/13 --  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 it has made
significant breakthroughs with its portfolio of novel drug candidates
for infectious disease, including fungal infections and Gram-negative
bacterium. Extensive screening has identified five promising drug
candidates for fungal infections, including PMX1502 and PMX1408 as
stand-outs for anti-Candida fungal activity to be used for both oral
and disseminated candidiasis. Current therapies today are not only
relatively ineffective, but are seriously limited by recurrence,
resistance and systemic toxicity.  
In particular, PMX1502 shows robust efficacy, systemic use and
selectivity in a disseminated candidiasis animal model. The compound
showed cidal activity rather than static effect and significant
reduction in fungal tissue burden. The activity of PMX1408 against
Candida and Aspergillus warrants further development of the compound
as a topical treatment for hard-to-treat infections. Given the
limitations of current standards of care, the Company believes that
new drugs for treatment of these indications are highly desirable. 
Drug-resistant bacteria are quickly becoming a source of global
concern and were recently the subject of a World Health Organization
warning in listing antibiotic resistance as one of the top three
public health threats of this century. According to a special
editorial in the Lancet this month, "superbugs," or drug-resistant
bacteria, threaten to erase a century of medical advances. This has
created an urgent need for development of new drugs, especially for
drugs focused on Gram-negative infections, which are typically far
more difficult to treat than Gram-positive infections. 
"The alarms have sounded globally, signaling the dire need for new
antibiotics and the premium prices that promising compounds can
command. Roche recently jumped back into the antibiotic markets by
agreeing to pay up to $548 million for a Phase II antibiotic
targeting Gram-negative pathogens," said Dr. Krishna Menon, Chief
Scientific Officer at Cellceutix. "We believe there is a great
interest in the pharmaceutical industry for clinical-stage
gram-negative compounds. We are extremely motivated to move the drugs
forward as quickly as possible to satisfy this interest. The latest
research with PMX1502 and PMX1408 well positions us to move into the
multi-billion-dollar anti-fungal and Gram-negative bacterium markets.
We knew we were gaining substantial assets with the PolyMedix
acquisition, but this is evolving into more than even I expected at
this point." 
Regarding bacterial infections, Cellceutix researchers have
identified a series of host defense protein (HDP)-mimetic compounds
that rapidly kill a variety of clinically-important Gram-negative
pathogens. Infections caused by these pathogens are very difficult to
treat because the bacteria are typically multi-drug resistant, which
can lead to life-threatening conditions. The Company's compounds are
active against some of the most problematic pathogens, such as
Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and
Acinetobacter baumannii as well as highly multi-drug resistant
ndm-1-producing K. pneumoniae. The Company's compounds exhibit low
toxicity against mammalian cell types, with in vivo studies showing
several of the compounds to be active in animal infection models. 
Separately, Cellceutix today announced that it has received the
Chemistry, Manufacturing and Controls ("CMC") section from
NYSE-listed Dr. Reddy's Laboratories Ltd. required for its
Investigational New Drug ("IND") application for Prurisol, the
Company's lead anti-psoriasis compound. 
Cellceutix's dermatology team is currently incorporating the CMC
section into the IND for submission to the U.S. Food and Drug
Administration ("FDA"). The Company is developing Prurisol under FDA
guidance that a 505(b)(2) designation is an appropriate developmental
pathway. 
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 a Phase 2/3 clinical trial 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 the first half of 2014 for Acute Bacterial
Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the
potential to be a single-dose therapy for multi-drug resistant
bacteria or a dosing regimen that is shorter than currently marketed
antibiotics. 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
info@cellceutix.com