Cellceutix Identifies Drug Candidates for Gram-Negative and Candida Fungal Infections
November 18 2013 - 7:00AM
Marketwired
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 - Nov 18, 2013) - 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 Email Contact
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