Cellceutix Submits Investigational New Drug Application (IND) for Clinical Trial of New Anti-Psoriasis Drug, Enrollment Under...
February 18 2014 - 7:00AM
Marketwired
Cellceutix Submits Investigational New Drug Application (IND) for
Clinical Trial of New Anti-Psoriasis Drug, Enrollment Underway in
Phase 2b Clinical Trials of Brilacidin
BEVERLY, MA--(Marketwired - Feb 18, 2014) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company"), a clinical stage
biopharmaceutical company developing innovative therapies in
oncology, dermatology, and antibiotic applications, announces today
that the Company has submitted an Investigational New Drug
Application ("IND") to the U.S. Food and Drug Administration
("FDA") for the clinical development of Prurisol as a potential new
treatment for psoriasis.
Per regulatory protocol, the FDA has 30 days to review the IND.
If the FDA in that time frame raises no questions, the first
clinical trial of Prurisol is allowed to begin.
Cellceutix is developing Prurisol under FDA guidance that a
505(b)(2) designation is an appropriate development pathway. The
initial clinical research will be a brief Phase 1 crossover study
expected to last approximately 45 days with the primary endpoint of
demonstration that Prurisol converts to abacavir in humans, as it
has been shown to do in animal models. Upon successful completion
of the crossover trial, the Company plans to initiate a larger
Phase 2/3 clinical trial under a 505(b)(2) designation, which would
permit Prurisol to move to advanced trials because the active
moiety of Prurisol is that of a drug already approved by the
FDA.
Additionally, Cellceutix is pleased to announce that recruitment
is underway in the Phase 2b clinical trial of Brilacidin for Acute
Bacterial Skin and Skin Structure Infections ("ABSSSI"). Brilacidin
is the Company's lead compound in a novel class of synthetic
immunomodulatory antimicrobials known as defensin-mimetics. The
randomized, double-blind Phase 2b trial is being conducted at
multiple centers in the U.S. to evaluate the safety and efficacy of
Brilacidin for ABSSSI utilizing three different dosing regimens of
Brilacidin as compared to daptomycin.
"2014 has begun with our Company meeting some very significant
milestones in the first two months," comments Leo Ehrlich, Chief
Executive Officer at Cellceutix. "Our team has moved with precision
to have Brilacidin enrolling patients in a mid/late-stage clinical
trial only five months after we acquired it. Now the IND for
Prurisol is filed, positioning us to initiate a third clinical
trial in an area of great unmet medical need."
With respect to upcoming research, Cellceutix management has
recently returned from meetings with potential formulation
developers regarding Brilacidin for ophthalmic and otitis
indications. The Company plans to aggressively pursue these
conditions as they represent very large markets with inadequate
antibiotics, offering an enormous opportunity for our shareholders.
This is a program with its own unique set of challenges but these
developers have outlined a comprehensive plan how to achieve the
criteria we set up for the formulation. Cellceutix anticipates
signing a formulation agreement in the coming weeks.
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 February 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.
INVESTOR AND MEDIA CONTACT: Cellceutix Corp. Leo Ehrlich
(978) 236-8717 Email
Contact
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