Cohort Completed in Cellceutix Clinical Trial of Prurisol for Psoriasis
May 05 2014 - 9:53AM
Marketwired
Cohort Completed in Cellceutix Clinical Trial of Prurisol for
Psoriasis
BEVERLY, MA--(Marketwired - May 5, 2014) - 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 the first cohort of patients has successfully completed
enrollment in the Company's clinical trial of anti-psoriasis drug
candidate Prurisol™.
The first cohort received 50mg of Prurisol™, with no
treatment-related serious adverse events or dose-limiting toxicity
reported. Cellceutix has been advised that a dose escalation
to 100mg has been approved for the second cohort and enrollment is
underway. The primary endpoint in the clinical trial is to
show that Prurisol™ safely converts to abacavir in healthy humans
as it did in animal models.
"We are very happy to have completed the first cohort and with
the progression of the study to date," commented Dr. Krishna Menon,
Chief Scientific Officer at Cellceutix. "Enrollment is going
very smoothly and we are optimistic that patient enrollment will be
successfully completed in mid-June. That will set the stage
for us to move forward into a Phase 2/3 trial under guidance from
the Food and Drug Administration that a 505(b)(2) pathway is an
acceptable approach for accelerated development of Prurisol™."
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
presently in 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
(978) 236-8717 Email Contact
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