Cellceutix Completes Patient Enrollment in Clinical Trial of Prurisol
June 02 2014 - 7:00AM
Marketwired
Cellceutix Completes Patient Enrollment in Clinical Trial of
Prurisol
Brilacidin Phase 2b Trial 60 Percent Enrolled, Seventh Cohort
Complete in Cancer Drug Trial
BEVERLY, MA--(Marketwired - Jun 2, 2014) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company"), a clinical stage
biopharmaceutical company developing innovative therapies in
oncology, dermatology, and antibiotic applications, reports today
that patient enrollment has been completed in the Company's Phase 1
crossover study of its anti-psoriasis drug candidate
Prurisol. Cellceutix expects lab results, pharmacokinetic
studies, and analysis to take approximately two months. If the
data shows bioequivalence of Prurisol with Abacavir Sulfate, the
Company will then schedule a meeting with the U.S. Food and Drug
Administration regarding initiating a Phase 2/3 trial of Prurisol
through the 505(b)(2) regulatory pathway.
Cellceutix would also like to update shareholders on other
ongoing clinical trials and laboratory research. The seventh
cohort has been completed in the Phase 1 trial of the Company's
anti-cancer drug candidate Kevetrin being conducted at Dana-Farber
Cancer Institute and Beth Israel Deaconess Medical Center. The
safety committee is scheduled to meet next week to determine the
dosing amount for the eighth cohort. Cellceutix anticipates
that dosing will be increased by about 33 percent, or approximately
215 mg/m2, but there are no assurances as any dosing increases are
at the sole discretion of the safety committee. As of today,
the Maximum Tolerated Dose (MTD) of Kevetrin has not yet been
reached.
The Phase 2b trial of Cellceutix's antibiotic Brilacidin is
progressing as planned with approximately 60 percent of patient
enrollment completed. As of today, no drug-related serious
adverse events have been reported in the trial.
Separately, Cellceutix last week entered into a research
agreement with a renowned non-profit research institution for
studies of anti-fungal compounds in Cellceutix's
portfolio. The research is to be funded by a $1.5 million
grant from the National Institute of Health, Small Business
Innovation Research (SBIR) to the non-profit institution. A
Notice of Grant Award Letter has been issued, but funding has not
yet commenced.
"We are very proud of how much we have grown in the past eight
months at Cellceutix and how many wheels are in motion studying our
extensive portfolio from early stages to nearing completion of a
Phase 2b trial," commented Leo Ehrlich, Chief Executive Officer at
Cellceutix. "In addition to the aforementioned clinical
trials, we have antibiotic and antifungal compounds being studied
at various leading universities across the country; Brilacidin
studies for diabetic foot ulcers ongoing; the Investigational New
Drug application being completed for a Phase 2 trial of Brilacidin
for oral mucositis; formulation work being conducted on Brilacidin
for ophthalmic and otitis therapies; and other research happening
for new drugs. While that's a mouthful, it still only covers a
portion of the day-to-day developments at our Company as we
relentlessly strive to meet our goals of providing therapies for
great unmet medical need and delivering strong shareholder
value."
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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