Cellceutix Clinical Trial of Anti-Cancer Drug Kevetrin Entering Eighth Cohort
June 16 2014 - 7:00AM
Marketwired
Cellceutix Clinical Trial of Anti-Cancer Drug Kevetrin Entering
Eighth Cohort
Enrollment in Phase 2b Trial of Novel Antibiotic Brilacidin
Approximately 70% Complete
BEVERLY, MA--(Marketwired - Jun 16, 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 safety committee overseeing the Phase 1 clinical
trial evaluating Cellceutix's lead anti-cancer drug Kevetrin for
solid tumors being conducted at Dana-Farber Cancer Institute and
Beth Israel Deaconess Medical Center has approved dosing for the
eighth cohort. The dosing was been increased approximately 33
percent from the seventh cohort to 215 mg/m2. Enrollment for
the eighth cohort is expected to commence shortly.
Cellceutix would also like to inform shareholders that
enrollment in the Phase 2b clinical trial of Brilacidin for Acute
Bacterial Skin and Skin Structure Infections (ABSSSI) is
approximately 70 percent complete. To date, no drug-related
serious adverse events have been reported.
The Company has been advised that the Brilacidin safety
committee meeting is scheduled for the end of June. Cellceutix
anticipates providing shareholders with an update on data from the
trial and any commentary from the safety committee in the first
half of July.
Cellceutix is delighted by the recent release of the final rule
by the U.S. Food and Drug Administration list of qualifying
pathogens under the Generating Antibiotic Incentives Now (GAIN)
Act. The list is advantageous to our Company's robust
portfolio of defensin mimetics, as the list contains many of the
pathogens we are working on. We expect to benefit from the
regulatory framework of the GAIN Act to expedite development.
Interested parties are encouraged to read the Federal Register to
learn more about the final rule list by the U.S. Food and Drug
Administration at:
http://www.gpo.gov/fdsys/pkg/FR-2014-06-05/pdf/2014-13023.pdf.
Additionally, Cellceutix has been informed that the U.S. Patent
and Trademark Office has issued a Notice of Allowance for the U.S.
Patent Application No. 13/730247 "Carbocyclic Nucleosides And Their
Pharmaceutical Use And Composition" with claims covering
Cellceutix's compound Prurisol. Cellceutix announced on June
2, 2014 that it has completed enrollment in a Phase 1 crossover
study of Prurisol as a new drug candidate for the treatment of
psoriasis and that lab results, pharmacokinetic studies, and
analysis are expected to take approximately two months.
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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