Seventh Cohort Underway in Cellceutix Clinical Trial of Kevetrin for Solid Tumors
March 19 2014 - 8:40AM
Marketwired
Seventh Cohort Underway in Cellceutix Clinical Trial of Kevetrin
for Solid Tumors
BEVERLY, MA--(Marketwired - Mar 19, 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 seventh cohort is now in progress in the Company's ongoing
Phase 1 clinical trial of Kevetrin™, Cellceutix's novel anti-cancer
drug candidate.
The seventh cohort dosing is 165 mg/m2 of Kevetrin™, compared to
110 mg/m2 in the prior cohort. Cellceutix is pleased to report
that Maximum Tolerated Dose (MTD) has yet to be reached through the
completion of six cohorts.
As announced on January 15, the U.S. Food and Drug
Administration approved an amendment to the trial protocol to limit
the maximum infusion timeframe to six hours throughout the
remainder of the trial. The implementation of the amendment at
the two hospitals took approximately two months.
"We are excited that the seventh cohort is underway as we feel
that we are drawing closer to achieving MTD, which represents a
milestone for our Company," commented Leo Ehrlich, Chief Executive
Officer of Cellceutix. "The internal procedures at the
clinical sites have moved a little more slowly than we hoped, but
that is beyond our control and not out of the ordinary when working
with some of the world's leading cancer research
centers. Kevetrin is in great hands and we are glad to be
moving towards completion of this study. On another note, we
have been updated that enrollment in our Phase 2b clinical trial of
Brilacidin for Acute Bacterial Skin and Skin Structure Infections
(ABSSSI) is progressing smoothly across multiple sites. We are
very pleased with the clinical development of both of these novel
compounds."
The clinical trial of Kevetrin is an open-label, dose-escalation
study being conducted at Harvard University's Dana-Farber Cancer
Institute and Beth Israel Deaconess Medical Center to assess the
safety and tolerability of Kevetrin™, a small molecule compound
shown in the laboratory to activate the key tumor suppressor
protein p53, in patients with advanced solid
tumors. Additional information on the trial can be found at:
http://www.clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix+kevetrin&rank=1
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 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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