CELLCEUTIX CORPORATION (OTCMKTS:CTIX) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
Phase 2a Trial of p53 Drug Candidate Kevetrin in the
Treatment of Platinum-Resistant/Refractory Ovarian
Cancer
Cellceutix Corporation:
A small mid-stage study is being initiated at a Texas cancer
center which is designed to evaluate Kevetrin for safety,
tolerability, as well as assess changes in select biomarkers and
objective tumor response. Cellceutix believes that this clinical
trial, using IV dosing, will directly inform how Kevetrin
modulates the p53 signaling pathwayone of the key questions asked
by pharmaceutical companies under Confidential Disclosure
Agreement (CDA). Furthermore, as the Company has recently
achieved 79 percent bioavailability of Kevetrin by oral
administration in animal testing, Cellceutix anticipates being
able to subsequently switch to oral dosing in future clinical
trials, resulting in more frequent and convenient drug delivery.
Bridging toxicology studies are now underway to enable this
transition to oral dosing of patients.
The trial, we will be using sophisticated molecular mapping
technology to analyze ovarian cancer tissue samples removed from
study participants. Such data, complementing that already
generated by testing discrete ovarian cancer cell-lines, will
anchor Cellceutixs understanding of Kevetrins multimodal
mechanism of action, providing a more complete understanding of
its full potential as a novel cancer treatment.
About Cellceutix Phase 2a Ovarian Cancer Trial
Design
CTIX-KEV-201 is an open-label, Phase 2a study evaluating the
safety, tolerability, and pharmacokinetics of Kevetrin as well as
changes in select biomarkers and objective tumor response when
administered to patients with platinum-resistant/refractory
ovarian cancer. The clinical trial comprises two different
short-term treatment regimens and will enroll an estimated 10
patients. Primary outcome measures include the incidence of
Treatment-Emergent Adverse Events (TEAEs) and changes in
pre-specified biomarkers (via tumor biopsy, examination of
ascites fluid and peripheral blood), pre-treatment and
post-treatment, at 3 weeks. Secondary outcome measures include
objective tumor response, per Response Evaluation Criteria in
Solid Tumors (RECIST) (version 1.1) and plasma concentrations of
Kevetrin.
For more information on the CTIX-KEV-201 Phase 2a study, please
visit: https://clinicaltrials.gov/ct2/show/NCT03042702
The above information is intended to be considered in the context
of the Company’s Securities and Exchange Commission (SEC)
filings and other public announcements that the Company may make,
by press release or otherwise, from time to time. The Company
undertakes no duty or obligation to publicly update or revise the
information contained in this report, although it may do so from
time to time as its management believes is warranted. Any such
updating may be made through the filing of other reports or
documents with the SEC, through press releases or through other
public disclosure.
The information presented in Item 7.01 of this Current Report on
Form 8-K shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the
Exchange Act), or otherwise subject to the liabilities of that
section, unless the Company specifically states that the
information is to be considered filed under the Exchange Act or
specifically incorporates it by reference into a filing under the
Securities Act of 1933, as amended, or the Exchange Act.
A WARNING ABOUT FORWARD-LOOKING STATEMENTS:
The information contained herein contains forward-looking
statements made to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995 including statements
concerning projected timelines for the initiation and completion
of clinical trials, our future drug development plans, other
statements regarding future product developments, including with
respect to specific indications, and any other statements which
are other than statements of historical fact. These statements
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.
About CELLCEUTIX CORPORATION (OTCMKTS:CTIX)
Cellceutix Corporation (Cellceutix) is a clinical-stage biopharmaceutical company. The Company is engaged in developing therapies with oncology, dermatology and antimicrobial applications. Cellceutix owns the rights to various drug compounds, including Kevetrin (thioureidobutyronitrile), which is its anti-cancer compound; Prurisol (KM-133), which is in development for psoriasis, and Brilacidin, which is its drug in a class of compounds known as defensin-mimetics. The Company’s clinical trials focus on evaluating its drug candidates, including Kevetrin for the treatment of cancers; Prurisol for the treatment of psoriasis, and Brilacidin for treatments of skin infections, prevention of oral mucositis complicating chemoradiation treatment for cancer, and ulcerative proctitis. The Company focuses on developing small molecule therapies to treat diseases in the areas of cancer, antibiotics and inflammatory disease. Kevetrin is a small molecule compound that induces activation of p53. CELLCEUTIX CORPORATION (OTCMKTS:CTIX) Recent Trading Information
CELLCEUTIX CORPORATION (OTCMKTS:CTIX) closed its last trading session down -0.03 at 1.04 with 224,765 shares trading hands.
