Cellceutix Provides Updates on Clinical Trials and Developments of Its Anti-Cancer, Anti-Psoriasis, and Antibiotic Compounds
January 15 2014 - 8:00AM
Marketwired
Cellceutix Provides Updates on Clinical Trials and Developments of
Its Anti-Cancer, Anti-Psoriasis, and Antibiotic Compounds
BEVERLY, MA--(Marketwired - Jan 15, 2014) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company"), a clinical stage
biopharmaceutical company developing innovative therapies in
oncology, dermatology, and antibiotic applications, today provides
shareholders with an update on the current status of the Company's
compounds in development.
Kevetrin, anti-cancer compound in a Phase 1 clinical trial for
solid tumors being hosted at Dana-Farber Cancer Institute and Beth
Israel Deaconess Medical Center:
To date, six cohorts have completed enrollment, with the sixth
cohort receiving infusions at 110 mg/m2. Maximum Tolerated
Dose ("MTD") has still not been reached. To date, one patient
has competed 7 dosing cycles; 2 patients have completed 5 dosing
cycles; 1 patient has completed 4 dosing cycles; 1 patient has
completed 3 dosing cycles; 8 patients have completed 2 dosing
cycles; and 7 patients have completed 1 dosing cycle. A dosing
cycle is 28 days.
As disclosed in December (See press release dated December 9,
2013), the Company had filed an amendment with the U.S. Food and
Drug Administration ("FDA") to modify the trial protocol to limit
the dosing infusion timeframe to a maximum of six hours, versus the
current protocol of 30 mg/m2 without a maximum infusion
timeframe. As dosing continued to increase without yet
reaching a MTD, the infusion duration became a concern as it could
become quite lengthy. We are pleased to report that yesterday the
FDA accepted our amendment. The FDA approval now allows for
enrollment to begin of the seventh cohort under the amended
protocol. The safety committee overseeing the trial has
approved dosing to be increased to 165 mg/m2 with a 6-hour maximum
infusion timeframe for the seventh cohort.
Cellceutix has been advised that requisite documentation is
prepared for the planned Phase 1b/2 clinical trial of Kevetrin in
combination with Cytarabine for Acute Myelogenous Leukemia to be
sponsored by the University of Bologna in Italy, The Italian
Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML)
and Acute Leukemia (GIMEMA Group) and hosted at European clinical
sites. We are now in the process of manufacturing a
formulation of Kevetrin for this trial.
Prurisol, anti-psoriasis compound being developed under FDA
guidance that a 505(b)(2) designation is an appropriate
developmental pathway:
Recently, the Company submitted the application to the
Institutional Review Board ("IRB") responsible for the planned
Phase 1 clinical trial of Prurisol. Upon IRB approval, the
Company will immediately file the Investigational New Drug ("IND")
application with the FDA to initiate a brief Phase 1 crossover
study to confirm that Prurisol converts into abacivir in the human
body, as it has been shown to do in animal models. The Phase 1
trial is expected to take approximately 45 days to
complete. Following successful completion of the crossover
study, Cellceutix will move forward with initiation of a larger
Phase 2/3 clinical trial under the pathway of a 505(b)(2), which
permits research to immediately move to advanced stages because
Prurisol is an ester of an drug already approved by the
FDA. Dr. Reddy's Laboratories has already manufactured
sufficient quantities of Prurisol for both the Phase 1 and Phase
2/3 trials.
Brilacidin, lead compound in a novel class of synthetic
immunomodulatory antimicrobials known as defensin-mimetics:
- ABSSSI (Acute Bacterial Skin and Skin Structure
Infections). On January 10, 2014, Cellceutix received IRB
approval for a U.S.-based phase 2b clinical trial in
ABSSSI. In this 200-patient study, three brilacidin dosing
regimens (two single-dose regimens and one 3-day regimen) will be
compared to a standard 7-day regimen of daptomycin. Site
initiation visits are planned, after which enrollment will
begin.
- Oral mucositis (OM): As disclosed in December (See press
release dated December 20, 2013), the Company filed an application
with the U.S. Food and Drug Administration requesting Orphan Drug
designation for its oral rinse formulation Brilacidin™-OM as a drug
candidate for the prevention of radiation or chemotherapy-induced
oral mucositis in patients with head and neck cancer. The company
is awaiting a response from the Agency. The company is
planning a U.S.-based Phase II trial of Brilacidin-OM for this
indication and plans an IRB submission at the end of 1Q 2014.
- Ophthalmic infections: As disclosed in November (See press
release dated November 4, 2013) 2013), the company has identified
ocular infections, such as keratitis, as an area of unmet medical
need and significant commercial potential, based on positive
preclinical data supporting safety, antimicrobial efficacy, and
prolonged residence time on the ocular surface with minimal
systemic exposure. The Company has received proposals for the
necessary formulation and will shortly select a manufacturer.
- Otitis media/externa: Preclinical studies in animals have begun
and formulation development is in progress.
"We are extremely pleased with the advancements of Kevetrin,
Brilacidin and Prurisol; their developments as a testament to the
dedication and hard work of our team," comments Leo Ehrlich, Chief
Executive Officer of Cellceutix. "Looking back at 2013, our
Company has experienced tremendous growth, moving forward in
clinical trials, adding very promising compounds to our portfolio
with the acquisition of PolyMedix assets, doubling the size of our
laboratory and strengthening our financial position. As
satisfied as we are with the accomplishments of 2013, we have
higher expectations for 2014 and again are striving to be an even
better, more formidable company at this time next year."
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
defensing-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
set to begin a Phase 2b trial in January 2014 for Acute Bacterial
Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the
potential to be a single-dose therapy for multi-drug resistant
bacteria or a dosing regimen that is shorter than currently
marketed antibiotics. 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.
Contact: INVESTOR AND MEDIA CONTACT: Cellceutix Corp. Leo
Ehrlich (978) 236-8717
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