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Cellceutix Corporation
(the "Company"), a clinical stage biopharmaceutical
company developing innovative therapies with oncology, dermatology,
and antimicrobial applications, is pleased to provide additional information from the Company's recently completed Phase 2b clinical
trial of Brilacidin for the treatment of Acute Bacterial Skin and
Skin Structure Infections (ABSSSI), as well as information on other pipeline developments.
On October 23rd 2014, Cellceutix announced positive top-line results
for the randomized double-blind study comparing three dosing regimens
of Brilacidin to daptomycin for the treatment of ABSSSI. The primary endpoint, defined as reduction of at least 20% in area of ABSSSI
lesion, relative to baseline, was achieved in the intent-to-treat
(ITT) population at 48-72 hours, for each of the three Brilacidin
dosing regimens, including two single-dose regimens, with results
that were comparable to the FDA-approved seven-day dosing regimen of daptomycin.
Cellceutix has continued to analyze the data within other populations
in the study in addition to the intent-to-treat population. The
Company is pleased to report that the results are also positive in
the Microbiological Intent-to-Treat population (MITT). This is an important population, as it consists of patients enrolled in the
trial who had cultures obtained at the baseline visit that were
positive for common ABSSSI pathogens. Most of these cultures grew Staphylococcus aureus, and approximately 40% of these were Methicillin-Resistant Staphylococcus aureus (MRSA). This is currently
the most important bacterial pathogen in patients with ABSSSI. As was seen in the ITT population, the primary endpoint in the patients with culture-positive ABSSSI was achieved for each of the three Brilacidin dosing regimens with similar results as for treatment with daptomycin
for seven days.
In communication with the FDA last week, Cellceutix was encouraged to submit additional information from the Phase 2b study, including
analyses of the recently obtained pharmacokinetic (PK) data. The
Company has requested its vendors to assist in preparation of this information for submission as soon as possible. Thereafter, the
Company will meet with the FDA to discuss the completed Phase 2b
study and to discuss the plans for Phase 3 studies.
Oral Mucositis- Institutional Review Board (IRB) Approval
Cellceutix has received Institutional Review Board (IRB) approval to initiate its Phase 2 study of Brilacidin-OM, the Company's novel oral rinse for the prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer. Study sites identified in the U.S. include MD Anderson Cancer Center at the University of Texas. A description of the study has now been
submitted to www.clinicaltrials.gov and is expected to be published
in the near term. In the U.S., no treatment is approved by the FDA to prevent the often debilitating condition of oral mucositis, the inflammation and ulceration that occurs in the mouth and affects the majority of patients who undergo chemoradiation.
$565,440 Grant Awarded for Research on Cellceutix Platform Technology
A key Cellceutix collaborator, Fox Chase Chemical Diversity Center,
has received a 1-year extension on a subcontract from the University
of Massachusetts (Amherst) under a UO1 National Institute of Health grant. The subcontract of $565,440 will be used to continue research
on the development of the Cellceutix platform technology of host
defense protein mimics (HDP mimics or defensin-mimetics) to combat serious and life-threatening infections caused by multi-drug
resistant Gram-negative bacteria. The target pathogens include
multi-drug resistant Acinetobacter baumannii, Pseudomonas aeruginosa
and the carbapenem-resistant Enterobacteriaceae (CRE) Klebsiella pneumoniae and Escherichia coli. Initial research will focus on continuing the development of lead compounds active against CRE organisms, including CTIX 1807, which has shown robust activity
against Klebsiella pneumoniae in a mouse tissue infection model.
Biotech Showcase: Kevetrin and Prurisol
Cellceutix will be updating shareholders on the latest developments
of the Kevetrin clinical trials for solid tumors ongoing at Dana
Farber Cancer Institute and Beth Israel Deaconess Medical Center and
the upcoming trial of Kevetrin for Acute Myeloid Leukemia (AML) being sponsored by the University of Bologna and its partners during the Biotech Showcase conference being held in San Francisco on January
12, 2015. Updates on the Company's Phase 2 trial of Prurisol
(abacavir acetate) for plaque psoriasis will also be provided at the conference.
New IND filing planned
Cellceutix is preparing a request for a pre-IND meeting with the FDA
to discuss clinical development plans to evaluate a Cellceutix defensin-mimetic for the treatment of serious gastrointestinal
diseases. Updates on this important development will also be provided
at Biotech Showcase.
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