BEVERLY, Mass., April 03, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), is pleased
to share further data supporting the p53 mechanism of action of Kevetrin in Ovarian Cancer (OC) at the American Association of
Cancer Research (AACR) Annual Meeting.
- Poster title: “Kevetrin induces p53-dependent and independent cell cycle arrest and apoptosis in ovarian cancer
cell-lines representing heterogeneous histologies”
- Presentation time: At the AACR Annual Meeting, from 8am to 12pm, Tuesday, April 4, 2017 in Washington,
D.C.
Previously, data have been presented from cell studies showing that Kevetrin stabilized wild type p53 and induced
transcriptional targets in human lung carcinoma. The current poster presentation includes key findings from studies that we have
performed to validate Kevetrin as a potential treatment for OC with varied p53 status. Endometrioid carcinoma (A2780, wt p53),
high-grade serous (OVCAR-3, mutant p53; OV-90, mutant p53) and atypical non-serous clear cell (SKOV-3, partially deleted p53) OC
cell-lines and tumors were treated with Kevetrin in these studies.
Key findings presented include: transcriptomic analyses, demonstrating Kevetrin modulation of p53 signaling pathways; and
induction of cell cycle arrest and apoptosis in Ovarian Cancer cell-lines and in xenograft tumors.
In a completed Phase 1 clinical trial, Kevetrin was well-tolerated with minimal adverse effects. A Phase 2a clinical trial in
Ovarian Cancer is currently underway in which similar analyses of pathway modulations by Kevetrin are being explored directly using
tumor biopsies before and after treatment.
On April 4, the scientific poster will be available for download on the Events and Presentations section of the Cellceutix
company website, linked to below:
http://www.cellceutix.com/new-events-and-presentations/
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About Kevetrin
Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing
activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell
mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the
body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical
Center, a Phase 1 clinical trial evaluating Kevetrin in treating advanced solid tumors has been successfully completed, with
patients showing good toleration and encouraging signs of potential therapeutic response. Cellceutix has initiated a Phase 2a trial
of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent Kevetrin administration (3 times
per week), escalating to higher dosing in the second cohort, and after trial completion will receive standard of care treatment.
Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even
multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma,
qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has
granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.
Learn more here:
http://www.cellceutix.com/kevetrin-1/
About Ovarian Cancer
Ovarian cancer is a common type of cancer that commonly begins in women’s ovaries. Malignant ovarian tumor cells metastasize
either directly through the organs of the pelvis region, or through the bloodstream, or the lymphatic system. The causes of ovarian
cancer are still not known, though women over the age of 63 represent more than 50 percent of newly diagnosed cases, with the
cancer more frequently found in white women than other ethnicities. Ovarian cancer ranks fifth in cancer deaths among women
worldwide. It is estimated that in 2016, in the United States, over 22,000 women will be diagnosed with ovarian cancer, with
approximately 14,000 women dying from the disease. A $1.6 billion market, current treatment is often limited to surgery and
chemotherapy and there is no cure.
More information can be found at:
https://seer.cancer.gov/statfacts/html/ovary.html
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
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 multiple diseases. Cellceutix believes it has a
world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively
seeking strategic partnerships. Cellceutix's psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently
launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's
anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute
and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 study. 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 in a Phase 2 clinical trial with its novel compound Brilacidin-OM (a defensin mimetic compound) for the prevention of
oral mucositis in patients with head and neck cancer. Interim analysis has shown Brilacidin-OM to have a high potential for
prevention of severe oral mucositis. Clinical results are consistent with those seen in an animal model in which the occurrence of
severe ulcerative oral mucositis was reduced by more than 94% compared to placebo. Cellceutix's lead antibiotic, Brilacidin, has
completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose
of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has
the potential to be a single-dose therapy for certain multi-drug resistant bacteria ("superbugs"). In an ongoing Phase 2 open label
Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin
for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). 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 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 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.
INVESTOR AND MEDIA CONTACT Cellceutix Corporation Leo Ehrlich info@cellceutix.com
