BEVERLY, MA--(Marketwired - August 20, 2015) - Cellceutix Corporation (
The trial has accomplished many of its goals and will be concluded shortly. Over 40 patients have been enrolled, providing ample data to confirm the safety of Kevetrin. Kevetrin has been well tolerated and the pharmacokinetic profile was dose dependent and predictable. Importantly, Cellceutix believes that p53 activation has been shown, as measured by p21 expression in peripheral blood samples. To that point, Cellceutix would like to share an excerpt from Company's annual report to the U.S. Food and Drug Administration concerning the Phase 1 trial.
"Of 40 subjects enrolled to date, 31 were evaluable for changes in p21 biomarker (pre-dose and at least 1 time point post-dose blood sample obtained after first dose of Kevetrin). Of the 31 evaluable subjects, 68% had an increase in p21 expression in a range of 3% to 205% and 48% had an increase in p21 expression of ≥ 10%, considered a meaningful increase.
Of the 15 evaluable subjects with gynecological cancers, p21 expression increased in 11 (73%) subjects. Also, p21 expression increased in both of the two subjects with prostate cancer."
These results support the concept that Kevetrin activates p53 by inducing p21 gene expression.
Although the goal of a Phase 1 trial is to evaluate the safety profile of a drug candidate, Cellceutix is optimistic about the potential effects of Kevetrin as evidenced by disease stabilization in several patients. This information has been presented to peers, such as at the latest American Society of Clinical Oncology meeting, and is publicly available on the Cellceutix website (http://cellceutix.com/events/#sthash.PPDX7mtb.dpbs). Final data for the safety observations in patients receiving Kevetrin as well as tumor response information will be presented after the completion of the study. We recommend that shareholders and other interested parties review ASCO presentations and reports by the Company.
The Company's previously reported mechanism of action (MOA) of Kevetrin strongly suggests that Kevetrin has great potential to enhance chemosensitivity. Multiple reports from different laboratories have shown that drugs modulating any of these: p531, HDAC2, c-MYC3(p53:Clin. Can. Research 2009 15, 6495-502; HDAC: Cancer Sci 2008 99, 378-84; c-Myc: Biomed Pharmacother 2015 73, 123-128) has shown enhanced sensitivity to chemotherapeutic drugs. p53 is major determinant of chemosensitivity in humans while mutant p53 proteins can induce drug resistance. Since Kevetrin modulates all of the above molecules, laboratory studies tested the sensitizing ability in mutant p53 cells and tumors which are refractory to chemotherapeutic agents. The combination of Kevetrin with chemotherapy drugs resulted in synergistic apoptosis at a much lower concentrations than with each agent individually. Thus, Kevetrin holds promise to maximize tumor cell killing when used in combination therapies. Laboratory studies conducted by Cellceutix and at leading institutions on the effects of Kevetrin in combination with approved cancer drugs, including studies against renal cancer, pancreatic cancer, ovarian cancer, glioblastoma and acute myeloid leukemia, have delivered promising data supporting the ability of Kevetrin to enhance chemosensitivity.
Additionally, research indicates that Kevetrin is not likely to alter hematological parameters, which would give Cellceutix the opportunity to combine an immunotherapy with Kevetrin for its maximum outcome. In this approach, Cellceutix believes Kevetrin can provide a significant advantage over other drugs in immuno-oncology combination studies.
The clinical data on Kevetrin, with consideration to extensive laboratory studies by Cellceutix and independent institutions, leaves the Company with many potential channels for mid-stage studies of Kevetrin as a monotherapy, combination therapy, or both. Presently, the Company is drafting a study protocol for a Phase 2/3 clinical trial on ovarian cancers.
"The information we have received on Kevetrin is exceptional, especially when viewed with the understanding that Kevetrin is being evaluated in cancer patients with no effective curative or surgical treatment options. The MOA and safety profile will allow us to explore dosing multiple times weekly and combination studies unlike many other drugs, while adding to our optimism that Kevetrin can be a first-in-class drug," said Leo Ehrlich, Chief Executive Officer. "We have a portfolio of excellent and very valuable compounds. In addition to advancing Kevetrin, the designing of the Phase 3 ABSSSI trial of Brilacidin is ongoing and our Phase 2 trial of Brilacidin-OM for oral mucositis is already enrolling at four clinical sites and we expect to begin recruitment at a fifth site next week. With the recent commencement of our Phase 2 trial of Prurisol for psoriasis, we are operating on all cylinders as we move forward toward our goals of developing best in class FDA approved drugs."
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1 El-Deiry WS. The role of p53 in chemosensitivity and radiosensitivity. Oncogene (2003) 22: 7486-7495. http://www.nature.com/onc/journal/v22/n47/full/1206949a.html
The Lunghi P. et al. The p53 family protein p73 provides new insights into cancer chemosensitivity and targeting. Clin Cancer Res (2009) 15: 6495 - 6502. http://clincancerres.aacrjournals.org/content/15/21/6495.long
2 Ozaki K, et, al. Histone deacetylase inhibitors enhance the chemosensitivity of tumor cells with cross-resistance to a wide range of DNA-damaging drugs.Cancer Sci (2008) 99: 376-384.
3 Guo G. New perspective on targeting the tumor suppressor p53 pathway in the tumor microenvironment to enhance the efficacy of immunotherapy. J Immunother Cancer (2015) 3: 9-20. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372251/
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 antimicrobial 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 in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, 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). 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.
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.
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