Cellceutix Submits Briefing Book For Phase 2 Trial Of p53 Targeting Drug For Ovarian Cancer
BEVERLY, MA--(Marketwired - January 19, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the briefing book with data collected during the Phase 1 clinical trial of Kevetrin for various advanced solid tumors has already been submitted to the U.S. Food and Drug Administration (FDA). This briefing book submission is in advance of the FDA meeting to discuss the planned Phase 2 clinical trial of Kevetrin for advanced ovarian cancer. Cellceutix is developing Kevetrin for ovarian cancer under an FDA Orphan Drug designation.
48 advanced-stage cancer patients were enrolled in the Phase 1 trial and received at least one dose of Kevetrin. 11 of the 48 patients in the trial had advanced ovarian cancer.
Kevetrin has a unique mechanism of action that enhances activity of p53, a key tumor suppressor protein, in both wild type and mutant p53-expressing tumors. In the Phase 1 trial, p53 activity is measured by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. p21 increased by = 10% in 48% of the 31 evaluable patients to date. Importantly, with respect to the planned Phase 2 trial for ovarian cancer, 8 of 11 subjects (73%) with advanced ovarian cancer had increases in p21 expression, indicative of activation of p53.
No evidence of adverse effects on liver, kidney or hematologic function related to Kevetrin was observed, regardless of dose. Therapeutic efficacy was not an endpoint in the Phase 1 trial. However, RECIST (Response Evaluation Criteria In Solid Tumors) criteria were used and several subjects had stable disease for several months during a Kevetrin treatment cycle of one dose per week for three weeks and then one week off. The longest enrolled subject has completed 15 cycles and remains enrolled in the trial.
In the planned Phase 2 ovarian cancer trial, Cellceutix intends to leverage the short half-life and strong pharmacokinetic profile of Kevetrin to change Kevetrin dosing from a single dose weekly to multiple doses weekly. The company expects that this will further increase p53 activity.
Ovarian cancer is a disease with a large unmet medical need and represents one of the fastest paths for approval for a clinically successful drug.
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 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.
48 advanced-stage cancer patients were enrolled in the Phase 1 trial and received at least one dose of Kevetrin. 11 of the 48 patients in the trial had advanced ovarian cancer.
Kevetrin has a unique mechanism of action that enhances activity of p53, a key tumor suppressor protein, in both wild type and mutant p53-expressing tumors. In the Phase 1 trial, p53 activity is measured by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. p21 increased by = 10% in 48% of the 31 evaluable patients to date. Importantly, with respect to the planned Phase 2 trial for ovarian cancer, 8 of 11 subjects (73%) with advanced ovarian cancer had increases in p21 expression, indicative of activation of p53.
No evidence of adverse effects on liver, kidney or hematologic function related to Kevetrin was observed, regardless of dose. Therapeutic efficacy was not an endpoint in the Phase 1 trial. However, RECIST (Response Evaluation Criteria In Solid Tumors) criteria were used and several subjects had stable disease for several months during a Kevetrin treatment cycle of one dose per week for three weeks and then one week off. The longest enrolled subject has completed 15 cycles and remains enrolled in the trial.
In the planned Phase 2 ovarian cancer trial, Cellceutix intends to leverage the short half-life and strong pharmacokinetic profile of Kevetrin to change Kevetrin dosing from a single dose weekly to multiple doses weekly. The company expects that this will further increase p53 activity.
Ovarian cancer is a disease with a large unmet medical need and represents one of the fastest paths for approval for a clinically successful drug.
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 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.