Kevetrin Update We met with the FDA division r
Post# of 72446
Posted On: 05/09/2016 7:31:57 PM
Kevetrin Update
We met with the FDA division responsible for ovarian cancer trials to discuss our clinical path forward. We were given guidance by the Agency in the design of trials for a quicker regulatory path towards (our goal of) regulatory approval. Based on this guidance, we intend to use a combination treatment exclusively in this study. The plan is for Kevetrin to be dosed in combination with liposomal doxorubicin (a drug already approved for treating ovarian cancer) due to Kevetrin's safety profile, potential ability to sensitize the tumor, as well as its abilities to cause apoptosis in cancer cells. In vitro and in vivo animal studies evaluating combinations of Kevetrin and various chemotherapies used in treatment of ovarian cancer have been completed and are supportive of the approach planned. The clinical trial protocol is planned for submission to FDA in May 2016.
In 2012, we entered into an agreement with Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard Medical School, on an innovative research project with Kevetrin. The Medical Center wished to exploit the nuclear and/or mitochondrial pro-apoptotic function of p53 in melanoma and renal cell carcinoma, two types of cancer that are particularly resistant to therapy. We are now engaged in discussions with the hospital as to the logistics and costs, net of grants, to move this project forward into Phase 2 studies of renal cell carcinomas. At this time our priority is to advance Kevetrin in the treatment of ovarian cancer.
The University of Bologna in Italy (the "University"
and The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) after testing Kevetrin in preclinical studies, approached us to test Kevetrin in a clinical trial against Acute Myelogenous Leukemia (AML). The study proposed is a Phase 2 trial evaluating Kevetrin as a single agent or in combination with cytarabine in patients with Acute Myelogenous Leukemia (AML). The protocol was submitted in May 2015 by the principal investigator to the institutional committee. In October 2015, we were advised by the Principal Investigator that there are difficulties with the funding in Italy and asked whether we would be interested in contributing financially to the study. At this time we have put this project on hold as we advance Kevetrin through the regulatory process. We expect to turn our attention back to this project once we further Kevetrin in ovarian cancer studies as the University data of its Kevetrin studies in AML has been encouraging.
In June 2013, we signed a Material Transfer Agreement with the University of Texas, MD Anderson Cancer Center. MD Anderson intends to utilize in vivo and in vitro methods to research specific pathways, gene expression, mechanism of action and apoptotic activity of Kevetrin in a range of concentrations and time points in both mutant and wild-type p53 Myeloma and Lymphoma cell lines. The National Cancer Institute estimates that more than 24,000 individuals will be diagnosed with myeloma in the United States in 2014, and more than 11,000 will die from this disease. They also wish to study our other cancer compounds against a broad array of Multiple Myeloma cell lines that are resistant to today's FDA-approved chemotherapies. MD Anderson is covering the expenses of the research, with Cellceutix only supplying the drugs. In May 2016, we sent requested Phase 1 pharmacokinetic data to MD Anderson.
https://www.sec.gov/Archives/edgar/data/13552...ix_10q.htm
We met with the FDA division responsible for ovarian cancer trials to discuss our clinical path forward. We were given guidance by the Agency in the design of trials for a quicker regulatory path towards (our goal of) regulatory approval. Based on this guidance, we intend to use a combination treatment exclusively in this study. The plan is for Kevetrin to be dosed in combination with liposomal doxorubicin (a drug already approved for treating ovarian cancer) due to Kevetrin's safety profile, potential ability to sensitize the tumor, as well as its abilities to cause apoptosis in cancer cells. In vitro and in vivo animal studies evaluating combinations of Kevetrin and various chemotherapies used in treatment of ovarian cancer have been completed and are supportive of the approach planned. The clinical trial protocol is planned for submission to FDA in May 2016.
In 2012, we entered into an agreement with Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard Medical School, on an innovative research project with Kevetrin. The Medical Center wished to exploit the nuclear and/or mitochondrial pro-apoptotic function of p53 in melanoma and renal cell carcinoma, two types of cancer that are particularly resistant to therapy. We are now engaged in discussions with the hospital as to the logistics and costs, net of grants, to move this project forward into Phase 2 studies of renal cell carcinomas. At this time our priority is to advance Kevetrin in the treatment of ovarian cancer.
The University of Bologna in Italy (the "University"
and The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) after testing Kevetrin in preclinical studies, approached us to test Kevetrin in a clinical trial against Acute Myelogenous Leukemia (AML). The study proposed is a Phase 2 trial evaluating Kevetrin as a single agent or in combination with cytarabine in patients with Acute Myelogenous Leukemia (AML). The protocol was submitted in May 2015 by the principal investigator to the institutional committee. In October 2015, we were advised by the Principal Investigator that there are difficulties with the funding in Italy and asked whether we would be interested in contributing financially to the study. At this time we have put this project on hold as we advance Kevetrin through the regulatory process. We expect to turn our attention back to this project once we further Kevetrin in ovarian cancer studies as the University data of its Kevetrin studies in AML has been encouraging. In June 2013, we signed a Material Transfer Agreement with the University of Texas, MD Anderson Cancer Center. MD Anderson intends to utilize in vivo and in vitro methods to research specific pathways, gene expression, mechanism of action and apoptotic activity of Kevetrin in a range of concentrations and time points in both mutant and wild-type p53 Myeloma and Lymphoma cell lines. The National Cancer Institute estimates that more than 24,000 individuals will be diagnosed with myeloma in the United States in 2014, and more than 11,000 will die from this disease. They also wish to study our other cancer compounds against a broad array of Multiple Myeloma cell lines that are resistant to today's FDA-approved chemotherapies. MD Anderson is covering the expenses of the research, with Cellceutix only supplying the drugs. In May 2016, we sent requested Phase 1 pharmacokinetic data to MD Anderson.
https://www.sec.gov/Archives/edgar/data/13552...ix_10q.htm
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