OVATION 2 is a Phase I/II study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer. The primary objective of the study is to evaluate safety and compare progression free survival between neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT. This is a randomized, open label, multicenter trial in which eligible subjects will be assigned 1:1 to the treatment and control arms. The phase I portion of the study will determine the dosing for the phase II portion, which will also evaluate safety, efficacy, and biological activity.
View the Ovation 2 Study at clinicaltrials.gov
OVATION I was a Phase I Study of the Safety & Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Standard Neoadjuvant Chemotherapy in Patients Newly Diagnosed with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. The primary endpoint was determination of a recommended Phase II dose of IMNN-001 in combination with standard neoadjuvant therapy. It had a standard 3+3 design with approximate 30% dose increments between successive cohorts of patients. The results of OVATION 1 have been published in the journal Clinical Cancer Research.
OVATION2: A Phase I/II Study Evaluating the Dosing, Safety, Efficacy and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PPC Lipopolymer)
Louisa M. McGregor Ovarian Cancer offers women’s health and wellness services, including public awareness and education of the signs, symptoms, and risk factors of ovarian cancer, proved support to those impacted by the disease and raises funds for research in order to find a screening test and a cure.
The OVATION 2 Study is a clinical research study to evaluate an investigational drug for the treatment of patients newly diagnosed advanced Ovarian Cancer.
View Trial on ClinicalTrials.gov
All eligible patients enrolled in the study will receive the standard treatment for their cancer.
50% will receive standard treatment (chemotherapy and surgery)
50% will receive a combination of standard treatment and an investigational drug, IMNN-001
This Phase I-II study evaluates the safety, efficacy, and biological activity of the medicine in approximately 110 volunteers. Volunteers have the disease or condition the medicine is designed to treat.
Phase I-II trials take place in hospitals, clinics or physician offices.
Patients are our partners, our inspiration, and are behind our commitment to IMUNON’s mission, goals, and development of IMNN-001.
IMUNON believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. For more information, visit ClinicalTrials.gov.
At this time, IMUNON is not offering IMNN-001 or any other investigational products under the Expanded Access program.
Expanded access, sometimes referred to as compassionate use, refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected.
A number of factors consistent with the US Food and Drug Administration and other regulatory agencies’ guidelines should be taken into account when considering expanded access.
IMUNON may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.