Clinical Studies

OVATION Studies—GEN-1 in ovarian cancer

OVATION 2 is a Phase I/II study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (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 GEN-1 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 GEN-1 (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 GEN-1 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.

View the Ovation I Study at clinicaltrials.gov

For Patients

 

About Ovarian Cancer

OVATION2: A Phase I/II Study Evaluating the Dosing, Safety, Efficacy and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated with PPC Lipopolymer)

Administered in Combination with Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

 

Ovarian Cancer Advocacy Programs

Tell Every Amazing Lady About Ovarian Cancer

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. www.TellEveryAmazingLady.org

Expanded Patient Access Policy

Patients are our partners, our inspiration, and are behind our commitment to IMUNON’s mission, goals, and development of GEN-1.

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 GEN-1 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.

They include:

  • The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
  • There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
  • Whether we have the ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients

If you have additional questions, please speak with your physician or call 609-482-2472.

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.