Date: 2015-09-30
Type of information: Recruitment of the first patient
phase: 1
Announcement: recruitment of the first patient
Company: Celsion (USA - NJ)
Product: GEN-1 IL-12 in combination with neoadjuvant chemotherapy
Action
mechanism: immunotherapy product/interleukin/protein. GEN-1 Immunotherapy has been designed using Celsion\'s proprietary TheraPlas™ platform technology. This IL-12 DNA plasmid vector is encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation.
Disease: ovarian cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This dose escalation study will determine a maximum tolerated dose and/or optimal biological dose of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) for carboplatin/paclitaxel combination in newly diagnosed ovarian cancer. (NCT02480374) The OVATION Study will seek to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The trial is designed to enroll three to six patients per dose level and will evaluate safety and efficacy and attempt to define an optimal dose for a follow-on Phase I/II study combining GEN-1 with Avastin® and Doxil®. In addition, the OVATION Study establishes a unique opportunity to assess how cytokine-based compounds such as GEN-1, directly affects ovarian cancer cells and the tumor microenvironment in newly diagnosed patients. The study is designed to characterize the nature of the immune response triggered by GEN-1 at various levels of the patients\' immune system, including: infiltration of cancer fighting T-cell lymphocytes into primary tumor and tumor microenvironment including peritoneal cavity, which is the primary site of metastasis of ovarian cancer;
changes in local and systemic levels of immuno-stimulatory and immunosuppressive cytokines associated with tumor suppression and growth, respectively; and
expression profile of a comprehensive panel of immune related genes in pre-treatment and GEN-1-treated tumor tissue.
These extensive mechanistic studies will assist in the design of novel combination approaches with immunotherapies and other anti-cancer agents driven by potential synergistic action mechanisms, and define an enhanced patient population based on molecular characteristics inherent to tumor tissue or the immune system.
Latest
news: * On September 30, 2015, Celsion Corporation, a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies for the treatment of cancer and other difficult-to-treat diseases, announced the enrollment of the first patient in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company\'s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed ovarian cancer patients who will undergo neoadjuvant chemotherapy. The first patient in the OVATION Study was enrolled at the University of Alabama at Birmingham (UAB). In addition to UAB, Oklahoma University Medical Center is now also recruiting patients in the OVATION Study. Celsion plans to initiate two additional sites in the coming months. Interim findings from this open label study are expected in the fourth quarter of 2015. The study will continue into the first half of next year at higher doses of GEN-1. * On September 9, 2015, Celsion Corporation announced that the OVATION Study, a Phase 1b dose escalating trial combining GEN-1 with neo-adjuvant therapies in newly diagnosed ovarian cancer patients, is expected to commence enrollment in the second half of 2015. The first OVATION site at the University of Alabama at Birmingham has been initiated, with three additional sites expected to follow shortly. Data from this open label study is expected in the fourth quarter of 2015, and will continue into the first half of next year at higher doses of GEN-1. This trial will provide a starting dose for a follow-on Phase I/II study combining GEN-1 with Avastin and Doxil. The Company also expects to commence a second ovarian cancer development program with initiation of a Phase I/II dose escalating trial evaluating GEN-1 in combination with Avastin® and Doxil® in platinum-resistant ovarian cancer patients later this year. This new combination study in platinum-resistant ovarian cancer is supported by two preclinical studies demonstrating that the combination of GEN-1 with Avastin® may result in significant clinical benefit with a favorable safety profile, as well as a prior Phase 1b trial of GEN-1 plus Doxil® in platinum resistant breast cancer patients. The Company is now completing a comprehensive series of pre-clinical safety and efficacy studies, and plans to initiate a third Phase I trial combining GEN-1 with current standard of care to treat newly resected glioblastoma multiforme (GBM) brain cancer patients in 2016.
