Celsion Corporation Receives FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer
Celsion’s Commitment to Promoting Immune System Solutions to Fight Life-Threatening Diseases
Granted an Accelerated Development Pathway
Designation Provides Potential for an Expedited Regulatory Review.
Fast Track designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need. According to the FDA, a Fast Track Drug must show some advantage over available therapy, including:
- Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
- Avoiding serious side effects of an available therapy
- Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
“Fast Track designation is an important step in developing GEN-1 for advanced ovarian cancer. Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market,” said
GEN-1 is the subject of Celsion’s Phase II OVATION 2 Study, which combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three adjuvant cycles of chemotherapy and up to nine additional weekly GEN-1 treatments, the goal of which is to delay progression and improve overall survival. The OVATION 2 Study is an open-label, 1-to-1 randomized trial, 80% powered to show the equivalent of a 33% improvement in progression-free survival (PFS) (HR=0.75), the primary endpoint, when comparing the treatment arm (standard of care + GEN-1) with the control arm (standard of care alone).
Patients in the Company’s completed Phase 1b dose-escalation OVATION I Study showed compelling objective response rates, with 100% of patients in high-dose cohorts experiencing a complete or partial response, and 67% of patients in lower-dose cohorts experiencing a complete or partial response. Further, R0 resections in the high-dose cohorts was 88%, compared with 33% in the low-dose cohorts.
|GEN-1 Population||PFS Hazard Ratio (Confidence Interval)|
|Intent-to-treat, n=15||0.53 (95% CI 0.16, 1.73); log-rank p=0.29|
|Per-protocol, n=14||0.33 (95% CI 0.08, 1.37); log-rank p=0.11|
About GEN-1 Immunotherapy
GEN-1, designed using
About Celsion Corporation
Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time and risk of failure of conducting clinical trials; the need for
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Source: Celsion CORP