Imunon, Inc. (IMNN), Wednesday announced final clinical data from the completed Phase 2 OVATION 2 clinical trial, evaluating IMNN-001 in combination with standard of care neoadjuvant and adjuvant chemotherapy in women with newly diagnosed advanced ovarian cancer.
The company revealed a median 14.7-month increase in Overall Survival or OS in women in the IMNN-001 treatment arm compared to standard of care alone, which is an improvement from the previously reported median 11.1-month increase in OS.
Additionally, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase inhibitors as part of maintenance therapy achieved a median increase in OS of 24.2 months compared to SoC chemotherapy alone.
Stacy Lindborg, president and chief executive officer of IMUNON, commented, "The strong response from our current trial investigators and the broader medical community supports our belief in the significant potential of IMNN-001 to make a meaningful difference in women's lives."
Moving ahead, the company focuses on executing its pivotal Phase 3 OVATION 3 trial. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for potential submission of a Biologics License Application for full approval of IMNN-001 to the U.S. Food and Drug Administration if the primary endpoint reaches statistical significance.
In the pre-market hours, IMNN is trading at $2.4, down 14.94 percent on the Nasdaq.
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