This designation helps speed the approval of potential medicines that address unmet medical needs in serious or life-threatening conditions. It grants greater access to FDA input throughout the regulatory process and makes GEN-1 eligible for accelerated approval and priority review, provided it meets certain criteria.
“Fast Track designation is an important step in developing GEN-1 for advanced ovarian cancer,” Michael H. Tardugno, Celsion’s chairman, president, and CEO, said in a press release.
Tardugno noted that patients with the disease currently have few treatment options.
GEN-1 is a non-viral nanoparticle that delivers the genetic sequence of the pro-inflammatory protein interleukin (IL)-12 to cells at the tumor site. The resulting sustained production of IL-12 in the vicinity of the tumor is expected to improve the infiltration of immune cells and boost immune attacks against the cancer, while avoiding the side effects (adverse events) of systemic IL-2 treatments.
The safety and anti-tumor activity of GEN-1 was demonstrated in an earlier Phase 1 trial, called OVATION 1 (NCT02480374). That study evaluated GEN-1 in combination with standard chemotherapy for newly diagnosed ovarian cancer patients scheduled for surgery.
Results showed that all patients receiving the highest GEN-1 doses experienced a partial or complete reduction in tumor burden, compared with 67% of those on the lowest doses. Most patients on the highest doses (88%) also had a complete surgical resection, meaning there were no microscopic signs of cancer remaining after the surgery.
A comparison with a control group outside the trial also showed that patients who received GEN-1 with chemo lived without signs of disease progression nearly two times as long as those who received chemo alone before their surgery. However, due to the low number of patients in each group, the difference did not reach statistical significance.
These encouraging results led Celsion to launch the OVATION 2 Phase 1/2 trial (NCT03393884). The study is recruiting an estimated 130 women across 24 sites in the U.S. and one in Canada. Information on contacts and locations can be found here.
Currently underway, with an estimated completion date of 2024, OVATION 2 is testing GEN-1 plus standard chemotherapy versus chemo alone in patients with advanced ovarian, fallopian tube, or primary peritoneal cancers who are scheduled for surgery.
In the Phase 1 part, researchers administered GEN-1 at a dose of 100 mg/m², injected into the abdominal cavity. Patients were assigned to chemo plus GEN-1 or chemo alone, both before and after surgery.
Initial results showed that, while all of the first 15 patients in the study had successful removal of their tumors, those given GEN-1 more often had a resection with clear margins under the microscope (88% vs. 50%). Having clear margins means that no cancer cells are seen at the outer edge of the tissue that was removed.
The Phase 2 part is now investigating whether this combination delays disease progression and extends patient survival.
“Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market,” said Tardugno. “We are optimistic that GEN-1 represents a game-changer for women with advanced ovarian cancer who have limited treatment options.”
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