The drug, GEN-1, is a DNA-mediated interleukin-12 immunotherapy. The drug utilizes TheraPlas, Celsion's proprietary synthetic nonviral nanoparticle delivery-system platform.
Celsion shares recently traded at $2.71, up 43%. It has traded on Monday as high as $3.19, up 68%. And it has leaped fivefold over the past six months amid enthusiasm for this drug and for the company’s effort to develop COVID vaccines.
“Fast Track designation is an important step in developing GEN-1 for advanced ovarian cancer,” Chief Executive Michael Tardugno said in a statement.
“Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market.”
Further, “Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical-trial design,” he said. “We are optimistic that GEN-1 represents a game-changer for women with advanced ovarian cancer who have limited treatment options.”
Celsion’s Phase 2 study combines GEN-1 with standard-of-care neoadjuvant chemotherapy in patients newly diagnosed with Stage 3/4 ovarian cancer. Neoadjuvant chemotherapy is designed to shrink cancer as much as possible and enable 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.
Celsion said its Phase 1 study showed seven out of eight patients in the GEN-1 treatment arm having a complete tumor resection.