As a fully-integrated oncology company, Celsion Corporation (NASDAQ:CLSN) has a transformational mission. It includes improving survival and providing cures for challenging cancers. The company says it has set out a Phase II OVATION 2 Study of GEN-1 targeting advanced ovarian cancer treatment. The first two patients in the Phase II portion of the study have been randomized even as the company prepares to enroll another 118 patients in the third quarter of 2021.
The OVATION 2 Study will be a combination of GEN-1 and standard-of-care neoadjuvant chemotherapy (NACT). The target shall be patients suffering from newly diagnosed Stage III/IV ovarian cancer.
GEN-1 Treatment versus the NACT-only Treatment
The Phase I portion of the OVATION 2 Study was carried out during the first half of 2020. The data reported that seven out of eight patients (87.5%) given the GEN-1 treatment arm showed successful tumor resections having demonstrated a complete tumor resection (R0).
On the other hand, the NACT-only treatment did not much success, having demonstrated an R0 resection rate of 50%. According to the Chief Medical Officer from Celsion, Dr. Nicolas Borys, results from GEN-1 showed a nearly doubled progression-free survival (PFS) in the patients. This is one of the many things motivating and pushing forward the Phase II study. According to the company’s CEO, there is a looming potential to alter the current treatment paradigm.
The Global Phase III OPTIMA Study of ThermoDox
ThermoDox is an advanced program and heat-mediated drug delivery technology. The study carried out at 65 clinical sites enrolled 554 patients. The primary sites were in China, Europe, Asia Pacific, and North America, and the secondary points of the study were safety, time to disease progression, and progression-free survival.
The technology is Celsion’s lead program and takes control over two mechanisms of tumor biology. Through them, it can deliver higher absorptions of drugs directly to the tumor site. Of importance to the company is being able to its goal of providing new, enhanced, and cost-effective therapeutic options to patients struggling to treat ovarian cancer. That is why it has engaged some of the leading researchers and investigators.