Jennerex Biotherapeutics has announced completion of enrolment in Phase 2b trial of Pexa-Vec (JX-594, pexastimogene devacirepvec) for the treatment of liver cancer.
A total of 120 patients were enrolled in the Traverse study designed to assess the efficacy and safety profile of Pexa-Vec against advanced primary liver cancer in patients failing prior therapy with sorafenib.
The investigational oncolytic immunotherapy Pexa-Vec is designed to de-bulk tumours via tumour cell lysis, induce a systemic anti-tumour immune response, and selectively target tumour vasculature resulting in a rapid reduction in tumour blood flow.
Jennerex president and chief executive officer Laurent Fischer said TRAVERSE was the largest study to date of Pexa-Vec.
"We would like to thank investigators and patients who participated in the study," Fischer said. "We believe that physician and patient interest in this trial validates our novel approach to treating HCC and underscores the need for new treatment options for liver cancer, the third most deadly cancer.
"We look forward to advancing Pexa-Vec into Phase 3 trials and the potential of developing a novel therapeutic option with meaningful efficacy."
The primary objective is to determine the overall survival for patients receiving Pexa-Vec with best supportive care, compared with those receiving best supportive care alone.
The study is being conducted at approximately 40 sites across North America, South Korea, Taiwan, Hong Kong, and Europe.
Image: A large liver tumour is removed from a 50-year-old man during an operation in King Saud Medical Complex, Riyadh, Saudi Arabia. Photo: courtesy of haitham alfalah.