Biotechnology company Candel Therapeutics has completed the enrolment of patients choosing active surveillance (PrTK04 – NCT02768363) under the Ulysses trial, a Phase II study of ProstAtak for prostate cancer.
The company said that enrolment is open for prostate cancer patients choosing radiation therapy as primary treatment (PrTK03 – NCT01436968).
ProstAtak, a Gene Mediated Cytotoxic Immunotherapy (GMCI) for the treatment of prostate cancer, is a low-toxicity immunotherapy that stimulates a patient’s immune system to generate a robust response against the cancer.
The Ulysses study has enrolled 190 patients at 22 clinical sites after it was expanded from an originally planned 156 patients due to demand from investigators and patients.
The primary endpoint for the trial is a change in tumour-risk markers, including tumour grade and extent of disease. Topline data is expected to be available in 2020.
Candel chief executive officer Estuardo Aguilar-Cordova said: “We are thrilled with the progress of the Ulysses study. We are grateful to the patients and doctors that are participating and are very hopeful that their efforts will result in better outcomes for future cancer patients.
“With side effects similar to those of a flu shot, ProstAtak could one day become a first-line pro-active surveillance option for the thousands of men diagnosed with low-risk prostate cancer every year.”
The company is also conducting PrTK03, a registration trial with ProstAtak for the treatment of intermediate-high risk localised prostate cancer patients who are undergoing radiation under a Special Protocol Assessment approved by the US Food and Drug Administration.
If it is successful, ProstAtak is expected to be the first therapeutic pharmaceutical for newly diagnosed prostate cancer.
Ulysses study lead investigator and director of the prostate cancer programme at the University of Chicago Scott Eggener said: “Men with low-risk prostate cancer benefit from active surveillance but a significant proportion have cancer progression and ultimately require surgery or radiation therapy.
“It would be very exciting if there was an easily delivered and safe intervention that significantly lowers the likelihood of these men ever requiring surgery or radiation.”