NEEDHAM, Mass., June 17, 2019 /PRNewswire/ -- Candel Therapeutics (a.k.a. Advantagene, Inc.) announced that it has completed enrollment of the "ULYSSES" trial, a Phase 2 study of ProstAtak® for prostate cancer patients choosing Active Surveillance (PrTK04- NCT02768363). Enrollment is still open for prostate cancer patients choosing radiation therapy as their primary treatment (PrTK03- NCT01436968). ProstAtak is Gene Mediated Cytotoxic Immunotherapy (GMCI™ - aglatimagene besadenovec (AdV-tk) plus oral valacyclovir)for treatment of prostate cancer. GMCI is an "off the shelf", low-toxicity immunotherapy that stimulates a patient's own immune system to generate a robust and precise response against their cancer.
In the USA, about 175,000 men are diagnosed with localized prostate cancer each year. Approximately one third of these patients choose Active Surveillance (AS), a strategy to monitor rather than radically treat their disease. If the disease progresses, radical surgery or radiation are still options. AS is chosen primarily to avoid or postpone the significant risk of urinary incontinence and sexual dysfunction often associated with radical treatments. The number of patients on AS has been steadily increasing over the past 5 years.
The ULYSSES study enrolled 190 patients at 22 clinical sites. The size of the study was expanded from an originally planned 156 patients due to investigator and patient demand. The primary endpoint for the trial is change in tumor-risk markers such as tumor grade and extent of disease. Other endpoints of interest include time to radical treatment and safety. Topline data is expected late next year.
"Men with low-risk prostate cancer benefit from active surveillance but a significant proportion have cancer progression and ultimately require surgery or radiation therapy," said Dr. Scott Eggener, Professor of Surgery and Radiology and Director of the Prostate Cancer Program at University of Chicago and a lead investigator in the Ulysses study. "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."
Candel is also conducting PrTK03, a registration trial with ProstAtak® for the treatment of intermediate-high risk localized prostate cancer patients undergoing radiation under a Special Protocol Assessment approved by the U.S. Food and Drug Administration. If proven efficacious, ProstAtak® will be the first and only therapeutic pharmaceutical available for newly diagnosed prostate cancer. The company is conducting additional GMCI™ clinical studies in pancreas, lung, and brain cancers with impressive clinical results to date.
"We are thrilled with the progress of the Ulysses study," stated Dr. Estuardo Aguilar-Cordova, Chief Executive Officer of Candel, "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."
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Advantagene, Inc. d.b.a. Candel Therapeutics is developing proprietary immuno-oncology platforms, including its Gene Mediated Cytotoxic Immunotherapy (GMCI™) and the oncolytic rQNestin34.5 platforms for the treatment of solid tumors.
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