The multi-center, open label, phase IIb study is being conducted by Cancer Trials Australia at three institutions, including Melbourne’s Austin Health, Royal Melbourne Hospital and the Peter MacCallum Cancer Centre.
The study is designed to confirm the safety profile of Pentrys and to evaluate its clinical efficacy by measuring serum prostate-specific antigen (PSA) responses. Physicians will assess the vaccine’s safety and effectiveness in stimulating the immune system, which is critical to delaying the progress of prostate cancer.
If vaccination is successful, vaccinated patients should produce antibodies and/or T cells that recognize the target p53 protein expressed on the cancer cells. The p53 target is seen by the immune system as foreign and these cells are destroyed.
“This is an important milestone in our Pentrys development program,” said Dr Leonard Firestone, the company’s newly-appointed CEO. “Our goal is to provide a treatment, which will improve the quality of life for these patients.”