US-based biotech company Inspyr Therapeutics has initiated its Phase II clinical trial by dosing the first patient with mipsagargin to treat newly diagnosed prostate cancer.
Mipsagargin is developed as a pro-drug that modifies itself into an active form only after it reaches the inside of the tumour.
It is designed to target prostate-specific membrane antigen (PSMA), an enzyme expressed on the surface of prostate-cancer cells and on tumour-associated blood vessels in other tumour types.
The Phase II trial is designed as an open-label, single-arm study and will be conducted at the University of Texas Health Science Centre (UTHealth), Houston.
The trial will involve patients with treatment-naïve prostate cancer before surgical removal of the tumour.
During the trial, the patients will be administered with mipsagargin, injected intravenously for the first three consecutive days of a 28-day cycle.
The trial is aimed at determining the efficacy of mipsagargin on the perfusion and volume of the prostate.
University of Texas / Memorial Hermann Cancer Centre professor and director and principal trial investigator Robert Amato said: “Mipsagargin presents a novel tumour-targeting approach to treating patients newly diagnosed with prostate cancer.
“My colleagues at UTHealth are focused on improving treatment options for prostate cancer patients, and we look forward to evaluating mipsagargin’s effectiveness in disrupting the blood supply of prostate tumours and killing prostate cancer cells, which could lead to tumour regression and potentially improved survival rates for patients diagnosed with this type of cancer.”
The company is expecting the top-line results of the clinical trial next year.