Endocyte to Begin Trial of Prostate Cancer Treatment
West Lafayette-based Endocyte Inc. (Nasdaq: ECYT) is moving forward with its recently-acquired late-stage prostate cancer therapy. The company says it will soon begin a phase 3 trial for PSMA-617, which it says could potentially lead to an early approval of the treatment.
Endocyte says the phase 3 VISION trial for PSMA-617 will include two interim assessments of efficacy. The company expects to begin enrollment in the trial in the second quarter and begin the first interim assessment in the second half of 2019.
Endoycte acquired the therapy in a $12 million deal with Germany-based ABX GmbH last October. At that time, the company said it hoped to complete the trial stages for PSMA-617 as early as 2020.
"Following a successful End of Phase 2 meeting with the FDA, we are excited to launch the VISION trial, a phase 3 registration trial of PSMA-617 in patients with prostate cancer,” said Mike Sherman, chief executive officer of Endocyte. "After extensive collaboration with prostate cancer specialists around the world, the robust and sophisticated VISION trial design will be attractive to patients and physicians when we begin enrollment in the second quarter of 2018. We expect 2018 to be a critical year of execution for us, as we will not only initiate VISION, but also bring our adaptor-controlled chimeric antigen receptor t-cell (CAR T-cell) program into the clinic in the fourth quarter of 2018."
The company is also reporting a full-year net loss of $55.1 million in 2017, compared to a net loss of $43.9 million the previous year. However, the company’s net loss for the fourth quarter narrowed to $8.6 million, compared to $11.1 million during the same quarter in 2016.