Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Therion Biologics has completed participant enrollment for its phase II clinical trial of its investigational targeted cancer therapy in patients with prostate cancer.
Subscribe to our email newsletter
The therapy, known as Prostvac-vf, is designed to stimulate the patient’s own immune system to seek out and destroy malignant cells expressing prostate-specific antigen (PSA), a substance often found to be at abnormally high levels in men with prostate cancer.
The study is designed to evaluate the safety and efficacy of Prostvac-vf in combination with GM-CSF in patients with androgen-independent prostate cancer. The study has enrolled 120 patients with metastatic disease at over 50 treatment centers across the US.
Patients randomized into the treatment group received an initial priming dose of Prostvac-vf in combination with GM-CSF, followed by six monthly vaccinations. Patients randomized into the control arm received inactive vaccine.
The primary endpoint of the study is progression-free survival, defined as the proportion of patients who remain alive and progression-free at the end of the 24 week study.
Mark Leuchtenberger, president and CEO of Therion said: “We anticipate completing the analysis of the phase II Prostvac-vt trial during the first quarter of 2006 and by the second half of next year phase III studies could be underway.”
The company reports it is currently considering whether to conduct further trials on the product in collaboration with the Eastern Cooperative Oncology Group.