GP Pharm to Begin Phase III Clinical Trial of Lutrate® Three Months for the Treatment of Advanced Prostate Cancer
GP Pharm, a pioneer in the development of drug delivery systems, will start the phase III clinical trial of three months Lutrate®, a formulation of a quarterly dose of Leuprolide based on sustained-release injectable microspheres technology for the treatment of advanced prostate cancer.
Lutrate (Leuprolide) is the first controlled-release drug system entirely developed by GP Pharm and comes in formulations one, three and six months. It is a hormonal treatment to prevent the reproduction of tumors in patients with advanced prostate cancer.
Currently, the formulation of one month (3.75mg Leuprolide Acetate) – a single injection in 30 days – has successfully completed the clinical trial with 160 patients in Europe and the US, and is currently awaiting its approval by the Health Authorities of Europe, Turkey and Mexico. It is already marketed in Peru, Uruguay, Chile and Argentina and it is also planned to shortly submit the registration dossier in the US, China, Russia and Canada.
Held in Washington (US) this month was the initial investigators’ meeting of the clinical trial of the new formulation of Lutrate three months that allows a single quarterly administration for the treatment of prostate cancer. It is a multi-centre study designed to evaluate the efficacy and safety of this new formulation. 160 patients with prostate cancer from 33 specialised medical centres in the US will be enrolled and the study will last 12 months.
As explained by the GP Pharm’s CEO, Alberto Bueno: “With these upcoming approvals of Lutrate we will be present in a market that represents more than €1bn worldwide, 60% of which is in America.”
Also, the new formulation Lutrate six months is in the preclinical phase and the clinical trial should be initiated at the beginning of next year.
Prostate cancer is the second most common cancer in men after skin cancer, and the second leading cause of cancer death in men after lung cancer. This type of cancer usually occurs more often in men older than 50 years.