First Patient Treated in Phase III Study with SC Administration of Debio 8206
News Dec 27, 2012
Debiopharm Group™ (Debiopharm) has announced the treatment of its first patient in a multicentre, open, non-comparative Phase III study to investigate the efficacy, safety, and pharmacokinetics of two subcutaneous (SC) injections of Debio 8206 (triptorelin pamoate 22.5 mg 6-month formulation) in patients with advanced prostate cancer.
The study will be conducted in the Republic of South Africa and will involve 120 patients suffering mainly from advanced prostate cancer.
Patients with recurrent lower stage prostate cancer and rising prostate specific antigen (PSA) following local therapy failure who are candidates for androgen deprivation therapy will also take part.
The 6-month formulation is currently commercialized for an administration by the intramuscular (IM) route in several countries.
“We believe that the SC route of administration of Debio 8206 will prove very convenient, in prostate cancer patients also suffering from concomitant diseases requiring anticoagulation treatments. In these patients SC administration is often preferred due to a potential risk of haematomas at the injection site after intramuscular injection,” said Rolland-Yves Mauvernay, President and founder of Debiopharm.
Patient evaluation will be primarily based on the efficacy in achieving castrate levels of testosterone (< 1.735 nmol/L [50 ng/dL]) 28 days after the first injection of Debio 8206 and in maintaining castrate levels of testosterone from Day 57 to Day 337. The safety profile will also be evaluated.
Additional efficacy measures will include the assessment of the percentage of patients who show an increase in testosterone levels 48 hours after the second injection of Debio 8206, as well as the absence of gonadotropin (LH) stimulation 2 hours after the second injection of Debio 8206 and the change in PSA from baseline to study end.
In addition, Debio 8206 pharmacokinetics and testosterone pharmacodynamics will be assessed in a subset of 15 patients.