Clinical Studies
Two clinical studies on Reniale® as a treatment for renal cell carcinoma (RCC) have been successfully completed so far.
A pilot study examined the safety and efficacy of Reniale® in patients with local renal cell carcinoma versus a historical control group of patients from the same hospital with a comparable disease pattern who received identical surgical treatment but no adjuvant therapy. The results showed that the course of disease (disease free period and overall survival) was clearly improved by treatment with Reniale®
In 1997 LipoNova AG commenced a randomised, open-label, Phase-III clinical study on Reniale®. 55 German clinics and 558 patients participated in the more than five year long study, which confirmed that Reniale® was safe and significantly efficacious.
- In clinical trials, Reniale® was the first autologous treatment demonstrated to be an efficacious and safe adjuvant treatment for non-metastatic RCC.
LipoNova AG plans to confirm these results by means of a further international Phase III clinical study, starting in 2008, to test Reniale® as an adjuvant therapy following tumour nephrectomy.
- In September 2007, LipoNova AG received positive FDA feed back on its overall clinical development program for Reniale®.
