Ad Hoc News (KC) 12-Mar-08
From Kidney Cancer Resource
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LipoNova AG: Local Supervisory Agency Approves Production license of LipoNova's Early-Stage Kidney Cancer Vaccine Reniale(TM)
Hannover, March 13, 2008. International, late-stage biotech company LipoNova AG (WKN LNAG00) has been notified by the local supervisory agency that the production license to produce its pioneering autologous vaccine Reniale(TM) for early-stage kidney cancer is re-approved. Before being allowed to deliver Reniale(TM) to patients, LipoNova AG has to finalize the validation of an assay which has been recently developed in consent with the supervisory agency. This process should take approximately one month to complete.
The approval is a critical milestone for the company as it means that LipoNova will be able to produce and out-license Reniale to potential partners world-wide. The company will now also be able offer the vaccine on a compassionate use basis to patients with early-stage kidney cancer ahead of official regulatory approval. Kidney cancer affects approximately 130,000 people in the western world and two-thirds of patients diagnosed with the disease will die within five years. Clinical trials have shown that Reniale can slow the progression of kidney cancer (D. Jocham et al., The Lancet, Vol 363, 2004) and unlike other drugs used to treat the disease, is free of side-effects which may adversely affect a patient's quality of life.
With the production approval in place, LipoNova plans to implement a strategy so that patient's world-wide can benefit from treatment with Reniale.
About LipoNova:
LipoNova is developing an effective therapy for non-metastatic renal cell carcinoma (RCC), a serious disease with high unmet medical need and we are pioneers in the development of autologous tumour vaccines, a new class of compounds for combating diseases of this type. We have successfully completed a Phase-III clinical study on adjuvant RCC with Reniale(R) our lead product, the world's first autologous treatment with proven efficacy and safety as an adjuvant therapy in non-metastatic RCC. LipoNova is well positioned to bring Reniale(R) to market with an international Phase III study planned to start 2008 and as this progresses, it will also expand its oncology franchise in the short to medium term through partnering, mergers and acquisitions.
Contact: LipoNova Oliver Keilhack CFO Tel: +49 (0) 511 54099-610 E-Mail: oliver.keilhack@liponova.de
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