LipoNova AG
LipoNova AG: LIPONOVA CONFIRMS U.S. AND E.U. REGISTRATION STRATEGY FOR ITS LEAD PRODUCT RENIALE®
LipoNova AG / Miscellaneous Release of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer / publisher is solely responsible for the content of this announcement. ---------------------------------------------------------------------- New renal cell cancer vaccine on track for development Hannover, Germany date to be inserted 2007 - LipoNova AG (WKN LNAG00) the pioneering developer of Reniale, the world’s first autologous vaccine for non-metastatic renal cell carcinoma (RCC), confirmed today its registration strategy for Reniale following the pre-IND meeting with the FDA in September. The next step is for LipoNova to submit the IND for Reniale’s® international phase III study in early 2008. The European registration process with the EMEA is expected to begin in parallel to the FDA’s approval of the study. 'Our pre-IND meeting with the FDA was very positive and we are well positioned to comply with the agency’s recommendations. Our objective has always been to bring Reniale® to the market as soon as possible for the benefit of patients with non-metastatic RCC suffering from this unmet medical need', commented Dr. Cornelius Sobel, Chief Executive Officer of LipoNova, Prof. Ronald M. Bukowski, CCF Taussig Cancer Center, Cleveland Clinic, USA, supported LipoNova’s plans, commenting 'This will make Reniale®, which has already shown efficacy and a good safety profile in a previous phase III study carried out in Germany, available for clinical trials very soon. At present, no approved adjuvant treatment exists for patients suffering from non-metastatic renal cell carcinoma after surgical removal of the tumour. Reniale® would be the world’s first autologous tumour vaccine and could satisfy the urgent need for a new treatment for this unmet medical need.' 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. LipoNova Oliver Keilhack CFO Tel: +49 (0) 511 54099-610 E-Mail: oliver.keilhack@liponova.de DeFacto Communications Sylvie Berrebi Tel : +44 (0)20 7861 3838 15.11.2007 Financial News transmitted by DGAP ---------------------------------------------------------------------- Language: English Issuer: LipoNova AG Feodor-Lynen-Str. 35 30625 Hannover Deutschland Phone: +49 (0)511-54099 0 Fax: +49 (0)511-54099 31 E-mail: info@liponova.de Internet: www.liponova.de ISIN: DE000LNAG002 WKN: LNAG00 Listed: Freiverkehr in Berlin, Düsseldorf, Stuttgart; Entry Standard in Frankfurt End of News DGAP News-Service ---------------------------------------------------------------------------
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