LipoNova AG
LipoNova AG: LipoNova got General Approval from FDA for the overall Developement Programm of the Autologous Tumor Vaccine in Renal Cancer
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. ---------------------------------------------------------------------- The US registration authority FDA shows LipoNova the way to the US market for its first product candidate Reniale(R) Hannover, Germany 18th September 2007 - LipoNova AG (WKN LNAG00) the pioneering developer of Reniale(R), the world’s first autologous vaccine for renal cell carcinoma (RCC) has been given the go-ahead by the FDA for its overall development program. The Pre-IND meeting has been the first milestone for LipoNova towards the approval of the new international phase III study. Dr. Cornelius Sobel, Chief Executive Officer said: 'We are delighted with the outcome of this meeting. Today marks a significant step towards Reniale(R) becoming available as the first ever autologous tumor vaccine for patients who have renal cell carcinoma. The approved program allows us to move to an international phase III trial, which demonstrates that our well-designed process meets the expectations of the agency. The FDA encouraged us to submit the IND for the phase III study which we plan to start in the first half of 2008.' Reniale(R) has previously been tested in a phase-III clinical study on adjuvant therapy of renal cell carcinoma in Germany which demonstrated positive therapeutic results with improved disease free and also overall survival rates while maintaining the quality of life. At present, no approved adjuvant treatment exists for patients suffering from renal cell carcinoma after surgical removal of the tumor. There is an urgent need for a new medical treatment for this unmet medical need. Reniale(R) would be the first autologous tumor vaccine anywhere in the world with no other comparable therapy on the market. In Europe and the USA about 100 thousand patients are diagnosed each year with RCC and the majority of them receive surgery to have the tumor removed and would then be candidates for the adjuvant treatment with Reniale(R). The revenues from a 40% take up of Reniale(R) by this patient population would be worth 1 billion Euros per year. The new study is expected to include 800 patients and recruitment may last approximately 24 months. The cost of the study is expected to range between 25-30 million Euros. About LipoNova LipoNova AG is the pioneering the development of autogolous tumor vaccines. LipoNova is the first company in the world operating in this area to conclude national phase III trials for Reniale(R), its lead product for the treatment of Renal Cell Carcinoma. LipoNova plans to develop Reniale(R) to international market readiness and to develop further life extending anti - cancer products using this technology. For further information please contact: 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 E-Mail: s.berrebi@defacto.com 18.09.2007 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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