Guest guest Posted January 11, 2008 Report Share Posted January 11, 2008 SinuNase interim, blinded data for CS (Graphic: Business Wire) (3º) 07/01/2008 14:00:00 Business Wire US0303711081 expected to provide physicians with a valuable tool to predict those patient candidates best suited to benefit from treatment with SinuNase - a comprehensive approach to diagnosis and treatment. BiovaxID Through our majority-owned subsidiary, Biovest International, Inc. (OTCBB:BVTI), we are extremely optimistic and excited regarding the progress of BiovaxID, a personalized cancer vaccine, now in a pivotal Phase 3 Fast-Tracked trial, that is initially targeting non-Hodgkin s lymphoma, with the potential to treat many difficult-to-treat B-cell related cancers such as multiple myeloma and chronic lymphocytic leukemia. BiovaxID is nearing the completion of an interim analysis for BiovaxID, and we expect to report the analysis of the unblinded results by the end of April 2008. Based on very favorable follow-up data from previous Phase 2 studies reported by the National Cancer Institute and independent research conducted in Spain, coupled with statistical evidence from blinded data suggesting that BiovaxID is achieving efficacy endpoints with an excellent overall safety profile, we remain confident that we will report statistically significant survival benefits; such positive results would allow us to move forward in seeking accelerated and conditional approvals in the U.S. and Europe later this year. Pending Milestones for BiovaxID in 2008: -- Report results from the unblinding and complete analysis of the pivotal Phase III clinical trial by the end of April 2008 -- Meet with the FDA to present data and determine registration pathways for accelerated approval in the U.S.by mid-calendar year 2008 -- Meet with the EMEA to present data and determine expedited registration pathways for conditional approval in EU by mid-calendar year 2008 -- Launch marketing and sales initiatives upon conditional approval -- Announce strategic, multi-national, marketing partnership BiovaxID is a customized therapy, unique from any other cancer vaccine, in the manner in which it is derived from a patient s own cancer cells; designed to harness the power of the patient s immune system, by " training " it to recognize and selectively destroy just cancerous lymphoma cells. http://www.infobolsa.es:80/v2002/Noticias/noticias_titulares2.asp?Fuente=IBNW & Fe\ chaNot=20080107 & Clasif=C & Numnot=104952 Quote Link to comment Share on other sites More sharing options...
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