Bavarian Biotech Report 2011/2012 (7MB) - Bio M

published positive topline data from its phase II SAPHIREtrial with resminostat, in patients with relapsed/refractoryHodgkin's Lymphoma (HL). The study confirmed safety ofthe drug and is well tolerated in this advanced stagepatient population.SuppreMol GmbH (Martinsried) has started the clinicalphase IIa with its lead compound SM101 in SystemicLupus Erythematosus (SLE). This study is designed as amulti-centric, randomized, double-blind, placebo-controlled,parallel group phase IIa study with 50 SLEpatients. In November 2011, the company has initiatedthe dosing of their international SMILE study (SM101 inSLE). The first patient was treated in Australia.One of the clinical highlights at the end of the year hasbeen announced by Micromet Inc. (Munich). The companyhas published remarkable results for their key productBlinatumomab, currently in a clinical phase II single-armdose ranging trial. 75% of patients, who received theselected dose achieved a complete remission, with nodetectable leukemic cell remaining. The data has beenpresented at the 53rd Annual American Society of Hematology(ASH) annual Meeting in Chicago.The total number of clinical studies in phase III reducedto 8 in the previous year. In November 2011, BavarianNordic A/S (München/Denmark) has started their pivotalphase III trial of PROSTVAC ® for patients with asymptomaticor minimally symptomatic metastatic castration-resistantprostate cancer. PROST-VAC ® represents an“off-the-shelf”therapeutic vaccine candidate that has the potential toextend the lives of people with advanced prostate cancer.Unfortunately, Curacyte AG (München) stopped theirclinical phase III distributive shock trial (“PHOENIX”).Patients in catecholamine-resistant, distributive shockwere treated with the Nitric Oxide (NO) scavengerPHP/Hemoximer. An independent Data Monitoring Boardconcluded the termination of this study.Wilex AG (Munich) has announced in October 2011 theFast Track designation for RENCAREX ® authorized by theUS Food and Drug Administration (FDA). The Fast Trackdesignation represents a process that facilitates thedevelopment, and expedites the review of drugs to treatserious diseases and fill an unmet medical need. Thepurpose is to receive important new drugs to the patientearlier. The announcement of the Fast Track designationhas initiated a milestone payment of USD 2.5 million byPrometheus Inc.Clinical development has to deal with sudden and sometimesunexpected results. To follow the Bavarian drugpipeline more precise please refer to the editor’s homepage.21