S*Bio Preliminary Clinical Data Presented at the 20th EORTC-NCI-ACR Symposium on 'Molecular Targets and Cancer Therapeutics'

2008-10-22

孤儿药小分子药物AACR会议

SINGAPORE, Oct. 22 /PRNewswire/ -- S*BIO Pte Ltd today announced that multiple presentations of pre-clinical and early clinical data for its HDAC inhibitor SB939 HDAC inhibitor SB939 will be made at the 20th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics" in Geneva, Switzerland. The results demonstrate that the "best-in-class" pre-clinical pro S*BIO's novel anti-cancer drug SB939 translates into the clinic. "We are pleased to announce clinical data from the ongoing Phase 1 trials of our orally-active HDAC inhibitor SB939 HDAC inhibitor SB939," said Dr. Jan-Anders Karlsson, CEO of S*BIO. "The pharmacokinetic and pharmacodynamic data obtained with SB939 in patients with advanced cancers are consistent with the superior HDAC inhibitor pro HDAC inhibitor pro we have previously demonstrated in pre-clinical studies." "We continue to develop SB939 in the clinic to gain additional data on its anti-cancer activity as well as to demonstrate further its good tolerability and superior oral PK/PD profile." Poster No. 136 Discovery of SB939, an HDAC inhibitor with a superior pre-clinical pro > SB939 is a potent HDAC inhibitor with superior anti-tumor efficacy and tolerability in pharmacological cancer models. The drug candidate also has favourable ADME, safety and pharmaceutical properties resulting in high and dose-proportional exposure after oral dosing. SB939 has a prolonged duration of action and is enriched in tumor tissue which may contribute to its potent anti-tumor activity and "best-in-class" profile. The structure-activity relationships leading to the discovery of SB939 will be discussed. Poster No. 83 A robust and quantitative biomarker assay for SB939, a potent, orally-active HDAC HDAC inhibitor A robust, sensitive and quantitative Western blot assay for measuring acetylated histone 3 in tissues has been developed to evaluate the target efficacy of SB939 and is currently being used to study PK/PD relationships in the ongoing Phase 1 clinical trials. These data demonstrate that the excellent PK/PD relationship observed in pre-clinical models is mirrored in patients with advanced solid malignancies. Poster No. 413 A Phase 1 dose escalation study of oral SB939 when administered thrice weekly (every other day) for 3 weeks in a 4-week cycle in patients with advanced solid malignancies SB939 shows excellent linear and dose-dependent oral exposure. It has a good PK/PD relationship, as well as promising clinical activity with a manageable toxicity profile. The recommended Phase 2 dose has been selected. About S*BIO Pte Ltd S*BIO is a privately-held biotech company focused on the research and clinical development of novel targeted small molecule drugs for the treatment of cancer with leading programs around histone deacetylases (HDAC) and kinases. S*BIO's lead candidate, SB939, entered the clinic in 2007. Its second compound, SB1518, commenced Phase1 clinical trials in 2008 and has received orphan drug designation from the U.S. FDA. A third compound, SB1317, is in pre-clinical development. In line with its vision to be a leading fully-integrated oncology-focused biotech company in Asia Pacific, S*BIO has established a state-of-the-art R&D infrastructure, complemented by a strong clinical development team. S*BIO has strong links with a network of medical oncologists in Asia Pacific and its investors include Bio*One Capital, Aravis Venture, Novartis Bioventures and other international funds. More information about S*BIO can be found at CONTACT: Stephen Keith Rhind, Senior Vice President, Corporate Development Ph.D. of S*BIO Pte Ltd, Tel: +65 6827 5000 (Singapore), or Stephen_rhind@sbio.com; Tony Russo, +1-212-845-4251, or Tony.Russo@russopartnersllc.com, or Andreas Marathovouniotis, +1-212-845-4235, or Andreas.Marathis@russopartnersllc.com, both of Russo Partners Web site:

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