S*Bio's Oral Histone Deacetylase (HDAC) Inhibitor SB939 Shows Tolerability and Safety in Phase 1 Clinical Trial in Patients with Advanced Hematologic Malignancies
12/7/2010 11:09:54 AM
SINGAPORE, Dec. 7, 2010 /PRNewswire/ -- S*BIO Pte Ltd today announced that data from a Phase 1 study for its oral histone deacetylase (HDAC) Inhibitor SB939 showed tolerability and safety in patients with advanced hematologic malignancies. Results were presented at the 52nd ASH Annual Meeting and Exposition in Orlando, Fla.
"SB939 was well tolerated with limited toxicities and demonstrated excellent pharmacokinetic properties in patients with hematologic malignancies," said Guillermo Garcia-Manero, M.D., principal investigator at M.D. Anderson Cancer Center. "Response data particularly in higher risk myelodysplastic syndrome and acute myelogenous leukemia encourage further exploration of the therapeutic benefit of SB939 in combination with other anti-cancer therapies."
Dr. Jan-Anders Karlsson, CEO of S*BIO, said, "We are encouraged by the results of the Phase 1 study and we are moving forward with further testing of this compound. We recently entered into a Phase 2 clinical trial of SB939 for the treatment of recurrent or metastatic prostate cancer."
Poster No. 3292
Phase 1 Study of the Oral Deacetylase Inhibitor, SB939, in Patients with Advanced Hematologic Malignancies
SB939 demonstrated excellent pharmacokinetic (PK) properties and target inhibition and was generally very well tolerated. Toxicities were generally mild to moderate in severity and easily managed compared with those associated with other HDAC inhibitors. The maximum tolerated dose (MTD) as defined for this regimen of SB939 in subjects with hematologic malignancies was not reached, and 100mg was determined to be the recommended dose. These findings indicate a favorable therapeutic index.
The primary objective in the Phase 1, multi-center, open-label, escalating dose cohort study, was to assess the safety and tolerability of SB939, administered orally once every other day 3 times a week for 3 weeks, repeated every 4 weeks, in patients with advanced hematologic malignancies. Secondary objectives included establishing the MTD and recommended Phase 2 dose of SB939 when administered as a single agent according to the study regimen, determining the dose-limiting toxicities (DLTs) of SB939, determining the PK profile of SB939, documenting anti-tumor activity and assessing the histone acetylation in PBMCs as well as other biomarkers.
SB939 is designed to be a "best-in-class" HDAC inhibitor, and has demonstrated the potential to bring additional therapeutic benefits due to its high potency, superior oral availability and good tolerability. In the second half of 2010, S*BIO anticipates that recruitment will commence for another Phase 2 clinical trial with SB939 in patients with translocation-associated sarcomas. This study will also be conducted in collaboration with the NCIC Clinical Trials Group. In cellular and preclinical models, HDAC inhibitors have been shown to inhibit synovial sarcoma growth. SB939's favourable side effect profile makes it an excellent candidate to address the urgent medical need for new therapeutic options for the treatment of this condition.
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 and is currently in Phase 2 trials. SB1518, S*BIO's potent and orally-active JAK2 inhibitor, entered the clinic in 2008 and has received orphan drug designation from the U.S. and the E.U. FDA. S*BIO has entered into a development collaboration, and option & license agreement with Onyx Pharmaceuticals, Inc. to develop and commercialize SB1518 and its other novel JAK2 inhibitor, SB1578 in North America and Europe. S*BIO's SB1317, a novel multikinase inhibitor, is in Phase 1 trials and under a worldwide exclusive license with Tragara Pharmaceuticals, Inc. for its development and commercialization.
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 a subsidiary of EDBI (EDB Investments), Aravis Ventures, Mitsui Ventures, Novartis Bioventures and other international funds. In 2009, S*BIO received the BioSpectrum Editor's Choice, Emerging BioScience Company of Singapore Award. More information about S*BIO can be found at www.sbio.com.