S*BIO Presents Positive Safety and Tolerability Results for Its Novel Oral JAK2 Inhibitor SB1518 From a Phase 1/2 Study for the Treatment of Myelofibrosis (MF)
SINGAPORE, June 13 S*BIO Pte Ltd today announced the presentation of positive safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) results for its novel oral JAK2 inhibitor, SB1518, at the 15th Congress of the European Hematology Association (EHA), June 10-13, in Barcelona, Spain.
Data was presented on the Phase 1 clinical results of the Phase 1/2 dose-escalation trial of SB1518 from 20 patients treated at multiple dose levels ranging between 100 mg to 600 mg once daily. Clinical improvements were observed in hemoglobin, platelet and splenomegaly categories. The dose-limiting toxicities were gastrointestinal related and were only seen at the 600 mg dose level. The study was conducted at three sites in Australia - Peter MacCallum Cancer Center, Royal Melbourne Hospital, and Royal Adelaide Hospital.
"The clinical findings demonstrate SB1518's potential as a viable treatment for myelofibrosis," said Dr. Jan-Anders Karlsson, CEO of S*BIO. "These results are consistent with the data presented at the ASH Annual Meeting in 2009 from our U.S. Phase 1 trials in which safety, tolerability and signs of activity in different disease states had been observed. The positive findings allowed us to advance rapidly our clinical program and complete enrollment of the Phase 2 myelofibrosis trials for SB1518 to test further the safety and efficacy of our compound."
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. 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. 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. S*BIO's SB1317, a novel multikinase inhibitor, is in pre-clinical development 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 of EDBI (EDB Investments), Aravis 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.
S*BIO Pte Ltd: Russo Partners: Stephen Keith Rhind, Ph.D. Tony Russo, Ph.D. +1 212-845-4251 Senior Vice President, Corporate Development Tony.Russo@russopartnersllc.com Andreas Marathovouniotis +1 Tel: +65 6827 5000 (Singapore) 212-845-4253 Stephen_rhind@sbio.com Andreas.Marathis@russopartnersllc.com
SOURCE S*BIO Pte Ltd
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