S*Bio to Initiate Global Phase 3 Clinical Trials of its Novel JAK2 Inhibitor Pacritinib for Treatment of Myelofibrosis (MF)
10/25/2011 11:28:21 AM
SINGAPORE, Oct. 25, 2011 /PRNewswire/ -- S*BIO Pte Ltd today announced plans to initiate a global Phase 3 clinical program of its novel JAK2 inhibitor pacritinib (SB1518), in the first half of 2012 to further demonstrate its activity and tolerability for the treatment of myelofibrosis (MF). The company is actively exploring partnering opportunities for the advancement of its leading JAK2 program.
"Data from Phase 1 and 2 clinical studies have demonstrated that pacritinib is well tolerated and active in the treatment of myelofibrosis, an orphan disease with a high unmet medical need," said Tamar Howson, interim CEO and board member of S*BIO. "We are moving forward with an aggressive and focused development plan with global Phase 3 trials for pacritinib to further demonstrate its clinical benefits in MF patients and to maximise the value of our JAK2 program. We are currently in the process of identifying a suitable partner for the Phase 3 studies and pacritinib's subsequent commercialization."
The primary objective of the double-blind, placebo-controlled Phase 3 studies is to compare the efficacy of pacritinib versus placebo in achieving clinically significant reduction in spleen size in MF patients with splenomegaly. Secondary outcomes of both studies include patient-reported change in the most bothersome symptom identified at baseline, duration of response, as well as overall survival. The trials will enrol up to 500 MF patients.
In Phase 2 studies, treatment with pacritinib resulted in sustained reduction in MF-associated splenomegaly with no evidence of myelosuppression and no exacerbation of cytopenias. Pacritinib is a small molecule JAK2-selective kinase inhibitor that demonstrated high potency in preclinical models against both the wild type JAK2 kinase and the JAK2 kinase with the V617F mutation. The V617F mutation is found in high frequency in myeloproliferative disorders such as MF. More than 50% of patients with MF possess the JAK2 mutation.
About S*BIO Pte Ltd
S*BIO is a privately-held biotech company focused on the clinical development of novel targeted small molecule drugs for the treatment of cancer with leading programs including kinases and histone deacetylases (HDAC). Pacritinib, or SB1518, S*BIO's potent and orally-active JAK2 inhibitor, entered the clinic in 2008 and has completed Phase 2 trials for MF. It has received orphan drug designation from the U.S. and the E.U. regulatory authorities. S*BIO's lead HDAC inhibitor, pracinostat (SB939), is currently in Phase 2 trials. 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.
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. More information about S*BIO can be found at www.sbio.com.
S*BIO Pte Ltd:
Tony Russo +1 212-845-4251
Interim CEO & Board Member
Andreas Marathovouniotis +1 212-845-4235
SOURCE S*BIO Pte Ltd