S*BIO Completes Enrollment of Patients in Phase 2 Clinical Trials for its JAK2 Inhibitor SB1518

10-Jun-2010 - Singapore

S*BIO Pte Ltd announced that it has completed enrollment of patients in two separate Phase 2 clinical trials for its potent and orally-active JAK2 inhibitor SB1518 at multiple clinical sites in the U.S. and Australia for the treatment of myelofibrosis (MF).

These two multi-center, single-arm, open-label studies are designed to evaluate the efficacy and safety of SB1518 in patients with MF. Based on the clinical data derived from the Phase 1 trial, 400mg orally once daily was selected as the recommended dose for the Phase 2 studies.

“Encouraging data from the Phase 1 trials of SB1518 allowed us to rapidly progress into Phase 2 studies,” said Dr. Jan-Anders Karlsson, CEO of S*BIO. “We completed the enrollment of our Phase 2 studies in a short period of time which further demonstrates the significant interest in SB1518 not only from the medical community but also from the patients. This marks another important milestone for S*BIO.”

Clinical results from the Phase 1 dose-escalation trial of SB1518 were presented in December 2009 at The American Society of Hematology 51st Annual Meeting and Exposition. The data demonstrated safety and tolerability for SB1518 in the treatment of myeloproliferative and other hematologic disorders. Dose levels ranging from 100mg to 600mg were administered once daily continuously in 28-day cycles in patients with advanced myelofibrosis (MF) and acute myelogenous leukemia (AML).

SB1518 demonstrated promising activity in MF patients. The drug candidate was also tested in four doses, from 100mg to 400mg per day, in heavily pre-treated relapsed or refractory Hodgkins (HL) and non-Hodgkins lymphoma (NHL) patients. SB1518 was well tolerated and clinical responses were observed in a variety of lymphoma subtypes.

https://www.bionity.com/en/news/118766/s-bio-completes-enrollment-of-patients-in-phase-2-clinical-trials-for-its-jak2-inhibitor-sb1518.html