Additional Data from Multiple Phase 1 and 2 Studies of S*BIO’s Novel JAK2 Inhibitor SB1518 Demonstrate Safety and Efficacy for Treatment of Symptomatic Myelofibrosis
SB1518 Alleviates MF-Associated Splenomegaly and Shows No Myelosuppression and No Exacerbation of Cytopenias
S*BIO Pte Ltd announced that additional data from multiple Phase 1 and 2 clinical studies of its novel JAK2 inhibitor SB1518 further confirmed safety and efficacy for the treatment of patients with symptomatic myelofibrosis (MF) and enlarged spleens. In the studies, SB1518 alleviated MF-associated splenomegaly and showed no evidence of myelosuppression and no exacerbation of cytopenias. Results will be presented at the American Society of Clinical Oncology (ASCO) 2011 Annual Meeting in Chicago and the 16th Congress of the European Hematology Association (EHA) in London.
“Data pooled from the two Phase 1 trials demonstrate sustained clinical benefit in MF patients when treated with SB1518,” said John Seymour, Head of the Department of Haematology at the Peter MacCallum Cancer Centre, Melbourne, “The once-daily dosing was well tolerated for over 2 years in on-going patients with no long-term toxicities observed.”
Ruben A. Mesa, M.D., principal investigator at Mayo Clinic, said, “The new data from the Phase 2 study clearly showed durable responses in both spleen volume reduction and in relieving MF related symptoms. More importantly, these treatment effects were observed in MF patients with significantly impaired hematopoiesis without further exacerbating cytopenias. These results show that treatment with SB1518 is particularly important for MF patients with impaired hematopoiesis. The side effects were generally low grade, easily manageable and there were no discontinuations due to GI toxicities.”
Dr. Jan-Anders Karlsson, CEO of S*BIO, added, “The data are further evidence that SB1518 is safe, effective and well tolerated in MF patients including those who present with severe splenomegaly.
The convenient once daily dose was well tolerated with manageable side effects across all studies. In light of these positive and encouraging results, we are rapidly advancing our JAK2 inhibitor through later-stage clinical studies.”
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