Navigation Links
S*BIO's Novel JAK2 Inhibitor Pacritinib (SB1518) Effectively Reduces Splenomegaly in Myelofibrosis (MF) Patients With Minimal Impact on Existing Cytopenias Providing Important Therapeutic Niche In Treatment of MF

SINGAPORE, Dec. 12, 2011 /PRNewswire/ -- S*BIO Pte Ltd today announced that results from a Phase 2 study demonstrated that its JAK2 inhibitor pacritinib (SB1518) effectively reduced splenomegaly in myelofibrosis (MF) patients, with minimal impact on existing cytopenias providing an important therapeutic niche in the treatment of MF. Results were presented at the 53rd ASH Annual Meeting and Exposition in San Diego.

"Pacritinib is an active drug for the treatment of splenomegaly in patients with primary myelofibrosis, post-polycythemia vera-myelofibrosis and post-essential thrombocythemia-myelofibrosis regardless of baseline thrombocytopenia," said Rami S. Komrokji, M.D., principal author of the oral presentation. "The once daily dose of pacritinib was well tolerated with manageable gastrointestinal toxicity as the main side effect. The minimal impact on existing cytopenias in MF patients provides an important therapeutic outcome for pacritinib in the treatment of this patient population. The results support the rapid advancement of pacritinib into Phase 3 clinical trials to further support its safety and efficacy."

The primary endpoint of pacritinib's Phase 2 study was to assess the spleen response rate, defined as a >/=35% reduction in MRI-measured spleen volume between baseline and week 24. Thirty-four MF patients were enrolled in the study. The most common treatment-related adverse events were gastrointestinal, which were generally low grade and easily managed.  Pacritinib was equally well tolerated by patients with normal platelet counts and those with thrombocytopenia and anemia. Thirty patients (88%) showed reduction in palpable splenomegaly, 14 (41%) showed decreases of >/=50% and five (15%) achieved clinical resolution of splenomegaly. Eight patients (24%) had decreases in spleen volume by >/=35%.  Spleen response rates were equivalent among patients with low baseline platelet counts and those with normal baseline counts.  At the six-month visit, a significant reduction (>2 point improvement in mean symptom score) was observed for MF-associated symptoms, including abdominal pain, bone pain, early satiety, worst fatigue, inactivity, night sweats and pruritus.

"There is a significant medical need in the treatment of myelofibrosis and the results from pacritinib's clinical trials encourage us to quickly move forward with a global Phase 3 study to further demonstrate pacritinib's clinical benefits and consequently capture an important niche market in the treatment of MF," said Tamar Howson, interim CEO and board member of S*BIO.

Pacritinib is a small molecule JAK2-selective kinase inhibitor, which has 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 frequencies in myeloproliferative disorders such as MF. It is estimated that approximately 50% of patients with MF possess the JAK2 mutation.

About S*BIO Pte LtdS*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*BIO Pte Ltd: Russo Partners:Tamar Howson

Tony Russo +1 212-845-4251Interim CEO & Board Member

Andreas Marathovouniotis +1 212-845-4235


Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. University Hospitals Seidman Cancer Center Tests Novel Drug That Makes Brain Tumors Glow Hot Pink
2. Novelos Therapeutics Prices $5.9 Million Public Offering
3. MacroGenics and Servier Enter Development and Commercialization Agreement for Novel Anti-Cancer Drug
4. Unigenes Proprietary Peptelligence™ Platform Used to Commence Cara Therapeutics Phase 1 Clinical Trial of Oral Novel Peripherally-Acting Kappa Opioid Agonist
5. New Study Points to Novel Mechanism by Which Tumors Escape Recognition by the Immune System
6. Cara Therapeutics Initiates Phase I Study with Oral Formulation of Novel Peripherally-Acting Kappa Opioid Agonist
7. Niiki Pharma Reports on Synergistic Activity of Novel Anti-Cancer Agent NKP-1339 with Other Anti-Cancer Agents
8. CureFAKtor Pharmaceuticals Demonstrates Novel Focal Adhesion Kinase (FAK) Inhibitor C4 Analogs Inhibited Pancreatic Cancer Tumor Growth as Single Agents
9. Childrens Hospital Boston and Pfizer Enter Into Novel Collaborative Research Agreement for Muscular Dystrophy Therapeutics
10. ChemoCentryx Reports Clinical Efficacy for CCX354, a Novel CCR1 Inhibitor in a Phase II Study in Patients with Rheumatoid Arthritis
11. Metabolex to Present Data on Arhalofenate, a Potential Novel Treatment for Gout, at the 2011 ACR/ARHP Annual Scientific Meeting
Post Your Comments:
(Date:6/24/2016)... KNOXVILLE, Tenn. , June 24, 2016 /PRNewswire/ ... market providing less invasive and more durable cerebrospinal ... million in funding.  The Series-A funding is led ... the Lighthouse Fund, and other private investors.  Arkis, ... less-invasive neurosurgical instrumentation and the market release of ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... , ... recently awarded their highest five-star rating to Best Buy Eyeglasses, ... the United States and Canada wear eyeglasses. Once considered to be a purely functional ... a fashion statement. Even celebrities use glasses as a way of creating an iconic ...
(Date:6/26/2016)... ... ... blind and certified personal trainer is helping to develop a weight loss fitness plan that ... the two major problems leading the fitness industry today:, , All ... They don’t eliminate all the reasons people quit their exercise program , ...
(Date:6/25/2016)... ... 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily ... of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures ... . Simply select a ProHand generator and drag it above media or text in ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of indulgence ... high can result in disappointment, perhaps even self-loathing. However, those who set the bar ... from reveals that behind the tendency to set low expectations is ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
Breaking Medicine News(10 mins):