Navigation Links
S*BIO Receives Orphan Drug Designation for JAK2 Inhibitor SB1518 for the Treatment of Myeloproliferative Disorders
Date:5/13/2008

SINGAPORE, May 13 /PRNewswire/ -- S*BIO Pte Ltd today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB1518, its potent and orally-active JAK2 inhibitor for the treatment of myeloproliferative disorders (MPD). The FDA accepted S*BIO's application upon review of preclinical data which demonstrated excellent anti-proliferative and anti-tumor activity, combined with very good tolerability of the JAK2 inhibitor.

"We are pleased to receive orphan drug designation for SB1518," said Dr. Jan-Anders Karlsson, CEO of S*BIO. "There is a great need for effective treatment of MPD caused by aberrant JAK2 signaling and SB1518 could potentially address this unmet medical need. The designation will allow us to optimize our development and regulatory strategy for SB1518."

MPD is a closely related group of hematological malignancies in which the bone marrow develops and functions abnormally. MPD is characterised by an excess of blood cells and the three main disorders include polycythemia vera (excess red blood cell mass), essential thrombocythemia (excess blood platelets) and myelofibrosis.

Orphan Drug Designation in the United States

Orphan drug is a designation by the FDA indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Orphan drug designation for SB1518 will entitle S*BIO to tax credits on clinical research after designation and seven years of marketing exclusivity. Other potential benefits include regulatory fee waivers, grants for clinical research and protocol assistance.

About SB1518

SB1518 is a small molecule JAK2-selective kinase inhibitor which has high potency against both the wild type JAK2 kinase and the JAK2 kinase with the V617F mutation. The V617F mutation is found in high frequencies in certain types of hematological disorders. By targeting the JAK2 activating mutation, SB1518 has the potential to interfere with a key mechanism driving the progress of a variety of cancers and other hematological disorders.

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, has entered the clinic in 2007. It recently announced that SB1518, has been selected as a clinical candidate and that a third compound, SB1317, is in pre-clinical development.

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 an experienced clinical development team. S*BIO has strong linkages with a network of medical oncologists in Asia Pacific and its investors include Bio*One Capital, Novartis Bioventures and other international funds. More information about S*BIO can be found at http://www.sbio.com.

S*BIO Pte Ltd: Russo Partners:

Stephen Keith Rhind, Ph.D. Tony Russo +1 212-845-4251

Senior Vice President, Corporate Tony.Russo@russopartnersllc.com

Development Andreas Marathovouniotis

Tel: +65 6827 5000 (Singapore) +1 212-845-4235

Stephen_rhind@sbio.com Andreas.Marathis@russopartnersllc.com


'/>"/>
SOURCE S*BIO
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
5. IsoTis Receives FDA Clearance for Accell Family of Products
6. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
7. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
8. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
9. XTL Receives Staff Letter From NASDAQ
10. XTL Receives Staff Letter From NASDAQ; XTL may Transfer its ADR Listing to the NASDAQ Capital Market
11. Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... Diego, Calif. (PRWEB) , ... May 25, 2016 , ... ... Diego area and has consistently been rated one of its top attractions. Fortune ... the globe to participate in a unique and intimate team-building experience. , Each event ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... ... Michael Fitzmaurice recently became double board-certified in surgery and surgery of the hand ... Dr. Fitzmaurice is no stranger to going above and beyond in his pursuit ...
(Date:5/25/2016)... LAKE CITY, UTAH. (PRWEB) , ... May 25, 2016 , ... ... efficiencies in healthcare information exchange, today announced that Charles W. Stellar has been named ... as WEDI’s interim CEO since January 2016. As an executive leader with more than ...
(Date:5/24/2016)... (PRWEB) , ... May 24, 2016 , ... ... attacks, diabetes, and traumatic injuries, will be accelerated by research at Worcester Polytechnic ... into engines of wound healing and tissue regeneration. , The novel method, developed ...
Breaking Biology Technology:
(Date:4/28/2016)... and BANGALORE, India , April ... EdgeVerve Systems, a product subsidiary of Infosys (NYSE: ... today announced a global partnership that will provide ... to use mobile banking and payment services.      ... a key innovation area for financial services, but it also ...
(Date:4/19/2016)... UAE, April 20, 2016 The ... as a compact web-based "all-in-one" system solution for all ... fingerprint reader or the door interface with integration authorization ... access control systems. The minimal dimensions of the access ... into the building installations offer considerable freedom of design ...
(Date:4/13/2016)... , April 13, 2016  IMPOWER physicians supporting ... are setting a new clinical standard in telehealth thanks ... By leveraging the higi platform, IMPOWER patients can routinely ... pulse and body mass index, and, when they opt ... and convenient visit to a local retail location at ...
Breaking Biology News(10 mins):