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SymBio Initiates Japanese Phase I Trial of Oral Rigosertib (SyB C-1101) in Frontline MDS

Published: Thursday, July 25, 2013
Last Updated: Thursday, July 25, 2013
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U.S. FDA has granted orphan drug designation for the use of rigosertib in MDS.

SymBio Pharmaceuticals Limited has announced that it commenced enrollment of its Phase I clinical trial for oral rigosertib (SyB C-1101) in frontline myelodysplastic syndrome (MDS) patients in Japan.

Under the terms of the license agreement concluded with Onconova Therapeutics, Inc. in July, 2011, SymBio has an exclusive license to develop and commercialize rigosertib in Japan and Korea. Rigosertib is a novel, patent protected inhibitor of PI3-kinase and PLK pathways in cancer cells.

MDS patients often require frequent blood transfusions due to the development of severe anemia (decrease in number of red blood cells), with a high rate of progression to acute myelogenous leukemia (AML). There are an estimated 11,000 MDS patients in Japan alone.

Currently there is no approved drug for patients who have experienced drug failure after frontline treatment of MDS using hypomethylating agents, and there is an urgent need to develop new therapies for the treatment of both relapsed/refractory (r/r) and frontline MDS.

Onconova Therapeutics, Inc. is currently conducting late stage clinical trials with rigosertib (ON 01910.Na) in the U.S. and Europe for the treatment of hematologic malignancies and solid tumors.

A pivotal trial in r/r MDS is underway using the intravenous (IV) formulation of rigosertib (SyB L-1101).

The U.S. FDA has granted orphan drug designation for the use of rigosertib in MDS, and has agreed to a Special Protocol Assessment (SPA) for this Phase III trial.

A pair of Phase II trials are underway in the U.S. for development of the oral formulation of rigosertib as frontline treatment for lower-risk MDS.

In addition to SymBio’s Phase I trial with oral rigosertib in frontline MDS, a Phase I trial in r/r MDS patients using the IV formulation of the drug is also underway in Japan.

SymBio is developing rigosertib expeditiously, shortening development time and making this innovative drug available to MDS patients in need.

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