December 7, 2015
SymBio Pharmaceuticals Limited

Fuminori Yoshida

Representative Director
President & Chief Executive Officer

Start of Japan Phase I Combination Clinical Trial ofOral Rigosertib and Azacytidine in Higher-risk MDSTOKYO, Japan, December 7, 2015 --- SymBio Pharmaceuticals Limited (Headquarters:Tokyo, “SymBio”) announced today the start of the Phase I clinical trial in Japan for oral
rigosertib (SyB C-1101, oral formulation) combined with azacytidine (Vidaza: currently
marketed by Nippon Shinyaku Co., Ltd.) in higher-risk myelodysplastic syndrome (MDS)
patients (“Phase I Combination Trial”).
SymBio has completed its Phase I clinical trial in Japan for oral rigosertib as a mono
therapy in transfusion-dependent lower-risk MDS patients on June 26, 2015 and uponcompletion of this Phase I Combination Trial, SymBio will consider participating in aglobal Phase III trial which its US partner, Onconova Therapeutics, Inc. (Headquarters:Newtown, PA, "Onconova") plans to initiate. According to Onconova, the Phase II trial
enrollment is complete and the company plans to present these study results at the 57th
ASH Meeting currently held from Dec. 5, 2015 to Dec. 8, 2015.
Start of the Phase I Combination Trial will not impact the Company’s financial forecast
for FY2015.
[Contact]
Investor Relations
Tel: +81 (0)3 5472 1125
About Myelodysplastic Syndrome (MDS)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 Japanalone, with the number of cases expected to increase as the population ages. MDS andAML are widely recognized as blood disorders that are difficult to manage given thelimited therapeutic options available for patients, particularly for patients who have adrug-resistant form of the disease. A high unmet medical need clearly exists for theestablishment of new effective therapies to treat both lower- and higher-risk MDS.
About azacytidine (Vidaza: currently marketed by Nippon Shinyaku Co., Ltd) Vidaza wasapproved in 2011, showing overall survival in the Phase III trial for the first time, and iscurrently used by MDS patients having difficulties in hematopoietic stem celltransplantation.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on
discovering and developing novel products to treat cancer. Onconova's clinical andpre-clinical stage drug development candidates are derived from its extensive chemical
library and are designed to work against specific cellular pathways that are important incancer cells, while causing minimal damage to normal cells. In addition to rigosertib,
Onconova's most advanced drug candidate under development, two other drug candidates
are in clinical trials and several other compounds in the pre-clinical stage of development.
For more information, please visit http://www.onconova.com.
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Ltd. was established in March, 2005, by Fuminori Yoshida who
previously served concurrently as Corporate VP of Amgen Inc. and founding President ofAmgen Japan. The company’s underlying corporate mission is to “deliver hope to patientsin need” as it aspires to be a leading specialty pharmaceutical company in Asia Pacificdedicated to addressing underserved medical needs with main therapeutic focus inoncology, hematology and pain management.

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