SymBio Pharmaceuticals Limited, a leading commercial stage specialty pharmaceutical company, announced the completion of patient enrollment of  its phase II clinical trial of Treakisym (bendamustine hydrochloride,  SyB L-0501) in  frontline  low-grade non-Hodgkin’s lymphoma (NHL) and mantle cell lymphoma (MCL) patients in Japan. This randomized trial is evaluating the combination of Treakisym and rituximab versus R-CHOP.

SymBio initiated this multicenter open-label phase II trial as a line extension study for Treakisym in November, 2011, in collaboration with Eisai. Completion of patient enrollment in this trial has occurred.

“Thus  far the study has progressed  smoothly  with no  serious adverse events  being reported,” said Fuminori Yoshida, president and CEO of SymBio. Trial results with data analysis and evaluation will be finalized as soon as possible.

In partnership with Eisai Co., Ltd. (Eisai), SymBio received marketing approval of Treakisym (SyB L-0501) in October, 2010, for the treatment of patients with relapsed/refractory low-grade NHL and MCLin Japan.

The number of low-grade non-Hodgkin’s lymphoma patients in Japan is estimated to be approximately 11,000, including 4,000 refractory/relapsed patients and 7,000 untreated patients. Currently, R-CHOP is prescribed as a standard therapy, however,  clinical  trial results  in  the  U.S. and Europe have shown superiority of the combination of rituximab and bendamustine (R-B) over R-CHOP in terms of safety and efficacy,  leading to the inclusion of R-B in  the  National Comprehensive Cancer Network (NCCN) guidelines, which are used by US physicians in prescribing oncology drugs.

SymBio has also initiated  development  of Treakisym in  refractory/relapsed  intermediate and high-grade  non-Hodgkin’s lymphoma, and  refractory/relapsed  multiple myeloma.  The company  also continues to pursue other indications in the hematology setting in order to maximize the potential of this ‘pipeline within a molecule’ and address other unmet medical needs.

Bendamustine was first synthesized in the early 1960s in former ‘East Germany’ by Jenapharm, and is currently marketed in Germany under the brand name “Ribomustin” as a treatment for non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia. Mundipharma has received market authorization in a number of EU countries for bendamustine under the brand name “Levact”. In the United States, the drug has been approved by the U.S. Food and Drug Administration and is marketed by Teva as Treanda for the treatment of chronic lymphocytic leukemia and relapsed indolent B-cell non-Hodgkin's lymphoma. SymBio Pharmaceuticals Limited originally acquired the exclusive right from Astellas Deutschland GmbH (Headquarters: Munich, Germany, formerly Astellas Pharma GmbH) to develop and commercialize bendamustine in Japan (December, 2005), followed by a second license agreement for the exclusive regional rights to China/Hong Kong, Taiwan, South Korea and Singapore (March, 2007).