SymBio Initiates Japan Phase 2 Trial of Bendamustine HCl (SyB L-0501) in MM
SymBio Pharmaceuticals Limited has announced that it has achieved first patient enrollment and started a phase 2 clinical trial on December 26 for bendamustine hydrochloride (SyB L-0501) in refractory and relapsed multiple myeloma (MM) patients in Japan.
The number of multiple myeloma patients in Japan is estimated to be around 13,000, with an equal number of refractory/relapsed and frontline patients.
Regarding SyB L-0501 development in MM, SymBio plans to prioritize development in refractory/relapsed MM patients who were previously treated with other oncology drugs due to the high unmet medical need.
In Japan, SymBio received marketing approval of TREAKISYM® (SyB L 0501) in October, 2010, for the treatment of patients with refractory/relapsed low-grade non-Hodgkin’s lymphoma 2 (NHL) and mantle cell lymphoma (MCL).
Working with Eisai Co. Ltd., TREAKISYM® is expected to achieve rapid market penetration in Japan.
SymBio has also initiated phase 2 trials for SyB L-0501 in refractory/relapsed intermediate and high-grade non-Hodgkin’s lymphoma patients.
The Company continues to pursue other indications for TREAKISYM® in the hematology space as nimbly as possible in order to maximize the potential of this ‘pipeline within a molecule’ and address other unmet medical needs in patients.
SymBio’s financial forecast for FY 2011 will not be revised due to the acceptance of clinical trial notification.