SymBio Completes Patient Enrollment for Mantle Cell Lymphoma in Bendamustine Phase II Clinical Study
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SymBio Pharmaceuticals Limited has completed target enrollment of patients with mantle cell lymphoma for an ongoing Phase II clinical study of Bendamustine after completing enrollment of patients with indolent non-Hodgkin’s lymphoma (iNHL). The Japan study is being conducted at 18 institutions nationwide since its initiation in December, 2007.
The company intends to collect efficacy and safety data in preparation for NDA filing. Due to completion of enrollment for iNHL and mantle cell lymphoma (MCL) patients earlier than originally planned, the company has expedited its development timeline of Bendamustine, with submission of the NDA now expected in the 4th quarter of 2009.
SymBio has acquired exclusive rights for the development and commercialization of bendamustine HCl in Japan, China (Hong Kong), Taiwan, Korea and Singapore from Astellas Pharma GmbH (currently, Astellas Deutschland GmbH, Munchen, Germany).
In Germany, bendamustine HCl is used as an anticancer drug under the brand name “Ribomustin.” On March 20, 2008, Cephalon, Inc. (Frazer, PA) received NDA approval from US FDA for TREANDA (bendamustine HCl) in the treatment of patients with chronic lymphocytic leukemia (CLL).
Cephalon has filed a supplemental NDA with FDA for use in patients with indolent low-grade NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen, and expects to receive FDA approval by the 4th quarter of this year. MAAs have also been filed with EMEA for use of bendamustine HCl in the treatment of iNHL, CLL and multiple myeloma (MM) in 13 European countries, excluding Germany and Bulgaria.
