SymBio Initiates Japan Phase 2 Trial of Bendamustine HCl (SyB L-0501) in Multiple Myeloma
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SymBio Pharmaceuticals Limited has announced that it has initiated a phase 2 clinical trial for its lead drug candidate, bendamustine hydrochloride (SyB L-0501), in previously untreated multiple myeloma (MM) patients in Japan as first-line therapy, the third clinical trials to be proceeded in accordance with the license agreement signed with Eisai Co., Ltd. Patients in this multicenter open-label trial will receive the drug in combination with prednisolone.
SymBio submitted A New Drug Application (NDA) for SyB L-0501 to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan under priority review on October 30, 2009, after receiving orphan drug designation for the treatment of refractory and relapsed indolent NHL and mantle cell lymphoma.
The company also has an ongoing international collaborative phase 2 trial of bendamustine HCI in combination with rituximab for the treatment of refractory and relapsed aggressive NHL in Korea and Japan which was initiated in March, 2010.
Symbio says that it plans to proceed with clinical trials as quickly as possible in order to bring this much-needed drug to patients.
SymBio holds exclusive rights to SyB L-0501, the company’s first drug candidate, from Astellas Deutschland GmbH for development and commercialization in Japan, China (HK), Taiwan, Korea and Singapore. SymBio and Eisai executed a license agreement for co-development and commercialization of SyB L-0501 in Japan in August, 2008, followed by a second license agreement for the exclusive development and commercialization of SyB L-0501 in Korea and Singapore in May, 2009.
SymBio and Cephalon executed a license agreement for development and commercialization of SyB L-0501 in China in March, 2009 (development and commercialization rights of bendamustine HCI are held by Cephalon, Inc. in North America, and by Mundipharma International Corp. Ltd. in Europe).
The drug is currently on the market in the U.S., and is listed as first-line therapy for indolent NHL and mantle cell lymphoma in NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology, the recognized standard for clinical policy in oncology.
SymBio submitted A New Drug Application (NDA) for SyB L-0501 to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan under priority review on October 30, 2009, after receiving orphan drug designation for the treatment of refractory and relapsed indolent NHL and mantle cell lymphoma.
The company also has an ongoing international collaborative phase 2 trial of bendamustine HCI in combination with rituximab for the treatment of refractory and relapsed aggressive NHL in Korea and Japan which was initiated in March, 2010.
Symbio says that it plans to proceed with clinical trials as quickly as possible in order to bring this much-needed drug to patients.
SymBio holds exclusive rights to SyB L-0501, the company’s first drug candidate, from Astellas Deutschland GmbH for development and commercialization in Japan, China (HK), Taiwan, Korea and Singapore. SymBio and Eisai executed a license agreement for co-development and commercialization of SyB L-0501 in Japan in August, 2008, followed by a second license agreement for the exclusive development and commercialization of SyB L-0501 in Korea and Singapore in May, 2009.
SymBio and Cephalon executed a license agreement for development and commercialization of SyB L-0501 in China in March, 2009 (development and commercialization rights of bendamustine HCI are held by Cephalon, Inc. in North America, and by Mundipharma International Corp. Ltd. in Europe).
The drug is currently on the market in the U.S., and is listed as first-line therapy for indolent NHL and mantle cell lymphoma in NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology, the recognized standard for clinical policy in oncology.
