SymBio Pharmaceuticals Limited has announced that it has commenced enrollment in a Phase 2 clinical trial in Japan for bendamustine hydrochloride (Brand Name: TREAKISYM®) in chronic lymphocytic leukemia (CLL) patients.
In partnership with Eisai Co., Ltd., SymBio received marketing approval for TREAKISYM® (SyB L-0501) in October, 2010, to treat Japanese patients with relapsed/refractory (r/r) low-grade non-Hodgkin’s lymphoma (LG-NHL) and mantle cell lymphoma (MCL).
CLL is a cancer of the blood characterized by the progressive accumulation of functionally incompetent lymphocytes, a type of white blood cell produced by the bone marrow and organs of the lymphatic system.
The number of CLL patients in Japan is estimated to be around 2,000. In the US and EU, bendamustine has been approved for the treatment of CLL where the disease accounts for an estimated 30% of all leukemia cases.
Due to the lack of effective therapies in Japan, CLL patients are seriously underserved and a high unmet medical need exists for the development of an effective alternative therapy.
In Japan, the Ministry of Health, Labour and Welfare (MHLW) Working Group has designated TREAKISYM® as a prioritized unapproved drug having high potential to address the lack of an effective therapy in CLL. TREAKISYM® was designated by MHLW as an orphan drug for the CLL indication in June, 2012.
SymBio has initiated several phase 2 trials for SyB L-0501. The Company continues to pursue other indications for TREAKISYM® in the hematology space as nimbly as possible in order to maximize the potential of TREAKISYM® and address other high unmet medical needs in patients.