SymBio Announces Completion of Patient Enrollment of TREAKISYM(R) (SyB L-0501)
Phase II Trial in Frontline Low-Grade Non-Hodgkin's
Lymphoma and Mantle Cell Lymphoma
TOKYO -- (Marketwire) -- 03/06/13 -- SymBio Pharmaceuticals Limited
(JASDAQ: 4582) announced the completion of patient enrollment of its
Phase II clinical trial of TREAKISYM(R) (bendamustine hydrochloride,
SyB L-0501) in frontline low-grade non-Hodgkin's lymphoma (NHL)(1)
and mantle cell lymphoma (MCL) patients in Japan. This randomized
trial is evaluating the combination of TREAKISYM(R) and rituximab
versus R-CHOP (2).
SymBio initiated this multicenter open-label Phase II trial as a line
extension study for TREAKISYM(R) 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(R) (SyB L-0501) in October, 2010, for
the treatment of patients with relapsed/refractory low-grade NHL and
MCL in 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, (3) which
are used by US physicians in prescribing oncology drugs.
SymBio has also initiated development of TREAKISYM(R) 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.
About Bendamustine Hydrochloride (SyB L-0501)
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(R)" 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(R)". In the United States, the drug has
been approved by the U.S. Food and Drug Administration and is
marketed by TEVA as TREANDA(R) 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).
TREAKISYM(R) for Injection, for intravenous infusion
For the treatment of relapsed or refractory forms of the
-- low-grade B-cell non-Hodgkin's lymphoma
-- mantle cell lymphoma
Dosage and Administration:
The standard adult dose of bendamustine
hydrochloride is 120 mg/m(2) infused intravenously over 60 minutes on
Days 1 and 2 of repeated 21-day cycles. The dose may be reduced as
deemed appropriate according to the patient's condition.
About SymBio Pharmaceuticals Limited
SymBio Pharmaceuticals Ltd,
established in March, 2005, by Fuminori Yoshida, who previously
served concurrently as Corporate VP of Amgen Ltd. and founding
President of Amgen Japan (currently Takeda Bio), aspires to be a
leading commercial stage specialty pharmaceutical company in Asia
Pacific dedicated to addressing underserved medical needs with main
focus in the areas of oncology, hematology and autoimmune disease.
The company's underlying corporate mission is "delivering hope to
patients in need".
(1)Non-Hodgkin's lymphoma: is a
diverse group of blood cancers that include any type of lymphoma,
excluding Hodgkin's lymphomas, in which B or T white blood cells
(lymphocytes) develop malignant growths. The disease is categorized
by progression and is divided into low-grade (slow-growing) and
intermediate to high-grade (fast-growing) types.
Combination therapy of Rituximab, Cyclophosphamide, Doxorubicin,
Vincristine, and Prednisolone.
(3)Network (NCCN) guidelines: In
alliance with 21 of the world's leading cancer centers, these
guidelines are widely recognized and used as the standard for
clinical treatment and policy in oncology by clinicians and payors.
Board Director, Corporate Officer, Chief Financial Officer
Tel: +081(0)3 5472 1125
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