SymBio Pharmaceuticals: Initiation of Phase I Clinical Trial for Oral TREAKISYM® in Progressive Solid Tumors

22-Jan-2018 Intellasia | BusinessWire | 6:30 AM Print This Post

TOKYO–(BUSINESS WIRE)–SymBio Pharmaceuticals Limited (Headquarters: Tokyo, “SymBio”) (JASDAQ:
4582) announced today that it has initiated a Phase 1 study in Japan for
oral TREAKISYM® in patients with progressive solid tumors.

SymBio holds approval for TREAKISYM® injectables which are
already used for the treatment of three indications of malignant
lymphoma (first-line and relapsed/refractory low-grade B-cell
non-Hodgkin’s lymphoma and mantle cell lymphoma, and chronic lymphocytic
leukemia). The purpose of the Phase 1 study is to evaluate the
recommended dose, dosage regimen, the tolerability1 and the
safety of oral TREAKISYM®, as it is a new formulation, and to
identify types of solid tumors that show promise for treatment.

Based on the efficacy and safety data related to TREAKISYM®
injectables that were demonstrated in the treatment of malignant
lymphoma, the purpose of this study is also to provide a new treatment
option for patients by developing the new oral formulation leveraging
superior traits and fewer adverse events, including alopecia, compared
with existing chemo therapy. Furthermore, SymBio will evaluate safer
dosage regimes with no adverse effect on efficacy by leveraging the
pharmacokinetic traits of the oral formulation, specifically, lowering
Cmax and administration in lower doses during the treatment period. Oral
formulation drugs can also be taken at home, eliminating the need for
the patient to visit the hospital for intravenous infusion and reducing
the treatment burden on the patient.

The development of oral TREAKISYM® is part of SymBio’s
strategy to develop a “TREAKISYM® platform.” For TREAKISYM®
injectables, the Phase III study for the indication of
relapsed/refractory diffuse large B-cell lymphoma is underway. Although
DLBCL accounts for the largest segment of malignant lymphoma in terms of
patient numbers, currently only multiple drug therapies are available
for r/r DLBCL. In addition, SymBio is deploying a sustainable growth
strategy and will maximize the value of TREAKISYM® by
significantly extending the product life through the development of
TREAKISYM® liquid formulations (TREAKISYM® Ready-to-dilute
and TREAKISYM® Rapid Infusion).2

1.   Tolerability refers to the degree to which overt adverse effects of
a drug can be tolerated by a human subject.
2. Please see SymBio’s press release of September 21, 2017: “Eagle
Pharmaceuticals Licenses Japanese Rights for Bendamustine
Hydrochloride Ready-to-dilute and Rapid Infusion Injection Products
to SymBio Pharmaceuticals Limited.”


TREAKISYM® (non-proprietary name: bendamustine hydrochloride), a
cytocide anti-cancer drug first used in Germany in the
1970s, is now widely used in more than 50 countries with indications for
low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic
lymphocytic leukemia.

Bendamustine is a unique compound having chemical properties of both an
alkylating agent3 and a metabolic antagonist4, and
a mode of action different from other anti-cancer drugs. It is expected
that bendamustine, given its unique properties, could be effective for
the treatment of solid tumors as well as malignant lymphoma. A number of
clinical studies of bendamustine injectables have been conducted outside
of Japan to explore this potential, with clinical efficacy reported for
certain solid tumors, including breast cancer, small-cell lung cancer,
and soft tissue sarcoma. Furthermore, clinical studies of oral
bendamustine for multiple myeloma, low-grade non-Hodgkin’s lymphoma, and
chronic lymphocytic leukemia have indicated favorable results with
respect to both safety and tolerability3 of oral formulation.

  • TREAKISYM® Intravenous Infusion 100 mg was approved in
    October, 2010 for manufacturing and marketing for the indication of
    relapsed/refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle
    cell lymphoma in Japan.
  • TREAKISYM® was approved for the additional indication of
    chronic lymphocytic leukemia in Japan in August, 2016.
  • TREAKISYM® Intravenous Infusion 25 mg, a standard low-dose
    product, was approved for manufacturing and marketing in Japan in
    September, 2016.
  • TREAKISYM® was approved for the additional indication of
    first-line treatment of low-grade B-cell non-Hodgkin’s lymphoma and
    mantle cell lymphoma in Japan in December, 2016.

TREAKISYM® has been marketed through Eisai Co., Ltd. since
December, 2010.

3.   An alkylating agent is a type of cytotoxic anti-cancer drug.
Alkylating agents inhibit DNA replication by attaching alkyl group
sites to the DNA chain.
4. A metabolic antagonist is a type of cytotoxic anti-cancer drug.
Metabolic antagonists prevent DNA replication and the growth and
division of tumor cells by interfering with the utilization of
substances produced in the metabolic process.

About SymBio Pharmaceuticals Limited

SymBio Pharmaceuticals Limited was established in March, 2005 by
Fuminori Yoshida who previously served concurrently as Corporate VP of
Amgen Inc. and founding President of Amgen Japan. In May, 2016 SymBio
incorporated its wholly-owned subsidiary in the U.S., SymBio Pharma USA,
Inc. (Headquarters: Menlo Park, California, President: Mr. Fuminori
Yoshida). SymBio’s underlying corporate mission is to “deliver hope to
patients in need” as it aspires to be a leading global specialty
biopharmaceutical company dedicated to addressing underserved medical
needs with main therapeutic focus in oncology, hematology and pain


SymBio Pharmaceuticals Limited
Investor Relations
Tel: +81
(0)3 5472 1125


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