SP-02:Darinaparsin

Initial indication: Peripheral T-Cell Lymphoma (PTCL)

    • Pipeline Code
    • Estimated Initial indication
    • Originator
  • Pre-
    clinical
  • Clinical Study
    Phase 1
  • Clinical Study
    Phase 2
  • Clinical Study
    Phase 3
  • NDA
  • App-
    roval
  • Lau-
    nch
  • Partner
  • SP-02

    Peripheral T-Cell Lymphoma

    ZIOPHARM Oncology, Inc
  • Japan, Korea, Taiwan, HK (Phase II, pivotal Study)
    China (Phase II/III, pivotal study preparation)
    US (Phase IIA, completion)
    EU (Pre-clinical, completion)
  • Meiji Seika Pharma:
    Japan
Pipeline Code
SP-02
Estimated Initial indication
Peripheral T-Cell Lymphoma
Originator
ZIOPHARM Oncology, Inc
  • Pre-
    clinical
  • Clinical Study
    Phase 1
  • Clinical Study
    Phase 2
  • Clinical Study
    Phase 3
  • NDA
  • App-
    roval
  • Lau-
    nch
Japan, Korea, Taiwan, HK (Phase II, pivotal Study)
China (Phase II/III, pivotal study preparation)
US (Phase IIA, completion)
EU (Pre-clinical, completion)
Partner
Meiji Seika Pharma:
Japan
SP-02

In March 2011, Solasia acquired the rights to SP-02 (darinaparsin) from ZIOPHARM Oncology, Inc. for Japan, China, Korea and other countries throughout Asia in March 2011, and worldwide rights including USA and European countries in July 2014. Darinaparsin is a novel mitochondrial-targeted agent (organic arsenic) being developed for the treatment of various hematologic and solid cancers. In a Phase II study in the U.S. , intravenous darinaparsin demonstrated evidence of clinical activity in malignant lymphoma,and in particular peripheral T-cell lymphoma (PTCL). Darinaparsin was granted Orphan Drug Designation in the U.S. and Europe as a treatment of PTCL and Solasia intends to seek similar status in Japan. ZIOPHARM is also currently studying darinaparsin in combination with CHOP (cyclophosphamide,doxorubicin, vincristine, and prednisone), the current standard of care for front line PTCL, to confirm the tolerability of the combination for a possible future trial in the front-line setting. An oral form is in a Phase I trial in solid tumors.

Development Strategy:Phase II Study (Japan, Korea, Taiwan, Hong Kong)

Asian Multinational Phase II study for the treatment of relapsed and refractory peripheral T-cell
lymphoma (PTCL) has commenced in March 2016.

Expected Target Indications

Peripheral T-Cell Lymphoma (PTCL)
Malignant lymphoma is a general term to describe tumors that have developed from lymphocytes, mainly in the immune tissue (lymph nodes). A variety of clinical pathological characterizations present in malignant lymphoma. Malignant lymphoma is classified Hodgkin Lymphoma (HL) and Non-Hodgkin’s Lymphoma (NHL). NHL mainly consists of B-cell lymphoma and T-cell lymphoma. It is reported that relative higher incidence of T-cell lymphoma rather than B-cell lymphoma in Japan and Asia. PTCL is a major subtype of T-cell lymphoma with a high incidence rate. Although there is no standard treatment established to treat PTCL, CHOP therapy is widely used as front line treatment. However, there is a large need for more effective and safer therapies as the clinical efficacy of CHOP to treat PTCL is limited. In addition, there are no standard salvage therapies for PTCL, and new, breakthrough therapies are needed.

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