Express Organic Arsenic Anticancer Therapy Submits a New Drug Application in Japan to Treat Lymphoma

▎The content team editor of WuXi AppTec On June 30, 2021, Solasia Pharma of Japan announced that it has submitted a new drug application (NDA) for its research drug darinaparsin to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of relapsed/refractory Peripheral T-cell lymphoma (PTCL)
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This is the first new drug application for darinaparsin in the world
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This new drug application is based on the positive results of Phase 2 clinical trials conducted in Asia
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Solasia plans to announce the test results at an upcoming international academic conference
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In addition, darinaparsin has obtained orphan drug designation for the treatment of PTCL in the United States and the European Union
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Darinaparsin is an organic arsenic compound with anti-cancer activity, which has been developed to treat a variety of blood cancers and solid tumors
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Its potential mechanism of action includes disturbing cell mitochondrial function, increasing the production of reactive oxygen species, and regulating intracellular signal transduction pathways
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It is believed to achieve anti-cancer therapeutic effects by inducing cell cycle arrest and apoptosis
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The results of a phase 1 clinical trial published in the Japanese Journal of Clinical Oncology this year showed that of the 14 patients who could be evaluated, 1 patient achieved complete remission, 3 patients achieved partial remission, and 6 patients had stable disease
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▲The change in tumor size of patients treated with darinaparsin in the phase 1 clinical trial (picture source: reference [2]) In June last year, Solasia announced that darinaparsin had reached the level in the phase 2 clinical trial for the treatment of patients with relapsed or refractory PTCL Primary endpoint
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Malignant lymphomas are divided into Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL), and non-Hodgkin's lymphoma is divided into two categories: B-cell lymphoma and T-cell lymphoma
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PTCL is a subtype of T-cell lymphoma.
Compared with other subtypes, the incidence of PTCL is relatively high.
The standard treatment of PTCL has not been established.
Due to the poor prognosis and difficult treatment of PTCL, there is a high degree of unmet medical needs
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Mr.
Yoshihiro Arai, President and CEO of Solasia, said: “So far, no standard treatment for relapsed/refractory PTCL has been established
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I believe that darinaparsin will provide patients and medical staff with a new mechanism of action that is different from approved drugs.
A new treatment option
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"Reference: [1] Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan.
Retrieved June 30, 2021, from https:// 20210630005395/en/[2] Ogura et al.
, (2021).
Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea, Jpn J Clin Oncol, DOI: 10.
1093/jjco/hyaa177 Note: This article aims to introduce the progress of medical and health research, not to recommend treatment plans
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If you need guidance on treatment plans, please go to a regular hospital
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