On June 19, 2022 Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter "Solasia") officially reported that an organoarsenic drug "DARVIAS Injection 135mg" (SP-02, hereinafter DARVIAS) has been approved for relapsed or refractory Peripheral T-Cell Lymphoma (hereinafter "PTCL") by the Ministry of Health, Labor and Welfare (MHLW). Solasia filed an NDA with the MHLW in Japan in June 2021 (Press release, Solasia, JUN 19, 2022, View Source [SID1234616087]). In October 2021, Nippon Kayaku Co., Ltd. (TSE: 4272, Headquarters: Tokyo, Japan, President: Atsuhiro Wakumoto) secured a license agreement with DARVIAS for marketing rights in Japan.
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DARVIAS, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. DARVIAS is believed to exert an anticancer effect by inducing cell cycle arrest and apoptosis. This approval is based on the result of an Asian Multinational phase II study of SP-02 in patients with relapsed or refractory PTCL, Japan being the first country in the world where it was approved.
Mr. Yoshihiro Arai, President and CEO of Solasia, commented for this approval as follows:
Since its founding, we have been focusing on developing new treatment options that solve the quality of life of patients in the treatment of cancer that affects one in two Japanese people. The two products, episil Oral Solution and Sancuso, which have been successfully developed so far, are not for the treatment of cancer itself, but used as supportive care such as suppression of nausea / vomiting caused by chemotherapy and alleviation of pain associated with oral mucositis caused by chemotherapy and radiotherapy. DARVIAS is our first NDA approved anticancer drug. Nippon Kayaku is our commercial partner with strengths in the field of oncology. We are very pleased to have this opportunity to deliver DARVIAS to nationwide medical institutions providing new cancer treatment by utilizing Nippon Kayaku’s extensive experience in oncology and contribute to the treatment of patients suffering from PTCL.
About DARVIAS
DARVIAS, an organoarsenic drug, is a novel anticancer agent targeting mitochondria.
DARVIAS provokes cell cycle arrest and apoptosis through disruption of mitochondrial functions and increased production of reactive oxygen species in tumor cells. In addition to the PTCL, it has been suggested that potential target indications be other hematologic cancers (lymphoma, leukemia), and solid tumors. Regarding future expansion of indications, Solasia will explore clinical development strategies in consultation with Nippon Kayaku. DARVIAS has been granted orphan drug designation in the US and EU.