Solasia Pharma KK officially announced today that the organoarsenic drug DARVIAS ® as Ministry of Health, Labor and Welfare  for the treatment of relapsed or refractory peripheral T-cell lymphoma (IM "PTCL" for short) has been approved. Solasia submitted the corresponding application to the MHLW in Japan in June 2021. In October 2021, Nippon Kayaku Co., Ltd. (TSE: 4272; HQ: Tokyo, Japan; President: Atsuhiro Wakumoto) signed a license agreement with marketing rights to DARVIAS® in Japan.

DARVIAS ® , an anticancer organic arsenic compound, is a novel mitochondrial-targeted agent developed for the treatment of various hematologic and solid tumors. The drug's intended mechanism of action involves disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. It is understood that DARVIAS ®has an anticancer effect by inducing cell cycle arrest and apoptosis. The approval is based on the results of a Phase II study of SP-02 in patients with relapsed or refractory PTCL conducted in several Asian countries, with Japan being the first country in the world to grant approval.

Commenting on the approval, Yoshihiro Arai, President and CEO of Solasia, said:
“Since our inception, we have focused on developing new treatments that improve the quality of life for cancer patients. Every second person in Japan is affected by cancer. The two products that have been successfully developed so far, the oral solution episil® and Sancuso®, are not intended for actual cancer treatment, but are used as adjuvant therapies, for example to suppress nausea/vomiting caused by chemotherapy and to relieve pain used in connection with oral mucositis secondary to chemotherapy and radiotherapy. DARVIAS ®is our first approved cancer drug. Nippon Kayaku is our business partner and has particular strengths in the field of oncology. We are very pleased to leverage Nippon Kayaku's extensive experience in oncology to bring DARVIAS ® to medical facilities nationwide as a new cancer therapy, thereby contributing to the treatment of patients with PTCL.”

About DARVIAS ®
The organoarsenic drug DARVIAS ® is a novel anticancer agent that targets the mitochondria.
DARVIAS® causes cell cycle arrest and apoptosis by disrupting mitochondrial function and increasing production of reactive oxygen species in tumor cells. In addition to PTCL, other hematological cancers (lymphoma, leukemia) and solid tumors are potential target indications. For future expansion of these indications, Solasia will explore clinical development strategies in consultation with Nippon Kayaku. DARVIAS® has been granted Orphan Drug Designation in the US and EU.

About Solasia
Solasia is an Asian specialty pharmaceutical company with a mission to provide "Better Medicine for a Sunnier Tomorrow". To address unmet medical needs in oncology, Solasia develops innovative medicines that help the company improve patient health and future prospects. For more information, please visit the company's website at https://solasia.co.jp/en/ .

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Contacts
Solasia Pharma KK
Toyokazu Ohata, Public Relations and Investor Relations,
Tel: +81 3 5843 8045
info@solasia.co.jp

 

Source:businesswire.com

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