Solasia Pharma: DARVIAS ® Injection 135mg (Generic Name: DARINAPARSIN /Development Code: SP-02) Approved in Japan
Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”) officially announced today 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. 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.
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.
About Solasia
Solasia is a specialty pharmaceutical company based in Asia, with a mission to provide “Better Medicine for a Brighter Tomorrow.” To address the unmet medical needs in the oncology field, Solasia develops innovative medicines to contribute to the better health and brighter future of patients. Please visit the company website at https://solasia.co.jp/en/ for more information.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220620005030/en/
Contact information
Solasia Pharma K.K.
Toyokazu Ohata, Public Relations and Investor Relations,
Tel. +81 3 5843 8045
info@solasia.co.jp
About Business Wire
Business Wire(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
“Functional Art” by Braun and Virgil Abloh - Co-Created for the Brand’s 100 Years in 2021 - Features in the First Museum Exhibition Devoted to Abloh’s Work30.6.2022 08:00:00 CEST | Press release
Braun, the design-centric German appliances brand, announces its sponsorship of the Brooklyn Museum’s presentation of Virgil Abloh: “Figures of Speech” that opens to the public on July 1st, 2022, and closes January 29, 2023. The exhibition, originally organized by the Museum of Contemporary Art Chicago, spans two decades of the artist’s multifaced career, including collaborations with artists such Takashi Murakami, Juergen Teller, and Arthur Jafa; material from his fashion label Off-White and items from Louis Vuitton, where he served as the first Black menswear artistic director; and unique pieces from brand collaborations including Braun. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220629005028/en/ (Photo: Business Wire) To celebrate 100 years of ‘good design’ in 2021, Braun entered a one-of-a-kind collaboration with Abloh that saw him delve into the Braun archives to update and co-curate the 1965 ‘Wandanlage’ hi fi audi
A Decade of Transparency in European Securitisation: European DataWarehouse Celebrates its 10 Year Anniversary30.6.2022 08:00:00 CEST | Press release
Today marks the 10th anniversary of European DataWarehouse (EDW), Europe’s first securitisation repository, established in 2012 as part of the European Central Bank’s ABS Loan-Level Initiative. In its first decade of operating as a market infrastructure, EDW has strengthened its position as Europe’s first securitisation repository through its registration by both the European Securities and Markets Authority (ESMA) and the Financial Conduct Authority (FCA). Since 2012, EDW has not only facilitated the centralisation, transparency, and standardisation of European loan-level data for the securitisation market, but has also contributed to countless consultations and regulatory initiatives that have shaped the disclosure frameworks in both the EU and UK financial markets. Reflecting on 10 years of progress, Dr. Christian Thun, CEO of EDW said, “EDW’s success has been achieved through the hard work and dedication of our team members and the continuous optimisation of our reporting solutions
H2SITE Raises 12,5M€ to Scale Membrane Reactor Breakthrough Technology30.6.2022 08:00:00 CEST | Press release
H2SITE, a deep-tech pioneer in on-site hydrogen (H2) production, announced today that it has raised 12,5 M€ in a Series A funding round led by Breakthrough Energy Ventures (BEV), with participation from Equinor Ventures, ENGIE New Ventures, TECNALIA and institutional investors from the Basque Country (Capital Riesgo País Vasco (EZTEN FCR) and Seed Capital Bizkaia (SCB)). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220629005760/en/ Membrane bundle for ammonia cracking reactor (Photo: H2SITE) The funding will accelerate the scale up of H2SITE's integrated membrane reactor and membrane separation technologies to obtain fuel cell purity hydrogen from ammonia or methanol cracking, or enable hydrogen transportation in existing natural gas infrastructure. H2SITE will also increase its membrane manufacturing capabilities, operating a world unique membrane manufacturing plant in the North of Spain. “While much focus is given to hy
SES’s C-band Satellite Successfully Launched Onboard SpaceX Rocket30.6.2022 00:53:00 CEST | Press release
SES announced today that the SES-22 satellite was successfully launched into space onboard a SpaceX Falcon 9 rocket from SpaceX’s Space Launch Complex 40 at Cape Canaveral Space Force Station in Florida, United States, at 5:04 pm local time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220629005978/en/ SES’s C-band Satellite Successfully Launched Onboard SpaceX Rocket (Photo: Business Wire) The first of SES’s C-band satellites dedicated to freeing up the lower 300 MHz of C-band spectrum is built by Thales Alenia Space, and will operate in the 135 degrees West orbital slot. It will deliver TV and radio to millions of American homes and provide other critical data transmission services. SES-22 is expected to start operations by early August 2022. The launch of SES-22 is part of a broader Federal Communications Commission (FCC) program to clear a portion of C-band spectrum to enable wireless operators to deploy 5G services ac
Long-Beleaguered Hotel Property in Paradise Valley, Arizona Gains New Owner30.6.2022 00:10:00 CEST | Press release
Walton Global, a real estate investment and land asset management company with US$3.6 billion under management, is pleased to announce its acquisition of the Smoke Tree Resort property located west of Scottsdale Road on Lincoln Drive in the Town of Paradise Valley, Arizona. The deal closed on June 29, 2022, with ST Holdings, a subsidiary of Scottsdale-based Walton Global Holding, LLC. Walton acquired the 5-acre property for $14 million with plans to build a new boutique hotel that will serve locals and support Arizona tourism. Walton intends to incorporate an elegance in the new design that Paradise Valley is known for and avoid controversial elements that have challenged Smoke Tree and other hotel redevelopments in the past such as roof top bars, condominiums, for-sale units, height, density and other concerns that have hampered revitalization efforts in the past. The distinctive and strategically positioned property was subject to bankruptcy and now has fresh opportunities and a rene