SOLASIA-PHARMA
30.6.2021 10:00:07 CEST | Business Wire | Press release
Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”) today announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW). Based on positive results of R&D on darinaparsin, centered primarily on the results of the Asian Multinational Phase 2 Study (study results released in June 2020), Solasia filed an NDA for the drug with the regulatory authority in Japan ahead of anywhere else in the world.
Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year. If approved and launched, darinaparsin would be the third drug Solasia successfully developed and brought to market since its founding and is expected to contribute to the treatment of PTCL.
Mr. Yoshihiro Arai, President and CEO of Solasia, commented as follows:
“No standard treatment has been established for relapsed or refractory PTCL as of yet. I firmly believe that darinaparsin, with its novel mechanism of action that differs from those of already approved drugs, will contribute to patients and healthcare providers at clinical sites as a new treatment option for relapsed or refractory PTCL. Since founding, Solasia has conducted R&D on five pipeline drugs. Of the five, we have successfully developed and brought to market two drugs, i.e., began providing them to patients, and today, we submitted an NDA for our first anti-cancer drug. Under our mission to provide patients with ‘Better Medicine for a Brighter Tomorrow’, we will continue aiming to contribute to patients’ treatment and enhanced quality of life. ”
About darinaparsin (SP-02)
Darinaparsin, 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. Darinaparsin is believed to exert anticancer effect by inducing cell cycle arrest and apoptosis. Darinaparsin has been granted orphan drug designation in the US and EU.
For more information, please visit at https://solasia.co.jp/en/pipeline/sp-02.html
About Asian Multinational Phase 2 Study
The Asian Multinational Phase 2 Study was a multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in patients with relapsed or refractory PTCL conducted in Japan, Korea, Taiwan, and Hong Kong. (CT.gov Identifier: NCT02653976).
Solasia plans to present the results of the study at an international academic conference to be held in the near future.
About peripheral T-cell lymphoma (PTCL)
Please visit at https://solasia.co.jp/en/pipeline/sp-02.html
About Solasia
Please visit at https://solasia.co.jp/en/
View source version on businesswire.com: https://www.businesswire.com/news/home/20210630005395/en/
Link:
About Business Wire
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
Grindr for Equality Commits to Connecting 10M to HIV Prevention by 202827.7.2026 16:31:00 CEST | Press release
New report finds PrEP awareness is high but access is low, as global HIV funding shrinks Grindr steps up Today at the 2026 International AIDS Conference, Grindr for Equality committed to connecting ten million LGBTQ+ people to HIV prevention by 2028, leveraging its platform reach to advance the global effort to end HIV by 2030. The commitment is rooted in Closing the Gap, a new Grindr for Equality report drawing on survey data from Grindr users across ten countries. The central finding is consistent across countries: people know about PrEP but they are not taking it. The barrier is access and the funding that existed to address it is disappearing. "Connecting people is what Grindr does at a scale and in communities that traditional public health systems don't effectively reach," said George Arison, CEO and Chairman of Grindr (NYSE: GRND). "The global HIV response is losing critical funding at the exact moment we should be accelerating to end HIV by 2030. Grindr has the reach and the re
InterSystems Launches Data Studio AI Assistant to Accelerate Enterprise Data Exploration and Insights27.7.2026 16:00:00 CEST | Press release
New Generative AI extension simplifies how teams explore, analyze, and visualize enterprise data InterSystems, a creative data technology provider powering some of the world's most important applications, today announced the general availability of InterSystems Data Studio™ AI Assistant, a new generative AI-powered extension for InterSystems Data Studio that helps organizations more easily understand, navigate, query, and visualize data through natural language interactions. As organizations move from AI experimentation to production deployments, many are discovering that the greatest challenge is not the AI model itself, but providing AI systems with access to trusted, current, and business-ready information. Enterprise data is often fragmented across applications, databases, cloud services, files, data warehouses, and departmental silos, making it difficult for users and AI systems to generate reliable insights. “Organizations are increasingly looking for ways to turn their data into
PMI U.S. Opens $1.2 Billion Aurora Campus, Strengthening U.S. Manufacturing and Export Capabilities27.7.2026 14:00:00 CEST | Press release
Landmark investment advances U.S. manufacturing leadership, creates high-quality jobs, and positions the Colorado location as a strategic production and export hub Philip Morris International Inc.’s (PMI) (NYSE: PM) U.S. businesses (PMI U.S.) today celebrated the opening of its Aurora, Colorado manufacturing campus, a landmark investment representing total capital expenditures of $1.2 billion from 2024-2028. The campus expands the company’s domestic manufacturing capabilities, strengthens supply chain resilience, and positions Aurora as a strategic production and export hub supporting future growth. The site began commercial production in July 2026 and produces ZYN nicotine pouches, joining PMI U.S.’s growing modern nicotine manufacturing network, which includes operations in Owensboro, Kentucky, and Wilson, North Carolina. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727514086/en/ PMI U.S. Opens $1.2 Billion Aurora Cam
Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million27.7.2026 13:20:00 CEST | Press release
Tecnotree, a global leader in AI-native Digital Business Support Systems (BSS) and digital platform solutions, today announced it has secured new digital transformation contracts across Latin America with a combined value of USD 8.8 million, reinforcing the company’s continued commercial momentum and expanding its presence across one of its key strategic growth markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727931342/en/ Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million Across the engagements, Tecnotree will deploy its AI-native digital platform and B2B Marketplace for enterprises to simplify customer and business operations through intelligent digital engagement, real-time monetization, digital commerce and partner ecosystem management and AI driven marketing and experience management. By providing a unified digital foundation, the platform enables communications
Pure Lithium Corporation Appoints Mercedes-Benz Battery Veteran Dr. Tobias Glossmann as Chief Product Officer27.7.2026 13:00:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery company and developer of the patented Brine to Battery™ technology, today announced the appointment of Dr. Tobias Glossmann as Chief Product Officer. In this role, Dr. Glossmann will lead product and technology strategy, guiding the translation of Pure Lithium’s battery science into engineered products and directing the company’s product engineering efforts. Dr. Glossmann joins Pure Lithium after a 25-year career across Mercedes-Benz companies, most recently serving as Principal Systems Engineer at Mercedes-Benz Research & Development North America. His work spanned advanced battery technology development, from materials through complete battery systems, and he held companywide responsibility for high voltage safety. His career began in 2001 with battery systems development at DaimlerChrysler in Ulm, Germany, and later in Michigan, giving him more than two decades of experience across cell chemistry
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom