Solasia Announces Positive Results of DARINAPARSIN in Pivotal Phase 2 Study for Peripheral T-Cell Lymphoma
Solasia Pharma K.K. (TOKYO:4597, Headquarters: Tokyo, President & CEO: Yoshihiro Arai, hereinafter “Solasia”), a specialty pharmaceutical company based in Asia, today announced the positive results from the pivotal Phase 2 study with SP-02 (a new anti-cancer drug, international generic name: darinaparsin, hereinafter “darinaparsin”) for relapsed or refractory peripheral T-cell lymphoma (hereinafter “PTCL”) in Asia.
- The primary endpoint (antitumor effect) was achieved.
- No new safety concerns were identified in the safety analysis.
- This study was conducted as the final registration trial for the indication of relapsed or refractory PTCL. Solasia begins preparing for the NDA Filing.
Darinaparsin is a novel mitochondrial targeting drug (organic arsenic compound) that has been developed for the treatment of various hematological cancers and solid cancers. This study was conducted as a multinational, multicentre, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in relapsed or refractory patients with PTCL in Japan, South Korea, Taiwan and Hong Kong.
Solasia holds an exclusive worldwide license to develop and commercialize darinaparsin. For Japan market, Solasia has already entered into an exclusive license agreement with Meiji Seika Pharma Co., Ltd., for the commercialization of darinaparsin, and for Latin America, with HB Human BioScience SAS. Based on these positive results, Solasia will actively seek licensing partners for the United States, Europe and other regions.
About darinaparsin (SP-02)
Darinaparsin is a novel mitochondrial-targeted agent (organoarsenic) being developed for the treatment of various hematologic and solid cancers. In a US Phase 2 study, darinaparsin demonstrated evidence of clinical activity in lymphoma, in particular PTCL. Furthermore, the Phase 1 study done in US, and the Pan-Asian Phase 1 study both demonstrated positive efficacy and safety. Darinaparsin has been granted orphan drug designation in US and EU.
For more information, please see at https://www.solasia.co.jp/en/pipeline/sp-02.html
About peripheral T-cell lymphoma (PTCL)
Malignant lymphoma is a general term to describe tumors that have developed from lymphocytes, mainly in the immune tissue (lymph nodes). A variety of clinical pathological characterizations present in malignant lymphoma. Malignant lymphoma is classified as Hodgkin Lymphoma (HL) and Non-Hodgkin’s Lymphoma (NHL). NHL mainly consists of B-cell lymphoma and T-cell lymphoma. It is reported that relatively higher incidence of T-cell lymphoma rather than B-cell lymphoma in Japan and Asia. PTCL is a major subtype of T-cell lymphoma with a high incidence rate. Although there is no standard treatment established to treat PTCL, CHOP therapy is widely used as front line treatment. However, there is a large need for more effective and safer therapies as the clinical efficacy of CHOP to treat PTCL is limited. In addition, there are no standard salvage therapies for PTCL, and new, breakthrough therapies are needed.
About Solasia
Solasia is a specialty pharmaceutical company based in Asia, with a mission of "Better Medicine for a Brighter Tomorrow". In order to address the unmet medical needs within the oncology area, we develop innovative medicines to contribute to the patient's healthy living and to provide treatment options for the healthcare providers.
For more information, please visit https://www.solasia.co.jp/en/
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/20200615005228/en/
Contact information
For further information, please contact:
Solasia Pharma K.K.
Rie Toyoda, Public Relations and Investor Relations,
Tel. +81 3 5843 8049
info@solasia.co.jp
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Pioneering Impact Strategy, Record EM Sustainable Finance (EMSF), Celebrates Its Fourth Anniversary With Strong Outperformance Since Inception1.7.2025 09:00:00 EEST | Press release
Record Currency Management, in partnership with UBS Wealth Management, is proud to celebrate the fourth anniversary of its pioneering Emerging Market Sustainable Finance (EMSF) Strategy. Operating at the intersection of impact investing, Emerging and Frontier Market currencies and private placements, the strategy offers investors an opportunity to achieve financial returns, alongside measurable impact. Since inception, EMSF has grown to over U$1 billion in AUM and delivered positive returns of +18.7% since inception. The strategy has significantly outperformed both USD and local currency EM Debt benchmarks with around 30% lower volatility - reaffirming that investors need not compromise between financial returns and measurable impact. By taking currency risk across a wide universe of emerging and frontier currencies, EMSF helps MDBs and DFIs raise local currency funding. This allows borrowers in Emerging Markets to receive funding in local currency, eliminating FX risk. Simultaneously,
Lazard Welcomes Klaus H. Hessberger as Managing Director and Global Co-Head of Financial Sponsors Group1.7.2025 08:50:00 EEST | Press release
Lazard, Inc. (NYSE: LAZ) today announced that Klaus H. Hessberger has been appointed to the firm as Managing Director, Global Co-Head, and Head of Europe for Lazard’s Financial Sponsors Group, based in London. Adam Cady, previously Lazard’s Head of Large-Cap Financial Sponsor Coverage North America in New York, has also been named Global Co-Head of the Global Financial Sponsors Group, running the team together with Klaus. These appointments reflect Lazard’s expanding connectivity and partnership with alternative asset managers, which continues to be a principal area of focus and a major source of future growth for the firm globally. Lazard’s recruiting efforts are also a key contributor to the firm’s long-term growth goals, with ongoing success in attracting top tier talent globally. “Klaus is a recognised leader in the global financial sponsor community with an impressive track record of advising global alternative asset managers and leading teams of highly experienced industry profes
Usercentrics Report Reveals: As Concern Over Data Use Grows, Transparency Becomes the Number One Driver for Building Trust1.7.2025 08:28:00 EEST | Press release
59% of consumers are uncomfortable with their data being used to train AI systems, according to a new report from privacy tech leader Usercentrics. But it isn’t AI itself that worries consumers - it’s the lack of clarity around how their data is used. Rather than rejecting innovation, people are demanding greater transparency and control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630843237/en/ How much do consumers trust companies in various industries when it comes to data collection and use? According to the State of Digital Trust 2025report, based on insights from 10,000 frequent internet users across Europe and the United States, digital privacy has become a strategic imperative. “We’re not witnessing a breakdown in trust, but a reset in expectations,” says Adelina Peltea, CMO at Usercentrics. “In the age of AI, giving users real control over their data isn’t just about compliance - it’s how brands build loyalty.
Galderma Announces Departure of Its Chief Financial Officer1.7.2025 08:00:00 EEST | Press release
Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that Thomas Dittrich, Chief Financial Officer, will be leaving the company to pursue another senior executive opportunity outside the organization. “We thank Thomas for his financial leadership and many contributions during his time at Galderma. He played a key role in establishing the financial discipline, operational readiness, and strategic clarity that will continue to guide us forward. We wish him every success in his next role and remain focused on further accelerating Galderma’s strong growth – from category leadership to becoming a true powerhouse in dermatology.” FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Thomas Dittrich will remain with the company as Chief Financial Officer through Q2 2026 to ensure a seamless transition through the close of the 2025 fiscal year. A successor will be announced in due course. “I want to thank Flemming, our Board of Directors, our investor
Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 21:30:00 EEST | Press release
Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s technology division NextChem, through its subsidiary KT TECH SpA, also signed a Basic Engineering, Critical and Proprietary Equipment Supply Agreement with Samsung E&A in connection with its proprietary NX AdWinMethanol®Zero technology supply to the project. Transition Industries is jointly developing the Pacif
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