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
AM Best Upgrades Fortegra Insurance Subsidiaries to A (Excellent)6.8.2026 15:00:00 CEST | Press release
Rating actions follow completion of the DB Insurance acquisition The Fortegra Group, Inc. (“Fortegra” or the “Company”), a global specialty insurer and part of DB Insurance Co., Ltd., today announced that AM Best has upgraded the Financial Strength Rating (FSR) of its insurance subsidiaries to A (Excellent) from A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICRs) to “a” (Excellent) from “a-” (Excellent). The outlook assigned to the ratings is stable, and AM Best removed the ratings from under review with positive implications. KBRA has also upgraded all of its ratings for the Company. The upgrade applies across Fortegra’s insurance platform. The property and casualty companies include Lyndon Southern Insurance Company, Insurance Company of the South, Response Indemnity Company of California, Blue Ridge Indemnity Company, Fortegra Specialty Insurance Company and Fortegra Europe Insurance Company SE. The life and health companies include Life of the South Insurance Co
Khimji Ramdas Group Chooses Rimini Street to Reduce SAP Support Costs, Protect 700+ Customizations and Reinvest Savings in Innovation6.8.2026 15:00:00 CEST | Press release
Omani conglomerate gains greater control over its IT roadmap, avoids migration pressure and funds AI and growth initiatives Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced that Khimji Ramdas Group, one of Oman’s largest privately held conglomerates, has selected Rimini Support™ for SAP, a move that has helped the organization reduce costs, reinvest savings in AI innovation and maintain its highly customized SAP ECC 6 environment with zero downtime. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806244148/en/ Khimji Ramdas Group Chooses Rimini Street to Reduce SAP Support Costs, Protect 700+ Customizations and Reinvest Savings in Innovation “Staying on SAP ECC is a strategic decision for us,” said Prashant Kumar, CTO, Khimji Ramdas Group. “We went to an industry analyst to ask what options
Naser Taher, Chairman and Founder of MultiBank Group, Honored by H.H. Sheikh Nahyan bin Mubarak Al Nahyan with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence6.8.2026 14:53:00 CEST | Press release
The recognition honors Naser Taher and MultiBank Group for its revolutionary advances in regulated digital assets, blockchain, and real-world asset tokenization Naser Taher, Chairman and Founder of MultiBank Group, has been honored with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence at the 9th Golden Excellence Awards 2026. The award was presented by H.H. Sheikh Nahyan bin Mubarak Al Nahyan, UAE Cabinet Member and Minister of Tolerance & Coexistence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806828617/en/ Naser Taher, Chairman and Founder of MultiBank Group, Honored by H.H. Sheikh Nahyan bin Mubarak Al Nahyan with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence. The recognition reflects MultiBank Group’s continued expansion into regulated digital assets through mb.io, the Group’s VARA-regulated cryptocurrency exchange. Through mb.io, clients can acces
Mary Kay’s Pink Changing Lives® Program Turns Purpose Into Measurable Impact for Women Around the World6.8.2026 14:05:00 CEST | Press release
More than 4 million women have benefited through nonprofit organizations supported by the program since its launch. Mary Kay Inc., a global advocate for women’s empowerment, proudly reaffirms its commitment to enriching women’s lives worldwide through its signature Pink Changing Lives® Program – a multi-faceted global initiative that blends purpose-driven giving with cause-marketing to create meaningful, measurable impact across communities. Since 1996, the program has provided over $230 million in monetary and product donations to nonprofit organizations empowering women, transforming women’s health and safety, and protecting our natural resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806671194/en/ Mary Kay China supports the Hope for Pearl Program, providing financial assistance to girls from economically disadvantaged areas to receive a life-changing education, opening doors to new possibilities and bright fu
Perpetuals Reports 380% Hypothetical Return in Backtest of AI Engine Powering Risk-Free Trading Platform ‘UpsideOnly’6.8.2026 14:00:00 CEST | Press release
Results provide early evidence that BayesShield can identify potentially profitable trading signals by finding repeatable skill in trader activity375-day backtest using Perpetuals’s production code generated a hypothetical 380% non-compounded return, a period in which Bitcoin fell 40.2%The strategy achieved a return-to-drawdown ratio of 4.4, a measure comparing its overall return with the largest decline it experienced during the test Perpetuals.com Ltd (Nasdaq: PDC) today announced backtest results for version two of BayesShield, its patent-pending AI engine developed for UpsideOnly. UpsideOnly is a risk-free paper trading platform where users simulate trades using virtual money across global equity, commodity, foreign exchange and crypto markets. The platform is powered by BayesShield, an AI model that uses machine learning to identify consistently successful traders. It generates automated signals when enough qualified traders independently take the same position at approximately th
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