SOLASIA-PHARMA
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/
View source version on businesswire.com: https://www.businesswire.com/news/home/20200615005228/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
Australian Defence Force Secures Satellite Communications on SES IS-2212.1.2026 22:30:00 CET | Press release
New agreement for uninterrupted UHF connectivity for Australian Defence Force through 2033, With Options Extending to 2041 Satellite communications solutions provider SES will provide secure uninterrupted satellite communications to the Australian Defence Force (ADF) for a minimum of 16 years thanks to a new extended agreement. The service will be provided via the SES Intelsat 22 satellite and an ultra-high frequency (UHF) military communications payload. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112137182/en/ Assistant Secretary Space Systems Branch, Michael Hunt, formalizes contract negotiations for the through-life support of the IS-22 satellite with Rory Welch, senior vice-president of service delivery at SES Space and Defense. Photos: Corporal Annika Smit Under the renewed arrangement, SES will reposition the IS-22 satellite to a new orbital slot specified by the ADF, continuing a mission that has been the corne
NetApp Appoints Paul Fipps to the Board of Directors12.1.2026 22:05:00 CET | Press release
NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that Paul Fipps, President of Global Customer Operations at ServiceNow, has joined its Board of Directors. The board now has ten directors, nine of whom are independent, and 50% of whom have been appointed within the last five years. Fipps brings more than 20 years of experience driving technology-enabled growth and customer transformation. At ServiceNow, he currently leads global sales, customer success, partner ecosystems, and field operations. He previously served as EVP of Worldwide Sales at ServiceNow and as President of Under Armour Connected Fitness and Chief Experience Officer at Under Armour, overseeing global direct-to-consumer, connected fitness, and digital experiences. He also previously served on the advisory board of Quantum Metric. Fipps holds a B.S. in Information Systems, an MBA from the University of Baltimore, and is a graduate of The Wharton School’s Advanced Management Program. “P
FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor12.1.2026 20:00:00 CET | Press release
Not intended for Canada-, UK- or US-based media Merck, a leading science and technology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor (TGCT). The application is based on the primary results and longer-term follow-up of the global Phase 3 MANEUVER study, which demonstrated deep and durable tumor responses and meaningful improvements in clinical outcomes with pimicotinib. “With pimicotinib, we have an opportunity to significantly advance care for people living with TGCT, a painful and debilitating disease that has few effective and well-tolerated treatment options beyond surgery,” said David Weinreich, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. “Based on clinical trial results showing not only a reduction in tumor burden, but also the ability to help alleviate symptoms like pain an
Fabentech receives Marketing Authorization for Ricimed®, an antidote against ricin poisoning12.1.2026 19:32:00 CET | Press release
First Marketing Authorization granted in France for the treatment of ricin poisoning, one of the most toxic natural substances in the world and a recognized priority biological threat. Ricimed® addresses a previously unmet medical need in the management of severe and potentially fatal ricin intoxications.Supported by the French Ministry of the Armed Forces and Veterans Affairs (the Directorate General of Armaments and the French Military Health Service), the development of Ricimed® illustrates Fabentech’s transition to a new scale and, with recent support from the European HERA Invest program, reinforces its positioning as a reference player in medical countermeasures against biological threats, serving both civilian and military markets. Fabentech, a French biopharmaceutical company specializing in medical countermeasures against biological threats, today announces that it has been granted Marketing Authorization for Ricimed®, a treatment for ricin poisoning. This press release featur
Traxys Group and the Shareholders of Comax2 AB - the holding company of Carbomax AB - sign Share Purchase Agreement to sell 100% interests to Traxys Group12.1.2026 19:20:00 CET | Press release
Traxys S.à.r.l., Investment Aktiebolaget Spiltan and other major shareholders of Comax 2 AB – the holding company of Carbomax AB –are pleased to announce that they have signed a Share Purchase Agreement (SPA) to sell 100% interests to Traxys Group. Carbomax AB is a leading Swedish trading house and industrial operator specializing in ferroalloys, carbon products and briquettes. The transaction aims to strengthen Traxys’ presence in the Scandinavian market and support the region’s transition toward sustainable steel production. Closing of the transaction is expected to occur in the first quarter 2026 following clearance by Swedish authorities, including foreign direct investment and antitrust approvals. Carbomax serves regional steel plants and most of foundries across the Nordics. With its strategic location near Västerås harbor and integrated processing capabilities Carbomax is well-positioned to capitalize on growing demand for green steel and sustainable raw materials. Mark Kristoff
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