SOLASIA-PHARMA
15.6.2020 09:50:08 CEST | Business Wire | Press release
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
Yamaha to Acquire Disguise, Expanding Its Capabilities in Integrated Audio, Video, Lighting and Media13.11.2026 08:00:00 CET | Press release
Acquisition combines Yamaha’s audio expertise with Disguise’s software and media server technologies Yamaha Corporation today announced an agreement to acquire Disguise Technologies Limited (“Disguise”), a London-based provider of software and media server technologies for live and immersive experiences. Yamaha will acquire the company by purchasing all shares in its parent, Butterfly Topco Limited. The acquisition will expand Yamaha’s capabilities beyond audio into integrated audio, video, lighting and media solutions, in line with its strategy to expand beyond hardware into software and services. By combining Yamaha’s audio expertise and global reach with Disguise’s software, technologies and worldwide partner network, the companies will be better positioned to deliver immersive experiences across live entertainment, sports and other venues. Disguise’s technology powers live and immersive experiences worldwide, including tours by Beyoncé and Taylor Swift and venues such as New York’s
Mexico Becomes the First Market Worldwide to Receive Approval for Galderma’s Restylane® Shaype™ for Both Chin and Its First Jawline Indication13.11.2026 07:00:00 CET | Press release
Restylane Shaype is now approved in Mexico for temporary augmentation in the chin area and improvement of jawline definition,1 with launch anticipated in H1 2027 Already approved across various markets globally for the chin area,2 this marks Restylane Shaype’s first approval for the jawline worldwide1 The first-and-only shaper on the hyaluronic acid (HA) market, Restylane Shaype features the firmest HA gel available and is powered by proprietary NASHA HD™ technology, developed to build and shape on bone for instant, natural-looking contour and definition3-6 The approval reinforces Galderma's commitment to advancing innovation in the HA category, enabling the company to meet diverse patient needs Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that Restylane Shaype has been approved for temporary augmentation in the chin area and improvement of jawline definition in Mexico.1 This is the product’s first approval globally for the jawline, and further expan
vVARDIS Announces Pricing of Initial Public Offering13.11.2026 06:02:00 CET | Press release
vVARDIS Holding AG (“vVARDIS”), a Swiss healthcare company operating in the dental med-tech sector, today announced the pricing of its initial public offering of 9,722,223 Class A ordinary shares at a public offering price of $18.00 per share. In connection with the offering, vVARDIS has granted the underwriters a 30-day option to purchase up to an additional 1,458,333 Class A ordinary shares at the initial public offering price to cover over-allotments. The Class A ordinary shares are expected to begin trading on the New York Stock Exchange on November 13, 2026 under the symbol “VVVV.” The closing of the offering is expected to occur on or about November 16, 2026 subject to the satisfaction of customary closing conditions. Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint bookrunning managers for the offering, with William Blair, UBS Investment Bank and Deutsche Bank Securities acting as bookrunners. A registration statement on Form F-1 relating to the offering has been file
Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4*12.11.2026 23:07:00 CET | Press release
The multi-level takeover includes a Throne Room, interactive photo opportunities, special lighting, and more The Empire State Building (ESB) is the gateway to Mount Olympus in Percy Jackson’s world, and now fans can experience the magic like never before. On Nov. 16, the Empire State Building Observation Deck (ESBOD) will unveil “Olympus Awaits,” a multi-level “Percy Jackson and the Olympians” takeover, in partnership with Disney+. The immersive takeover – included with every Observation Deck ticket – will feature an epic Throne Room, interactive photo opportunities, surprise giveaways, ESB x “Percy Jackson” merch, and more, available through Dec. 4, 2026.* This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112442266/en/ Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4* “This immersive NYC experience
Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application12.11.2026 18:09:00 CET | Press release
Veristat’s InStat™ delivers submission-ready tables, listings, and figures (TLFs) in one week using validated statistical engines, shortening the critical path from database lock to submission VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes. Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks
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