Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan
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
Please visit at https://solasia.co.jp/en/
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Solasia Pharma K.K.
Rie Toyoda, Public Relations and Investor Relations,
Tel. +81 3 5843 8049
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
Peru Holds a Ribbon Cutting Ceremony at Its Pavilion at Dubai Expo and Wins 4 World Travel Awards22.10.2021 19:15:00 CEST | Press release
The Dubai World Expo took place in an electrifying musical atmosphere where thousands of attendees were captivated by the variety of artistic, musical and cultural expressions that characterize the different regions of Peru. All this was part of the inauguration of the Peru Pavilion at the most important cultural event in the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211022005454/en/ Peru inaugurated its Pavilion at Expo 2020 Dubai and received four awards from the “Tourism Oscars.” (Photo: Business Wire) The Peru Pavilion was inaugurated by the Commissioner General for Peru at the Expo, Amora Carbajal, and Najeeb Mohammed Al-Ali, Executive Director of Expo 2020 Dubai, in front of official representatives from different country pavilions. “The purpose of the pavilion is to offer a complete learning experience about ancient Peruvian wisdom throughout the visit, communicating the importance of the heritage, biodive
Schlumberger Announces Third-Quarter 2021 Results22.10.2021 12:50:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the third-quarter 2021. Third-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeSept. 30, 2021Jun. 30, 2021Sept. 30, 2020SequentialYear-on-yearRevenue* $5,847 $5,634 $5,258 4% 11% Income (loss) before taxes - GAAP basis $691 $542 $(54) 28% n/m Net income (loss) - GAAP basis $550 $431 $(82) 28% n/m Diluted EPS (loss per share) - GAAP basis $0.39 $0.30 $(0.06) 30% n/m Adjusted EBITDA** $1,296 $1,198 $1,018 8% 27% Adjusted EBITDA margin** 22.2% 21.3% 19.4% 90 bps 280 bps Pretax segment operating income** $908 $807 $575 12% 58% Pretax segment operating margin** 15.5% 14.3% 10.9% 120 bps 460 bps Net income, excluding charges & credits** $514 $431 $228 19% 126% Diluted EPS, excluding charges & credits** $0.36 $0.30 $0.16 20% 125% Revenue by Geography International $4,675 $4,511 $4,210 4% 11% North America* 1,129 1,083 1,034 4% 9% Other 43 40 14 n/m n/m $5,847 $5,634 $5,258 4% 11% *Schlumberger dive
Disruptive.Asia: Huawei's Ryan Ding and Peng Song Discuss How Operators Can Leverage Connectivity to Unlock New Growth22.10.2021 12:30:00 CEST | Press release
Disruptive.Asia reported that Ryan Ding and Peng Song stressed the growing importance of connectivity in driving industry growth and generating value amid a rapidly evolving landscape at the 7th Ultra-Broadband Forum (UBBF 2021) in Dubai, which is jointly hosted by the UN Broadband Commission and Huawei. Ding, Executive Director of the Board and President of the Carrier Business Group, Huawei, said that connectivity has made it possible to innovate, especially in a digital age where increasing efficiency has become paramount. The pandemic has also ushered a paradigm shift in connectivity, as homes turned into multi-functional centers for education, work, and business. It became increasingly clear that connectivity not only drives digital economies forward but also maintains the functioning of society. Peng, President of the Global Carrier Marketing & Solution Sales Department, Huawei, said that looking at connectivity through Huawei's C.A.F (Coverage, Architecture and Fusion) model can
Suzano Brings Its Target for Capturing 40 Million Tons of Carbon From the Atmosphere Forward To 202522.10.2021 12:19:00 CEST | Press release
Suzano, the world's leading eucalyptus pulp producer and a global benchmark in the manufacture of bioproducts developed from eucalyptus, announces today that it has revised one of its 14 long-term goals – collectively known as Suzano’s “Commitments to Renewing Life”*. Suzano’s goal to remove 40 million tons of carbon from the air by 2030 has been brought forward by five years to 2025. With this revision, Suzano reinforces its capacity to make an even more positive contribution to the planet's climate by achieving net carbon removals from the atmosphere at a faster pace than previously expected. The new five-year target will be supported by the expansion of Suzano’s forest covering which will involve both an uplift in commercial planting operations and setting aside new designated conservation areas that were previously anthropized. Alongside these improvements, Suzano will maintain its focus on reducing carbon emissions across its own operations and supply chain and will continue to im
AntChain Launches Its First Security Chip and New Blockchain Platform Powered by Privacy Computing Technology22.10.2021 12:01:00 CEST | Press release
AntChain, the flagship technology brand of Ant Group, today unveiled two new products at the Apsara Conference 2021 in Hangzhou – the FAIR platform and the T1 security chip – to ensure the security and trustworthiness of data flows within blockchain networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211022005166/en/ Yan Ying, technical director of AntChain, unveiled the FAIR platform at the Apsara Conference on October 22, 2021. (Photo: Business Wire) Based on AntChain’s upgraded technical architecture, the FAIR platform natively integrates privacy-preserving computation (PPC) and blockchain technologies in a unified platform, unleashing the value of data flows over their entire lifecycle. FAIR is designed to address pain points in multi-party collaboration on data flows, which is increasingly common on the industrial internet. It replaces traditional “PPC plus blockchain” dual-system architecture, integrating the two
Egle Therapeutics Raises 40 Million € Series a to Develop First-In-Class T-regulatory Cells Therapies Based On Treg-starvers22.10.2021 11:30:00 CEST | Press release
Egle Therapeutics SAS (Egle), an emerging biotechnology company focused on developing First-In-Class immunotherapies targeting immune suppressor regulatory T-cells (Tregs) for oncology and autoimmune diseases, today announces that it has completed a €40M ($46.4M) Series A financing. The Series A was co-led by LSP and Bpifrance through their InnoBio 2 fund. Fund+, Bioqube Ventures and Takeda Ventures, Inc. also participated in this round. Egle Therapeutics was founded in early 2020 with a vision to become a game changer in the field of Tregs immunomodulation through the unique concept of Tregs starving and specifically targeting the most immunosuppressive ones. Spun out of Institut Curie, Egle’s scientific foundation leverages unprecedented, computational-based, IL-2 modified variants and newly tumor-associated Treg targets to build a furnished pipeline of First-In-Class immunocytokines against Tregs. The new capital will be used primarily to advance 2 leads assets into the clinic and f
HFZA inks investment deal with ArcelorMittal DSTC FZE22.10.2021 10:00:00 CEST | Press release
The Hamriyah Free Zone Authority (HFZA) has added another industry leader to its investors base after ArcelorMittal Projects, part of the ArcelorMittal Group, the world’s leading Steel and Mining company, recently acquired the assets of a Pipe & Coating Mill located at Hamriyah Free Zone and leased 1.38 million square feet of Industrial land. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211022005020/en/ Signing of the Memorandum (Photo: Business Wire) The announcement was made during the signing of a memorandum of understanding (MoU) by HE Saud Salim Al Mazrouei, Director of Hamriyah Free Zone Authority, and Johannes De Schrijver, CEO of ArcelorMittal Projects. According to the agreement, the company shall provide complete, customized, and sustainable steel solutions and services via three specialized and project-related business lines: Foundation Solutions, Solar Projects, and Energy Projects (Anti-corrosion coating solut
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