Business Wire

Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan

Share

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/

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Solasia Pharma K.K.
Rie Toyoda, Public Relations and Investor Relations,
Tel. +81 3 5843 8049
info@solasia.co.jp

About Business Wire

Business Wire
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

Ipsen Receives CHMP Negative Opinion for Palovarotene as a Treatment for Fibrodysplasia Ossificans Progressiva in E.U.27.1.2023 07:00:00 CET | Press release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended not to grant marketing authorization for investigational palovarotene as a treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). In the E.U. there are currently only symptomatic treatments for FOP, which do not reduce the formation of extra-skeletal bone in patients with the condition. Ipsen will be requesting a re-examination of the CHMP opinion, based on scientific data available from the existing palovarotene clinical trial program. FOP causes permanent and continuous new bone formation in soft and connective tissues, like muscles, tendons and ligaments, a process known as heterotopic ossification (HO).1 Once formed, it is irreversible.1 The average age of diagnosis is 5 years old2 and ultimately FOP shortens the median life expectancy to 56 years as untimely death is

Green Steel Technology Company Boston Metal Announces $120M Series C Financing Led by ArcelorMittal27.1.2023 06:01:00 CET | Press release

Boston Metal, a company developing technology to fully decarbonize steel production, today announced the $120 million first close of Series C fundraising led by multinational steel company, ArcelorMittal S.A. (NYSE: MT). Microsoft's Climate Innovation Fund and SiteGround Capital also joined as new investors in this round, alongside current investors. ArcelorMittal’s lead investment was made through its XCarb® Innovation Fund. Commenting, Aditya Mittal, CEO, ArcelorMittal, said, “In Boston Metal, we are investing in a team that has made impressive progress over a relatively short period of time, developing a technology that has exciting potential to revolutionize steelmaking. In our extensive discussions with them, we have been impressed by the passion and vision they have to contribute to the decarbonization of steelmaking. They are an exciting and welcome addition to the XCarb® Innovation Fund’s portfolio.” Boston Metal’s patented Molten Oxide Electrolysis (MOE) process is being comme

Toyota Tsusho, IIJ, NEC, and NTT Com Sign Contract with Uzbektelecom for Telecommunications Infrastructure Development Project27.1.2023 06:00:00 CET | Press release

Toyota Tsusho Corporation ("Toyota Tsusho"), Internet Initiative Japan Inc. ("IIJ"), NEC Corporation ("NEC"), and NTT Communications Corporation ("NTT Com") announced today the conclusion of a contract with Uzbektelecom, a state-owned telecommunications operator in Uzbekistan, for a telecommunications infrastructure development project ("the Project") to provide data center and telecommunications infrastructure for an advanced data communication system ("the System"). Installation of the System is scheduled to begin in 2023 and the sequential launch of operations is expected to significantly improve the communications environment of Uzbekistan. 1. Background In response to the rapidly growing data communication demand driven by the digitalization of various industries, Uzbekistan is expanding its telecommunications infrastructure aimed at issues such as improving communications quality and closing the digital divide between urban and rural areas. In accordance with this background, the

Bermuda Risk Summit 2023 – 27 January Last Chance to Secure Early Bird Rate26.1.2023 18:44:00 CET | Press release

Potential attendees of the BermudaBusinessDevelopmentAgency’s (BDA) second annual Bermuda Risk Summit, being held at the Hamilton Princess & Beach Club from March 6-8, are reminded the early bird registration price will end tomorrow, Friday, 27 January. Included in the early bird price are keynote breakfasts, networking breaks and lunches, an evening seaside soiree, and an island lunch cruise. Overseas guests should also act before midnight on Monday, February 6 to secure special hotel room rates starting at $359 (plus tax). From February 7, hotel room rates will increase significantly, or be completely sold out, due to limited availability. To book your room please call 1-441-295-3000 or the Global Reservations Centre on 1-800-441-1414. Alternatively, click hereto reserve your room online. Please use the booking code: ‘BermudaRisk’ to take advantage of the preferred rate. The Bermuda Risk Summit, which has the Association of Bermuda Insurers and Reinsurers (ABIR) and EY as headline sp

Verimatrix Secure Delivery Platform Marks Its First Year with Billions of Video Viewership Licenses Served26.1.2023 17:45:00 CET | Press release

Regulatory News: Verimatrix, (Euronext Paris: VMX) (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced its Verimatrix Secure Delivery Platform quickly reached billions of delivered video viewership licenses in less than a year since its launch. The company also debuts key enhancements that provide even greater value to media companies, content owners, streaming media providers and operators. As a single pane of glass experience, the Verimatrix platform secures enterprises by protecting and monitoring their content, applications and devices through a streamlined cloud-based solution that brings a highly noticeable combination of cost savings and efficiency while also maximizing agility for the content delivery process. Newly released enhancements include: Full Verimatrix XTD integration, including App Shield and threat monitoring – offering unmatched visibility into potentially dangerous enterprise threat blind spots Integration

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