Solasia kondigt aan dat patiëntenregistratie het beoogde aantal gevallen voor Darinaparsin fase 2 cruciale studie voor T-cellymfoom heeft bereikt
TOKIO-(BUSINESS WIRE)- Solasia Pharma K.K. (TSE:4597, hoofdkantoor: Tokio, President & CEO: Yoshihihiro Arai, hierna “Solasia”), een gespecialiseerd farmaceutisch bedrijf gevestigd in Azië, kondigde vandaag aan dat de patiëntenregistratie het beoogde aantal gevallen voor de Darinaparsin Fase 2 studie heeft bereikt.
De Fase 2 studie wordt uitgevoerd als een multinationale, multicentrische, enkelarmige, open-label, niet-gerandomiseerde studie om de werkzaamheid en veiligheid van darinaparsinemonotherapie bij recidiverende of refractaire patiënten met perifere T-cellymfoom (hierna “PTCL”) in Japan, Zuid-Korea, Taiwan en Hongkong te evalueren. Patiënten zullen maximaal 6 cycli van darinaparsine ontvangen, en de werkzaamheid zal worden gemeten met tumorreactie als primaire uitkomstmaatstaf.
Deze studie is een centrale (eind)studie voor PTCL gebaseerd op voorafgaand overleg met de autoriteit. Op dit moment verwacht Solasia de studieresultaten in 2020 bekend te maken.
Solasia Announces Patient Registration Reached Target Number of Cases for Darinaparsin Phase 2 Pivotal Study for T-Cell Lymphoma
TOKYO–(BUSINESS WIRE)– Solasia Pharma K.K. (TSE:4597, Headquarters: Tokyo, President & CEO: Yoshihiro Arai, hereinafter “Solasia”), a specialty pharmaceutical company based in Asia, today announced that patient registration reached the target number of cases for the darinaparsin Phase 2 study.
The Phase 2 study is being 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 peripheral T-cell lymphoma (hereinafter “PTCL”) in Japan, South Korea, Taiwan and Hong Kong. Patients would receive maximum 6 cycles of darinaparsin, and the efficacy would be measured with tumor response as primary outcome measure.
This study is a pivotal (final) study for PTCL based on prior consultation with the authority. At present, Solasia expects to announce the study results in 2020.
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. Going forward, Solasia will actively seek licensing partners outside of Asia.
Through the active development of darinaparsin, Solasia will continue to strive for providing new treatment option for PTCL patients. Furthermore, Solasia will continue to pursuit the possibility for developing other indications in cancer field following PTCL.
About darinaparsin
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 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/20190917005574/en/
Contacts
Solasia Pharma K.K.
Rie Toyoda, Public Relations and Investor Relations,
Tel. +81 3 5843 8049
Check out our twitter: @NewsNovumpr