SYK Atalydd Tavalisse (fatantinib) Astudiaeth Cam 3 yn Japan wedi Llwyddo!

Yn ddiweddar, cyhoeddodd Rigel Pharmaceuticals fod ei bartner Kissei Pharmaceuticals wedi rhyddhau canlyniadau rheng flaen cadarnhaol o astudiaeth glinigol Cam 3 a gynhaliwyd yn Japan. Mae'r astudiaeth yn gwerthuso Tavalisse (fostamatinib disodium hexahydrate) ar gyfer trin cleifion sy'n oedolion â thrombocytopenia imiwnedd cronig (ITP).

The results of this phase 3 clinical study (n=34) showed that the proportion of patients in the Tavalisse treatment group who achieved a stable platelet response was significantly higher than that in the placebo group. A stable platelet response is defined as: in the last 6 planned visits during the 14-24 week of treatment, at least 4 blood platelet counts are ≥50,000 platelets/μL. In this study, the safety of Tavalisse was consistent with other clinical trials, and no new or abnormal safety issues were found.

Ym mis Hydref 2018, llofnododd Rigel a Kissei drwydded unigryw a chytundeb cyflenwi i ddatblygu'r holl arwyddion presennol a phosibl o fostamatinib yn Japan, Tsieina a De Korea. Yn yr Unol Daleithiau, cymeradwywyd fostamatinib ym mis Ebrill 2018 a'i farchnata o dan yr enw masnach Tavalisse ar gyfer trin cleifion sy'n oedolion ag ITP cronig nad ydynt wedi ymateb yn ddigonol i driniaethau blaenorol.

Tavalisse cynhwysion actif fferyllol

Mae Tavalisse yn atalydd tyrosine kinase dueg geg (SYK), sy'n mynd i'r afael ag achosion hunanimiwn sylfaenol y clefyd trwy atal dinistrio platennau, gan ddarparu opsiwn triniaeth newydd pwysig i gleifion sy'n oedolion ag ITP cronig.

Dr. Wolfgang Dummer, Executive Vice President and Chief Medical Officer of Rigel, said: "These Phase 3 research results add a lot of evidence to prove that fostamatinib may provide meaningful benefits for patients with ITP. Fostamatinib has a unique mechanism of action that addresses ITP by preventing platelet destruction. Potential autoimmune causes. We are also continuing to evaluate the potential of fostamatinib to treat warm antibody autoimmune hemolytic anemia (wAIHA), another rare blood disease in which the immune system destroys blood cells."