Replies to post #155203 on Biotech Values

[DewDiligence]

It’s somewhat unsettling to see CTIC mentioned in a serious post :- )

[jq1234]

Pacrinitib 2nd MF ph3 trial: againt Jakafi

[It took at least 9 months to get SPA for this trial - see Message#155203]

PERSIST-2 is a 300 patient randomized, open-label, multi-center pivotal trial in patients with myelofibrosis whose platelet counts are <100,000/uL. The trial will evaluate pacritinib as compared to best available therapy, including approved JAK2 inhibitors that are dosed according to the product label for myelofibrosis patients with thrombocytopenia. Patients will be randomized (1:1:1) to receive 200 mg pacritinib twice daily, 400 mg pacritinib once daily or best available therapy. The agreed upon co-primary endpoints are the percentage of patients achieving a 35 percent or greater reduction in spleen volume measured by MRI or CT at 24 weeks of treatment and the percentage of patients achieving a Total Symptom Score (TSS) reduction of 50 percent or greater using six key symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MF-SAF) diary.

http://investors.celltherapeutics.com/phoenix.zhtml?c=92775&p=irol-newsArticle&ID=1861837&highlight=


The previous ph3 was similar Jakafi ph3:

PERSIST-1 is a multicenter, randomized, controlled Phase 3 trial comparing the efficacy and safety of pacritinib with that of best available therapy in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. A total of 270 eligible patients will be randomized 2:1 to receive either pacritinib 400 mg taken orally, once daily or the best available therapy. Best available therapy includes any physician-selected treatment with the exclusion of JAK inhibitors. There will be no exclusion by patient platelet count. The primary endpoint will be the percentage of patients achieving a = 35% reduction in spleen volume measured by MRI or CT at 24 weeks of treatment. The trial is expected to enroll patients at clinical sites in Europe, Australia and the United States.

http://investors.celltherapeutics.com/phoenix.zhtml?c=92775&p=irol-newsArticle&ID=1772683&highlight=