CTI BioPharma’s Pacritinib Meets One Co-Primary Endpoint, Just Misses Another, In PERSIST-2

The US company is encouraged by top-line efficacy Phase III results showing pacritinib was effective in high-risk myelofibrosis patients with low platelet counts, and has said it is working with the FDA to lift the clinical hold imposed earlier this year because of side-effect concerns.

CTI BioPharma Corp. has been able to analyze top-line efficacy results from around a third of patients with myelofibrosis and thrombocytopenia enrolled in the PERSIST-2 Phase III study, treated before the FDA-imposed clinical hold came into effect in February, that show pacritinib met one of the co-primary endpoints of the study, and narrowly missed meeting the second.

The analysis gives some encouragement to the Seattle, Washington-based company that has been under a cloud since the FDA issued a full clinical hold on pacritinib, an investigational oral JAK2/FLT3 inhibitor, in February 2016 because of concerns about excess mortality and other adverse events, including intracranial

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from R&D

In Brief: Tourmaline Reports Positive Topline Phase II Results for Pacibekitug In CKD

 

Based on first positive results for any quarterly IL-6 inhibitor, company plans to initiate Phase III cardiovascular outcomes trial.

Boehringer’s Next Generation IPF Drug Underwhelms

 

The company hoped its follow-up to blockbuster Ofev could clearly improve efficacy and safety benefits, but the full Phase III results from nerandomilast’s FIBRONEER-IPF fall short of a slam dunk.

Affimed’s ASCO ‘Hail Mary’ As Survival Chances Slim

 
• By 

The German biotech has been forced into insolvency and NASDAQ suspension.

In Brief: Essence Raises Ionis Tryngolza Hypertriglyceridemia Filing Hopes

 

Tryngolza has met endpoints in a moderate hypertriglyceridemia trial. Positive results in severe disease in Q3 could allow for a filing for a broader patient population than its currently approved indication of familial chylomicronemia syndrome.

More from Scrip

HHS Intensifies Pressure On Pharma With MFN Pricing Benchmark

 

The Trump administration released more details on “most favored nation” price targets drug companies are expected to apply to US drug prices.

Asia Deal Watch: Lilly Partners With Rznomics On Hearing Loss

 

Plus deals involving Minghui/Qilu, LENZ/Lotus, Amicus/Dimerix, Sanofi/Dr. Reddy’s, Henlius/Lotus, Apnimed/Desitin, Formosa/Saval, DAAN/GC Cell, VelaVigo/Ollin and Sol-Gel/Mayne.

Boehringer’s Next Generation IPF Drug Underwhelms

 

The company hoped its follow-up to blockbuster Ofev could clearly improve efficacy and safety benefits, but the full Phase III results from nerandomilast’s FIBRONEER-IPF fall short of a slam dunk.