Cell Therapeutics Reaches Agreement with FDA on SPA for Planned Pivotal Phase 3 Trial of Pacritinib in Myelofibrosis


Crypto Whales Are Loading Up — Are You?

New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


Cell Therapeutics (NASDAQ: CTIC) today announced that the company reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the planned pivotal Phase 3 clinical trial, known as the PERSIST-2 trial, evaluating pacritinib compared to best available therapy, including approved JAK2 inhibitors such as ruxolitinib, in patients with myelofibrosis whose platelet counts are <100,000 3 ul.  the spa is a written agreement between cti and the fda regarding design, endpoints planned statistical analysis approach of trial to be used in support potential new drug application (nda) submission. persist-2 second two phase clinical trials patients with myelofibrosis.  expects initiate fourth quarter 2013. "the worked closely us achieve during first cycle review protocol for pacritinib," stated james a. bianco, m.d., cti's president ceo.  "as result spa, which established on design regulatory approval, we expect that will

ENTER TO WIN $500 IN STOCK OR CRYPTO

Enter your email and you'll also get Benzinga's ultimate morning update AND a free $30 gift card and more!

See full press release

Crypto Whales Are Loading Up — Are You?

New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.


Posted In: NewsGuidanceContractsManagementGlobal