CTI BioPharma Reports Mixed Pacritinib Study Data, Stock Up

CTI BioPharma Corp.’s (NASDAQ:CTIC) shares gained 14.9% after the company announced top-line results from a phase III study (PERSIST-2) on pacritinib, wherein the study met one of the co-primary endpoints.

The PERSIST-2 study evaluated pacritinib in comparison to the best available therapy (BAT (LON:BATS)), including Incyte Corporation’s (NASDAQ:INCY) Jakafi (ruxolitinib), for the treatment of myelofibrosis in patients whose platelet counts were less than 100,000 per microliter.

Results from the study demonstrated a statistically significant improvement in spleen volume reduction (SVR) in patients treated with pacritinib, thereby meeting one of the co-primary endpoints. Although the study failed to meet the co-primary endpoint of greater than 50% reduction in Total Symptom Score (TSS), its preliminary analysis approached marginal significance in comparison with BAT.

The most common adverse events associated with pacritinib were diarrhea, nausea and vomiting, which were found to be generally manageable.

Note that in Aug 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high-risk myelofibrosis, including but not limited to patients with disease-related thrombocytopenia, patients experiencing treatment-emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on other JAK2 therapy.

We remind investors that in Feb 2016, the FDA had placed the company’s Investigational New Drug (IND) application for pacritinib on a full clinical hold. The company is currently working with the FDA to seek to address their recommendations for getting pacritinib off the hold.

CTI BioPharma currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Anika Therapeutics Inc. (NASDAQ:ANIK) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . Both the stocks sport a Zacks Rank #1 (Strong Buy).

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