Baxter and CTI Claim a Win in PhIII Blood Cancer Study
Monday, March 9, 2015
Source: Fierce Biotech
Some 15 months after Baxter ($BAX) signed on with CTI BioPharma--then called Cell Therapeutics--on a late-stage therapy for myelofibrosis called pacritinib, the partners say they have come up with statistically significant topline data on its effectiveness and safety. But after the biotech's many twists and turns taken trying to advance pixantrone over the years, a few longtime observers preferred to wait and see the actual numbers before deciding for themselves.
CTI ($CTIC) got $60 million upfront and a promise of $112 million in development milestones from Baxter back in the fall of 2013 for their partnership, gaining some badly needed credibility for itself after the FDA scorned pixantrone and the biotech's failed attempt to win an approval for lymphoma. This morning investigators say that their blood cancer drug produced a statistically significant response in reduction of spleen volume, even regardless of low initial platelet counts, but said the details will be held back for a scientific conference. The primary endpoint was a reduction of 35% or more in spleen volume compared with best available therapy--aside from JAK2 inhibitors.
There was also a reduction in transfusion dependence in a group of 50 patients. On the safety front three patients stopped therapy and 9 more had to have their doses reduced due to diarrhea, though the researchers say that the safety profile looked "consistent" with Phase II.