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news.YM BioSciences has recruited first patients in a Phase II trial to evaluate CYT387 administered twice-daily (BID) for the treatment of myelofibrosis.
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The trial aims to investigate the safety and tolerability of YM’s JAK1/JAK2 inhibitor, as well as its efficacy in reducing spleen size, improving constitutional symptoms and reducing transfusion dependence in patients with myelofibrosis.
In the BID trial, spleen size will be evaluated both by palpation and by magnetic resonance imaging (MRI) for all patients enrolled.
YM president and CEO Nick Glover said the favorable safety profile of CYT387 observed to date provides them with the opportunity to acquire further safety and efficacy data for CYT387 at doses complementary to those evaluated in their ongoing 166 patient Phase I/II trial.
"Initial data from the BID trial will be used to further enhance our pivotal trial designs, and the substantial volume of patient data from the combined studies will be an important component of any future marketing application," Glover said.