The California-based biotech has announced that J&J’s review of the data from two studies of its drug, imetelstat, warranted continued work in myelodysplastic syndromes and myelofibrosis.
In the first trial (IMerge), a data package and proposed trial design updates will be provided to the FDA. The second trial (IMbark) will continue unchanged to evaluate maturing efficacy and safety data, including an assessment of overall survival.
The Geron/J&J partnership dates back to 2014, when J&J's Janssen unit agreed to pay $35 million up front to collaborate on Geron's imetelstat, with up to $900 million more if the treatment hit development, regulatory and commercial goals.
Geron expects this Phase 3 stage of IMerge to be opened for patient enrollment in the fourth quarter of 2017.