Geron managed to sorely disappoint investors this morning, watching its share price $GERN plunge 27% after investigators at J&J cut loose a low dose of their partnered cancer drug imetelstat and suspended enrollment on the high end until it gets a better look at more mature data from patients who have already been treated.
The company says that the low 4.7 mg/kg dosing arm registered a disappointing response, adding that those patients would be given a chance to transfer to the 9.4 mg/kg dose.
The company statement included this on the high dose:
In the 9.4 mg/kg dosing arm, even though at the week 12 data assessment an insufficient number of patients met the protocol defined interim criteria, this arm warrants further investigation because encouraging trends in the efficacy data were observed. Patients already enrolled in this arm may continue to receive imetelstat. New enrollment in this arm will be suspended while the trial continues in order to obtain additional and more mature data that includes a longer follow-up of patients at 24 weeks, consistent with the co-primary efficacy endpoints. The number of patients enrolled to date is expected to be sufficient to inform potential future development of this dose.
J&J, Geron reports, is planning another assessment in Q2 2017, reserving the right to continue the study or simply shut it down.
Things had begun to look better for Geron back in 2014, when the FDA lifted clinical holds on imetelstat and J&J stepped in with a deal to split R&D costs and pay up to $935 million in fees and milestones.
Only $35 million of that package, though, was provided as an upfront.
Geron has been looking for therapeutic gold for more than 20 years, but punted its ambitions in stem cells back in 2011 so it could rebrand itself as a cancer company. Almost all of its eggs, though, are in the imetelstat basket.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,700+ biopharma pros who read Endpoints News by email every day.Free Subscription