Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Medicines Agency (EMA) has granted orphan drug designation for Tolero Pharmaceuticals' alvocidib to treat patients with acute myeloid leukemia (AML).
Subscribe to our email newsletter
The drug is being developed for the treatment of patients with relapsed/refractory and frontline intermediate or high-risk AML and is currently been evaluated in multiple Phase II clinical trials involving around 400 of these patients.
The company said that intermediate and high-risk AML patients are determined by a profile of clinical, cytogenetic and molecular features, and they have a poor prognosis due largely to the limited effectiveness of current therapeutic options.
Tolero chief executive officer David Bearss said: "The granting of orphan drug designation by the EMA for alvocidib underscores the great unmet medical need for patients with AML, many of whom experience limited effectiveness with current therapies.
"Alvocidib has demonstrated high response rates to date in patients with AML, and we look forward to initiating Phase 3 clinical trials this year."
Alvocidib is a potent small molecule inhibitor of cyclin-dependent kinases (CDKs), which are regulatory proteins that are critical to cellular replication and regulation of gene expression.