The Food and Drug Administration (FDA) has granted Orphan Drug Designation to zotiraciclib (Adastra Pharmaceuticals) for the treatment of glioma. 

Zotiraciclib  potently inhibits cyclin-dependent kinase 9 leading to apoptotic effect and modulation of the cell cycle. It blocks the activity of RNA polymerase II, leading to depletion of the key cancer cell survival protein, c-Myc.

A phase 1b, dose-finding clinical trial is underway, examining zotiraciclib in combination with temozolomide in treating recurrent malignant gliomas. The Company say they expect topline data from this trial in early 2020. There is also a separate phase 1b trial of zotiraciclib ongoing in elderly patients with IDH1R132H-non mutant and MGMT promoter-unmethylated anaplastic astrocytoma or glioblastoma.

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“Data from the ongoing clinical trials of zotiraciclib have been encouraging and are suggestive of a therapy that is safe and capable of eliciting clinical benefit in high grade gliomas,” said Scott Megaffin, CEO of Adastra. “We greatly look forward to reporting top-line data from the NCI Phase 1b study in early 2020.”

The Company believes that zotiraciclib offers the potential to target multiple cancer indications where Myc overexpression is a known factor, including gliomas and hepatocellular tumors.

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