OncoEthix presents Phase I interim results for novel anticancer compound OTX015 at AACR 2014

OncoEthix, the Swiss-based specialist in oncology drug development, today announced that the interim results from its ongoing Phase I clinical trial of OTX015, in patients with hematologic malignancies, were presented at the annual American Association of Cancer Research (AACR) meeting in San Diego. The interim data demonstrates meaningful clinical activity and excellent tolerance for patients on a daily oral dose of OTX015, a novel first-in-class synthetic small molecule inhibitor of BET bromodomain proteins 2/3/4. These proteins are considered potential cancer targets, as they play a pivotal role in regulating the transcription of growth-promoting and cell cycle regulators, especially c-MYC.

Following on from Phase Ia trials in healthy volunteers, the primary objective of the Phase Ib, multi-centre, clinical study was to determine the maximum tolerated dose (MTD) of OTX015 that could be administered to patients with acute leukaemia or other hematologic malignancies. Patients were dosed at 10, 20, 40, or 80 mg once daily (QD) or 40 mg twice daily (BD). This two strata Phase 1 study, which started in January 2013, was also designed to provide further safety, pharmacokinetic and pharmacodynamic data.

The OTX015 interim Phase Ib results showed linear pharmacokinetics and excellent tolerance in both acute leukaemia and patients with other hematologic malignancies at once daily 80 mg doses. For acute leukaemia patients the MTD was not reached at 80 mg QD or 40 mg BID. Likewise, the MTD was not reached at 80 mg QD for patients with other hematologic malignancies, but in contrast this was exceeded at 40 mg BID in these patients, suggesting schedule-dependent toxicity.

“We are pleased by these positive interim Phase Ib results for our lead compound, OTX015.” said Dr Patrice Herait, CMO of OncoEthix. “We are now performing dose escalation studies and expanding the patient cohorts at our five investigational sites across Europe to complete this Phase I clinical study.”

Dr Esteban Cvitkovic, Founder and CSO of OncoEthix, added, “With these promising results we will continue to develop this new class of anticancer molecule, OTX015, for specific indications in acute leukaemia and other hematologic malignancies, as well as exploring its potential as a treatment for solid tumours.”