LAUSANNE, Switzerland--(BUSINESS WIRE)--Oncoethix, the Swiss-based specialist in oncology drug development, today announced that the first patient has been enrolled in an international, open-label, non-randomized, multicenter Phase 1b trial of OTX015 in advanced solid tumors. The trial will be coordinated by Dr Lillian Siu, MD, of the Princess Margaret Hospital, Toronto, Canada, who is Professor of Medicine at the University of Toronto, and Director of the Phase 1 program.
The trial seeks to enrol up to 98 patients across seven centers in five countries (Belgium, Canada, France, Spain and Switzerland), including the Institut Gustave-Roussy in Paris, where Professor Jean-Charles Soria is the Principal investigator. Three patients have already been enrolled. The trial aims to determine, in a first step, the suitability of five solid tumor indications under investigation (BRD-NUT Midline Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer harbouring a rearrangement ALK gene/fusion protein or KRAS mutation, and Castrate-Resistant Prostate Cancer and Pancreatic Ductal Carcinoma) to be progressed into the Phase 2a part of the trial.
Dr Esteban Cvitkovic, MD, Founder and Chief Scientific Officer, Oncoethix, commented: “This multicenter Phase 1b trial is an important step for OTX015, as it will provide key safety and efficacy data in several solid tumor types, after having characterized its single agent safety and activity profile in the Acute Leukemias and Lymphomas in Phase 1 trial (OTX015_104). The solid tumor indications approach selected for OXT015 is based on compelling data from our own preclinical pharmacology program. We have also initiated a multicentric (France, Switzerland) Phase 2a trial in recurrent glioma.”
OTX015 is 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.
Coordinating investigator Dr Lillian Siu commented: “OTX015 is a promising drug that has shown outstanding early results in hematologic cancer studies and we are delighted to have commenced the solid tumor trial at the Princess Margaret Cancer Centre in Canada.”
Bertrand Damour, Chief Executive Officer at Oncoethix, added “We believe that OTX015 has the potential to be an important new drug across a number of advanced solid tumors and the start of the Phase 1b is a key milestone for the Company. We are also ahead of schedule in our hematologic cancer program and will be releasing further data from this program at NCI/EORTC/AACR in November and the American Society of Hematology in December.”
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About Oncoethix
Founded in 2009, Oncoethix is a Swiss-based privately held biotechnology Company that is developing a small portfolio of oncology drug candidates. The Company’s lead product, OTX015, is an orally administered synthetic small molecule targeted to BET bromodomain proteins 2/3/4. OTX015 was in-licensed from Mitsubishi Tanabe Pharma Corporation in March 2012 following completion of Phase 1 clinical studies in healthy volunteers.
Oncoethix has raised a total of 28 Million CHF (~US$30 Million) to date: investors include Index Ventures, Endeavour Vision, SV Life Sciences and Edmond de Rothschild Investment Partners.
For more information please see: www.oncoethix.com
About the trial
The primary objective of the Phase 1b trial is to determine the maximal tolerated dose (MTD) of OTX015 administered orally to patients with selected advanced solid tumors. In addition, the trial will assess the safety profile, characterize the pharmacokinetic parameters and determine the antitumor activity of OTX015 in selected advanced solid tumors.
The trial will be performed in two parts, dose escalation and expansion. In 48 patients, dose escalation to the MTD will be evaluated in two regimens in parallel. In first regimen patients will receive oral OTX015 once daily for 21 consecutive days and, in the second regimen, they will receive it once daily on days 1 to 7 and this will be repeated every three weeks (21-day cycles; 1 week on/2 weeks off). The expansion part of the study will determine the efficacy of OTX015 in 50 patients in the five indications.
For more information on the Advanced Solid Tumors trial please see:
https://clinicaltrials.gov/ct2/show/NCT02259114?term=OTX015&rank=2
