Date: 2017-01-09
Type of
information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Roche (Switzerland)
Product: RG6016
Action
mechanism:
- enzyme inhibitor/LSD1 inhibitor. RG6016, previously known as ORY-1001, is a highly potent and selective oral epigenetic inhibitor that modulates LSD1, a histone demethylase that removes (“erases”) signals in the histone, provoking changes in the reading context of the chromosome and turning off genes. Aberrant “erasing” activity may lead to disease. LSD1 has been related with several malignancies such as solid tumours and haematological diseases. In Leukemia RG6016 affects AML stem cells, a sub-population of cancer cells that has been proposed to be responsible for frequent relapses of the disease. RG6016 also significantly
reduces tumour cell load and increases survival time in mouse models of acute lymphoblastic leukaemia.
- Roche licensed in the global development and commercial rights to RG6016, previously known as ORY-1001 in 2014. After completion of the first trial in acute leukemia, sponsored by Oryzon and currently in the process of final data analysis and closing, Roche is solely responsible for the further clinical development of RG6016. Preliminary efficacy data obtained in the Phase IIA arm of this first clinical study in Leukemia was presented at the ASH meeting in San Diego.
Disease: small cell lung cancer
Therapeutic
area: Cancer - Oncology
Country: Canada, Denmark, France, Spain
Trial
details: This Phase I, open-label, multicenter study is designed to assess the safety and tolerability of RG6016 in participants with relapsed extensive-stage disease small cell lung cancer. This dose escalation and expansion study plans to determine the maximum tolerated dose and/or optimal biological dose as a recommended Phase 2 dose for RG6016, based on the safety, tolerability, pharmacokinetic and pharmacodynamic profiles observed after oral administration of the drug. (NCT02913443)
Latest
news:
- • On January 9, 2017, Oryzon Genomics announced that the first patient has been treated in the Phase I study of RG6016, a LSD1 inhibitor, in small cell lung cancer (SCLC). This clinical trial is executed by Roche. Roche has started a dose finding and expansion study of RG6016 administered orally in participants with relapsed, extensive-stage disease small cell lung cancer (ED SCLC). The study initially will be conducted in several European countries and Canada.
Is
general: Yes
