Date: 2016-11-10
Type of information: discontinuation of development
phase: 3
Announcement: discontinuation of development
Company: OncoGenex Pharmaceuticals (USA - WA)
Product: custirsen
Action
mechanism: antisense oligonucleotide. Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration. By inhibiting clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On November 10, 2016, OncoGenex Pharmaceuticals announced its third quarter 2016 financial results. * On October 13, 2016, OncoGenex Pharmaceuticals announced results from the final analysis of the Phase 3 ENSPIRIT trial of custirsen in patients whose non-small cell lung cancer (NSCLC) has progressed following initial treatments. The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with docetaxel compared to docetaxel alone. The median overall survival for the custirsen arm was 9.0 months versus 7.9 months for the control arm with a hazard ratio of 0.915 (one-sided p=0.178). Safety results were consistent with those observed in previous trials of custirsen in combination with chemotherapy. "Following the negative results of previous custirsen trials, an early final analysis of the ENSPIRIT trial was conducted in an effort to conserve capital and extend our cash runway," said Scott Cormack , President and CEO of OncoGenex. "We will continue to take appropriate steps to realize the most value for our shareholders once we receive the results of our apatorsen Phase 2 Borealis-2 bladder cancer trial which are expected by the end of October." OncoGenex is continuing to work with MTS Health Partners who has been advising the company in the exploration of strategic alternatives since mid-August.
The company also announced it has discontinued the development of its custirsen program after the AFFINITY and ENSPIRIT Phase 3 clinical trials failed to meet their primary endpoints.
