A recent announcement from OncoGenex Pharmaceuticals Inc. declares the company executed an initial understanding with Teva Pharmaceutical Industries Ltd. to regain the rights for custirsen, the investigational compound that is currently undergoing a Phase 3 trial for lung and prostate cancer. This results form the end of the collaboration between OncoGenex and Teva, which took place back in 2009.
The initial understanding between the two parties states that once the final agreement is set, Teva will pay $27 million to OncoGenex, allowing it to take full responsibility concerning all custirsen related expenses, including those related to the Enspirit trial’s regulatory activities that Teva is currently managing and manufacturing.
OncoGenex hopes that the payment received from Teva will allow the company to achieve crucial conclusions and results from the Affinity trial along with the continuation of the Enspirit trial.
Scott Cormack, CEO and President of OncoGenex said in a press release, “Teva’s strategic focus has shifted away from oncology research and development. However, OncoGenex remains committed to the continued investigation of custirsen, particularly in patients who have advancing disease despite previous treatments. This agreement provides OncoGenex with greater control of custirsen’s development, including the modification of the enspirit statistical analysis plan to involve a more rigorous second interim futility analysis to be completed in the second quarter of 2015 that, if passed, would enable the trial to continue with a smaller enrollment requirement, increased confidence in success and shorter time to regulatory submission.”
The $27 million payment should allow the conclusion of the Affinity trial, with complete data analysis by the end of 2015 or beginning of 2016, along with the continuation and conclusion of the Enspirit trial in the first half of 2015. Furthermore, this sum should allow the achievement of important apatorsen clinical goals, such as completing patient enrolment in the Borealis-2 trial and assure data from the Rainier and Spruce clinical trials.
According to the American Lung Association, about 159,260 Americans died from lung cancer in the past year, representing 27 percent of all cancer-related deaths. Due to the high prevalence of this malignancy, the importance of this agreement becomes clear, since it will allow completion of several major clinical studies with important practical outcomes.