All Topics → Forum: Clinical Trials, Research News, Podcasts, Study Results → Topic: Reolysin Phase II trial 2X OS for patients with P53 mutation
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Posted on: Jun 19, 2017 11:07AM
The results show patients with mutated p53 metastatic breast cancer that were treated with REOLYSIN in combination with paclitaxel (n=30) had a median OS of 20.9 months versus 10.4 months (n=31) in patients treated only with paclitaxel. Without P53 mutation overall survival increased to 17.4 months.
The company, Oncolytics, received Fast Track FDA status.
In July at FDA end of Phase II meeting Oncolytics will ask for outright approval for Reolysin.
I have Colon Cancer Stage IV and believe that Reolysin will work for me since I have mutated P53. If it is approved for mBC I could use it off label so I have an interest in the outcome. This is the way cancer will be treated in the future, by mutations, biomarkers, instead of by cancer type.
The side affects of Reolysin are almost nil with some patients getting a fever that last a median of six hours.
If Reolysin is not approved now the FDA will ask for a Phase III trial that will take years and a lot of people will not get the benefit I being one of them.