- Citius Pharmaceuticals Inc. CTXR published the first results of the phase 3 trial of I/ONTAK (E7777) for persistent or recurrent cutaneous T-cell lymphoma (CTCL).
- I/ONTAK (E7777) is an IL-2-diphtheria toxin fusion protein. No new safety signal has been identified.
- Citius plans to file a marketing application with the FDA in 2H of 2022.
- The Independent Review Committee (IRC) determined that the study achieved an ORR of 36.2% (25 of 69 patients).
- An investigator efficacy analysis determined that the study achieved an ORR of 42.3% (30 of 71 patients).
- The median duration of response was 6.5 months (IRC) and 5.7 months (investigator).
- The clinical benefit ratio was observed at 49.3% (IRC) and 53.5% (investigator).
- Read more : FDA signs Citius Pharma’s Phase 2 trial with Halo-Lido in hemorrhoids.
- The FDA recently provided additional written comments indicating that their assessment of effectiveness will be based on the results of studies showing the lower limit of a 95% confidence interval to exceed a clinically relevant response rate.
- In the trial, the ORR should be supported by an adequate magnitude of duration of response and an acceptable risk/benefit ratio.
- Price action: CTXR shares are down 4.39% at $1.76 in the last check trading session on Wednesday.
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