US-based immuno-oncology firm TapImmune has amended the Phase II clinical trial of its therapeutic peptide vaccine TPIV200 following discussions with the US Food and Drug Administration (FDA).
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The trial will now include stage III and IV ovarian cancer patients who are in remission after receiving their first round of successful platinum-based chemotherapy.
Enrolment for this amended protocol has been started and expands the number of subjects planned to be recruited into the double-blind controlled trial to 120.
The trial is designed to evaluate the vaccine as a potential maintenance therapy to prevent disease recurrence following standard-of-care platinum-based chemotherapy.
Increased study size is intended to allow better assessment of the immunotherapy effect, as well as to obtain statistically significant efficacy data.
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By GlobalDataTapImmune Clinical Development head Dr Richard Kenney said: "Shifting our focus to earlier in the treatment cycle enables TapImmune to showcase the potential of our novel T-cell vaccine in a much larger patient population.
“Furthermore, should TPIV 200 demonstrate a significant benefit for these women in prolonging the time to disease recurrence, the company will be well positioned within the current treatment paradigm for ovarian cancer, which now includes the PARP inhibitor niraparib for treating patients with recurrent disease."
During a prior Phase I trial, TPIV200 was found to target the over-expressed folate receptor alpha protein and demonstrated sustained immune responses in ovarian cancer subjects.
With TPIV200, the firm intends to target the population of patients who are in their first remission after platinum therapy, as there is currently no approved therapeutic option available to prevent recurrence of the disease.
Image: TapImmune amends Phase II clinical trial to focus on a larger population of women. Photo: courtesy of PRNewsfoto / TapImmune.
