On December 22, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other technologies for targeting and treating cancer, reported that its independent Data Monitoring Committee (DMC) has completed review of an interim analysis of the Company’s ongoing Phase 3 clinical trial of its PSMA-targeted SPECT/CT imaging agent candidate, 99mTc-MIP-1404 (1404), and recommended that the trial continue (Press release, Progenics Pharmaceuticals, DEC 22, 2016, View Source [SID1234517186]).
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"The growing acceptance of active surveillance among men with lower-grade prostate cancer presents a significant opportunity for 1404 to enable clinicians and patients to accurately and non-invasively visualize and manage their disease," said Mark Baker, Chief Executive Officer of Progenics. "We are pleased that the DMC has determined that the trial should continue. The decision to undergo more invasive treatments, such as radical prostatectomy, is a difficult one for both patients and their families given the severity of potential side effects, and we look forward to the completion of this study as we work to introduce new and effective surveillance options."
This Phase 3 study enrolls patients in the U.S. and Canada with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. The study is designed to evaluate the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and sensitivity to identify patients with clinically significant disease.
Approximately 190 of a planned 450 patients have been enrolled in the trial to date.
A modification to the trial protocol has been proposed by the Company and agreed to by the U.S. Food and Drug Administration (FDA). The change permits patients with low to very low grade prostate cancer to participate in the trial without having to undergo a radical prostatectomy. In these patients, histopathology of tissues obtained from biopsies of those patients (rather than from radical prostatectomies) will be used as the truth standard in determining the specificity and sensitivity of 1404 imaging. The modification of the protocol was proposed in response to a lower percentage of patients enrolled in the trial having clinically insignificant disease, which is likely due to the emerging trend for more men with low-grade disease to use active surveillance for the management of their prostate cancer rather than undergo radical prostatectomy. The Company plans to monitor enrollment of patients based on the prevalence of clinical significant disease before determining whether any adjustment is needed to the sample size of the study.
Mr. Baker continued, "Our modification to the protocol reflects emerging trends among men with low grade disease to increasingly favor the use of active surveillance versus more aggressive measures, consistent with treatment guidelines. We believe that this shift underscores the potential for agents such as 1404 to address the growing active surveillance market. In addition, we expect that the protocol modification will allow for a better balance in the enrollment of subjects with clinically significant disease versus those with indolent disease, with the goal of evaluating the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and the sensitivity of 1404 imaging to identify patients with clinically significant disease."