Zenith Epigenetics Announces Clinical Advancement of ZEN-3694
CALGARY, Alberta, Dec. 19, 2019 (GLOBE NEWSWIRE) -- Zenith Epigenetics Ltd. (“Zenith” or the “Company”) announced today the significant clinical advances of ZEN-3694, the Company’s lead compound being developed for epigenetic combination therapies in oncology.
“I am very pleased to report these significant advances in our ZEN-3694 clinical program,” said Donald McCaffrey, Chief Executive Officer of Zenith. “It is clear that ZEN-3694 is safe and active, as shown by clinical data in multiple indications. The US FDA has given us positive feedback on potential development paths for our metastatic castration resistant prostate cancer program, including the potential for an accelerated approval. In the meantime, we continue to evaluate a number of scenarios for progressing ZEN-3694 towards registration-enabling studies.”
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Zenith has completed the Phase 1b/2, ZEN-3694 + enzalutamide combination trial in mCRPC patients who had progressed on an androgen receptor (AR) antagonist, abiraterone and/or enzalutamide. In these poor prognosis patients, where there is no standard of care, the data show that ZEN-3694 + enzalutamide provided a significant and meaningful radiographic progression-free survival benefit of approximately 44 weeks compared to approximately 24 weeks for patients receiving only the AR antagonist. Furthermore, the benefit was particularly significant in low AR signaling and/or AR independent tumors, which do not respond to AR antagonist monotherapy.
Detailed results of the Phase 1b/2 mCRPC study are expected to be presented at future conferences and / or in future publications; additional information to come.
Triple Negative Breast Cancer (TNBC) – Collaboration with Pfizer
The TNBC collaboration study, combining ZEN-3694 with Pfizer’s talazoparib, a poly ADP ribose polymerase inhibitor (PARPi), is progressing well with clinical activity in some patients dosed to date. As a result, Zenith is exploring the potential to expand the study to include additional tumor types with significant unmet need that are expected to respond to ZEN-3694 + talazoparib. Details on the TNBC study expansion is expected to be made available in H1 2020.
Zenith Capital Corp. is a biotechnology investment company originally spun out of Resverlogix Corp. (TSX: RVX) in 2013. Zenith Epigenetics Ltd., a wholly-owned subsidiary of Zenith Capital Corp., is a clinical stage biotechnology company focused on the discovery and development of novel therapeutics for the treatment of cancer and other disorders with significant unmet medical need. Zenith Epigenetics is developing various novel combinations of BET inhibitors with other targeted agents. The lead compound, ZEN-3694, is in clinical development for metastatic Castration Resistant Prostate Cancer (“mCRPC”) and Triple Negative Breast Cancer.
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This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. In particular, this news release includes forward looking information relating to comments made by the US FDA on potential development paths for ZEN-3694 in the Company’s mCRPC program including the potential for accelerated approval, the Company’s plans to progress ZEN-3694 towards registration-enabling studies, the clinical advancement of ZEN-3694 in the Company’s mCRPC and TNBC programs, the potential to expand indications in the TNBC program with Pfizer, the presentation of ZEN-3694 data at future conferences and publications and the safe, therapeutic potential of ZEN-3694 in combination with standard of care therapies used in oncology. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. Zenith disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.