Zenith Announces Initiation of Phase 1b Clinical Combination Trial for ZEN-3694
CALGARY, Dec. 14, 2016 /PRNewswire/ - Zenith Capital Corp. ("Zenith" or the "Company") today announced that its wholly owned subsidiary, Zenith Epigenetics Ltd. ("Zenith Epigenetics"), has initiated a Phase 1b clinical trial in metastatic Castration Resistant Prostate Cancer ("mCRPC") patients, dosing ZEN-3694 in combination with enzalutamide. In this Phase 1b trial, Zenith Epigenetics will be evaluating the safety, pharmacokinetics, and efficacy of ZEN-3694 in combination with, enzalutamide (Xtandi) in mCRPC patients that have progressed on first-line standard-of-care anti-androgen therapy. The trial will encompass a dose escalation phase and an expansion phase, designed to potentially show early proof-of-concept. The trial also includes a broad translational program, measuring target modulation as well as evaluating potential pharmacodynamic biomarkers for identifying patients who may benefit the most from the combination treatment.
"We are excited to reach this second important milestone for Zenith Epigenetics and the development of ZEN-3694. There remains a significant unmet need and poor prognosis for mCRPC patients who have progressed on anti-androgen therapies. Recognizing the importance of combination treatment for bromodomain ("BET") inhibitors for these patients, places Zenith Epigenetics at the forefront of development of these novel epigenetic drugs for the treatment of metastatic Castration Resistant Prostate Cancer" stated Mr. Donald McCaffrey, President and Chief Executive Officer. "
Zenith Epigenetics continues to advance its single agent Phase 1 clinical trial with ZEN-3694, working with prominent clinical investigators and the Prostate Cancer Clinical Trial Consortium ("PCCTC") who collectively have been instrumental in developing leading drugs for the treatment of mCRPC, including enzalutamide and abiraterone (Xtandi and Zytiga respectively).
Zenith Epigenetics has also developed strong pre-clinical rationale for developing ZEN-3694 in other oncology indications which may be explored in future clinical programs.
Additional trial details and updates can be found at: www.clinicaltrials.gov.
About mCRPC
mCRPC is a major unmet medical need due to its widespread occurrence and incurable status. Current standard of care for this disease are androgen receptor (AR) antagonists (enzalutamide) or androgen synthesis inhibitors (abiraterone). While most patients display an initial response to these agents, eventually even responding patients develop drug resistance via various mechanisms. There is currently no effective therapy for these patients. Recent pre-clinical evidence has shown that bromodomain (BET) inhibitors can be efficacious in mCRPC patients that are resistant to current therapies.
About Zenith
Zenith Capital Corp. is a biotechnology investment company. 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. Zenith Epigenetics Ltd.'s bromodomain (BET) inhibitors are being advanced in several oncology indications and have the potential to impact multiple additional diseases as well. The lead compound, ZEN-3694, is in clinical development for mCRPC.
SOURCE Zenith Capital Corp.
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