Alla Chem Announces Initiation Of Phase I Clinical Studies Of ONC1-13B, A New Effective Anti-Androgen For The Treatment Of Prostate Cancers
May 14, 2014 — AllaChem, LLC announces initiation of Phase 1 clinical study of ONC1-13B in patients with metastatic Castration Resistant Prostate Cancer (mCRPC). ONC1-13B is a next in-class small molecule anti-androgen for the treatment of Prostate Cancers. In preclinical studies, it was shown that ONC1-13B efficiently inhibits androgen receptor signaling pathway by preventing binding to androgens, blocking its nuclear translocation and transcriptional co-activator complex formation (A. V. Ivachtchenko et al. Preclinical Development of ONC1-13B, Novel Antiandrogen for Prostate Cancer Treatment. J. Cancer 2014, 5(2), 133-142).
The Phase 1 open-label, dose-escalation clinical study will evaluate the safety, tolerability and pharmacokinetics of ONC1-13B in patients with mCPRC. Pharmacokinetics will be investigated after single and multiple (for 3 weeks) doses. To determine maximal tolerated dose ONC1-13B will be administered once daily in doses up to 320 mg (40, 80, 160, 240 and 320 mg/day) up to 72 weeks. Up to 40 patients will be included in the trial. Other endpoints include assessment of effect of ONC1-13B on the disease progression (according to the RECIST 1.1criteria) and on PSA (prostate-specific antigen) expression.
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