Alla Chem, LLC Announces Initiation of Phase I Clinical Studies of ONC1-13B, a New Effective Anti-Androgen for the Treatment of Prostate Cancers

Hallandale Beach, Fl –May 14, 2014 — Alla Chem, 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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