Rexahn Pharmaceuticals, Inc. (REXN)

[MilesTeg]

Rexahn ASCO Abstract--RX-0201

Abstract:
Background: RX-0201 is a 20-mer oligonucleotide that is complementary to AKT-1 messenger ribonucleic acid (mRNA). The specificity of RX-0201-mediated effect on AKT-1 mRNA levels was examined in human renal cell carcinoma (von Hippel-Lindau protein-deficient renal cell carcinoma cell line) UMRC2 cells and resulted in a reduction of AKT-1 mRNA levels Methods: The current study is a proof of concept phase 1b/2, multicenter, open label study conducted in 2 stages. Stage 1 is an open-label, dose-escalation phase 1b study of RX-0201 administered in combination with everolimus. RX-0201 will be administered by a 24 hour continuous intravenous infusion for 14 days followed by 7 days of rest. It is expected that 250 mg/m2/day or a lower dose of RX-0201 will be identified as safe and well-tolerated when administered in combination with 10 mg of everolimus. The dose of RX-0201 identified in Stage 1 will be studied further in Stage 2 which is the randomized, open-label, 2-arm study of RX-0201 in combination with 10 mg of everolimus versus 10 mg of everolimus alone. Up to 8 cycles of study treatment will be permitted. Approximately 9 subjects are targeted to receive escalating doses of RX-0201 in combination with everolimus in Stage 1. The initial dose of RX-0201 is 125 mg/m2/day. In Stage 2 approximately 30 subjects are planned to be randomized in a 1:2 ratio (i.e., up to 10 subjects in the everolimus arm and up to 20 subjects in the everolimus/RX-0201 arm). Eligible subjects must have confirmed histologic or cytologic evidence of renal cancer with a clear cell component, measurable or evaluable disease as defined by RECIST, received at least 1 course of therapy with a VEGFR inhibitor and progressed within 6 months of planned first dose of on study treatment and received no more than 3 prior treatments of systemic renal cancer therapy. Radiological imaging for disease assessments will be according to RECIST ver. 1.1 Clinical trial information: NCT02089334

http://abstracts.asco.org/156/AbstView_156_151541.html