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December 4, 2012
09:12 EDTRNNSabby Management reports 9.61% passive stake in Rexahn
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February 8, 2016
09:06 EDTRNNRexahn completes stage 1, begins enrollment in stage 2 Archexin Phase IIa trial
Rexahn Pharmaceuticals announced that it has identified a maximum tolerated dose and completed Stage 1 of a dose-escalation Phase IIa clinical trial of Archexin in combination with everolimus, a widely used chemotherapy drug, in patients with metastatic renal cell carcinoma. In addition, Rexahn also announced that it has commenced enrollment in Stage 2 of the Phase IIa Archexin clinical trial to evaluate safety and efficacy of the combination. "Data from the first phase of the Archexin clinical trial have yielded exciting preliminary clinical findings suggesting that Archexin, in combination with everolimus, showed evidence of a potential dose and time-dependent clinical benefit in patients with advanced, metastatic kidney cancer," said Dr. Ely Benaim, Chief Medical Officer for Rexahn. "The data from Stage 1, which were recently presented at the American Society for Clinical Oncology Genitourinary Cancers Symposium, show three patients who have experienced stable disease for 383, 191, and 122 days, respectively, and two patients who experienced a tumor burden reduction of 16% and 36%, respectively as of January 6, 2016." The results indicated that at the dose levels tested to date, Archexin appeared to be safe and well tolerated. The most commonly reported adverse event in patients taking both Archexin and everolimus is thrombocytopenia. To date, no adverse events have been dose limiting. Stage 2 of the Phase IIa clinical study - which has commenced enrolling patients, is a randomized, open-label, two-arm dose expansion study of Archexin in combination with everolimus, versus everolimus alone to determine safety and efficacy of the combination. The trial is anticipated to enroll up to 30 RCC patients who will be randomized to receive either Archexin in combination with everolimus, or everolimus alone, in a ratio of 2:1. The maximum tolerated dose of 250 mg/m2/day of Archexin - identified in Stage 1, will be administered along with 10 mg of everolimus versus 10 mg everolimus alone. The primary endpoint of Stage 2 is the percentage of progression free patients following eight cycles of therapy. Patients are scanned for the assessment of tumor progression after every 2 cycles of therapy. Secondary endpoints include pharmacokinetic profile, incidence of adverse events, changes in clinical laboratory tests and vital signs over time, tumor response, duration of response, time to response, and response rate. Exploratory endpoints include blood levels of AKT pathway biomarkers, tumor apoptosis biomarkers, or other relevant biomarkers.

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