Replies to post #1900 on Rexahn Pharmaceuticals, Inc. (REXN)

[freshy]

Cool! By chance do you know aprox. date of Q1 finish?
(on or about?)

[8thwaste]

Based on the dosing timeline and previous PR date, we should be getting an update Tuesday or Wednesday of next week.

Rexahn Initiates Phase IIa Clinical Trial of Archexin® in Patients with Metastatic Renal Cell Carcinoma
FDA has Granted Orphan Drug Designation for Renal Cell Carcinoma

Rockville, MD, January 14, 2014 – Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company, announced today the initiation of a Phase IIa clinical proof-of-concept trial to study the safety and efficacy of Archexin® in patients with metastatic renal cell carcinoma (RCC). Archexin was previously granted Orphan Drug Designation for the RCC indication.

The Phase IIa Archexin proof-of-concept clinical trial is a multi-center study designed to evaluate the efficacy of Archexin in combination with everolimus (Afinitor®) to treat metastatic RCC patients and will be conducted in two stages. Stage 1 will be dose ranging with up to 3 cohorts of 3 RCC patients to determine its maximum tolerated dose in combination with everolimus. Based on previous clinical data the target dose of Archexin is anticipated to be no more than 250 mg/m2 per day. The decision to enroll the next group of patients and escalate the dose will be made after completion of the first 21 day cycle of treatment. Patient assessments will include safety, pharmacokinetics, laboratory and physical exams. Once the maximum tolerated dose of Archexin in combination with everolimus has been determined, thirty RCC patients will be randomized to either Archexin in combination with everolimus or everolimus alone, in a ratio of 2:1.