UPDATE: Rexahn Pharmaceuticals (RNN) Posts Q1 Loss of 9c/Share; Updates on Pipeline
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Rexahn Pharmaceuticals (AMEX: RNN) reported Q1 EPS of ($0.09), $0.07 worse than the analyst estimate of ($0.02).
From the company's 10-Q:
Pipeline Update:
Supinoxin™ (RX-5902)
The Company initiated a Phase I clinical trial of Supinoxin in cancer patients with solid tumors in August 2013, which is ongoing and is expected to be completed in the fourth quarter of 2014. In March, the Company announced the initial results from the trial. The maximum tolerated dose (MTD) of Supinoxin has not yet been achieved. Three dosing cycles have been completed (25, 50 and 100 mg) and no drug related adverse events have been reported. The fourth dosing cycle (150 mg) is ongoing. Pharmacokinetic analysis has shown that Supinoxin displays dose-proportional exposure and an estimated oral bioavailability of 51%. The pharmacokinetic profile of Supinoxin is similar to what has been seen in preclinical studies.
RX-3117
Rexahn initiated a Phase Ib clinical trial of RX-3117 in cancer patients with solid tumors in December 2013. The Company expects to complete patient enrollment for the trial in the fourth quarter of 2014 or early 2015. The Phase Ib trial is a multi-center dose-escalation study which will evaluate the safety, tolerability, dose-limiting toxicities and MTD of RX-3117 in patients with solid tumors. Secondary endpoints will include characterizing the pharmacokinetic profile of RX-3117 and evaluating the preliminary anti-tumor effects of RX-3117. Rexahn has completed one dose cycle (30 mg) and is in the middle of the second dose cycle (100mg).
Archexin®
Rexahn continues to enroll metastatic renal cell carcinoma patients in its Phase IIa proof-of-concept clinical trial for Archexin. Rexahn has previously received orphan drug designation for this indication. The 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. The first stage will be dose ranging, with up to three cohorts of three RCC patients to determine its MTD in combination with everolimus. Once the MTD 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. Rexahn plans to complete the initial safety component of this study in the fourth quarter of 2014.
For earnings history and earnings-related data on Rexahn Pharmaceuticals (RNN) click here.
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