Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer is providing a quarterly update today on its three clinical development programs and financial results.
“We are excited about the progress of the Supinoxin™, RX-3117 and Archexin
clinical development programs. As we continue through the end of 2013, and into the first quarter of 2014, we look forward to updating our shareholders on the initiation of the Phase I clinical trial with RX-3117, the initiation of the Phase IIa clinical trial with Archexin in metastatic renal cell carcinoma, and the initial clinical data from the Phase I clinical trial with Supinoxin,” commented Rexahn’s Chief Executive Officer Peter D. Suzdak, PhD. “We are also pleased that we were able to strengthen the balance sheet recently which will allow us to increase the momentum for the clinical development of our pipeline.”
The Phase I dose-escalation clinical trial of Supinoxin (RX-5902) in cancer patients with solid tumors began enrolling patients in August 2013. Patient enrollment in the third dosing group was recently initiated, and Rexahn anticipates updating investors with available clinical data from this trial by the end of the first quarter of 2014. The Phase I trial is designed to evaluate the safety, tolerability, and the maximal tolerated dose of Supinoxin. This evaluation is being conducted in three clinical oncology centers in the United States. Each patient has the ability to continue on the drug up to six cycles of treatment. Patients are assessed by CT or MRI prior to the start of therapy and after every two cycles of therapy to track tumor progression.
Rexahn is preparing to initiate a Phase I clinical trial of RX-3117 in cancer patients with solid tumors in December 2013. The design of this study is based partially on the initial data obtained in an exploratory Phase I clinical trial of RX-3117 in cancer patients conducted in Europe in 2012. This upcoming dose-escalation clinical trial will be conducted in multiple clinical sites in the U.S. for cancer patients with solid tumors. Patients will receive RX-3117 orally three times a week for three weeks followed by one week off. Patients will have the ability to continue on the drug up to eight cycles of treatment. The decision to enroll the next group of patients and escalate the dose will be made after one cycle of treatment, based on safety and tolerability. Patients will be assessed for tumor progression by CT or MRI prior to the start of therapy and after every two cycles of therapy.