Rexahn provides update on Phase I Supinoxin trial in cancer patients with solid tumors

Enrollment into four dose groups has been completed (25, 50, 100 and 150 mg) and no drug related adverse events have been reported. The fifth dose group (225 mg) is ongoing. The maximum tolerated dose of Supinoxin has not yet been achieved. Pharmacokinetic analysis has shown that Supinoxin displays dose-proportional exposure and an estimated oral bioavailability of 51%.

"With the fourth dosing group now complete, we continue to be encouraged by the pharmacokinetics and safety of Supinoxin in patients who have received multiple cycles of treatment. We are on schedule to complete enrollment of patients in this clinical trial by the end of 2014," stated Rexahn’s Chief Executive Officer, Peter D. Suzdak, Ph.D.

"We look forward to the data from this trial, which will further guide the clinical development of this compound."

The Phase I trial of Supinoxin, which was initiated in August 2013, is a dose-escalation study designed to evaluate the safety, tolerability, dose-limiting toxicities and MTD in patients with solid cancer tumors that have previously failed treatment with approved therapies and shown progression of disease.

Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of Supinoxin. This trial 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 (a dosing cycle is defined as 3 weeks of drug treatment followed by 1 week off) if no disease progression is seen.

Patients are assessed by CT or MRI prior to the start of therapy and after every two cycles of therapy to assess tumor progression. The trial is using an accelerated dose-escalation design: one patient is treated per dose cycle until a grade 2 related adverse event occurs then three patients will be treated per dose cycle.

The decision to escalate dose is made by the data monitoring safety board (DMSB) after completion of one cycle of treatment based on safety and tolerability. Patients have the possibility to receive up to 6 cycles of treatment if the disease does not progress. Tumor biopsy samples are taken to assess the biomarker phospho-P68.