ROCKVILLE, Md.–(BUSINESS WIRE)–
Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage biopharmaceutical company announced today initial data for the Phase I dose-escalation clinical trial of SupinoxinTM (RX-5902) initiated in August 2013. This trial was designed to study safety and efficacy in patients with solid cancer tumors.
The study is still ongoing and the maximal tolerated dose (MTD) 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) has been initiated. Two patients have received 2 cycles of treatment and one patient has received 6 cycles of treatment. Pharmacokinetic analysis has shown that SupinoxinTM 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.
Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer commented, “We are encouraged that Supinoxin is safe and well-tolerated over the dose range tested in cancer patients with solid tumors who have received multiple cycles of treatment. In addition, the pharmacokinetic profile and oral bioavailability of Supinoxin is consistent with preclinical studies. These data are very encouraging, and we look forward to sharing additional data from the trial when it is completed later this year.”
The Phase I trial of Supinoxin, which was initiated in August 2013, is a dose-escalation study which will 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 and 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 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.
