Rexahn Presents Preliminary Efficacy Data From Phase IIa Trial Of RX-3117 In ABC

(RTTNews) - Rexahn Pharmaceuticals Inc. (RNN) announced an update on the safety and efficacy of RX-3117 in an ongoing Phase IIa clinical trial in advanced bladder cancer at the 2017 European Society for Medical Oncology or ESMO Congress in Madrid, Spain.

The poster presentation is an update on the progression free survival (PFS) of patients enrolled in stage 1 of the Phase IIa study in advanced and metastatic bladder cancer. The initial data from these patients was reported in June at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting. Patients had actively progressing bladder cancer with distant metastases to multiple sites including the liver, lung, lymph nodes and pelvis.

Six of the ten patients had three or more prior treatments for metastatic cancer and nine had failed on gemcitabine. These patients would usually be offered palliative or supportive care and expected progression free survival is two or three months. There are no approved treatments for metastatic bladder cancer patients who have failed two or more prior therapies.

In stage 1 of the current study, four of ten patients treated with RX-3117 exhibited progression free survival of greater than 5 months and one of these patients is continuing in the study with stable disease at 259 days. Two patients had a reduction of 19% and 15% in tumor size. The predefined efficacy criteria for continuing the study to enroll additional patients was two of ten patients achieving a progression free survival of 4 months or a partial or complete tumor response. These criteria have been met and the study is enrolling an additional 10 patients in this second stage. RX-3117 was very well tolerated. The most common side effects were mild nausea, vomiting diarrhea and fatigue and only two subjects had thrombocytopenia. There were no dose-limiting toxicities.

The ongoing Phase IIa clinical trial is a multicenter, open-label single-agent study of RX-3117 being conducted at 6 clinical centers in the United States. Patients receive a 700 mg daily oral dose of RX-3117, five times weekly on a three weeks on, one week off dosing schedule in a 28 day cycle for up to eight treatment cycles, or until their disease progresses.