Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) reported an interim update on the efficacy and safety of RX-3117 in an upcoming Phase IIa clinical study in metastatic bladder cancer at the ASCO 2017 Annual Meeting.
Ely Benaim, M.D., the Chief Medical Officer of Rexahn, reported that the trial achieved predefined standard for efficacy in metastatic bladder cancer. 20% of subjects demonstrated progression free survival of over six months and tumor reduction was noted in some patients. It is not anticipated in people with metastatic bladder cancer who have failed three or more previous cancer therapies and have advanced resistance to many of anticancer agents.
Current alternatives for these subjects are usually limited to best supportive or palliative care. So, the company is extremely delighted with the outcome in this initial stage of the trial and they will continue to register additional patients into the next phase of this Phase 2a study.
People suffering with metastatic bladder cancer and also who have advanced resistance to gemcitabine treatments, are extremely tough to treat. It was extremely unexpected to witness prolonged stable disease in people in this trial who had failed numerous prior treatments that comprised cisplatin/ gemcitabine and immunotherapy, so this initial report is extremely encouraging. RX-3117 seems to be remarkably well-tolerated and safe with no visible dose limiting side-effects.
Rexahn presented the updated efficacy report for RX-3117 from an underway Phase 2a clinical study in metastatic bladder cancer earlier this month in a poster presentation. The poster presentation announced data on the preliminary ten patients registered into stage I of a two stage Phase 2a trial in metastatic bladder cancer. Subjects registered into stage I of the clinical study had progressing bladder cancer with distinct metastases to numerous sites counting the liver, lymph nodes, pelvis and lung. In stage I of the current trial, two of ten patients cured with RX-3117 showed progression free survival of over 6 months.