Rexahn Pharmaceuticals, Inc. (REXN)

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Rexahn Pharmaceuticals Presents Preliminary Efficacy Data from the Ongoing Phase IIa Clinical Trial of RX-3117 in Metastatic Bladder Cancer at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting


RX-3117 Monotherapy Increased Progression Free Survival and Showed Evidence of Tumor Shrinkage in Patients with Metastatic Bladder Cancer Resistant to Gemcitabine who had Failed on Multiple Prior Treatments

Stage 2 of the Study has Begun, Based on Positive Preliminary Efficacy Results from Stage 1

ROCKVILLE, Md., June 04, 2017 (GLOBE NEWSWIRE) -- Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing innovative, targeted therapeutics for the treatment of cancer, today announced an interim update on the safety and efficacy of RX-3117 in an ongoing Phase IIa clinical trial in metastatic bladder cancer at the American Society for Clinical Oncology (ASCO) 2017 Annual Meeting.

“The study achieved our predefined criteria for efficacy in metastatic bladder cancer,” said Ely Benaim, M.D., Chief Medical Officer, Rexahn. “Twenty percent of patients showed progression free survival of greater than 6 months and there was tumor reduction in some patients. This is not expected in patients with metastatic bladder cancer who have already failed 3 or more prior cancer therapies and have developed resistance to most anticancer agents including gemcitabine. Current options for these patients are usually limited to palliative or best supportive care. So we are very pleased with the outcome in this first stage of the study and we will continue to enroll additional patients into the second stage of this Phase IIa study.”

“Patients with metastatic bladder cancer, who have already developed resistance to gemcitabine and other anticancer treatments, are very difficult to treat,” said Dr. Sumanta Pal, Associate Professor at City of Hope Comprehensive Cancer Center, Duarte, California. “It was very unexpected to see prolonged stable disease in patients in this study who had failed multiple prior treatments that included gemcitabine/cisplatin and immunotherapy, so these preliminary data are very encouraging. RX-3117 also appears to be remarkably safe and well-tolerated with no dose limiting side-effects.”

RX-3117 Phase IIa Clinical Data

The updated efficacy data for RX-3117 from an ongoing Phase IIa clinical trial in metastatic bladder cancer are being presented on Sunday June 4, 2017 in a poster presentation entitled Activity of RX-3117, an oral antimetabolite nucleoside, in subjects with metastatic bladder cancer resistant to gemcitabine: Preliminary results of a phase Ib/IIa study authored by Drs. S Pal, J Gong and V Chung (City of Hope Comprehensive Cancer Center, CA); Dr. J Picus (Division of Oncology, Dept. of Medicine, Washington University School of Medicine, MO); Dr. S Tagawa (Sandra and Edward Meyer Cancer Center, Weill Cornell Medicine, NY); Dr. S Gupta (Huntsman Cancer Institute at the University of Utah, UT) and Rexahn Pharmaceuticals.

The poster presentation reported data on the first ten patients enrolled into stage 1 of a two stage Phase IIa study in metastatic bladder cancer. Patients enrolled into stage 1 of the clinical trial had actively progressing bladder cancer with distant metastases to multiple sites including the liver, lung, lymph nodes and pelvis. Seven of the ten patients had three or more prior treatments for metastatic cancer and nine had failed on gemcitabine given in combination with cisplatin or carboplatin. These patients would usually be offered palliative or supportive care and expected progression-free survival is two to three months. Currently, 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, two of ten patients treated with RX-3117 exhibited progression free survival of greater than 6 months and one of these patients is continuing in the study with stable disease at 175 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 at least 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. To date a total of 12 patients have been enrolled. Fifty-percent (50%), or six, of the patients have stable disease for greater than 56 days and three of the twelve remain in the study with prolonged stable disease, with all patients remaining in the study having stable disease for at least 56 days. RX-3117 appears to be 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.

A copy of the ASCO poster can be viewed on the company’s website at https://rexahn.com/cms/media-center/publication/posters/

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