Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), a clinical stage biopharmaceutical company developing next generation targeted therapeutics for the treatment of cancer, today announced it has initiated stage 2 of the Phase Ib/IIa clinical trial with the novel oral anti-cancer agent RX-3117 in relapsed or refractory pancreatic cancer patients. The decision to proceed was based on satisfying the predefined criteria for preliminary efficacy for stage 1 of the trial. RX-3117 was safe and well tolerated with preliminary efficacy seen in pancreatic cancer patients for whom three prior therapies had been ineffective.
“These data are very promising since there are no available treatments for pancreatic cancer patients who have failed three prior therapies. These patients would usually be offered palliative or best supportive care. Having 40% of patients showing responses beyond 2 months is certainly encouraging. I look forward to further evidence of benefit at the end of the trial,” said Ely Benaim, M.D., Chief Medical Officer for Rexahn.
“The initiation of stage 2 of the Phase Ib/IIa clinical trial in refractory metastatic pancreatic cancer marks a major milestone in the RX-3117 clinical development program,” commented Peter D. Suzdak, Ph.D., Chief Executive Officer. “Results from stage 1 of the Phase Ib/IIa clinical trial have been submitted for presentation at the European Society for Medical Oncology (ESMO) conference that will take place in October 2016.”
The ongoing Phase Ib/IIa clinical trial is a multicenter, open-label single-agent study of RX-3117 being conducted at 10 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. The study follows a two-stage design. In stage 1 of the trial, up to 10 patients with relapsed or refractory metastatic pancreatic cancer were enrolled. Based on predefined criteria, if 20% or more of the patients had progression free survival of > 4 months, or an objective clinical response rate and reduction in tumor size, then an additional 40 pancreatic cancer patients would be enrolled into stage 2.
Patients enrolled into stage 1 of the clinical trial had actively progressing disease, with 44% of them having failed > 3 prior cancer therapies (including 5-FU and gemcitabine-based therapies). RX-3117 was shown to be safe and well tolerated in this patient group. The clinical study is still on-going. However since the predefined efficacy criteria have been achieved, stage 2 of the study has been initiated. (Original Source)
Shares of Rexahn Pharmaceuticals have a 1-year high of $0.65 and a 1-year low of $0.24. The stock’s 50-day moving average is $0.26 and its 200-day moving average is $0.29.
On the ratings front, FBR analyst Vernon Bernardino reiterated a Buy rating on RNN, with a price target of $3, in a report issued on August 9. The current price target implies an upside of 1100.0% from current levels. According to TipRanks.com, Bernardino has a yearly average return of -14.9%, a 28% success rate, and is ranked #3998 out of 4124 analysts.
Rexahn Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company. It dedicates to the discovery, development and commercialization of innovative treatments for cancer and other medical needs. The company currently has three clinical stage oncology candidates, Archexin, RX-3117, and Supinoxin and a robust pipeline of preclinical compounds to treat multiple types of cancer. It has also developed proprietary drug discovery platform technologies in the areas of nano-medicines, 3D gold and times.