Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN) announced an update on the safety and efficacy of RX-3117 in an ongoing Phase IIa clinical trial in metastatic pancreatic cancer at the American Society for Clinical Oncology (ASCO) 2017 Gastrointestinal Cancer Symposium in San Francisco California.
“The data on progression free survival in metastatic pancreatic cancer patients treated with RX-3117 is very encouraging with 20% of patients exhibiting progression free survival of greater than 5.6 months (with one patient having progression free survival of 7.2 months). A majority of the patients enrolled in the trial have already failed 3 or more prior cancer therapies. Current options for these patients are usually limited to palliative or best supportive care; there are no drugs approved for metastatic pancreatic cancer patients that have failed two or more prior therapies,” said Ely Benaim, M.D., Chief Medical Officer for Rexahn.
“Rexahn’s development strategy for RX-3117 in pancreatic cancer is to continue to develop RX-3117 as monotherapy for patients with metastatic disease who have failed on two or more prior therapies, and also, in parallel, to develop RX-3117 in combination with Abraxane® (paclitaxel protein bound) for patients with metastatic pancreatic cancer who have received no prior chemotherapy treatment. Since there are no drugs approved for patients who have failed two or more therapies, there may be an accelerated regulatory pathway for approval for this patient population, assuming we continue to see efficacy with RX-3117. In addition, during the first quarter, Rexahn plans to initiate a Phase IIa clinical trial of RX-3117 in combination with Abraxane® in newly diagnosed metastatic pancreatic cancer patients. We expect the initial data from this trial will be available in early 2018,” commented Peter D. Suzdak, Ph.D. CEO of Rexahn.
RX-3117 Phase IIa Clinical Data
The updated efficacy data for RX-3117 from an ongoing Phase IIa clinical trial in metastatic pancreatic cancer were presented on Friday January 20, 2017 in a poster presentation entitled “RX3117, An Oral Antimetabolite Nucleoside Shows Activity in Subjects with Pancreatic Cancer. Preliminary Results of Stage 1 of the Phase 2a Study” authored by Drew W. Rasco (South Texas Accelerated Research Therapeutics, San Antonio, Texas), Jaime R. Merchan (Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida) and Rexahn Collaborators.
Patients enrolled into stage 1 of the clinical trial had actively progressing disease with 55% of them having received 4 or more prior cancer therapies (including 5-FU and gemcitabine-based therapies). These patients would usually be offered palliative or supportive care. There are no approved treatments for pancreatic cancer patients who have failed three or more prior therapies and their survival is usually less than 2 months. In the current study more than 20% of patients treated with RX-3117 exhibited progression free survival of greater than 5.6 months (with one patient having progression free survival of 7.2 months). An additional 20%, for a total of 40%, of the patients exhibited progression free survival of 2.5 months. RX-3117 was shown to be safe and well tolerated in this patient group. The most frequently reported drug-related adverse events were mild to moderate fatigue and diarrhea. Patients in Stage 1 of the clinical trial are still being monitored for survival. However, since the predefined efficacy criteria have been achieved, stage 2 of the study has been initiated which entails enrolling an additional 40 metastatic pancreatic cancer patients. An initial data read out from stage 2 of the trial is expected in late 2Q or early 3Q 2017.
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 have progression free survival of > 4 months, or an objective clinical response rate and reduction in tumor size, then an additional 40 pancreatic cancer patients can be enrolled into stage 2. (Original Source)
Shares of Rexahn Pharmaceuticals are up nearly 4% to $0.18 in early trading Friday. RNN has a 1-year high of $0.42 and a 1-year low of $0.13. The stock’s 50-day moving average is $0.16 and its 200-day moving average is $0.21.
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 November 7. The current price target represents a potential upside of 1665% from where the stock is currently trading. According to TipRanks.com, Bernardino has a yearly average loss of 21.2%, a 20% success rate, and is ranked #4298 out of 4365 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.