On January 22, 2019 Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical-stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, reported updated, preliminary data from the ongoing Phase 2a clinical trial of RX-3117 in combination with ABRAXANE (paclitaxel protein-bound particles for injectable suspension) in first-line metastatic pancreatic cancer patients at the 2019 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers (ASCO GI) Symposium on January 18, 2019 (Press release, Rexahn, JAN 22, 2019, View Source [SID1234532825]).
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The multicenter, single-arm, open-label study is designed to evaluate RX-3117 in combination with ABRAXANE in first-line metastatic pancreatic cancer patients. The Phase 2a trial is expected to enroll 40 evaluable patients. As of January 9, 2019, 36 patients were enrolled into the study, and 24 patients had at least one scan on treatment and were included in the evaluation of overall response. One patient (1/24, 4.2%) had a complete response (CR) after 6 cycles of treatment and eight patients (8/24, 33.3%) had a partial response (PR). A further 13 patients had stable disease (13/24, 54.2%). The overall response rate (ORR) was 38%, and the disease stabilization rate at eight weeks was 92%. The combination of RX-3117 and ABRAXANE appears to be safe and well-tolerated. The most common related adverse events were nausea, diarrhea, fatigue, alopecia, decreased appetite, rash, vomiting, and anemia.
While no head-to-head studies have been conducted between RX-3117 and gemcitabine in metastatic pancreatic cancer, for background purposes, the registration trial for the combination of gemcitabine and ABRAXANE demonstrated an ORR of 23%.
"We continue to be encouraged by the preliminary data from this study," said Ely Benaim, M.D., chief medical officer of Rexahn. "Because most patients are still being treated in the study, it is too early to estimate progression free survival, but we expect to complete enrollment and report additional efficacy data later this year."
A copy of the poster is available on the Company’s website at View Source
About RX-3117
RX-3117 is a novel, investigational, oral, small molecule nucleoside compound. As observed in preclinical studies, once intracellularly activated (phosphorylated) by uridine cytidine kinase 2 (UCK2), it is incorporated into the DNA or RNA of cells and inhibits both DNA and RNA synthesis, which induces apoptotic death of tumor cells. Due to the high level of overexpression of UCK2 in cancer cells, RX-3117 offers the potential for a targeted anti-cancer therapy with an improved efficacy and safety profile. RX-3117 is currently being studied in a Phase 2a clinical trial in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) in first line metastatic pancreatic cancer patients and a Phase 2a clinical trial in patients with advanced or metastatic bladder cancer. It has received Orphan Drug designation for the treatment of pancreatic cancer. Additional information on RX-3117 can be found at: View Source
ABRAXANE is a registered trademark of Celgene Corporation.