Rexahn Pharmaceuticals Presents Preliminary Safety and Efficacy Data From Ongoing Phase 2a Clinical Trial of RX-3117 in Combination With Abraxane® in Patients Newly Diagnosed With Metastatic Pancreatic Cancer
Combination of RX-3117 and Abraxane Appears Safe and Well-Tolerated When Administered at the Recommended Phase 2 Dose of RX-3117 and the Maximal Labeled Dose of Abraxane
Preliminary Efficacy was Observed With One Complete Response, Three Partial Responses and Eight Patients With Stable Disease in the First 14 Evaluable Patients
Highlights from the poster reflecting data as of
“These preliminary data are encouraging, showing that the combined administration of RX-3117 and Abraxane in newly diagnosed metastatic pancreatic cancer patients appears to be safe and well tolerated and showing evidence of clinical activity,” said Dr.
“The safety profile of RX-3117 continues to be encouraging as it can be administered at its recommended Phase 2 dose together with the maximal labeled dose of Abraxane without producing an increase in severe adverse events,” said
The current trial, which is a multicenter, open-label, 2 stage Phase 1b/2a study, is designed to assess the safety, tolerability and efficacy of the combined administration of the maximal labeled dose of Abraxane and the full Phase 2 dose of RX-3117 in newly diagnosed metastatic pancreatic cancer patients. Phase 1 was a dose-finding, open-label study of oral RX-3117 administered in combination with nab-pac to subjects with newly diagnosed met-PC. RX-3117 was administered at a dose of 700 mg orally once-daily for 5 consecutive days with 2 days off per week and Abraxane (nab-pac) was administered at a dose of 125 mg/m2 once weekly for 3 weeks with 1 week off per 4-week cycle. In stage 1 of the trial, the combination of RX-3117 and nab-pac appeared to be safe and well-tolerated and not associated with dose-limiting toxicities following one cycle of treatment. In stage 2, a total of 40 subjects will be recruited into the study for up to 8 cycles of combined therapy. Currently there are 14 patients that had at least one on-study scan (after 2 cycles of therapy) 11 of who are still receiving treatment in the study. The complete data from these, and all patients, are expected to be available in the first half of 2019.
A copy of the poster is available on the Company's website at https://rexahn.com/cms/media-center/publication/posters/.
RX-3117 is a novel, investigational, oral, small molecule nucleoside compound. Once intracellularly activated (phosphorylated) by 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 over expression 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® (nab-paclitaxel) 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: https://rexahn.com/cms/portfolio/rx-3117/.
Abraxane is a registered trademark of
About Rexahn Pharmaceuticals, Inc.
To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about Rexahn’s plans, objectives, expectations and intentions with respect to the ongoing Phase 2a clinical trial of RX-3117 in combination with Abraxane®, future operations and products, the path of clinical trials and development activities, and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn’s actual results to be materially different than those expressed in or implied by Rexahn’s forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer; drug candidates being in early stages of development, including clinical development; the ability to initially develop drug candidates for orphan indications to reduce the time-to-market and take advantage of certain incentives provided by the
Source: Rexahn Pharmaceuticals