Rexahn Pharmaceuticals announced today that Teva Pharmaceutical Industries has decided, for strategic reasons, not to exercise its option to license RX-3117 from Rexahn. As a result, the Research and Exclusive License Option (RELO) Agreement for RX-3117 between Rexahn and Teva has been terminated and Rexahn will retain all the global development and commercialization rights to RX-3117, a novel DNA and RNA synthesis inhibitor for the treatment of solid cancer tumors.
In July 2013, pursuant to the RELO agreement, Teva submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for RX-3117 which has now cleared the FDA’s 30 day review period. Under the RELO agreement, Teva had 45 days from the filing of the IND to exercise the option to exclusively license RX-3117.
According to Teva, "RX-3117 appears to have potential in various indications, but does not align with Teva’s new Oncology strategy."
Rexahn will continue to advance the clinical development of RX-3117 and expects to finalize the timeline for initiating a Phase I clinical study in cancer patients within the next three months.
"Rexahn looks forward to advancing the clinical development of RX-3117," Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer commented. "RX-3117 has already demonstrated safety and oral bioavailability in cancer patients, and has the potential to treat a wide variety of solid cancer tumors. We will explore potential partnering opportunities with oncology focused pharmaceutical companies for this compound, as we continue to make progress in the clinical development of RX-3117."
RX-3117 is a novel small molecule anti-metabolite compound that inhibits DNA and RNA synthesis and induces apoptotic cell death of tumor cells. Preclinical studies have shown RX-3117 to be effective in both inhibiting the growth of various human cancer xenograft models, including colon, lung, renal and pancreatic, as well as overcoming chemotherapeutic drug resistance. In August 2012, Rexahn reported the completion of an exploratory Phase I clinical trial of RX-3117 in cancer patients conducted in Europe. The clinical trial demonstrated that RX-3117 is orally bioavailable with no adverse events reported over the dose range tested.