"Rexahn has made the decision to focus in the near term on our oncology program after evaluating how best to apply our resources in order to realize near term value appreciation for our shareholders," stated Dr. Chang Ahn, Chairman and CEO of Rexahn. "We have sufficient funding to carry the company forward through 2012. The accelerated development of the company's potent anti-cancer compounds will enable Rexahn to drive short term value while supporting our longer term competitive position."
Dr. Ahn added, "Though we were disappointed in the Serdaxin Phase IIb results that we announced in November 2011, we are pleased with the important progress made during the year in our oncology programs. Due to this progress we are in a position to achieve several key milestones in 2012. In the next 12 to 18 months, we expect to substantially add to and advance our oncology pipeline by taking multiple compounds into human trials, as well as to aggressively seek partnerships for several of our oncology assets."
Rexahn Goals for 2012:
-- Pursue new partnerships. Rexahn actively seeks to form new product collaborations in addition to its partnership with Teva Pharmaceutical Industries. This could include out-licensing or co-developing Rexahn's promising oncology assets in order to expedite clinical development, scientific platform alliances to maximize the utility of the Company's three powerful discovery platforms, and research collaborations to further expand the pipeline.
-- Advance clinical program for RX-3117. In September 2009, Rexahn entered into a commercialization and development agreement with Teva Pharmaceutical Industries Limited for RX-3117. Under the agreement, Rexahn is eligible to receive development, regulatory, and sales milestone payments, as well as royalties on net sales worldwide. In the first quarter of 2012, Rexahn expects to initiate an exploratory first-in-human Phase I clinical trial for RX-3117. RX-3117 has shown potent anti-tumor effects in xenograft human tumor models. Preclinical studies have revealed the compound's high bioavailability and good safety profile, which is the current first-line therapy for pancreatic and other cancers.
-- Initiate clinical program for RX-5902. In the second quarter of 2012, Rexahn expects to file an Investigational New Drug application for a first-in-human clinical trial for RX-5902, an orally available, first-in-class inhibitor of p68 RNA helicase for the treatment of various solid tumors, in particular melanoma. Preclinical studies have demonstrated the inhibition of tumor growth and enhanced survival in in vivo animal xenograft models, synergistic action when combined with known anticancer agents, and potent anti-growth activity in drug-resistant cancer cells. A unique, nano-based clinical oral formulation has been developed.
-- Complete clinical trial of Archexin to treat pancreatic cancer. Rexahn expects to report the results of its Phase II clinical trial of Archexin in pancreatic cancer in the third quarter of 2012. Archexin is a first in class, potent Akt protein kinase inhibitor with the potential to inhibit cancer cell survival and proliferation, angiogenesis, and drug resistance. Archexin has FDA Orphan drug designation for five different cancer types, including renal cell carcinoma, glioblastoma, pancreatic, stomach, and ovarian cancers.
-- Initiate clinical program for RX-8243. Rexahn expects to file an Investigational New Drug application in late 2012 or early 2013 for RX-8243, a small molecule inhibitor of Ark 1 kinase and other Ser/Thr kinase for the treatment of various solid tumors. RX-8243 showed better efficacy than paclitaxel in the paclitaxel-insensitive colon xenograft model and potent anti-growth activity in drug-resistant cancer cells.
-- Evaluate options for CNS program (Serdaxin and Zoraxel). Rexahn is exploring options for further development of Serdaxin and Zoraxel, including out-licensing or divesture of the compounds, entering a co-development partnership, and continuation of clinical trials in Major Depressive Disorder for Serdaxin and Erectile Dysfunction for Zoraxel.
-- Continue new CEO search. Rexahn continues its search for a Chief Executive Officer (CEO) to succeed Dr. Chang Ahn, who currently serves as both CEO and Chief Science Officer (CSO) until a new CEO is in place. The company expects to name a new CEO in early 2012.