REXAHN REPORTS POSITIVE PHASE I RESULTS FOR AKT INHIBITOR

Rexahn Pharmaceuticals has announced the conclusion of the Phase I clinical trials of its leading oncology candidate, RX-0201.

RX-0201 is a first-in-class signal inhibitor that directly blocks the production of Akt, a protein kinase that plays a key role in cancer progression. Akt is over-activated in a significant number of cancers, such as breast, colorectal, gastric, head and neck, ovarian, pancreatic, prostate and thyroid cancers. Akt's transformation ability, as well as its role in cancer progression, makes it a highly attractive and unique target in the treatment of cancer, according to the company.

The trial of RX-0201 was an open-label, dose-escalation study intended primarily to determine the safety and tolerability of the drug in patients with advanced cancer. The trial has demonstrated that the dose limiting toxicity of RX-0201 occurs at 315 mg/m2 dose in the form of fatigue. No other serious adverse reactions such as hematological toxicities were observed in this study. The company expects to file a complete final report of Phase I results with the FDA in early 2007.

Phase II of the RX-0201 clinical trial is expected to begin in early 2007 in patients with advanced renal-cell carcinoma who have failed previous treatments. The company has received orphan drug designation from the FDA for RX-0201 for five cancer indications, including renal-cell carcinoma, ovarian cancer, glioblastoma, stomach cancer and pancreatic cancer. In the future, the company plans to apply RX-0201 to the treatment of orphan indications and other cancers.