• 10/18/2006
  • New Rochelle, NY
  • press release
  • Genetic Engineering News (www.genengnews.com)

Rexahn Pharmaceuticals (OTCBB:RXHN.OB), a clinical stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for cancer, disorders of the central nervous system and unmet medical needs, today 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.

The clinical trial of RX-0201, which took place at Georgetown University and the University of Alabama, 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.

Of the clinical trial, Dr. Chang Ahn, Chairman and CEO of Rexahn, said, “We are very pleased that RX-0201 has successfully concluded Phase I. As a company that is focused on developing less toxic and targeted therapies for patients, it is of prime importance to us that our candidates are more than tolerable for patients. We aim to have a better safety profile with our drugs than those currently on the market. I am very pleased that RX-0201 has been proven not only to be a reasonably safe drug thus far, but also fatigue is its only major toxicity. I look forward to advancing to the next phase.”

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 trial is the first of multiple trials planned for RX-0201.

In January 2005, the Company received “orphan drug designation” from the Food and Drug Administration for RX-0201 for five cancer indications, including renal cell carcinoma, ovarian cancer, glioblastoma, stomach cancer, and pancreatic cancer. The orphan drug program is intended to provide patients with faster access to drug therapies for diseases and conditions that affect fewer than 200,000 people. Companies that receive orphan drug designation are provided an accelerated review process, tax advantages, and seven years of market exclusivity in the United States.

In the future, the Company plans to apply RX-0201 to the treatment of orphan indications and other cancers.