Rexahn Initiates First Clinical Trial; RX-0201 Phase I Clinical Trial for Patients with Malignancy

6/1/2004

From: Ava Iyer of Rexahn Corporation, 240-453-6230; Lombardi Cancer Center at Georgetown University, 202-444-4000 (Cancer Line)

ROCKVILLE, Md., June 1 -- Rexahn Corporation, a privately held emerging biopharmaceutical company, announced today it will initiate its first clinical trial program for the treatment of patients with advanced or metastasized cancers in June 2004. The Phase I clinical study will be conducted at Georgetown University Hospital's Lombardi Cancer Center in Washington, DC. RX-0201, Rexahn's lead drug candidate, 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. The trial will evaluate the safety and pharmacokinetics of RX-0201 as well as any anti-tumor response in the cancer patients.

Dr. Chang Ahn, Chairman and CEO of Rexahn, said, "RX-0201 directly targets the communications system of cancer cells. Disrupting the signals responsible for disease progression offers a more targeted and less toxic therapeutic approach for cancer."

Due to its important role in cancer, Akt has been extensively studied as an important drug target. Data suggests that over- activation or over-expression of Akt promotes the proliferation of tumor cells, inhibits apoptosis (cell death) and enhances angiogenesis (new blood vessel formation) critical for tumor growth.

Dr. Ahn continued, "Akt essentially enables the survival of tumor cells under conditions in which those cells should die. Therefore Akt is, in principle, an attractive drug target for the treatment of cancer. RX-0201 directly inhibits Akt at its production level, thereby blocking the proliferation of tumor cells and inducing cell death (apoptosis)."

While many signal inhibitors affecting Akt pathways are currently under development, most target upstream events (e.g. growth factor receptors and PI3K). Clinical researches have demonstrated in at least 12 major human cancers that Akt is over- activated, making inhibitors of upstream targets ineffective.

In pre-clinical studies, RX-0201 inhibited the expression of Akt mRNA and protein and suppressed tumor growth in various human cancer models. Furthermore, RX-0201 was well-tolerated in animals and showed no severe side effects. Dr. John Holaday, founder of EntreMed and Chairman of Harvest Bank of Maryland, commented, "Under Dr. Ahn's leadership, Rexahn has made great strides in developing a revolutionary new cancer therapeutic that directly targets a critical process in the proliferation of cancer cells. The Akt inhibitor has an exceptional preclinical profile against many different forms of cancer, and we are looking forward to its successful evolution into the clinic."

Rexahn will file an orphan drug application for RX-0201 with the Food and Drug Administration (FDA) to accelerate the clinical development process. The FDA orphan drug grant program also funds clinical research to accelerate the development of products that demonstrate promise to treat rare diseases affecting fewer than 200,000 Americans.

Principal investigator John Marshall, MD, Director of Developmental Therapeutics in Lombardi Cancer Center, commented, "Our Developmental Therapeutics group at the Lombardi Comprehensive Cancer Center is very excited about partnering with Rexahn in the development of a compound with such great potential. The pre-clinical data with this compound is very impressive and our expectations are that the anti-cancer activity seen in the lab will translate to our patients with advanced cancer. We expect the phase I portion of the research to move very quickly."

About Rexahn

Rexahn is a privately held emerging biopharmaceutical company focusing on the development of signal inhibitor drug therapies for the treatment of cancer and other diseases. The company is based in Rockville, Md.

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of Rexahn as of the date of this release. These forward-looking statements are not guarantees for future performance. Actual results could differ materially from those currently anticipated to due to a number of factors including risks relating to the early stage of products under development; uncertainties relating to the clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialization of the Company's proposed products.