Rexahn Announces Advances in Phase I Cancer Clinical Trial; Company Planning for Phase II as RX-0201 Showing Limited Side Effect Profile.ROCKVILLE, Md. -- Rexahn Pharmaceuticals (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:RXHN), a pharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for cancer and disorders of the central nervous system, today announced the status of Phase I clinical trials of one of its leading oncology candidates, RX-0201. RX-0201 is a first-in-class signal inhibitor that directly blocks the production of Akt, a protein kinase protein kinase /pro·tein ki·nase/ (pro´ten ki´nas) an enzyme that catalyzes the phosphorylation of serine, threonine, or tyrosine groups in enzymes or other proteins, using ATP as a phosphate donor. , playing a key role in cancer progression. The trial, which is ongoing at Georgetown University Georgetown University, in the Georgetown section of Washington, D.C.; Jesuit; coeducational; founded 1789 by John Carroll, chartered 1815, inc. 1844. Its law and medical schools are noteworthy, and its archives are especially rich in letters and manuscripts by and and the University of Alabama The University of Alabama (also known as Alabama, UA or colloquially as 'Bama) is a public coeducational university located in Tuscaloosa, Alabama, USA. Founded in 1831, UA is the flagship campus of the University of Alabama System. , is designed to determine the safety and tolerability of RX-0201 in patients with cancer. The trial protocol calls for patients to undergo two cycles of two weeks on the drug and one week off. At 192 mg/M(2), patients showed no dose limiting toxicity. Currently, patients are being entered on 315 mg/M(2). On the basis of the Phase I results to date, Rexahn has initiated planning of a Phase II program. Dr. Chang Ahn, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Rexahn, said, "We are very pleased with the limited side effect profile of RX-0201. Once the maximum tolerated dose is established in Phase I, we will enter Phase II where we anticipate longer dosing cycles." RX-0201 is planned to enter Phase II later this year. In January 2005, the Company received "orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation" from the Food and Drug Administration for RX-0201 for the following cancers: stomach, ovarian, pancreas, brain, and kidney. 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Additional information about Rexahn is available at http://www.rexahn.com About RX-0201 Rexahn has targeted regulation of Akt-1 activity as an effective way to control survival of cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping. See also: Cancer . One approach to regulating Akt-1 is to use antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). oligonucleotides to modify and regulate the gene that controls the expression and production of Akt-1. Rexahn's RX-0201 is a 20-mer oligonucleotide that is complementary to Akt-1 mRNA. RX-0201 is able to induce marked reduction in Akt mRNA and protein expressions in cells from human carcinomas by transducing signals for cellular proliferation and anti-apoptotic effects, resulting in an undesirable survival environment for cancer cells. RX-0201 strongly inhibits proliferation of various human cancer cells at nanomolar concentration levels, and is highly effective in reducing tumor burdens in animal models. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. This press release contains statements (including projections and business trends) that are forward-looking statements. Rexahn's actual results may differ materially from the anticipated results and expectations expressed in these forward-looking statements as a result of certain risks and uncertainties, including, Rexahn's lack of profitability, its auditor's going concern qualification and the need for additional capital to operate its business to develop its product candidates; the risk that Rexahn's development efforts relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc its product candidates may not be successful; the possibility of being unable to obtain regulatory approval of Rexahn's product candidates; the risk that the results of clinical trials may not be completed on time or support Rexahn's claims; demand for and market acceptance of Rexahn's drug candidates; Rexahn's reliance on third party researchers and manufacturers to develop its product candidates; Rexahn's ability to develop and obtain protection of its intellectual property; and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, Rexahn assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise. |
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