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FDA Grants Epeius Biotechnologies' Rexin-G a Third Orphan Drug Designation, This Time for the Treatment of Soft Tissue Sarcomas
Date:7/9/2008

cols were established for each particular type of tumor. The importance of these progressive dose-escalation studies -- which clearly establish safety before escalating to more potent tumoricidal dose levels -- is of primary concern in the development of a new genetic medicine like Rexin-G. Moreover, the establishment of a functional dose-response relationship is of fundamental significance, not only in terms of basic pharmacology, but in establishing the physiological mechanisms-of-action that are of major importance in determining the predictability of a new anti-cancer agent and ultimately in gaining full regulatory approval for Rexin-G in the United States.

Based on the scientific and medicinal merits of Rexin-G, as well as the rarity, seriousness, and lack of effective therapies for metastatic cancers, the granting of a third Orphan Drug Designation by the FDA at this time is both encouraging and confirmatory. Orphan Drug Designation provides important economic incentives and powerful market protections that encourage the development of innovative products in the cancer field. U.S. Orphan Drug Designation provides seven years of market exclusivity for Rexin-G, a reduction in fees and taxes, and additional regulatory support for ongoing R&D initiatives.

About Epeius Biotechnologies

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems. To learn more about our pipeline of biotechnologies and products that are currently available for licensing and clinical development, please visit our website, http://www.epeiusbiotech.com.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

This release was issued on behalf of the
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SOURCE Epeius Biotechnologies
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