SAN MARINO, Calif., July 8 /PRNewswire/ -- Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Based on several criteria, including the rarity, seriousness, and current lack of effective therapies for metastatic osteosarcoma, as well as the scientific and medicinal merit of Rexin-G, the granting of Orphan Drug Status by the FDA validates the unique clinical development strategy of Epeius Biotechnologies: that is, to demonstrate the profound single-agent efficacy of Rexin-G where traditional treatments have historically failed.
The FDA Orphan Drug Act was designed to encourage the development of new products that demonstrate significant promise for the treatment of very serious or life-threatening conditions that are relatively rare, affecting fewer than 200,000 persons in the United States. 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 R&D initiatives.
Rexin-G, the lead product of Epeius Biotechnologies, is the first in a
series of tumor-targeted anti-cancer agents designed to seek out and
accumulate in metastatic cancers that have spread throughout the body,
delivering a lethal payload of genetic medicine to tumor cells and their
associated blood supplies without harming normal cells, tissues, or organ
systems. Specifically designed to function within the context of the human
circulatory system, the demonstration of single agent-efficacy by Rexin-G
in Stage IV or metastatic osteosarcoma (ASCO, 2008) is an indication of the
remarkable clinical potential of the precision targeting technologies
embodied in its design. The
|SOURCE Epeius Biotechnologies|
Copyright©2008 PR Newswire.
All rights reserved