SAN MARINO, Calif., July 9 /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 all soft tissue sarcomas. This latest approval is the third clinical indication for which Rexin-G has been formally recognized by the FDA in the United States. This latest approval for Rexin-G validates the company's remarkable strategy of addressing a global unmet medical need by caring for one individual patient, one particular type of tumor, one otherwise intractable cancer at a time.
The clinical development of Rexin-G worldwide has been equally remarkable. Beginning with the most serious and life-threatening forms of pancreatic cancer, Rexin-G has demonstrated unprecedented single-agent efficacy in metastatic cancers of the colon, breast, skin, lung, and bone in a progressive program of expanded access that continues to achieve historic milestones. Eschewing any trappings of personal accomplishment, Epeius gives credit to the dedication and efforts of the many pioneering oncologists, the progressive medical institutions, and the conscientious regulatory agencies who have all served to guide Rexin-G, with its elegant tumor-targeting nanotechnologies, to the bedside. Most recently, Rexin-G has been approved in the Philippines for the treatment of all solid tumors that are refractory to standard chemotherapies.
In addition to developing the first and so far only tumor-targeted
genetic medicine that has been validated in the clinic, Epeius
Biotechnologies has assumed the daunting responsibilities of advancing
these enabling platform technologies safely and effectively through an
arduous array of regulatory hurdles and medical proofs-of-principle that
are required for a radically new medicine. Initial Phase I safety studies
established the general safety of Rexin-G, followed by Phase I/II efficacy
studies where optimal clinical proto
|SOURCE Epeius Biotechnologies|
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