Annual Summary of Regulatory Activities for Aezea® (cenersen)
21 September, 2009, Omaha, NE
Eleos Inc. today released the annual summary of its regulatory activities concerning the company's lead therapeutic, Aezea® (cenersen).
July 27, 2009: ELP1020 Clinical Trial Application Authorized in France
March 30, 2009: ELP1020 Clinical Trial Application Authorized in Germany
March 30, 2009: FDA Accepts Proprietary Name Aezea®
December 3, 2008: Aezea® Granted Orphan Drug Designation in Europe for CLL
October 24, 2008: ELP1020 Clinical Trial Application Authorized in the U.K.
July 22, 2008: US Patent and Trademark Office Approves Aezea® Registration
July 15, 2008: ELP1020 Clinical Trial Application Authorized in Canada
About Aezea
Aezea is an antisense drug product that suppresses the expression of structurally normal or mutated p53. Cancer cells subvert the normal functioning of this protein in ways that promote their survival, including protection against the killing effects of chemotherapy or radiation. Preclinical data suggests that in normal cells, however, p53 mediates many of the chemotherapy or radiation toxicities often seen in cancer patients. Thus Aezea is expected to sensitize many cancer types, independently of their p53 mutational status, to both radiation treatment and a wide range of existing chemotherapeutic agents while simultaneously protecting normal tissues, including bone marrow, gastrointestinal epithelium and hair follicles, from standard cancer treatment toxicities.
About orphan drug designation
Orphan drug laws in both the U.S. and Europe provide economic incentives to biotechnology and pharmaceutical companies to encourage the development of drugs for rare diseases. Orphan drug status provides a seven-year period of exclusivity following FDA marketing approval in the U.S., and a ten-year period of exclusivity in Europe. Other incentives in the U.S. include tax credits related to development expenses, waiver of prescription drug filing fees (exceeding $1 million per application) and FDA assistance in clinical trial design.
About Eleos Inc.
Eleos Inc. is a privately held biopharmaceutical company headquartered in Omaha, Nebraska, with clinical and regulatory offices in Plymouth, Minnesota.
Contacts:
Corporate Office
F.J. Daugherty, MD
CEO
3616 South 149th St.
Omaha, Nebraska 68144
Phone: 402.393.3034
Fax: 402.393.2521
Regulatory Affairs
Dayton Reardan, PhD
Vice President
3033 Campus Drive
Suite W125
Plymouth, Minnesota 55441
Phone: 763.519.8600
Fax: 763.519.861
