Orphan drug laws are designed to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases. In 2006, Aezea received orphan drug designation in both the U.S. and Europe for the treatment of acute myelogenous leukemia (AML).
“Eleos is very pleased to have been awarded a second orphan drug designation for Aezea,” said Dr. Larry J. Smith, Chief Science Officer. “This should enable us to develop the compound for CLL in a more rapid, cost-effective manner than would otherwise be possible.”
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.
Aezea has been shown to sensitize proliferating malignant stem cells to low dose chemotherapy. This finding may allow a new cancer treatment strategy to emerge, consisting of Aezea plus low dose anticancer therapy to eliminate malignant stem cells over time.
Eleos has recently completed a Phase II clinical study of Aezea in AML and is currently involved in an ongoing Phase II study in CLL. Additional studies in AML and malignant melanoma are planned for later this year.
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 (over $1 million per application for 2008) 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. The company was formed in 2001 to develop its lead compound, Aezea, for the treatment of cancer.
Contact Information F. Joseph Daugherty, MD Dwight Hanson Chief Executive Officer Chief Financial Officer Eleos Inc. Eleos Inc. One Valmont Plaza One Valmont Plaza Suite 301 Suite 301 Omaha, NE 68154 Omaha, NE 68154 Phone : (402) 255-5775 Phone : (402) 255-5765 fjd@eleosinc.com dhanson@eleosinc.com
www.eleosinc.com
Disclaimer This media release may contain forward-looking statements about Eleos Inc. Such forward-looking statements can be identified by the use of forward-looking terminology such as "will", "should", "expects", "plans", "believes", "may", or similar expressions intended to identify forward-looking statements. Such statements, including those relating to timing and progress of clinical and preclinical programs, reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Eleos undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.
