Eleos Inc. Announces Aezea® (cenersen)
Granted Third US Orphan Drug Designation by FDA
Press Release Issued - 31 July 2008, Omaha, NE
Eleos Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Aezea for the treatment of patients with malignant melanoma (stage IIb to IV). Aezea is an investigational drug that is not approved for any indication in any market at this time.
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), and earlier this year for chronic lymphocytic leukemia (CLL).
“Eleos is very pleased to have been awarded additional orphan drug designation for Aezea,” said Dr. Larry J. Smith, Chief Science Officer. “Preclinical studies suggest that Aezea has the potential to intervene in several mechanisms that are important for the viability of this form of cancer.”
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 are expected to be initiated early next year.
About malignant melanoma
Melanoma treatments and outcomes have not changed in 30 years, so any advance in treatment would benefit patients. While melanoma afflicts over 550,000 patients in the United States each year, 88% have localized disease usually cured by local surgery. Fortunately, only 10% or about 50,000 patients require systemic treatment beyond the surgical removal of the primary skin lesion. Eleos plans to initiate a clinical trial in stage 4 metastatic patients, those with the most severe form of melanoma. The company is currently considering either uveal or cutaneous melanoma for the first clinical trial of Aezea in a solid tumor.
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:
Dr. F. J. Daugherty, CEO
One Valmont Plaza
Suite 301
Omaha, Nebraska 68154
Phone: (402) 255-5775
Fax: (402) 255-5778
fjd@eleosinc.com
Mr. Dwight Hanson, CFO
One Valmont Plaza
Suite 301
Omaha, Nebraska 68154
Phone: (402) 255-5765
Fax: (402) 255-5778
dhanson@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.
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