Aeterna Zentaris reports trial results and orphan drug designation Print E-mail
By Staff and Wire Reports   
Tuesday, 05 October 2010 13:26

Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a late-stage oncology drug development company whose AEZS-130 (macimorelin, SolorelTM) is currently in a Phase 3 trial as a diagnostic test for AGHD, has been granted Orphan Drug Designation for this indication by the FDA.

AGHD affects 35,000 adult Americans, with 6,000 new adult patients diagnosed each year. Growth hormone (GH) not only plays an important role in growth from childhood to adulthood, but helps promote good health throughout life. AGHD is usually characterized by low energy levels, decreased strength and exercise tolerance, increased weight or difficulty losing weight, emotional changes, anxiety and impaired sleep. Available diagnostic tests for AGHD are complex and can produce significant side effects.

The Company announced that an interim review of a Phase 3 trial of AEZS-130, demonstrates the compound may provide a simple, well-tolerated and safe oral diagnostic test for Adult Growth Hormone Deficiency (AGHD).

The data was presented earlier today by Beverly M.K. Biller, M.D. of the Harvard Medical School/Massachusetts General Hospital in Boston, at the 5th International Congress of the Growth Hormone Research Society (GRS) and the Insulin-like Growth Factors (IGF) Society in New York City. AEZS-130 (macimorelin, SolorelTM) has been granted Orphan Drug Designation by the Food and Drug Administration (FDA) as a diagnostic test for AGHD.

"Following this encouraging data, we look forward to completing this Phase 3 trial by the end of this year and filing a New Drug Application in the first half of 2011", stated Juergen Engel, Ph.D., president and CEO at Aeterna Zentaris. "In line with our innovative approach, AEZS-130 (macimorelin, SolorelTM) could become the first approved oral test for the diagnosis of AGHD, providing patients with an accurate and more convenient alternative to the current intravenous tests."

The two-way crossover study included 42 patients with confirmed AGHD or multiple pituitary hormone deficiencies and a low insulin-like growth factor-I. A control group of 10 subjects without AGHD were matched to patients for age, gender, body mass index and (for females) estrogen status. The main goal of the study was to measure the accuracy of AEZS-130 (macimorelin, SolorelTM) in diagnosing AGHD.

The most frequent side effects following administration of AEZS-130 (macimorelin, SolorelTM) or GHRH-ARG, were taste disturbance (23% and 13%, respectively) and facial flushing (2% and 23%, respectively).




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