QUÉBEC CITY, Oct 5 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), today announced that an interim review of a Phase 3 trial of AEZS-130 (macimorelin, SolorelTM), 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.
The study was initiated to compare the performance of AEZS-130 (macimorelin, SolorelTM) against the then-available diagnostic growth hormone releasing hormone (GHRH) + Arginine (ARG) standard test. GHRH was subsequently removed from the market in 2008. At the time of removal, the trial consisted of 42 patients with AGHD and ten control subjects. The performance of both diagnostic tools in these patients was examined by investigators who were encouraged by the preliminary sensitivity and specificity estimates for AEZS-130 (macimorelin, SolorelTM).
"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."
In the study, investigators found that at peak growth hormone responses, oral AEZS-130 (macimorelin, SolorelTM) demonstrated 95% sensitivity and 90% specificity in identifying patients who should receive therapy for AGHD, as compared to the then-available standard intravenous test of GH releasing hormone (GHRH) followed by arginine (ARG) which had an 86% sensitivity and 90% specificity. Study Design 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.
Each patient received two dosing regimens in random order, while fasting, at least 1 week apart. One regimen consisted of a 1 µg/kg (max. 100 µg) dose of GHRH (Geref Diagnostic®, Serono) with 30 g of ARG (Ar-Gine®, Pfizer) administered intravenously over 30 minutes; the other regimen was a 0.5 mg/kg dose of AEZS-130 (macimorelin, SolorelTM) given in an oral solution of 0.5 mg/ml.
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).
The poster titled, "AEZS-30 (Macimorelin, SolorelTM) an Oral Ghrelin Mimetic GH Secretagogue, as a Potential Diagnostic Test for Adult GH Deficiency", Biller, Beverly M.K., M.D., K.C.J. Yuen, V. Bonert, M. Chen, A. Dobs, J.M. Garcia, M. Kipnes, M. Molitch, R. Swerdloff, C. Wang, D. Cook, I.R. Altemose, G.R. Merriam is available at http://www.5grs-igf.org/final_grs_igf_abstracts.pdf. About AEZS-130 (macimorelin, SolorelTM) AEZS-130 (macimorelin, SolorelTM), currently in a Phase 3 trial as a diagnostic test for AGHD, has been granted Orphan Drug Designation for this indication by the FDA. A novel, oral ghrelin agonist AEZS-130 (macimorelin, SolorelTM) works by binding to the growth hormone secretagogue receptor GHS-R1A, which is the receptor for the physiological peptide ligand ghrelin. This mechanism of action was determined previously by binding studies assessing the affinity for the GHS-R1A by using membrane preparations from human pituitary gland, as well as transiently expressing LLC-PK1 cells (ref. 1).
Reference 1: Guerlavais et al. (2003). New active series of growth hormone secretagogues. J. Med. Chem. 46, 1191-1203. About AGHD 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. About Aeterna Zentaris Inc. Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential novel treatments for multiple myeloma, colorectal, prostate, bladder, ovarian and endometrial cancers. The company's innovative approach is to tailor treatments to a patient's specific condition and unmet medical needs. The Company's deep pipeline is drawn from its own research and development library of 120,000 molecules, delivering constant and long-term access to state-of-the-art therapeutic options. For more information please visit www.aezsinc.com. Forward-Looking Statements This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are required by a governmental authority or applicable law.
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