Thursday, June 25, 2015 8:05:13 AM
7:30 am ET June 25, 2015 (PR Newswire)
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company") announced today that it has executed a definitive agreement with Ergomed PLC ("Ergomed"), pursuant to which Ergomed will manage the new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen(TM) (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD").
David A. Dodd, Chairman, President and Chief Executive Officer of the Company remarked regarding the selection of Ergomed, "We have great confidence in Ergomed's ability to conduct our confirmatory clinical study of Macrilen(TM) on schedule and within budget. Ergomed's performance as our clinical research organization supporting our pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer has been excellent. We are committed to Macrilen(TM) because of our confidence in its efficacy and safety and the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD."
Miroslav Reljanovic, M.D., CEO of Ergomed said, "We are delighted that Aeterna Zentaris has selected us to manage their confirmatory study of Macrilen(TM). We have a strong and deep working relationship with the Company's scientific staff and hold them in the highest regard."
About the Study
The confirmatory Phase 3 clinical study of Macrilen(TM) will be conducted as a two-way crossover study with the insulin tolerance test as the benchmark comparator. The study population will consist of patients with a medical history documenting risk factors for AGHD and will include a spectrum of patients from those with a low risk of having AGHD to those with a high risk of having the condition. Based on meetings with the US FDA as well as the European Medicines Agency (the "EMA") and subsequent written scientific advice, the Company believes that the study meets FDA's and EMA's study-design expectations allowing US and European approval, if successful.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin, under the trade name MacrilenTM, has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this novel patented compound.
About Adult Growth Hormone Deficiency (AGHD)
AGHD affects approximately 75,000 adults across the U.S., Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that 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 and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the potential inability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance 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, unless required to do so by a governmental authority or by applicable law.
SOURCE Aeterna Zentaris Inc.
Recent AEZS News
- Aeterna Zentaris Announces Effective Date of Share Consolidation • GlobeNewswire Inc. • 05/01/2024 11:55:00 AM
- Ceapro Receives Final Court Approval for Merger with Aeterna Zentaris • GlobeNewswire Inc. • 03/28/2024 11:55:00 AM
- Ceapro Receives Final Court Approval for Merger with Aeterna Zentaris • GlobeNewswire Inc. • 03/28/2024 11:55:00 AM
- Aeterna Zentaris Reports Fourth Quarter and Full Year 2023 Financial Results and Announces Completion of Enrollment in Ongoing Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency • GlobeNewswire Inc. • 03/27/2024 12:05:00 PM
- Aeterna Zentaris and Ceapro Merger Approved by Securityholders at Special Meetings • GlobeNewswire Inc. • 03/12/2024 06:10:53 PM
- Aeterna Zentaris and Ceapro Merger Approved by Securityholders at Special Meetings • GlobeNewswire Inc. • 03/12/2024 06:10:00 PM
- Leading Independent Proxy Advisory Firm ISS Recommends Aeterna Zentaris and Ceapro Securityholders Vote FOR the Arrangement Agreement to Approve the Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 02/26/2024 12:30:00 PM
- Leading Independent Proxy Advisory Firm ISS Recommends Aeterna Zentaris and Ceapro Securityholders Vote FOR the Arrangement Agreement to Approve the Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 02/26/2024 12:30:00 PM
- Aeterna Zentaris Issues Letter to Shareholders and Management Proxy Circular Ahead of Special Meeting of Shareholders to Approve Merger of Equals with Ceapro • GlobeNewswire Inc. • 02/15/2024 10:50:00 PM
- Form F-1 - Registration statement for certain foreign private issuers • Edgar (US Regulatory) • 02/15/2024 09:54:45 PM
- Form 20-F/A - Annual and transition report of foreign private issuers [Sections 13 or 15(d)]: [Amend] • Edgar (US Regulatory) • 02/15/2024 02:33:18 PM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 12/22/2023 09:42:20 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/14/2023 12:50:09 PM
- Aeterna Zentaris and Ceapro Announce Merger of Equals to Create a Diversified Biopharmaceutical Company • GlobeNewswire Inc. • 12/14/2023 12:50:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/09/2023 01:05:28 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/09/2023 01:05:15 PM
- Aeterna Zentaris Reports Third Quarter 2023 Financial Results • GlobeNewswire Inc. • 11/09/2023 01:00:00 PM
- Aeterna Zentaris to Participate at the Virtual Investor Ask the CEO Conference • GlobeNewswire Inc. • 10/11/2023 12:00:00 PM
- Aeterna Zentaris to Present at the H.C. Wainwright 25th Annual Global Investment Conference • GlobeNewswire Inc. • 09/05/2023 12:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2023 12:05:31 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2023 12:05:18 PM
- Aeterna Zentaris Reports Second Quarter 2023 Financial Results • GlobeNewswire Inc. • 08/09/2023 12:05:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/13/2023 11:30:15 AM
- Aeterna Zentaris Outlines Progress on Development Pipeline Programs and Provides Corporate Update • GlobeNewswire Inc. • 07/13/2023 11:30:00 AM
- Aeterna Zentaris to Participate in the Virtual Investor Summer Spotlight Series • GlobeNewswire Inc. • 07/05/2023 12:45:00 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM