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AEterna Zentaris (AEZS): FDA Grants IND to Investigator at Baylor College of Medicine for Phase 2A Trial with AEZS-130 in Cancer Cachexia



11/28/2011 11:51:42 AM

QUÉBEC CITY, Nov. 28, 2011 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the U.S. Food and Drug Administration (FDA) has granted Jose M. Garcia, MD, PhD, Assistant Professor, Division of Diabetes Endocrinology and Metabolism, Departments of Medicine and Molecular and Cell Biology, Baylor College of Medicine and Michael I. DeBakey Veterans Administration Medical Center, in Houston Texas, an Investigational New Drug (IND) approval for the initiation of a Phase 2A trial to assess the safety and efficacy of repeated doses of the Company's ghrelin agonist, AEZS-130 (macimorelin), in patients with cancer cachexia. Cachexia, which is characterized by diminished appetite and food intake in cancer patients, is defined as an involuntary weight loss of at least 5% of the pre-illness body weight over the previous 6 months.

Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "This trial is further proof of the versatile potential of AEZS-130. Not only are we developing AEZS-130 as a supportive treatment in cancer care, but we are also developing it as the first oral diagnostic test for Adult Growth Hormone Deficiency for which we have already initiated the preparation for an NDA filing in the United States."

Jose M. Garcia, MD, PhD, the principal investigator added, "Weight loss and decreased appetite (cachexia and anorexia) are devastating complications of cancer. However, treatments for this condition are lacking. Ghrelin agonists have the potential of benefiting these patients by virtue of their anabolic and appetite-stimulating properties. The current proposal will explore the safety and efficacy of the novel ghrelin agonist, AEZS-130, in this setting. If effective, this could allow subjects to receive more effective doses of chemotherapy and to have a better functional status. The results generated by the proposed experiments will set the bases for future trials in this and other wasting conditions that also are very prevalent including chronic obstructive pulmonary disease (COPD), renal failure or chronic heart failure (CHF)-induced cachexia."

The Study

This is a double-blind, randomized, placebo-controlled Phase 2A trial to test the effects of different doses of the ghrelin agonist, AEZS-130, in 18 to 26 patients with cancer-cachexia. The study will be conducted under a cooperative research and development agreement (CRADA) with the Michael I. DeBakey Veterans Administration Medical Center which will be funding the study. AEZS-130 will be provided by Aeterna Zentaris. The study will involve 3 sequential groups receiving differing doses of AEZS-130. Each dose group will have 6 patients who will receive AEZS-130 and 2 patients who will receive placebo. After analysis of safety and efficacy at each dose level vs. placebo, a decision will be taken either to decrease or increase the dose. If there are major safety issues, the study will be stopped. For this study, adequate efficacy will be defined as a 0.8 kg of body weight gain or a 50 ng/mL increase in plasma IGF-1 levels. The primary objective of the study is to evaluate the safety and efficacy of repeated oral administration of AEZS-130 at different doses daily for 1 week in view of developing a treatment for cachexia. The following parameters will be recorded to assess efficacy during the study: change of body weight, change of IGF-1 plasma levels, and change of quality of life score (Anderson Symptom Assessment Scale, FACIT-F). Other secondary objectives will include food intake, change of appetite, muscle strength and energy expenditure.

About Cancer Cachexia

Over 1,500,000 new diagnoses of cancer are made in the U.S. every year. In most cases, this condition can have a significant impact on the individuals' survival and quality of life. Cachexia, a complex metabolic syndrome associated with underlying illness, is common in patients with cancer. These patients have diminished appetite, food intake and insulin sensitivity which contribute to a decrease in functional performance, takes a heavy toll on patients' quality of life and is associated with poor survival.

Despite the significant burden that cachexia and other cancer-related symptoms such as anorexia and poor functional status represent to cancer patients, these symptoms often remain undiagnosed and untreated. Moreover, there are currently no approved treatments for cancer-related cachexia and off-label treatments used for this condition such as appetite stimulants (e.g., megestrol acetate) are largely ineffective and are associated with potentially serious side effects (i.e., adrenal insufficiency, hypogonadism, deep venous thrombosis, etc).

About AEZS-130

AEZS-130, a ghrelin agonist, is a novel orally active small molecule that stimulates the secretion of growth hormone. It can be used in both endocrinology and in oncology indications. In endocrinology, the Company has completed a Phase 3 trial for use as a simple oral diagnostic test for adult growth hormone deficiency (AGHD). AEZS-130 works by stimulating a patient's growth hormone secretion, which normally only occurs during sleep, after which a healthcare provider will measure how well the body responds to that stimulation based on the patient's growth hormone levels over a period of time. Low growth hormone levels, despite giving an effective stimulating agent, confirm a diagnosis of AGHD. AEZS-130 has been granted orphan-drug designation by the FDA for use as a diagnostic test for growth hormone deficiency. Aeterna Zentaris owns the worldwide rights to AEZS-130 which, if approved, would become the first orally administered diagnostic test for AGHD. In oncology, an IND has been granted for a Phase 2A trial with AEZS-130 in cancer induced cachexia, a disease which leads to significant weight loss and diminished functional performance. Since ghrelin agonists such as AEZS-130 have been shown to stimulate food intake and increase body weight in rats and mice, AEZS-130 could lead to better quality of life for patients with cancer induced cachexia. Ghrelin agonists have been in clinical trials for over a decade and have demonstrated good safety and efficacy profiles.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential treatments for various cancers including colorectal, multiple myeloma, endometrial, ovarian, prostate and bladder cancer. The Company's innovative approach of "personalized medicine" means tailoring treatments to a patient's specific condition and to unmet medical needs. Aeterna Zentaris' deep pipeline is drawn from its proprietary discovery unit providing the Company with 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 harbour provisions of the U.S. 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, 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 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 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, unless required to do so by a governmental authority or by applicable law.


SOURCE AETERNA ZENTARIS INC.


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