Wednesday September 5, 11:29 am Eastern Time
Press Release
SOURCE: Alteon Inc.
Alteon's ALT-711 Phase IIa Study Published as 'Breakthrough Information' in Circulation, Journal of the American Heart Association
- Novel Drug Demonstrates Ability to Reverse Stiffening of Arteries That Occurs With Aging -
NOTE: Johns Hopkins Medicine and the National Institute on Aging have also issued press releases on this news. Their releases can be accessed at hopkinsmedicine.org and nih.gov
RAMSEY, N.J., Sept. 5 /PRNewswire/ -- Alteon Inc. (Amex: ALT - news) announced today that the Phase IIa study of its novel drug ALT-711, an Advanced Glycosylation Endproduct (A.G.E.) crosslink breaker, has been selected for ``Rapid Track'' publication in ``Circulation: Journal of the American Heart Association.'' The study, ``Improved Arterial Compliance by a Novel Advanced Glycation End-Product Crosslink Breaker,'' is now posted at the AHA Circulation web site, circulation.org, and the manuscript will be published in the September 28, 2001, issue of the journal. Rapid Track articles are designated by the journal editor as ``breakthrough information.''
In this study, ALT-711 was shown to restore the cardiovascular system to a younger state by reversing the stiffening of the arteries that occurs in aging patients. This progressive stiffening can result in systolic hypertension.
Study investigators at nine U.S. clinical sites tested the effects of ALT-711 on blood pressure and vascular elasticity in 93 individuals over the age of 50 with measurably stiffened vasculature including systolic blood pressure of at least 140 mmHg and pulse pressure of at least 60 mmHg. The Phase IIa study demonstrated that treatment with ALT-711 increased the ability of the diseased large arteries to stretch by 11-18%, reversing the pathologic stiffening and bringing them approximately 30% back to normal.
Study results showed that ALT-711 treatment also resulted in significantly reduced arterial pulse pressure, defined as the difference between systolic blood pressure (the upper number) and diastolic blood pressure (the lower number). In addition, the drug was well tolerated.
Vascular stiffening and its related increase in the heart's workload is a ``huge epidemiological problem, affecting about half of all individuals over the age of 60,'' said David A. Kass, M.D., lead author of the study and Professor of Medicine and Biomedical Engineering at Johns Hopkins University School of Medicine. ``Many recent epidemiological studies have shown that pulse pressure is the leading risk factor for cardiovascular disease in the elderly,'' he said.`` Left untreated, the condition can lead to high blood pressure, congestive heart failure or other disorders.'' The study was conducted by researchers at Johns Hopkins University School of Medicine, the National Institute on Aging and others.
The Phase IIa trial was a double-blind, placebo-controlled study. Patients in the study received oral tablets of ALT-711 or placebo for 56 days. Patients who were on other antihypertensive medications (nearly 90% of them), were maintained on their therapies throughout the course of the trial. Results with ALT-711 were over and above this standard treatment. The drug works directly on diseased structures of the vessel walls, distinguishing ALT-711 from any other cardiovascular drug currently prescribed.
ALT-711, an orally active thiazolium-based compound, is the first of a new pharmaceutical class that catalytically breaks bonds, or crosslinks, created in the arteries and other tissues when glucose attaches to a protein such as collagen or elastin. These glucose/protein complexes, or Advanced Glycosylation End-product (A.G.E.) crosslinks, result in ``hardened'' or toughened tissues and impaired flexibility and function of many body organs, including the heart. A.G.E. crosslinks, which accumulate with age and are accelerated in diabetes, have been implicated in some of the deterioration associated with aging and diabetes, such as elevated systolic blood pressure, stiffened arteries, impaired kidney function and retinopathy. ALT-711 offers the possibility of the first therapeutic approach to ``breaking'' A.G.E. crosslinks, the benefit of which may be to reverse tissue damage caused by aging and diabetes, thereby restoring flexibility and function.
Clinical Development Continues: The SAPPHIRE Phase IIb Trial of ALT-711
Based upon the positive Phase IIa data, Alteon recently has initiated the Phase IIb SAPPHIRE (Systolic And Pulse Pressure Hemodynamic Improvement by Restoring Elasticity) trial of ALT-711 in patients with isolated systolic hypertension (ISH). The SAPPHIRE trial extends the range of doses and the dosing period of ALT-711 in the previous Phase IIa trial and will continue to evaluate the drug's ability to lower systolic blood pressure and pulse pressure in aging and diabetic patients.
In the SAPPHIRE trial, ALT-711 will be tested in 450 patients at approximately 40 sites throughout the United States. Recruited patients will receive ALT-711 tablets once a day for six months, in addition to their existing medications. The study will consist of five treatment arms, comprised of four different dose levels of ALT-711 plus placebo. Patients enrolled in the trial must be older than 50 years of age and have systolic blood pressure of greater than 160 mmHg and diastolic blood pressure of less than 90 mmHg. The trial will include both non-diabetic and diabetic patients. Potential patients who meet these criteria and are interested in participating, can contact Alteon at clinicaltrialinformation@alteonpharma.com.
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