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Alagebrium: 2010 - A Breakthrough Year in Aging Research?

Mark Twain: "The reports of my death have been greatly exaggerated"






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February 1, 2010

Alagebrium: 2010 - A Breakthrough Year in Aging Research?

Numerous lines of evidence suggest that the major difference between old people and young people is not in their cells but in the extracellular matrix which surrounds their cells. Random collisions between highly reactive molecules and cellular constituents such as proteins can produce harmful cross links between molecules. Cells have mechanisms which can repair the damage caused by these collisions within the cells themselves but no such mechanisms exist to repair the damage to the environment in which the cells live. Alagebrium (ALT-711) is one of the promising new drugs called "cross link breakers" which can put this hypothesis to the test. Cross link breakers offer mankind the promise of an indefinite lifespan, if not immortality.

"Alagebrium is an AGE-breaker, a compound that dissolves some forms of advanced glycation end-products (AGEs), compounds implicated in the damage of aging. Unfortunately, the specific types of AGEs affected by alagebrium, also known as ALT-711, are more important in rats than humans. The promising results in animals were never replicated in human studies. It now seems that the company running human trials to find some beneficial use for alagebrium is giving up the ghost: "Synvista Therapeutics, Inc. today announced that, following a review of its clinical development portfolio and its current financial status, the Board of Directors and management have determined that it is in the best interest of the Company to focus its resources on maximizing the value of its diagnostic assets and to terminate all ongoing clinical trials of its product candidates alagebrium ... In light of the Company's cash position and current negative economic and capital markets conditions, if the Company is unable to enter into such transactions in a timely manner, the Company's ability to continue operations beyond the second quarter of 2009 is in doubt."

The End of ALT-711 / Alagebrium

Mark Twain: "The reports of my death have been greatly exaggerated"

"The reports of my death have been greatly exaggerated."

This is also true of the reports of the demise of ALT-711. They are taking volunteers for a new study for this year.

"New evidence suggests that the structural plasticity of myocardial cells in the elderly may be functionally constrained by the accumulation of toxic metabolites called advanced glycation end-products (AGEs). AGEs are arrays of protein which have been non-enzymatically cross-linked by sugars; these arrays increase the stiffness of arterial walls and the myocardium. Investigators have recently developed a drug capable of cleaving AGE cross-links. Termed ALT-711, this drug has been shown to be safe in human studies with varying degrees of efficacy on endpoints such as blood pressure and non-invasive indices of diastolic function. Based on animal studies, we hypothesize that AGE cross-links must be broken before a meaningful improvement in cardiac compliance can occur with exercise training in sedentary seniors.

Hypothesis: We hypothesize that AGE cross-links must be broken before a meaningful improvement in cardiac compliance can occur with exercise training in previously sedentary seniors; the combination of the AGE cross-link breaker, ALT-711, with exercise training will be superior to either intervention alone in improving cardiac compliance in these subjects.

Specific Aim: To test this hypothesis, we will study four groups of previously sedentary senior subjects for one year with the following interventions: A) sedentary controls taking placebo; B) sedentary subjects taking ALT-711; C) subjects undergoing moderate intensity exercise training while taking placebo and D) subjects undergoing moderate intensity exercise training while taking ALT-711...

The risks of the study are primarily imposed by the dosing of our investigational drug, which has a favorable side effect profile, and the placement of a peripherally inserted right heart catheter, which carries minimal risk when placed by an experienced cardiovascular specialist in a catheterization lab. Hence, in the final analysis, we feel the benefits to both the enrolled individual and to society far outweigh the risks of participation."

Eligibility

Ages Eligible for Study:

65 Years to 80 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: Yes

The Effect of Exercise and Alagebrium on the Diastolic Function of the Heart (AGE)

Experimental Drug Decreases Age-Related Blood Vessel Stiffening

Beneficial effects of C36, a novel breaker of advanced glycation endproducts cross-links, on the cardiovascular system of diabetic rats

Alagebrium

James Francis Durante on being young at heart






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