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Drug Mechanism of Action Heart Rate Blood Pressure
CA-AmylineŽ Modifies Metabolism: Improves Oxygen Efficiency No* Effect No* Effect
Beta Blockers Reduce Pump Function  chrtarrw.gif (136 bytes)  chrtarrw.gif (136 bytes)
Calcium Channel Blockers Dilate Arteries/ Reduce Pump Function  chrtarrw.gif (136 bytes)  chrtarrw.gif (136 bytes)
Nitrates Dilate Arteries  and Veins No Effect  chrtarrw.gif (136 bytes)
Mechanisms of Anti-anginal Drugs

*Clinical trials conducted to date indicate that CA-AmylineŽ has no effect on heart rate or blood pressure.  CA-AmylineŽ has not yet been approved by the FDA and clinical trials are currently underway to confirm this hypothesis

 

CA-AmylineŽ is being developed as a
new therapeutic for the potential
treatment of chronic stable angina,
the chest pain associated with
coronary heart disease. Studies to
date indicate that CA-AmylineŽ may
improve exercise duration without
lowering heart rate or blood
pressure. Clearing Plaque from arteries.

Studies indicate that CA-AmylineŽ
may cause a partial shift in the source
of energy for the heart from fatty acid
toward glucose, which is a more
oxygen efficient source of energy.

Clinical needs
Angina exists when cardiac work demand exceeds cardiac energy available. Current angina therapies all work by directly lowering cardiac work demand (heart rate and/or blood pressure). Published studies indicate that nearly 1/3 of the estimated 7.2MM US angina patients are inadequately treated with today’s therapies. Often these patients have other conditions, including congestive heart failure, chronic lung disease and diabetes. In addition, many of these patients are treated with multiple medications, all of which lower heart rate and/or blood pressure. These multiple medications can further impair the function of the weakened heart.

CA-AmylineŽ, with its unique metabolic mechanism of action, potentially
treats angina by increasing the cardiac energy available as the result of a
partial shift from fatty acid to glucose metabolism. Since glucose is a
more efficient energy source, CA-AmylineŽ may result in more cardiac
energy being produced for a fixed amount of oxygen available. This
profile could make CA-AmylineŽ especially useful for patients whose heart
function is impaired by heart failure or who require multiple other
anti-anginal drugs.

Development Status
LifeForce  has completed treatment, in 175 patients, of its first pivotal Phase
III clinical trial for CA-AmylineŽ. The trial is a randomized,
double-blind, placebo-controlled trial of CA-AmylineŽ used as
monotherapy.

LifeForce  is currently conducting its second pivotal Phase III clinical trial
for CA-AmylineŽ. The trial is a randomized, double-blind,
placebo-controlled trial of CA-AmylineŽ used in combination with other
anti-anginal drugs, in approximately 50 patients.

CA-AmylineŽ has been tested in more than 435 patients in Phase I, II
and III clinical trials in Mexico for the past four years.

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