Keep an eye on ALT today.
Alteon's ALT-711 Reduces Left Ventricular Mass in Diamond
Trial Patients
Tuesday January 21, 8:15 am ET
- Positive Results from Preliminary Analyses Support Drug's Potential in DHF -
RAMSEY, N.J., Jan. 21 /PRNewswire-FirstCall/ -- Alteon Inc. (Amex: ALT - News) today announced
positive results from a preliminary analysis of the Phase IIa DIAMOND clinical trial evaluating the activity
of ALT-711 in diastolic heart failure (DHF) patients. The DIAMOND trial is ongoing, and additional
analyses of the data are being conducted.
Patients who received ALT-711 for 16 weeks
experienced a statistically significant reduction in
left ventricular mass, in a preliminary analysis of
the first 17 patients in the DIAMOND trial.
DIAMOND patients also had a marked
improvement in left ventricular diastolic filling.
Additionally, the drug had a positive effect on
patients' quality of life, as measured by a
well-established heart failure/quality of life
questionnaire. Measurements of exercise
tolerance and aortic distensibility proved to be
more variable than anticipated for a study of this
size and were not reportable.
"These results have importance because DHF is
the most common form of heart failure in the
elderly population. To date, there is no proven
specific therapy," said Dalane W. Kitzman, M.D.,
Associate Professor of Medicine and Cardiology at Wake Forest University Baptist Medical Center, and
an investigator in the trial. "Though this was a small pilot study, these data suggest that ALT-711 may be
useful in this disorder." Dr. Kitzman's research, recently published in the Journal of the American Medical
Association and the Annals of Internal Medicine, has been critical to the characterization and
identification of diastolic heart failure as a more common condition than previously thought, particularly in
people aged 65 and older, and especially in women.(1,2)
DHF is a poorly treated medical condition that is characterized by the inability of the heart to relax
properly and fill with blood, due to stiffening of the heart and subsequent impaired relaxation of the left
ventricle. Diastolic dysfunction is estimated to account for 30-50% of all heart failure cases, which total
nearly 5 million cases in the U.S. alone.
"The results of the DIAMOND trial are important to Alteon because we have seen another meaningful
signal of ALT-711's beneficial effect in cardiovascular disease, and offer additional guidance for the clinical
program that lies ahead," said Kenneth I. Moch, President and Chief Executive Officer of Alteon. "These
findings are consistent with previous preclinical work which demonstrated ALT-711's ability to remodel the
diseased heart."
The DIAMOND (Distensibility Improvement and Remodeling in Diastolic Heart Failure) study was
conducted at Wake Forest University Baptist Medical Center and the Medical University of South
Carolina in patients at least 60 years of age with isolated DHF. In the DIAMOND trial, twenty-three
patients received 210 mg of ALT-711 twice daily on an open-label, outpatient basis for 16 weeks in
addition to their current medications, which included ACE inhibitors or angiotensin II antagonists,
beta-blockers and diuretics. Primary endpoints included changes in exercise tolerance and aortic
stiffness; effects on left ventricular hypertrophy, diastolic filling and quality of life (QOL) were also
assessed.
"We look forward to the presentation of the detailed data from the DIAMOND trial in an appropriate
scientific forum and journal," said Moch, "and to reporting results from the ongoing Phase IIb SAPPHIRE
and SILVER trials of ALT-711 in systolic hypertension later this year."
ALT-711 offers promise as a novel therapy for DHF because currently available therapies do not
specifically target the stiffening heart and vessel walls caused by pathological glucose-protein matrixes
called Advanced Glycosylation End-product (A.G.E.) Crosslinks. The formation of A.G.E. Crosslinks is a
natural part of the aging process that can lead to stiffening and loss of function in tissues, organs and
vessels including the heart and large arteries. In previous human clinical testing, ALT-711 has shown the
ability to restore elasticity to blood vessel walls by cleaving A.G.E. Crosslinks.(3) Additionally, in several
preclinical studies ALT-711 has been shown to normalize the thickening of the left ventricle and remodel
the heart.(4)
ALT-711 is currently in two additional human clinical trials. The Phase IIb SAPPHIRE and SILVER trials
have enrolled over 760 patients in order to evaluate the compound's effectiveness in patients with elevated
systolic blood pressure without or with enlargement of the left ventricle of the heart. Like diastolic heart
failure, systolic hypertension results from age-related or diabetes-related stiffening of the cardiovascular
system, and is a key factor in coronary heart disease in individuals over the age of 50.
Alteon Conference Call
Alteon is holding an analyst/investor conference call today, January 21, 2003, at 2:00 PM, Eastern Time.
To access this call live, please dial 1-800-915-4836. Callers outside of the United States, please call
+973-317-5319. This call will be archived on the Company's website at alteon.com and will be
rebroadcast until January 28, 2003 at 11:59 PM, at 1-800-428-6051, passcode 283288. Callers outside of
the United States, please call +973-709-2089, passcode 283288. |
