Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Alteon (ALT) -- Ignore unavailable to you. Want to Upgrade?

To: tnsaf who wrote (303)	11/21/2001 4:06:34 PM
From: tnsaf	Read Replies (1) \| Respond to of 318

Alteon Initiates Second Phase IIb Trial of ALT-711 in Systolic Hypertension - Compound May Have Broad Beneficial Effect In Reversing Cardiovascular Disease - RAMSEY, N.J., Oct. 23 /PRNewswire/ -- Alteon Inc. (Amex: ALT - news) announced today that it has initiated a second Phase IIb trial of ALT-711, an orally active drug that has demonstrated a broad beneficial effect in reversing cardiovascular disease. The SILVER (Systolic Hypertension Interaction with Left VEntricular Remodeling) trial will evaluate the blood pressure lowering effects of ALT-711 in patients who have systolic hypertension and left ventricular hypertrophy (LVH), a thickening of the heart tissue that results from hypertension. LVH can lead to decreased cardiac output, the inability to meet the circulatory needs of the body, and to heart failure itself. ALT-711 is concurrently being tested in humans with systolic hypertension alone in the Phase IIb SAPPHIRE (Systolic And Pulse Pressure Hemodynamic Improvement by Restoring Elasticity) trial, which was initiated in July 2001. Patients who are excluded as patients in the SAPPHIRE trial because of LVH will be target candidates for the SILVER trial. The SAPPHIRE and SILVER trials collectively will enroll 630 patients, with data expected in the second half of 2002. ALT-711 is the most clinically advanced drug in a new class of compounds, known as Advanced Glycosylation End-product (A.G.E.) Crosslink Breakers, which were discovered by Alteon. By ``breaking'' the pathological bonds that cause tissues, organs and vessels to stiffen and lose function over time, ALT-711 has demonstrated the ability to reverse certain age-related and diabetes-related conditions. In a 93-patient Phase IIa clinical trial, treatment with ALT-711 resulted in statistically significant and clinically meaningful effects of increasing vascular wall elasticity and lowering pulse pressure, each major contributing factors in cardiovascular disease. ``The SILVER trial is an important addition to our overall clinical strategy,'' said Robert C. deGroof, Senior Vice President, Scientific Affairs. ``Evaluating the interaction between systolic hypertension and LVH in the SILVER trial will help us build a solid foundation for a subsequent pivotal Phase III program.'' ``The results from these trials are critical in providing further proof of the value of A.G.E. compounds and ALT-711 in treating cardiovascular disease,'' said Kenneth I. Moch, Chairman and CEO. ``Its mechanism of action is new and novel, and is unrelated to that of any pharmaceutical agent either currently prescribed or in clinical development. Importantly, as in our Phase IIa trial, the ongoing SAPPHIRE and SILVER trials will use ALT-711 in addition to currently prescribed hypertension medications. Market estimates indicate that 15-20 million patients in the U.S. suffer from systolic hypertension.'' Additional background information on systolic hypertension follows this press release. The SILVER and SAPPHIRE Trials The SILVER trial will test ALT-711 in 180 patients at the approximately 40 sites throughout the United States that are also conducting the ongoing 450 patient SAPPHIRE trial. Recruited patients will be randomized to one of two treatment arms and receive ALT-711 or placebo tablets once a day for three months, in addition to their existing medications. Patients enrolled in the trial must be older than 50 years of age, have a systolic blood pressure of greater than 160 mmHg and diastolic blood pressure of less than 90 mmHg, and have thickening of the left ventricle of the heart as measured by echocardiography. The trial will include males and female, non-diabetic and diabetic patients. As with the SAPPHIRE trial, the primary endpoints of the study will be the change in systolic blood pressure, and change in pulse pressure (the difference between the systolic and diastolic blood pressure). In addition, secondary endpoints will include additional blood pressure measurements and change in certain urological characteristics. ALT-711: Consistent Beneficial Data in Cardiovascular Disease Through its unique mechanism of action, ALT-711 is the first compound in development that breaks A.G.E.-derived crosslinks between proteins, potentially restoring flexibility and function to tissues, vessels and organs throughout the body. Normal structure and function is preserved while abnormal crosslinking is reduced. Evidence of the positive effect of ALT-711 on the cardiovascular system continues to grow. In a Phase IIa human trial, 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, increasing the ability of the diseased large arteries to stretch by 11-18%, and bringing them approximately 30% back to normal. The study was designated as ``breakthrough information'' and selected for ``Rapid Track'' publication in Circulation: Journal of the American Heart Association, and was published in the September 25, 2001, issue of the journal. Earlier in 2001, the ALT-711 Phase IIa data was featured at the March 2001 American College of Cardiology (ACC) meeting in a ``Late Breaking Clinical Trials Special Scientific Session'' and further chosen as one of four highlights of the Hypertension Section of the ACC meeting. Evidence that ALT-711 may be effective for improving cardiovascular remodeling in hypertension was presented by University of Minnesota researchers at the American Heart Association's 55th Annual Fall Conference and Scientific Sessions of the Council for High Blood Pressure Research on September 23, 2001. This preclinical study demonstrated the ability of ALT-711 to decrease the thickening of the heart and improve the function of the endothelium in rats with hypertension. The research team tested ALT-711's ability to selectively break the cross-linking of collagen that contributes to cardiovascular disease in aging and diabetes. ALT-711 normalized left ventricular fibrosis, or the thickening of the left ventricle of the heart, and improved the function of the endothelium, the part of the cardiovascular system that regulates both the relaxation and contraction of blood vessels and contributes to the maintenance of the vascular structure. Preclinical studies of ALT-711 conducted by researchers from The National Institute on Aging and Johns Hopkins Geriatric Center demonstrated the ability of the compound to significantly reduce arterial stiffness in elderly monkeys. Another study, in aged dogs, found that administration of ALT-711 for one month resulted in an approximate 40% decrease in age-related ventricular stiffness. This decrease was accompanied by an overall improvement in cardiac function. Reductions in blood pressure have also been observed in preclinical models of diabetic hypertension.