By Charles Craig
Results from a Phase II trial of Alteon Inc.'s pimagedine for prevention of diabetes-related complications showed the drug lowered cholesterol and albumin levels, which are markers for dyslipidemia and kidney disease.
Kenneth Moch, chief financial officer of Alteon, said the Phase II trial was conducted in Israel and enrolled 90 Type II diabetes patients with dyslipidemia, which is high cholesterol. The patients were randomized to receive either pimagedine or a placebo.
The findings, Moch said, support the Ramsey, N.J., company's belief that pimagedine has the potential to be "a broad spectrum" treatment for prevention of diabetic complications, such as kidney disease, retinopathy and dyslipidemia, which leads to atherosclerosis.
The drug is in two Phase III trials for prevention of kidney disease associated with Type I and Type II diabetes. Results are expected in mid-1998 from the study involving Type I diabetics and in mid-1999 for the trial with Type II diabetics.
Pimagedine is designed to inhibit formation of advanced glycosylation end-products (AGE) by preventing glucose from binding to proteins. Accumulation of AGE is associated with elevated glucose levels, such as those found in diabetes patients, and can cause damage to the kidneys and other organs. When glucose links up with proteins it changes their structure from flexible to stiff, causing cells, tissues and blood vessels to harden.
An indication diabetes is damaging kidneys is high levels of albumin in urine. In the Phase II Israel trial, pimagedine lowered albumin levels by an average of 40 percent.
As for pimagedine's potential effect on lipid, or cholesterol, levels, Alteon officials suggested one way lipids can build to dangerously high levels is when glucose binds with low density lipoproteins (LDL), changing their structure and preventing them from being cleared from the blood.
In the Israel trial, Alteon officials said, statistical significance was achieved in lowering lipid levels, suggesting pimagedine was performing its task of blocking glucose from attaching to LDL.
Alteon's stock (NASDAQ:ALTN) closed Thursday at $4.25, up $0.625. *