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Positive phase II results reported on cholesterol management vaccine.
2003 NOV 19 - (NewsRx.com & NewsRx.net) -- Avant Immunotherapeutics, Inc., (AVAN) announced positive preliminary results from a placebo-controlled phase II clinical study of its experimental cholesterol management vaccine, CETi-1.
Results showed that the vaccine was well-tolerated, immunogenic and produced an increase in HDL-cholesterol from baseline in all groups. For the high dose group, the increase in HDL-cholesterol from baseline was statistically significant. This increase was greater than the increase in HDL-cholesterol for the placebo population, but the difference was not statistically significant.
The study was designed to investigate the ability of CETi-1 to increase HDL-cholesterol in two groups of patients, those who were taking statin therapy and those who were not. In the population who were not receiving statin therapy (approximately two-thirds of the patients in the clinical trial) the high dose group of patients demonstrated an 8.4% increase in HDL-cholesterol, which met the primary endpoint for this study as the increase was statistically significant from both baseline and placebo. For the population who were concurrently using statins, however, the study did not show significant changes in HDL-cholesterol.
"We are very pleased that the vaccine worked as designed to elicit anti-CETP antibodies in an extremely high percentage of patients treated, approximately 90%," said Una S. Ryan, PhD, Avant president and CEO. "We are analyzing the complex data from this clinical trial and will evaluate all possibilities for the continued development of this vaccine, including the possibility of initiating an additional phase II study at different doses, with different frequency of treatment or in a different patient population. We may also explore changes in the vaccine's formulation to elicit a more robust antibody response.
The 203 patients participating in the trial received either placebo or vaccine at one of three doses, followed by additional vaccinations at ...
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