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AVANT Completes Enrollment in Phase I Study of CETP Vaccine in Healthy Volunteers
NEEDHAM, Mass., Feb. 3 /PRNewswire/ -- AVANT Immunotherapeutics (Nasdaq: AVAN) today announced the completion of enrollment in a double-blind placebo controlled, Phase I trial of its CETP vaccine (CETi-1) in 48 adult volunteers. The trial is being conducted at the Chicago Center for Clinical Research under the supervision of Principal Investigator Dr. Michael Davidson, a leading authority on cholesterol metabolism. The objective of the study is to evaluate the safety of CETi-1 in adults. CETi-1 is being developed for the management of patients with low levels of HDL (high-density lipoprotein) cholesterol. HDL at proper levels has the potential to reduce atherosclerosis and consequently heart disease.
CETi-1 is designed to raise serum HDL cholesterol levels by blocking the transfer of cholesterol from HDL to LDL (low-density lipoprotein). HDL (often referred to as 'good' cholesterol) acts to protect against atherosclerosis while LDL (often referred to as 'bad' cholesterol) acts to promote atherosclerosis. CETi-1 induces antibodies against a portion of the serum protein responsible for this transfer, cholesteryl ester transfer protein (CETP). Atherosclerosis is an underlying cause of heart attacks, strokes, and peripheral vascular disease, and the cause of over 50% of the deaths in the Western World.
"We are delighted to have completed enrollment on schedule," said Alistair Wheeler M.D., Vice President, Medical Affairs at AVANT. "All 48 patients have been treated and are in the follow up period of the study. Dr. Davidson and his staff have done an outstanding job of recruiting patients and collecting high quality data." The study is placebo-controlled and the results remain blinded to everybody concerned. The object of the study is to demonstrate the safety of single administrations of CETi-1 at four different dosage strengths.
"This study was not designed to demonstrate efficacy," emphasized Dr. Wheeler, "and, given the Phase I dosing regimen, we would not expect to see an antibody response. That will likely have to wait for Phase II, which we look forward to initiating as soon as we have received the data from Phase I."
Michael Davidson MD, Principal Investigator in the study and CEO of the Chicago Center for Clinical Research said, "We are very pleased to have completed enrollment for this study. Low HDL-cholesterol is a major risk factor for ischemic heart disease and inhibition of CETP is a very appropriate therapeutic target in our efforts to reduce the incidence of atherosclerosis. I am very excited about the potential for a CETP vaccine as a treatment to reduce the incidence of heart disease."
AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human immune response to prevent and treat disease. The Company's lead therapeutic program is focused on compounds that inhibit the inappropriate activity of the complement cascade that is a vital part of the body's immune defense system. The Company is also engaged in the development of Therapore(TM), a novel system for the delivery of immunotherapeutics for chronic viral infections and certain cancers. The Company and its collaborators are developing vaccines using its proprietary adjuvants, Adjumer(R) and Micromer(R), for the prevention of respiratory syncytial virus (RSV), Lyme disease, and several other vaccine targets. In a further collaboration, the Company is developing an oral human rotavirus vaccine, and is developing its own proprietary vaccine for the management of atherosclerosis.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through the Company's site on the World Wide Web: avantimmune.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements which reflect AVANT's current views with respect to future events and financial performance. The words "believe," "expect," "anticipate," and similar expressions identify forward-looking statements. Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: (1) the ability to successfully complete development and commercialization of products, including the cost, scope and results of preclinical and clinical testing; (2) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies; (3) changes in existing and potential relationships with corporate collaborators; (4) the time, cost and uncertainty of obtaining regulatory approvals; (5) the ability to obtain substantial additional funding; (6) the ability to develop and commercialize products before competitors; and (7) other factors detailed from time to time in filings with the Securities and Exchange Commission.
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SOURCE: AVANT Immunotherapeutics, Inc.
CONTACT: Una S. Ryan, Ph.D., President and CEO, 781-433-0771, or Avery W. Catlin, Chief Financial Officer, 781-433-0771, both of AVANT Immunotherapeutics, info@avantimmune.com, or Media: Joan Kureczka or Jesse Fisher of J. Kureczka Associates, 415-821-2413, jkureczka@aol.com |
