AVANT Completes Enrollment in CETi-1 Phase II Study
NEEDHAM, Mass.--(BW HealthWire)--Aug. 1, 2002--AVANT Immunotherapeutics, Inc. (NASDAQ: AVAN - News) announced today it has completed enrollment in the placebo-controlled Phase II study of its cholesterol management vaccine (CETi-1) in approximately 200 subjects with low levels of HDL (high-density lipoprotein) cholesterol.
AVANT's cholesterol management agent, CETi-1, is designed to raise serum HDL (high-density lipoprotein) cholesterol levels by blocking the transfer of cholesterol from HDL to LDL (low-density lipoprotein). CETi-1 induces antibodies against a portion of CETP, the serum protein responsible for this transfer. HDL (often referred to as 'good' cholesterol) acts to protect against atherosclerosis while LDL (often referred to as 'bad' cholesterol) acts to promote atherosclerosis.
"We have completed enrollment of all subjects in this study, with the highest dose group having received their initial injection," said Alistair Wheeler, MD, Vice President, Medical Affairs of AVANT Immunotherapeutics, Inc. "This injection is followed by additional vaccinations at 4 weeks and 8 weeks, with a final booster at 6 months. We then follow the subjects for an additional six months until one year after their initial injection.
"We are half way through this important two year study, and we are on schedule to report results in the second half of 2003," Dr. Wheeler concluded.
"We are very pleased to have achieved such a significant milestone in this lengthy trial," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics, Inc. "We are hopeful that this investigational vaccine will offer new avenues for helping people more effectively manage their cholesterol, something that research is showing has importance for a variety of medical conditions."
AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human immune system to prevent and treat disease. The company is developing a portfolio of vaccines against viral and bacterial diseases, including single-dose oral vaccines aimed at protecting travelers from cholera, typhoid fever and other illnesses. In addition, the company is conducting clinical studies of a proprietary vaccine candidate for cholesterol management. AVANT further leverages the value of its technology portfolio through corporate partnerships. Current collaborations encompass the development of an oral human rotavirus vaccine, vaccines to combat threats of biological warfare, and vaccines addressed to human food safety and animal health.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our 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 CETi-1 and of other products; (2) the cost, timing, scope and results of ongoing safety and efficacy trials of CETi-1 and other preclinical and clinical testing; (3) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies of CETi-1 and other products; (4) the ability of the Company to manage multiple late stage clinical trials for a variety of product candidates; (5) the volume and profitability of product sales of Megan®Vac 1 and other future products; (6) changes in existing and potential relationships with corporate collaborators; (7) the cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers (8) the timing, cost and uncertainty of obtaining regulatory approvals to use CETi-1, among other purposes, to raise serum HDL cholesterol levels and for other products; (9) the ability to obtain substantial additional funding; (10) the ability to develop and commercialize products before competitors; (11) the integration of Megan Health's business and programs; (12) the ability to retain certain members of management; and (13) other factors detailed from time to time in filings with the Securities and Exchange Commission.
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Contact:
AVANT Immunotherapeutics, Inc.
Una S. Ryan, 781/433-0771
Avery W. Catlin, 781/433-0771
info@avantimmune.com
or
For Media:
Kureczka/Martin Associates
Ellen Martin, 510/832-2044
jkureczka@aol.com |
