PRE-CLINICAL SAFETY AND TOXICITY TESTS OF ALPHA-HGA SHOW POSITIVE RESULTS
PRE-CLINICAL SAFETY AND TOXICITY TESTS OF ALPHA-HGA SHOW POSITIVE RESULTS Phase I/II study on HIV patients planned to start early 2005 Tripep AB (publ), the Swedish biotechnology company focusing on HIV therapy, has completed the pre-clinical safety evaluation studies on the Company's new anti-HIV candidate drug alpha-HGA necessary for the planned phase I/II clinical trial. The safety and toxicology studies were designed in accordance with international requirements for the safety evaluation of human pharmaceuticals and were performed by Scantox A/S in Denmark. These studies showed that alpha-HGA is a compound with very low toxicity. The in vitro and in vivo safety pharmacology studies showed that alpha-HGA had no untoward effect on the cardiovascular, respiratory and central nervous systems. In addition, the repeat dose (four weeks) in vivo toxicology studies showed that alpha-HGA when administered to rats and mini-pigs for four weeks did not produce any systemic toxicological effects. At doses of 50 times the anticipated human dose of alphaHGA, only signs of a local gastric irritant effect could be observed when administering the drug orally as a hydrochloride salt. "This is the most important data we have received to date and paves the way for us to take alpha-HGA into clinical trials. The data obtained from these studies will allow the clinical trial application and investigator's brochure to be finalised and submitted to the regulatory authorities in Thailand where the phase I/II clinical study on HIV infected individuals is planned to start early next year" says Tripep's CEO, Professor Anders Vahlne. Please also see today's press release regarding the financing of Tripep AB (publ). For more information, please contact: Rolf Nordström, Chairman, Tripep AB Tel: +44 20 7839 8686, mobile phone: +44 7776 137 400 E-mail: rolf.l.nordstrom@btinternet.com Anders Vahlne, CEO and Head of Research, Tripep AB Tel: +46 35 31755, mobile phone: +46 709-28 05 28 E-mail: anders.vahlne@labmed.ki.se Conor McCarthy, NCB, Dublin, Ireland Tel: +353 1 611 5989, mobile phone: +353 87 290 0409 E-mail: conor.mccarthy@ncb.ie Lisa Baderoon, Rebecca Skye Dietrich Buchanan Communications Tel: + 44 20 7466 5000, mobile phone: +44 7721 413 496 E-mail: lisab@buchanan.uk.com Notes to Editors: Tripep AB is a Swedish biotechnology research company that develops and commercialises candidate drugs based on patented technologies. Its main focuses are: - research and development of an HIV-inhibiting drug, - preclinical research focusing on the development of therapeutic and prophylactic vaccines against HIV and Hepatitis C, and - the RAS ® technology platform. For more details of the company's technologies, please refer to the company's web site at www.tripep.se ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2004/10/12/20041012BIT22240/wkr0001.pdf