Tripep drug ready for study on HIV patients in Thailand

The Swedish biotechnology company Tripep AB, which is 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 in Thailand.
     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 drug 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 alpha-HGA, 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.

Related Posts

Leave a Reply

Your email address will not be published. Required fields are marked *