New analysis method part of new plan for clinical development of GPG

New analysis method part of new plan for clinical development of GPG® Tripep's board has adopted a new plan for the clinical development of GPG® based on a newly developed method for direct measurement of GPG® in blood. Tripep has also filed a patent application for a breakdown product of GPG® with an antiviral effect. In previous clinical studies Tripep has not been able to measure the presence of GPG® in blood. Instead, it relied on an indirect method of measuring the presence of antiviral activity in blood after administration of GPG® The company has now developed a method that enables the direct measurement of GPG® concentrations in blood. Quality assurance of the method is expected to be completed by March/April 2002. Tripep has also found that one of the breakdown products of GPG® has a favorable HIV-inhibiting effect. GPG® is thus partly a "pro-drug," i.e., a molecule from which an active drug is created within the body. A separate patent application has been filed for this active breakdown product. An analysis method for this breakdown product is also under development. In the event that the breakdown product accounts for all or part of the HIV-inhibiting activity, the development of GPG® into a drug can nevertheless continue. When the above-described work has been completed (estimated in spring 2002), Tripep has decided - upon the advice of its Scientific and Clinical Advisory Boards, respectively - to start a new phase I study aimed at ascertaining the best administration form for GPG® The reason for this is that patients' uptake of GPG® in the ongoing phase II study is feared to have been affected by the dosage form used (gelatin capsules). Gelatin consists largely of the same amino acids as GPG® , and it is suspected that this might have hindered the uptake of GPG® from the intestines into the blood. Therefore, aiming at investigating this, other dosage forms, including a dose powder developed by Tripep, will be clinically evaluated. In parallel with this, GPG® may eventually also be administered by injection to another group. Contingent upon favorable results in these uptake studies on healthy volunteers, the start of a phase II clinical study is planned for the second half of 2002. The patients in the phase II study will be therapy- naive HIV-infected patients, i.e., patients who have not previously been treated for their HIV infection. The objective of the study is to determine if GPG® affects the replication of HIV in humans in the same beneficial way as has been shown in test tubes. For further information, please contact: Hans Möller, President and CEO, tel. +46-8-449 84 80, mobile: +46-708-15 16 89, e-mail: hans.moller@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/2001/12/12/20011212BIT00060/bit0002.doc http://www.waymaker.net/bitonline/2001/12/12/20011212BIT00060/bit0002.pdf