Pharmexa submits phase 3 application for TeloVac trial

By Elaine Rigoli

Tampa, Fla., June 7 - Pharmexa said Wednesday that it has submitted it phase 3 application for the TeloVac trial, in which GV1001 is tested together with a combination of the chemotherapy drugs gemcitabine (Gemzar) and capecitabine (Xeloda).

The TeloVac trial is planned to consist of three equally sized arms, according to a news release.

Patients with non-resectable pancreatic cancer will be randomly distributed into one of the three arms:

• 370 patients will be treated with gemcitabine and capecitabine in a standard treatment;

• 370 patients will be treated first with gemcitabine and capecitabine for eight weeks, following which they will be treated with GV1001;

• 370 patients will be treated with gemcitabine and capecitabine and with GV1001 at the same time.

The primary endpoint in the TeloVac trial is survival, and the secondary endpoint is time to progression.

"The TeloVac trial is a large and ambitious trial and if the results are positive, it could have an enormous impact on Pharmexa. Both our own PrimoVax phase 3 trial, which we recently had approved in a number of European countries and the TeloVac trial, for which we have now submitted an application, are designed to stand alone for registration purposes. We are impressed with the commitment shown by the U.K. cancer doctors to the TeloVac trial and to GV1001 and we look forward to working with them in the coming years," chief executive officer Jakob Schmidt said in the release.

Pharmexa is an international biotech company based in Hoersholm, Denmark.

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