PARIS ¿ The Strasbourg-based gene therapy company Transgene SA initiated another Phase II clinical trial of its MVA-HPV-IL2 vaccine, this time in the indication of vulvar intraepithelial neoplasia (VIN3).

A Phase II trial of the same immunotherapeutic vaccine for the treatment of cervical cancer started in October. (See BioWorld International, Oct. 24, 2001.)

This trial is being conducted at two hospitals in the Paris area ¿ Cochin and Ambroise Pari ¿ and will involve up to 30 women suffering from VIN3. It will be placebo controlled and evaluate the efficacy of multiple subcutaneous injections of the MVA-HPV-IL2 vaccine. Its efficacy will be measured in terms of the elimination of lesions in at least half the treated women after six months.

VIN3 is the most severe of the three forms of vulvar intraepithelial neoplasia, a vulvar tissue disease caused by changes in the cells of the tissue that allow them to grow abnormally. In a small number of cases, VIN can evolve into invasive cancer of the vulva, and current treatments are both unpleasant for the patient and often ineffective, since relapse is common.

Transgene CEO Gilles Belanger said, ¿If efficacy is demonstrated in the Phase II clinical trial, we will seek orphan drug status for this indication in order to make the treatment more rapidly available to patients.¿

The MVA-HPV-IL2 vaccine uses the MVA vector, a highly attenuated pox virus, to express two human papillomavirus (HPV) antigens found in HPV 16, the E6 and E7 proteins. The objective of treating VIN3 sufferers with MVA-HPV-IL2 is to induce an efficient immune response against HPV 16 and to produce the same anti-lesion effect obtained in earlier animal studies.

Explaining the company¿s overall plan of campaign for this product, Belanger said, ¿Demonstrating the efficacy of our MVA-HPV-IL2 vaccine candidate in different stages of diseases linked to HPV infections is part of our strategy of developing this product candidate as a therapeutic vaccine.¿

The product has undergone Phase I clinical trials in the U.S. and Europe in which it was tested on patients suffering from various stages of cervical lesions. The trials demonstrated both the safety and tolerability of the vaccine, and provided evidence of an immune response in some patients. The Phase II trial in cervical cancer is being conducted at two centers in Mexico.