Positive phase II for Transgene vaccine candidate

In the trial the drug was specifically evaluated in the treatment of high-grade cervical intraepithelial neoplasia (CIN), an intermediate disorder which results from the common sexually transmitted disease human papilloma virus, and eventually leads to cervical cancer. The only currently available treatment of high-grade CIN is surgical resection of the lesions.

In the trial, TG4001 administration enabled surgery to be avoided in 9 out of 18 women. According to the recommendations of the American Association of Cancer Research task force on the treatment and prevention of intra-epithelial neoplasia, obtaining a 50% regression rate in high-grade CIN with a new treatment is clinically meaningful.

“We are extremely pleased by these results. We believe that they are the first validation of the therapeutic vaccination approach in infectious diseases,” said Philippe Archinard, chief executive officer of Transgene. “These data constitute a significant breakthrough and validate our vaccine technology platform. Our objective is an effective vaccine for pre-cancerous lesions to speed up the fight against cervical cancer which remains a serious health concern globally.”

Based on these results, Transgene will actively pursue the clinical development of TG4001 with the aim of making therapeutic vaccination a non-invasive and safe alternative to the surgical resection of precancerous cervical lesions.

Results from the trial were presented on Tuesday by Dr Jean-Luc Brun, clinical investigator, during the Eurogin 2006 Congress held in Paris.