PARIS ¿ The Strasbourg-based gene therapy company Transgene initiated a Phase II trial of its MVA-HPV-IL2 immunotherapy for cervical cancer at two centers in Mexico.

The trial is being conducted on a cohort of up to 57 women suffering from human papillomavirus-16 cervical cancer that is at different stages of development and is either resistant to radiotherapy or has recurred after radiotherapy.

The trial, which will evaluate the efficacy of multiple subcutaneous injections of the product, will be conducted in two stages following an optimized design protocol. In the first stage, an interim evaluation will be made on the basis of a study of 22 assessable patients six months after treatment. If at least five of those subjects are found to have responded to treatment, a further 35 patients will be recruited for a second stage of product evaluation.

The MVA-HPV-IL2 therapy works by inducing an immune response against HPV 16, the virus responsible for cervical cancer, and producing an antitumor effect. It uses Transgene¿s second-generation modified virus ankara (MVA) vector to express two HPV antigens found in HPV 16 ¿ the E6 and E7 proteins. The MVA vector is a highly attenuated pox virus that has the advantages of a strain that has been extensively tested as a smallpox vaccine in humans combined with the ability to stimulate a strong immune response to antigens. The sequence coding for the interleukin-2 (IL-2) cytokine is included to help stimulate specific T-cell responses.

The potency of MVA-HPV-IL2 in treating cervical cancer was demonstrated in animal models and in Phase I trials conducted in the U.S. and Europe, which were completed in the first half of this year and yielded ¿very encouraging data,¿ said Transgene¿s CEO, Gilles Biranger.

The company¿s chief financial officer, Paul Bikard, told BioWorld International that another product using the second-generation MVA vector, MVA-Muc1-IL2, was ¿still scheduled to enter Phase II trials during the fourth quarter of this year, or in January at the latest.¿ It was developed for the treatment of breast, prostate, lung and other cancers, and the Phase II trials, which are to be conducted in Europe and the United States, will be in the indications of breast and lung cancer.

Transgene said in April that it was refocusing its activities on the discovery and development of immunotherapies for cancer. A second family of cancer treatments it is developing is immune enhancement gene therapies entailing the injection of the vector carrying the appropriate cytokine directly into the tumor.

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