Transgene announced encouraging results from the phase II clinical trial of its MVA-HPV-IL2 vaccine candidate in patients with human papilloma virus (HPV)-related disease.
"The data we collected from our phase II program points to a very interesting new approach to the treatment of HPV-related affections," stated Jean-François Carmier, CEO of Transgene. "We believe in the potential of our product candidate as a therapeutic vaccine and we are extending its evaluation into both cervical dysplasia and the earlier stage of silent HPV infection."
HPV is the most common sexually transmitted disease, infecting almost 300 million women worldwide. HPV type 16, one of the High-Risk HPV types (HR-HPV), is responsible for more than half of all cervical cancers. Most infected people spontaneously eliminate their viral infection within six to 12 months. Patients who do not eliminate their virus and develop long-lasting HR-HPV infection are at greatest risk of developing cervical cancer. Cervical cancer is the second leading cause of cancer-related mortality by cancer in women worldwide, causing about 470,000 deaths per year, 80 per cent of which occur in under-developed countries.
Patrick Squiban, MD, vice president, Regulatory and Medical Affairs, noted: "Our approach is consistent with the recommendations of prominent HPV and cancer researchers worldwide who have called for developing a therapeutic agent to prevent progression through the various stages of HPV-related disease. We believe that conducting a trial focused on the highest dose of MVA-HPV-IL2 and delayed surgery is the right step toward achieving this goal."
MVA-HPV-IL2 was simultaneously tested in 20 patients with vulvar intra-epithelial neoplasia (VIN3). Clinical results showed no significant difference in the patients treated with the vaccine compared to the controlled placebo group. In view of the dose-related effect seen in the CIN2/3 trial, these results were probably due to the low dose used (5.10 6 pfu) and the advanced stage of the disease of these patients.