| San Antonio, Texas, December 10, 1999 — At the 22nd Annual Breast Cancer Symposium, TRANSGENE (NASDAQ:TRGNY; Nouveau Marché: TRANSGENE) today presented the results from a Phase II clinical trial using the Company's cancer vaccine, VV-MUC1-IL2, in women with metastatic breast cancer. These data, combined with pre-clinical data and results from another clinical trial in men with prostate cancer, demonstrate a favorable safety profile and anti-tumor activity in selected patients with advanced cancer treated with VV-MUC1-IL2. VV-MUC1-IL2 is a cancer vaccine in which the genes for the tumor antigen MUC1 and the immune stimulant IL2 have been inserted into a vaccinia virus. Treatment with the vaccine is intended to induce a reaction by the body's immune system against the MUC1 tumor antigen. MUC1 has been detected in tumor tissues of a majority of patients with breast cancer, prostate cancer, as well as several other types of tumors. |   |
The Phase II study presented by Dr. David Miles of the Imperial Cancer Research Fund at Guy's Hospital, London, was conducted in 31 patients at sites in the United Kingdom, France, Belgium, and Israel. Treatment with the vaccine resulted in objective tumor regression and a partial remission in two patients, both of whom had advanced metastatic disease that did not respond to either chemotherapy or hormonal therapy.
"These results are notable in that we saw systemic anti-tumor activity," said Dr, Miles. "The ability to induce a partial remission in patients with visceral metastases who have progressive disease after intensive chemotherapy is important evidence of the potential role of therapeutic vaccines in the treatment of cancer."
"The use of vaccines for advanced cancer could represent an important new avenue in cancer treatment," said Michael Ross, Vice President of Medical and Regulatory Affairs of TRANSGENE. "The MUC1 tumor antigen provides an avenue to attack breast cancer, prostate cancer as well as other types of cancers. TRANSGENE's proprietary vaccinia virus platform has enabled us to move this product forward very rapidly."
The MUC1 product is part of TRANSGENE's broader effort to develop technologies that will enhance the human immune system's ability to reject cancer cells. Utilizing the same vaccinia virus vector, TRANSGENE has a second cancer vaccine in clinical trials based on the MVA strain carrying the genes for antigens from the human papilloma virus (HPV) type 16, which is responsible for more than 50% of cases of cervical cancer. TRANSGENE's second major focus in oncology is the general enhancement of the body's immune response to cancer, with currently three products in clinical trials: Adenovirus-IL2, Vero-IL2, and Adenovirus-IFN-γ.
"We are extremely encouraged by TRANSGENE's clinical progress in each of our anti-cancer initiatives," said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "This continued success and our commitment to an extensive and diverse vector platform confirms our dedication to the field of gene therapy."
TRANSGENE, based in Strasbourg, France, with US offices near Boston, Massachusetts, is a leading integrated gene therapy company dedicated to the discovery and development of gene delivery technologies and gene therapy products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. The Company's proprietary technology platform consist of multiple vector families with a special emphasis on vaccinia virus, adenovirus and synthetic vectors. TRANSGENE has entered in two significant partnerships with Schering-Plough and Human Genome Sciences.
Source: Transgène
