-Received Notice of Allowance of Additional US Patent for Cancer Vaccines-Strasbourg, France, September 14, 1999 — TRANSGENE (NASDAQ:TRGNY; Nouveau Marché: TRANSGENE) announced today the initiation of its first clinical trial with MVA-HPV-IL2, the Company's sixth product in the clinic. The Phase I clinical trial is being conducted at the Baylor College of Medicine in Houston, Texas, in patients with grade 3 cervical intraepithelial neoplasia (CIN3), a pre-cancerous stage disease, under a TRANSGENE sponsored Investigational New Drug (IND). This is the company's third IND approved by the Food and Drug Administration. Two additional Phase I clinical trials with the same product are being implemented in the United States and in Switzerland.
The MVA-HPV-IL2 product is part of TRANSGENE's effort to develop cancer vaccines to enhance the human immune system's ability to reject cancer cells. The MVA-HPV-IL2 vaccine consist of TRANSGENE's proprietary vaccinia virus vector 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 the cases of cervical cancer. Approximately 100,000 cases of cervical cancer are newly diagnosed in Europe and the United States per year. The clinical trials with this product are designed to explore its potential utility in the treatment and prevention of cervical cancer caused by HPV16.
In addition, TRANSGENE announced that it received Notice of Allowance from the United States Patents and Trademarks Office of a key patent covering its cancer vaccines technology. The patents, entitled "Expression of a tumor-specific antigen by a recombinant virus vector and use thereof", covers methods of treating virally-induced tumors and viral vectors encoding at least the essential region of a non-structural protein from papillomavirus, especially selected E1, E2, E4, E5, E6 and E7 of HPV-16. The US patent adds to TRANSGENE's portfolio of patents previously granted in Europe, the United States and Japan protecting intellectual property on the cancer vaccines technology which TRANSGENE is developing through the clinical trial above-mentioned.
"With this sixth product entering clinical development, TRANSGENE confirms its dedication to lead the development of gene therapy products, in particular in the field of oncology" said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "We are pleased to see this commitment supported by a strong patent position, allowing TRANSGENE to foresee the development of this additional product on a worldwide basis."
TRANSGENE's other approaches in oncology include another cancer vaccine using the vaccinia virus in which the virus expresses MUC1, a tumor antigen expressed in a wide range of adenocarcinomas, which is in Phase clinical trials in the United States and Europe, in patients with breast and prostate cancers. The major direction of TRANSGENE's anti-cancer program 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.
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 five vector families, including three of viral origin (adenovirus, retrovirus, vaccinia virus) and two of non viral origin (cellular and synthetic vectors). TRANSGENE currently has four Phase II studies ongoing in four different types of cancers. TRANSGENE has entered in two significant partnerships with Schering-Plough and Human Genome Sciences.
Source: Transgène
