Transgene Reports Positive Interim Phase II Data from MVA-Muc1-IL2 Cancer Vaccine Program STRASBOURG, France, Feb. 9 /PRNewswire-FirstCall/ -- Transgene (Nasdaq: TRGNY; Euronext: FR0005175080) announced today encouraging interim results in three Phase II clinical trials of its MVA-Muc1-IL2 cancer vaccine candidate in lung, prostate and kidney cancers. The three ongoing trials are designed to assess MVA-Muc1-IL2 in different treatment modalities: in combination with standard chemotherapy (lung cancer); at different dosing schedules (prostate cancer); and in combination with standard immunotherapy (kidney cancer). Trial highlights Transgene reported the following accomplishments in its MVA-Muc1-IL2 Phase II clinical programs: -- Enrollment is completed for the Phase II trials in non-small cell lung cancer and metastatic renal cell carcinoma. -- Good tolerance and safety have been observed at all doses and dosing schedules tested. -- An encouraging rate of tumor responseswas observed in a preliminary analysis of the lung cancer trial of MVA-Muc1-IL2 in combination with chemotherapy. -- A highly significant decrease in PSA progression rate in the prostate cancer trial indicates biological activity. "We are delighted with the progress shown by our Phase II interim data," stated Jean-Francois Carmier, Chief Executive Officer of Transgene. "It confirms the potential of our MVA-Muc1-IL2 cancer vaccine candidate as an innovative and safe therapeuticapproach for the treatment of cancer at different stages of the disease." Lung Cancer The lung cancer trial is evaluating the efficacy of subcutaneous injections of MVA-Muc1-IL2 in patients with advanced non-small cell lung cancer (stage IIIb and IV). The trial was designed to include up to 66 patients with no prior treatment for their advanced disease. The trial is being conducted in two randomized, parallel single arms in order to achieve similar patient characteristics in each arm. The primary end point of the trial is tumor response rate. The patients in the first arm are being treated with MVA-Muc1-IL2 in combination with a standard chemotherapy (Vinorelbin / Cisplatin). In the second arm the patients are treated first with MVA-Muc1-IL2 alone for six weeks, then with MVA-Muc1-IL2 in combination with chemotherapy. A classical two-stage design is being used to evaluate the tumor response rates and assess whether the treatment has sufficient activity against the disease to warrant further development. The statistical hypothesis reflecting the chosen lower and upper target response rates to be reached (20 and 40 percent, respectively) requires at least five responses out of 18 patients in the first stage in either arm, in order to proceed to the second stage, and 11 responses out of 33 patients at the end of the second stage. To date five partial responses validated by central review according to the RECIST criteria (international CT scan evaluation) have been documented in the first arm. These responses have been observed among the first 12 patients evaluated. These promising responses have justified moving forward to the second stage of the trial. The response duration ranged from 114 to 195 days, which is encouraging considering thesample group of predominantly stage IV patients. Moreover, four disease stabilizations have also been observed. Enrollment in the first arm is now complete and further data will be reported during the second quarter of 2004. In the second arm, treatment with MVA-Muc1-IL2 alone resulted in disease stabilizations for four patients out of 16, during 91 to 236 days. As the required number of responses was not reached, recruitment in the second arm has been discontinued at the end of the first stage to focus efforts on the first arm. Professor Elisabeth Quoix, MD, of the Pneumology Department at Hospital Lyautey in Strasbourg, France, and chair person of the Thoracic Oncology Francophone Intergroup, stated: "It is very interesting to see a rate of clinical responses superior to that expected from chemotherapy alone, particularly in this advanced patient population. Based on these results we were very encouraged to move to the second stage of the trial, to treat more patients and to confirm this improved rate of responses." Prostate Cancer The prostate cancer trial is evaluating MVA-Muc1-IL2 in patients who have had primary treatment by surgery or radiation and subsequently had progressive elevation of their PSA (Prostate Specific Antigen) level without documented evidence of metastatic disease, which suggests residual or recurrent prostate cancer. The trial is taking place in the United States as a Phase II multi-center, randomized, open label trial to assess the clinical and biological effects of two different vaccination schedules. The patients in the first arm receive a weekly 108 pfu injection of MVA-Muc1-IL2 for six weeks and thereafter every three weeks. Patients in the second arm receive the same treatment every three weeks. The primary efficacy endpoint of the trial is a decrease of fifty percent or more in PSA compared with the baseline level. The trial follows a two-stage design: fifteen patients are treated in the first stage in each arm, with an additional cohort of ten patients to be enrolled if at least one objective response is observed in the first stage. A secondary endpoint is an impact on the PSA progression rate. Although the primary endpoint has not been reached to date, interim analysis performed on the 21 patients enrolled demonstrated a statistically significant decrease in the PSA progression rate (p