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Data Presented on MVA-MUC1-IL2 Cancer Vaccine at ASCO and ASGT Annual Meetings

STRASBOURG, France, June 8 /PRNewswire-FirstCall/ -- Transgene (Nasdaq: TRGNY; Euronext: FR0005175080) announced today the presentation of updated interim results of ongoing Phase II clinical trials with its MVA-Muc1- IL2 therapeutic cancer vaccine candidate in lung and prostate cancers. Data from the ongoing phase II trial in lung cancer were presented on Monday, June 7 at the 2004 American Society of Clinical Oncology (ASCO) Annual Meeting in New Orleans, Louisiana. Data from the ongoing phase II trial in prostate cancer were presented on June 4 at the 7th Annual Meeting of the American Society of Gene Therapy (ASGT) in Minneapolis, Minnesota.

"We were very pleased to have the opportunity to present these results at such renowned events as the ASGT and ASCO Annual Meetings," said Jean-Francois Carmier, Chief Executive Officer of Transgene. "We are excited to share these results with leaders in both the fields of cancer and gene therapy."

Non-small-cell lung cancer

The current phase II trial is evaluating the efficacy of subcutaneous injections of MVA-Muc1-IL2 at a dose of 108 pfu in association with a cisplatin/vinorelbine-based chemotherapy in patients with advanced or metastatic non-small-cell lung cancer (stage IIIB or IV).

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 order to proceed to the second stage, and 11 responses out of 33 patients at the end of the second stage. Enrollment is now complete.

The following responses were observed in the first 18 patients who received upfront the combination of MVA-Muc1-IL2 with chemotherapy and have been evaluated for response (stage 1 of the study):

* seven patients have responded to the treatment according to the RECIST criteria (partial responses, of which five have been validated to date in central review); and * five patients had their disease stabilized for more than twelve weeks.

Together, these results indicate that 12 out of 18 patients have benefited from the combination of MVA-Muc1-IL2 vaccination with chemotherapy. In the sub-group of metastatic disease (14 patients with stage IV), 11 patients (79%) showed clinical benefit (partial and stable diseases). Results from the ongoing stage 2 of the study are expected in the coming months.

Prostate cancer

The prostate cancer trial is evaluating MVA-Muc1-IL2 in patients who have had primary local 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. There is increasing interest, as suggested by various publications and meetings, to propose new treatments at this stage of rising PSA.

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.

To date, 30 patients have been included and PSA data is available for 29 of them to allow calculation of the change in the PSA doubling-time (PSA-DT) induced by the vaccination. PSA-DT increased three-fold in patients receiving the weekly injections and almost two-fold in patients receiving the three-week schedule. Using a model-based analysis of the patient population, these changes in the PSA-DT are highly significant with p

Good tolerance and safety of MVA-Muc1-IL2 were observed in both studies. About MVA-Muc1-IL2 cancer vaccine

Transgene's MVA-Muc1-IL2 uses the Modified Vaccinia Ankara virus vector, a highly attenuated poxvirus that combines distinguishing advantages for an optimized systemic vaccination.

* MVA is a highly attenuated strain which has been tested extensively in humans as a smallpox vaccine and is known to strongly stimulate the immune response to antigens. * Muc1 is a major tumor-associated antigen that provides a viable target for vaccination. * MVA-Muc1-IL2 expresses the entire Muc1 gene sequence and has the potential to generate an immune response to all antigenic epitopes of Muc1. * The sequence coding for the cytokine Interleukin 2 (IL2) is included to help stimulate specific T-cell response.

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