Transgene: Data Presented at The American Association of Cancer Research Annual Meeting Suggest Significant Opportunities for Anti-Cancer Immunotherapy Ad-IL2 Product Candidate STRASBOURG, France, April 14 /PRNewswire-FirstCall/ -- Transgene (Nasdaq: TRGNY; Nouveau Marche: FR0005175080) reported today the progress and encouraging data from its immunotherapy research and development program of Ad-IL2 that were presented in poster sessions at the 95th annual meeting of the American Association of Cancer Research (March 27-31, 2004) in Orlando, FL. Transgene's two posters presented data from the ongoing phase I/II clinical trial in patients with melanoma and other solid tumors as well as results from pre-clinical experiments in animal tumor models. "We were pleased to present these data at the A.A.C.R. annual meeting," stated Jean Francois Carmier, Chief Executive Officer of Transgene. "They indicate a promising potential for our Ad-IL2 cancer immunotherapy program. In addition to the initial results in the clinic of Ad-IL2, our pre-clinical data from the combination with conventional therapies open up numerous therapeutic opportunities for this product candidate. We are in the process of preparing a Phase II trial for the beginning of next year." Phase I/II clinical trial: results encourage expansion of the trial The Ad-IL2 immunotherapy product candidate is being tested in patients with metastatic melanoma or with other advanced solid tumors accessible to intra-tumoral injection. To date a total of 26 patients, 17 suffering from melanoma and nine from other solid tumors, have received intra-tumoral administrations (2 to 19 injections) of Ad-IL2. All the patients included in the trial have progressive disease refractory to standard therapies. The trial started as a standard dose escalation phase I and was then expanded as a Phase I/II to test an intensified dosing schedule and a combination with a standard chemotherapy. Analysis of data collected on these patients show that the treatment is well tolerated up to the highest dose level tested (3.1011 viral particules), with injection site reactions, fever, headache, and transient lymphopenia as the main side effects. Dose dependent levels of the interleukin-2 cytokine in the sera of the patients are clearly observed. Evaluation of the tumor response shows a significant rate of responses, with four patients stable for at least three months (3 to 9 months) and three cases of tumor regression (two partial and one complete). The stabilizations were observed at the two highest dose levels and the tumor shrinkages were seen in the ten patients at the highest dose. Based on these positive data in terms of tolerance and dose-dependent product activity, the trial will be further expanded to obtain additional data. Pre-clinical program: foundation for new therapeutic approaches In parallel of the ongoing phase I/II trial, Transgene is pursuing an extensive pre-clinical program in murine models to identify the most promising development directions for the product, based on the synergistic interactions between cytokines such as Interleukin 2 and certain chemotherapy drugs that have been suggested from various pre-clinical studies performed over the last 20 years. Transgene's pre-clinical research scientists are testing this concept of 'chemo-immunotherapy' with Ad-IL2, with the objective of decreasing the toxicity and improving the efficacy of the treatment, in comparison to the treatment with recombinant Interleukin 2. Intratumoral injections of Ad-IL2 in combination with systemic cisplatin administrations resulted in a significant frequency (p=0.016) of tumor eradication (57%, n=56) in the murine colon carcinoma CT26 model, as compared to the group treated with cisplatin alone (15%, n=52) or to the group treated with Ad-IL2 alone (28%, n=64). The combination modality was also superior in its capacity to eradicate distant, un-treated tumors in mice bearing tumors in the contra-lateral, non-treated flanck, resulting in a significant increase of survival in the group (p