Transgene: Data Presented at The American Association of Cancer Research Annual Meeting Suggest Significant Opportunities for An
14 April 2004 - 3:01PM
PR Newswire (US)
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