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Transgene Presents Data 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