Transgene Presents Data on MVA-MUC1-IL2 Cancer Vaccine at ASCO and ASGT Annual Meetings
June 08 2004 - 12:01AM
PR Newswire (US)
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