Transgene Reports Positive Interim Phase II Data from MVA-Muc1-IL2 Cancer Vaccine Program
08 Febrero 2004 - 11:00PM
PR Newswire (US)
Transgene Reports Positive Interim Phase II Data from MVA-Muc1-IL2
Cancer Vaccine Program STRASBOURG, France, Feb. 9
/PRNewswire-FirstCall/ -- Transgene (Nasdaq: TRGNY; Euronext:
FR0005175080) announced today encouraging interim results in three
Phase II clinical trials of its MVA-Muc1-IL2 cancer vaccine
candidate in lung, prostate and kidney cancers. The three ongoing
trials are designed to assess MVA-Muc1-IL2 in different treatment
modalities: in combination with standard chemotherapy (lung
cancer); at different dosing schedules (prostate cancer); and in
combination with standard immunotherapy (kidney cancer). Trial
highlights Transgene reported the following accomplishments in its
MVA-Muc1-IL2 Phase II clinical programs: -- Enrollment is completed
for the Phase II trials in non-small cell lung cancer and
metastatic renal cell carcinoma. -- Good tolerance and safety have
been observed at all doses and dosing schedules tested. -- An
encouraging rate of tumor responseswas observed in a preliminary
analysis of the lung cancer trial of MVA-Muc1-IL2 in combination
with chemotherapy. -- A highly significant decrease in PSA
progression rate in the prostate cancer trial indicates biological
activity. "We are delighted with the progress shown by our Phase II
interim data," stated Jean-Francois Carmier, Chief Executive
Officer of Transgene. "It confirms the potential of our
MVA-Muc1-IL2 cancer vaccine candidate as an innovative and safe
therapeuticapproach for the treatment of cancer at different stages
of the disease." Lung Cancer The lung cancer trial is evaluating
the efficacy of subcutaneous injections of MVA-Muc1-IL2 in patients
with advanced non-small cell lung cancer (stage IIIb and IV). The
trial was designed to include up to 66 patients with no prior
treatment for their advanced disease. The trial is being conducted
in two randomized, parallel single arms in order to achieve similar
patient characteristics in each arm. The primary end point of the
trial is tumor response rate. The patients in the first arm are
being treated with MVA-Muc1-IL2 in combination with a standard
chemotherapy (Vinorelbin / Cisplatin). In the second arm the
patients are treated first with MVA-Muc1-IL2 alone for six weeks,
then with MVA-Muc1-IL2 in combination with chemotherapy. 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 either arm, in order to proceed to the second stage, and
11 responses out of 33 patients at the end of the second stage. To
date five partial responses validated by central review according
to the RECIST criteria (international CT scan evaluation) have been
documented in the first arm. These responses have been observed
among the first 12 patients evaluated. These promising responses
have justified moving forward to the second stage of the trial. The
response duration ranged from 114 to 195 days, which is encouraging
considering thesample group of predominantly stage IV patients.
Moreover, four disease stabilizations have also been observed.
Enrollment in the first arm is now complete and further data will
be reported during the second quarter of 2004. In the second arm,
treatment with MVA-Muc1-IL2 alone resulted in disease
stabilizations for four patients out of 16, during 91 to 236 days.
As the required number of responses was not reached, recruitment in
the second arm has been discontinued at the end of the first stage
to focus efforts on the first arm. Professor Elisabeth Quoix, MD,
of the Pneumology Department at Hospital Lyautey in Strasbourg,
France, and chair person of the Thoracic Oncology Francophone
Intergroup, stated: "It is very interesting to see a rate of
clinical responses superior to that expected from chemotherapy
alone, particularly in this advanced patient population. Based on
these results we were very encouraged to move to the second stage
of the trial, to treat more patients and to confirm this improved
rate of responses." Prostate Cancer The prostate cancer trial is
evaluating MVA-Muc1-IL2 in patients who have had primary 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. 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. The primary efficacy endpoint
of the trial is a decrease of fifty percent or more in PSA compared
with the baseline level. The trial follows a two-stage design:
fifteen patients are treated in the first stage in each arm, with
an additional cohort of ten patients to be enrolled if at least one
objective response is observed in the first stage. A secondary
endpoint is an impact on the PSA progression rate. Although the
primary endpoint has not been reached to date, interim analysis
performed on the 21 patients enrolled demonstrated a statistically
significant decrease in the PSA progression rate (p