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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