trials preliminary results
results of all clinical trials conducted in 1998 confirmed
the excellent safety profile and the patient tolerability
of AE-941. At year end, AE-941 had been tested in
over 500 patients. All trials were done in hospitals
under the regulations of the Health Protection Branch
(HPB) in Canada and the Food and Drug Administration
(FDA) in the U.S.
clinical trials were conducted in 1998 for AE-941/Neovastat. The first trial evaluated the
safety of AE-941/Neovastat as a cancer monotherapy in solid refractory lung, prostate and
breast tumor cancer patients; the second trial assessed the safety of AE-941/Neovastat as
a treatment for refractory solid tumor cancer alone, or in combination with chemotherapy
In both trials,
AE-941/Neovastat continued to show excellent patient tolerability.. The safety and
tolerability of AE-941/Neovastat is particularly important as, unlike some cancer
therapies, it will have to be administered on a long-term basis to control the formation
of new blood vessels, thereby inhibiting tumor growth.
Phase I/II Refractory Lung Prostate or Breast
The Phase I/II study
recruited 186 patients in Canada and the U.S. with refractory lung, prostate or breast
cancer. Results for the 80 lung cancer patient cohort were presented at the European
Society of Medical Oncology (ESMO) in Athens in November 1996.
The results of the
lung cancer cohort showed that AE-941/Neovastat/ when administered as a monotherapy, had
no dose-limiting toxicity and no serious adverse events related to its administration.
The efficacy analysis
showed that patients receiving the highest dose of AE-941 experienced greater clinical
benefits, that is slower tumor progression, reduced body weight loss and reduced
consumption of analgesics. The patients also experienced a longer median survival time
compared to historical controls.
for the prostate cancer cohort were presented at the European Association of Cancer
Research (EACR) in Sweden in August 1998.
Results-Refractory Lung Cancer
|A smaller proportion of patients
having received the highest dose of AE-941/Neovastat experienced body weght loss more than
5%, tumor progression of more than 25%, or a deterioration of at least 2 of 4 conditions
represented by clinical index (body weght loss, analgesic consumption, ECOG scale and
tumor progression), relative to those who received the lowest dose.
|These results were consistent
with the lung cancer cohort`s and showed an excellent
safety profile and a trend towards a dose-response effect
with regard to the efficacy endpoints, where the highest
dose of AE-941/Neovastat was the most effective.
Phase I Refractory Solid Tumors
This study includes 67
patients who were treated with AE-941/Neovastat as a monotherapy and 59 patients treated
with AE-941/Neovastat in combination with chemotherapy and/or radiotherapy. The interim
safety results of this study, which confirmed earlier results obtained with
AE-941/Neovastat, showing no dose-limiting toxicity and an excellent safety and
tolerability profile, were presented at the XVI Chemotherapy Symposium in New York in
November 1998.The results of the study relating to the administration of AE-941/Neovastat
in combination with chemotherapy and radiotherapy are particularly important as they form
part of the rationale for the NCI-sponsored Phase III pivotal trial
using AE-941/Neovastat in combination with conventional therapies.