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Clinical trials preliminary results

The 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.

Two 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 or radiotherapy.

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 Cancer

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.

Preliminary results for the prostate cancer cohort were presented at the European Association of Cancer Research (EACR) in Sweden in August 1998.

Phase I/II Results-Refractory Lung Cancer

Efficacy data

Efficacy data

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.

Copyright 2001