Aeterna Laboratories Inc has reported results of a Phase III trial in renal cell carcinoma, a form of kidney cancer, evaluating Neovastat, the Company's antiangiogenic compound. Results showed that the study, involving 305 patients refractory to immunotherapy, did not meet its primary endpoint of improving overall median survival time. However, significant survival advantage was observed in a subgroup of healthier patients with clear cell histology and only a single metastatic site. This 38 patient subgroup showed a median survival time of 26.3 months for those treated with Neovastat compared to 12.6 months for patients receiving a placebo (p(equal sign)0.0236).
Gilles Gagnon, AEterna's President and Chief Executive Officer, stated, "While this trial in refractory renal cell carcinoma did not reach its primary endpoint, the results observed for the subgroup of patients with a single metastatic site suggest Neovastat may be useful in treating specific forms of kidney cancer. Furthermore, this trial generates very useful data for our current Phase III trial in non-small cell lung cancer. The significant increase in median survival time for the renal cell carcinoma subgroup which was at an earlier disease stage compared to the overall cohort, seems to suggest that treatment with Neovastat in earlier stage cancer could be more efficacious." The Phase III trial in non-small cell lung cancer is enrolling newly diagnosed patients for front line treatment with Neovastat.
"This Phase III renal cell carcinoma trial showed that Neovastat had an excellent safety profile," emphasized Dr. Pierre Champagne, Medical Director and Vice President, Clinical Affairs at AEterna.
Furthermore, patients in the non-small cell lung cancer trial are administered Neovastat in combination with chemotherapy and radiotherapy. Based on prior antiangiogenesis trials in cancer, the approach of front line therapy with best standard treatment is regarded as the strategy most likely to show clinical benefit.