n interim analysis has been performed in Active Biotech AB’s (OMX Nordic: ACTI) ongoing Phase II/III clinical study of ANYARA, in patients with advanced renal cell cancer
Lund, Sweden | May 13, 2008 | An interim analysis has been performed in Active Biotech AB’s (OMX Nordic: ACTI) ongoing Phase II/III clinical study of ANYARA, in patients with advanced renal cell cancer.
This analysis was performed earlier than originally planned due to a faster patient recruitment than anticipated. To date approximately 250 patients have been recruited into the study. The study protocol has recently been reviewed in a protocol assistance procedure by EMEA and the primary as well as all secondary endpoints were endorsed. In this interim analysis safety, efficacy, as well as certain biomarkers were evaluated in approximately 200 patients. No safety concerns significantly affecting the risk/benefit ratio for ANYARA were identified.
Based on the study data, Active Biotech has decided to proceed, in accordance with the study protocol, into the pivotal Phase III stage of the study to further evaluate the effect of ANYARA for treatment of renal cell carcinoma. The study will enroll approximately 500 patients to evaluate the anti-tumor effect of ANYARA in combination with interferon-alpha, compared to interferon-alpha alone. The primary endpoint is overall survival. “This is a very important milestone for ANYARA. The results from this controlled trial
support the further development in the continued Phase III part of the study”, says Sven Andréasson, CEO Active Biotech “.
After consultation with the regulatory authorities, Active Biotech will follow advice given and not publish any further details pertaining to the performed interim analysis. This decision is made in order not to compromise enrollment and integrity of the ongoing trial.
SOURCE: Active Biotech AB
Post Views: 153
n interim analysis has been performed in Active Biotech AB’s (OMX Nordic: ACTI) ongoing Phase II/III clinical study of ANYARA, in patients with advanced renal cell cancer
Lund, Sweden | May 13, 2008 | An interim analysis has been performed in Active Biotech AB’s (OMX Nordic: ACTI) ongoing Phase II/III clinical study of ANYARA, in patients with advanced renal cell cancer.
This analysis was performed earlier than originally planned due to a faster patient recruitment than anticipated. To date approximately 250 patients have been recruited into the study. The study protocol has recently been reviewed in a protocol assistance procedure by EMEA and the primary as well as all secondary endpoints were endorsed. In this interim analysis safety, efficacy, as well as certain biomarkers were evaluated in approximately 200 patients. No safety concerns significantly affecting the risk/benefit ratio for ANYARA were identified.
Based on the study data, Active Biotech has decided to proceed, in accordance with the study protocol, into the pivotal Phase III stage of the study to further evaluate the effect of ANYARA for treatment of renal cell carcinoma. The study will enroll approximately 500 patients to evaluate the anti-tumor effect of ANYARA in combination with interferon-alpha, compared to interferon-alpha alone. The primary endpoint is overall survival. “This is a very important milestone for ANYARA. The results from this controlled trial
support the further development in the continued Phase III part of the study”, says Sven Andréasson, CEO Active Biotech “.
After consultation with the regulatory authorities, Active Biotech will follow advice given and not publish any further details pertaining to the performed interim analysis. This decision is made in order not to compromise enrollment and integrity of the ongoing trial.
SOURCE: Active Biotech AB
Post Views: 153
