18 June 2013 - 18 June 2013 - French pharmaceutical group Ipsen (EPA:IPN) unveiled yesterday mixed results from a Phase IIIb trial of its Somatuline Autogel (lanreotide) 120mg, intended as a first-line treatment for newly diagnosed acromegaly patients with a macroadenoma.

The open-label, one-year study trial, dubbed PRIMARYS, evaluated the investigational use of the product in 90 patients with newly diagnosed acromegaly.

The results showed that the study did not achieve statistical significance regarding its primary efficacy endpoint, tumour volume reduction using Magnetic Resonance Imaging (MRI). However, there were observed clinically relevant tumour volume reductions in most patients. Data from secondary biomarker endpoints of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels further backed these results, the company added.

Baseline GH level was the main factor identified as potential predictor for tumour response to primary therapy.

As of mid-May, Somatuline (30mg) and Somatuline Autogel (60mg, 90mg,120mg) were marketed in more than 55 countries and registered in 70 countries worldwide as therapies of acromegaly and/or neuroendocrine tumours.