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Ipsen and Lexicon report positive carcinoid syndrome drug trial data
Ipsen and its partner Lexicon Pharmaceuticals have announced positive results from a pivotal phase III trial of their new carcinoid syndrome therapy telotristat etiprate.
Results from the TELESTAR study have demonstrated the efficacy and safety of telotristat etiprate for carcinoid syndrome patients with metastatic neuroendocrine tumor inadequately controlled by somatostatin analog (SSAs) – the current standard of care.
Patients who added telotristat etiprate to SSAs experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period, thus meeting the study's primary endpoint.
Ipsen and Lexicon entered into an exclusive licensing agreement for the drug in October 2014, with Lexicon retaining sole rights to commercialise the drug in the US and Japan.
Claude Bertrand, executive vice-president for research and development and chief scientific officer at Ipsen, said: "Should telotristat etiprate be approved, its oral formulation would satisfy an unmet medical need for patients with carcinoid syndrome not adequately controlled with SSAs therapy."
The company expanded its portfolio of therapies for the management of neuroendocrine tumours with the acquisition of OctreoPharm Sciences earlier this year.
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