Positive Clinical Trial Results for Novartis’ Signifor
Novartis have released data from a phase III clinical trial suggesting that their somatostatin analogue, Signifor, could be effective for the growth hormone disorder, acromegaly.
The recent clinical trial assessed a once-monthly intramuscular formulation, named Signifor LAR, in patients with acromegaly where standard therapies had been ineffective. Signifor has already been approved by regulators in a twice-daily dosage to treat Cushing’s disease.
Acromegaly occurs when the pituitary gland produces excessive levels of growth hormone, resulting in abnormal growth of the feet, hands and face in addition to other complications like arthritis, diabetes, kidney disease and cancer.
The clinical trial tested two doses (40mg and 60mg) in 198 patients. Results from the clinical study found that Signifor was more effective in controlling levels of both growth hormone and insulin-like growth factor-1 (IGF-1), in comparison to continued use of the standard somatostatin analogue treatments (Novartis’ long-acting Sandostatin LAR or Ipsen’s Somatuline Autogel).
The majority of patients can be effectively treated for acromegaly using older drugs such as octreotide, but inadequate control of growth hormone and IGF-1 remains an issue for many patients.
Novartis have already submitted Signifor LAR for regulatory approval in the US and Europe, and is also testing the new Signifor formulation for Cushing’s disease, which they are expecting to submit for approval sometime in 2015.
Interim president of Novartis Oncology and global head of oncology development and medical affairs, Alessandro Riva, commented that the “results strengthen our understanding of this rare endocrine disorder and suggest pasireotide LAR may offer benefit for acromegaly patients whose disease is not fully controlled on their current therapy.”