Clinical Trial of Novel Octreotide Formulation for the Treatment of Acromegaly

Diego Ferone, MD, PhD, University of Genoa and Chief of the Endocrine Unit at San Martino Hospital, discusses a novel octreotide formulation for the treatment of acromegaly.
Acromegaly is a rare endocrine disorder that results from the overproduction of growth hormone (GH) in the pituitary gland. It is most often diagnosed in middle-aged adults, although symptoms can appear at any age. Signs and symptoms include abnormal growth and swelling of the hands and feet; bone changes that alter various facial features; arthritis; carpal tunnel syndrome; enlargement of body organs; and various other symptoms. The condition is usually caused by benign tumors on the pituitary called adenomas. Rarely, it is caused by tumors of the pancreas, lungs, and other parts of the brain stimulating the pituitary gland to produce GH.
The standard of care treatment for pituitary neuroendocrine tumors and acromegaly is a long-acting, once a month injectable formulation of octreotide. The new formulation of octreotide is a fluid crystal formulation, allowing subcutaneous self administration. The new formulation also can be kept at room temperature, as opposed to the refrigeration required by the original formulation. As Dr. Ferone explains, this provides possibilities for greater patient access and adherence to the treatment.
ACROINNOVA 1 is a phase 3, open-label, single-arm, multicenter trial assessing the safety and efficacy of subcutaneous octreotide in patients with acromegaly. ACROINNOVA 2 is an ongoing, phase 3, randomized, double-blind, placebo-controlled, multi-center trial assessing the safety and efficacy of subcutaneous octreotide in patients with acromegaly. The primary endpoint of no serious adverse events has been observed, along with the secondary endpoint of better biochemical control of IGF1 levels. These outcomes lead to increased quality of life and patient self-confidence with the treatment.
Chapters:
ENDO Presentation: Novel Octreotide Formulation 00:00
Next Steps 7:17