Edotreotide (SMT487) is a DOTA-containing somatostatin analog. Edotreotide binds with high affinity to somatostatin receptors. Somatostatin receptors are predominantly overexpressed by neuroendocrine tumors. On 15 September 2016, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorisation for the orphan medicine edotreotide (SomaKit-TOC) intended for use in Positron Emission Tomography (PET) imaging in adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs). SomaKit TOC was designated as an orphan medicinal product on 19 March 2015. 68Ga-Edotreotide, distributed under the brand name TOCscan® (Sogacin® in Austria/ France), is the companion diagnostic in ITM´s theranostic approach for the treatment of neuroendocrine tumors (NETs). N.c.a. 177Lu-Edotreotide is known as an innovative Targeted Radionuclide Therapy agent with favorable safety profile and promising efficacy. N.c.a. 177Lu-Edotreotide received an Orphan Designation as treatment of gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) based on academic clinical Phase II data suggesting a significant benefit (substantially improved progression-free survival, PFS).

DAPTA (D-ala-peptide T-amide) is a synthetic peptide that prevents HIV entry by blocking binding of HIV gp120 protein with CCR5 receptor. In a small clinical study of internasal formulation of DAPTA in long-term infected HIV patients, administration of DAPTA led to decrease in the amount of virus isolated from white blood cells, an increase in gamma-interferon secreting T-cells in the absense of drug-related toxicity. In another clinical study DAPTA in combination with antiretroviral therapy reduced the peripheral (plasma and serum) viral load, but did not reduce the CSF viral load.

Mannose 6-phosphate (M6P) has type-I integral membrane receptors. M6P-receptors bind and transport M6P-enzymes to lysosomes, but it can also modulate the activity of a variety of extracellular M6P-glycoproteins (i.e., latent TGFbeta precursor, urokinase-type plasminogen activator receptor, Granzyme B, growth factors, Herpes virus). M6P has been demonstrated to reduce active TGF-β1 expression on cultured tendon fibroblasts and improved range of movement in a rabbit flexor tendon injury model. Studies of M6P in relation to skin scarring demonstrate improvement in scar cosmesis and accelerated return of normal dermal architecture. Juvidex, a formulation of M6P, inhibits the activation of TGF-beta1 and TGF-beta2, which are present at high levels in adult wounds that scar. On the other hands, M6P in a 600 mM hypertonic solution (Adaprev) potentially acts via a physical, non-chemical, hyperosmotic effect.