Date: Nov 02, 2015 Source: Bloomberg (
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AADi, LLC announced the initiation of its registration trial for advanced Perivascular Epithelioid Cell tumors (PEComa) with ABI-009, its targeted albumin-bound mTOR inhibitor. ABI-009 is the nanoparticle albumin-bound (nab®) version of the mTOR inhibitor sirolimus or rapamycin and leverages the same technology of the nab® platform that is behind the success of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound). ABI-009 was licensed to AADi in 2014 by Celgene Corporation. AADi plans to develop ABI-009 initially in oncology and cardiovascular indications. A phase 1 trial for ABI-009 was completed in patients with advanced non-hematologic malignancies in which the drug was well tolerated with evidence of activity in heavily pretreated patients. AADi also has an ongoing phase 1/2 trial of ABI-009 for the treatment of non-muscle invasive bladder cancer that is being conducted as part of a Fast-Track STTR grant awarded to AADi from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). In addition to these studies, AADi plans to initiate a phase 2 trial in patients with various solid tumors that have been selected for mTOR pathway activations. As part of its focus in cardiovascular disease, AADi plans to initiate clinical studies with ABI-009 in the treatment of pulmonary arterial hypertension, a rare, progressive and debilitating disease that is highly dependent on mTOR activation, and which occurs due to abnormal constriction of the arteries in the lungs resulting in shortness of breath and increasing stress on the heart or heart failure.