The aim of this project is to reformulate a highly lipophilic anti-cancer agent, valrubicin (AD-32) that has only been approved for vesicular treatment of bladder cancer due to its poor dose limiting toxicities due to poor water solubility. LipoMedics will reformulate valrubicin (AD-32) utilizing a robust, novel biocompatible drug delivery system, composed of reconstituted high density lipoprotein (rHDL) nanoparticles that are particularly effective in improving solubility and safety of poorly soluble drugs. The additional advantage of formulating drugs with rHDL is the selective targeting toward malignant tumors via the SR-B1 receptor. LipoMedics intends to conduct proof of concept studies to evaluate therapeutic efficacy of the rHDL/AD-32 drug formulation versus that of the free drug. These studies will include assessment of cytotoxicity versus cancer cells, stability of the rHDL/AD-32 formulation and tumor suppression studies in mice. The major goal of these studies is to demonstrate enhancement in therapeutic efficacy of AD-32 via encapsulation in rHDL nanoparticles. Based on previous studies, it is anticipated that AD-32, as an initial model, and subsequently a wide range of similarly lipophilic drugs, can be reformulated to produce clinically effective anti-cancer drugs as well as profitable ventures for biotech entrepreneurs.
