Retinoids are a class of structural Vitamin A analogs that influence cellular proliferation and differentiation, while exhibiting broad chemo-preventive activity in carcinogenesis models.  Some retinoid analogs induce apoptosis in malignant cell lines using novel mechanisms that do not require retinoid receptor pathways.  Retinoic acids and retinols are soluble compounds that serve as the active ingredient in several parenteral products on the market.  In contrast, neutral (uncharged) retinoids are poorly soluble and current dosage forms are unable to achieve adequate systemic exposure following oral or parenteral administration.  The limited options for administration of these novel retinoids are major impediments in realizing their therapeutic potential. 

SciTech has undertaken a research program to develop formulations for intravenous administration of neutral retinoids that induce apoptosis in a RAR/RXR-independent fashion.  These well-tolerated formulations (no cremophor or other polyoxy surfactants) are targeted for clinical development as cancer chemotherapeutics and possess pharmaceutical characteristics desirable in the ambulatory care setting.  The feasibility, rodent safety, and anti-tumor efficacy of prototype formulations were refined and substantiated  in both in vivo and in vitro tests using SBIR Phase 1 support from the National Institute of Health.

SciTech's current research, funded by an SBIR Phase II grant, has been focused on ensuring that this lipid based delivery formulation could be reproduced outside of a sterile laboratory. Campbell University's department of Pharmaceutical Sciences has partnered with SciTech to develop this scale-up formula which will be used for mass-reproduction in a manufacturing environment. The altered formulation will soon undergo animal tests to confirm its validity. Once tests substantiate the expected success for this intravenous delivery formulation, it could have wide use beyond drug delivery of our Vitamin A analog. It will conceivably allow for the creation of dozens of potentially effective and marketable cancer drugs that previously could not be systemically absorbed. A significant financial opportunity is only a few years from achieving market potential.