SciTech has developed a novel, nanoparticulate IV drug delivery platform for intravenous (IV) delivery of a potent anticancer drug, Fenretinide.  The formulated product is designated as ST-001.  Fenretinide is a well known experimental anticancer drug which belongs to a class of vitamin A analogs known as retinoids. 

In cancer, deregulation or dysregulation of the processes involved in programmed cell death (apoptosis) is accepted as one fundamental component in the pathogenesis of the disease.  Apoptosis is a highly regulated intracellular process that enables cells to respond to both external death receptor signals and intracellular stress signals (such as DNA damage) in order to remove damaged cells from the body.  In the vast majority of human tumors the capacity of a tumor cell to undergo apoptosis is impaired and the transformed cell is able to remain in a viable state even though such cells would be self-eliminated under the typically rigid set of normal conditions.

There is a substantial body of medical literature showing that Fenretinide has exceptional anticancer activity in both the experimental and clinical settings because it destroys cancer cells via its efficient induction of apoptosis selectively in tumor cells.  Clinically, the drug is effective in treating and preventing cancer when plasma levels reach a base-line level for several days.  Unfortunately, Fenretinide is poorly soluble and to date has not been fully pursued clinical therapeutic setting because appropriate plasma levels of the drug cannot be attained in patients using the available oral (capsule) drug formulations.  The oral formulation of Fenretinide that has been tested in clinical trials is poorly bioavailable, limiting the achievable peak levels and systemic exposure.  SciTech has solved this problem with Fenretinide and overcome the impediment of delivering the drug safely at functional levels by crafting a novel, and patented, product that is physically designed to deliver concentrations of Fenretinide that efficiently and effectively induce apoptosis in the experimental setting. The composition of this lipid emulsion formulation/delivery system is so fully defined and high strength that the potential for adverse effects from exposure to common excipients, such as surfactants and triglycerides, is minimized.

In preclinical rodent pharmacology studies, SciTech’s product achieved higher plasma and tissue levels of the drug than did a higher oral dose of the previously used Fenretinide capsules. Preliminary toxicity in rodents demonstrate that intravenous treatment of Fenretinide in the form of ST-001 is tolerable and establishes a potential starting dose for human Phase I studies.

SciTech’s ST-001 will first enter Clinical Trials to target B-cell malignancies (Non-Hodgkin’s lymphoma (NHL), mantle cell lymphoma, and chronic lymphocytic leukemia). Alternatively, ST-001 will be tested in an exploratory IND in both Phase 1 & 2 clinical trials in which the drug is co-administered with rituximab as part of front-line CHOP-R therapy for the treatment of NHL. As reported in the medical literature, ST-001 is likely to have application in the more common solid tumor indications like breast, prostate, and lung cancers, but SciTech will defer pursuing these applications until the product has proven its value in the treatment of NHL or skin related cancers.