Congratulations to Iwao Ojima, Director, Institute of Chemical Biology and Drug Discovery (ICB&DD) and Project Leader, and Ramesh Gupta, Vice President, ChemMaster International Inc. and Principal Investigator) on receiving a Phase II STTR/SBIR award from the National Cancer Institute (NCI) for the project, “Preclinical Studies on Polyunsaturated Fatty Acid-Taxoid Conjugate for IND Filing.” The NCI scored this Phase II STTR/SBIR proposal as outstanding and awarded $2.7 million for two years.
The aim of this project is to advance a new tumor-targeting chemotherapeutic agent, PUFA-Taxoid (invented by Ojima), to treat a variety of human tumors associated with pancreatic, colon, breast, and lung cancers as well as to perform preclinical toxicology studies required for IND (Investigational New Drug) filing and FDA approval for clinical studies. Thus, the key technical objectives in the Phase II studies are further expansion of the current in vivo studies on tumors that are refractory to the currently used anticancer agents; Pharmacokinetics/ pharmacodynamics (PK/PD) studies including half-life, distribution, metabolism, and maximum tolerated dose, as well as all other preclinical toxicology studies necessary for IND filing; and optimization of the preparative methods in 200g scale for the reliable production of PUFA-Taxoid in GMP and the development of validation methods for the various intermediates in the synthetic sequence.
Currently there are no really effective drugs that can abolish human colon and pancreatic cancers because of the overexpression of MDR phenotypes as well as other drug resistance mechanisms involved in these cancers. Remarkably PUFA-Taxoid (omega-3 fatty acid–taxoid conjugate) can penetrate into these tumors selectively and bypass the MDR and other drug-resistant apparatuses, thereafter inducing cancer cell death. The development of PUFA-Taxoid for a possible efficacious treatment of colon, pancreatic, lung, breast, and other forms of cancer would benefit increasing numbers of these cancer patients.
This STTR/SBIR project involves ChemMaster International Inc. (Francis Johnson, President) and ICB&DD as well as two contract research organizations. The ICB&DD team includes Ojima, Thomas Zimmerman (Director, Division of Laboratory Animal Resources; School of Medicine), Peter Tonge (Director, Translational Experimental Therapeutics Laboratory; School of Medicine; Department of Chemistry), and Stanley Zucker (Department of Medicine).