Research

Preclinical Pharmacology Research
Determinations of antitumor efficacy, animal toxicology, chemical analytics, sterility, storage and stability of these formulations are processed at M.D. Anderson Cancer Center, University of North Texas Health Sciences Center, Johns Hopkins University Cancer Center, University of Western Ontario/Lawson Institute and commercial laboratories in the USA, Austria, and Canada.

Registration Plans
Phase I dose finding study in normal volunteers in 3rd Q 2011 with liposomal curcumin (Clinicaltrials.gov) In the 4th Q. following IND submission to the FDA, Phase Ib-II clinical trials of pancreatic cancer, lymphoma, and Parkinson’s disease in Vienna, Austria, Westchester County Medical Center, NY and MD Anderson Cancer Center Houston, Texas are planned. IND applications for nanocurcumin will be submitted in the 4th Q, 2011.

Current Status of the GMP Liposomal Curcumin Formulation
Animal studies (Langendorff assay) of liposomal protection against cardiac potassium channel current inhibition by curcumin and methanesulfanalide are ongoing.

Current status of the GMP Nanocurcumin formulation
Scale-up GMP manufacturing is in process at Regis Technologies Inc. Illinois.
Preclinical applications are ongoing with non-GMP nanocurcumin including dog toxicology.

Current status of the PLGA- Liposomal - Curcumin formulation
Non-clinical stability, and pre-clinical efficacy immediate and ten day extended release kinetics following subcutaneous injection is ongoing at Univ. North Texas. A planned Therapeutic study of Goto-Kakizaki type 2 diabetic rats at Nucro-technics, and Park7-knockout rats at the Lawson Neurologic Institute Canada are planned.

Manufacture
The active pharmaceutical principle curcumin is manufactured in India. The lipocurcumin formulation is manufactured in Austria. Nanocurcumin is manufactured in the U.S.A.