Subchronic Intravenous (I.V.) Toxicity Study in Rats

SUMMARY

"Six Sprague-Dawley male rats were given an intravenous infusion of lipid-coated microbubbles (Filmix) at an average dosage of 0.14 ml/kg, 3 times weekly for 6 weeks. Blood samples were obtained at 2 and 6 weeks for a serum chemistry profile of some 19 parameters. At the conclusion the animals were sacrificed, subjected to a gross autopsy, organ weights obtained for 7 critical organs and the tissues fixed for histological examination [by Dr. Stuart Wyand, Professor of Pathobiology, University of Connecticut]."

"A comparison of the 6 week versus 2 week chemistry values show some differences and elevations in a number of the parameters examined with the most prominent difference occurring in the LDH values. The gross and microscopic pathology examinations did not reveal any lesions related to the administration of the test material. Furthermore, there were no atheromata, mural thrombi or emboli seen in any of the tissues examined."

"These results support the safety of Filmix for single or two times administration for clinical trial."

Robert West, Ph.D.
Consulting Pharmacologist/Toxicologist
FOOD, DRUG, CHEMICAL SERVICES, INC., Stamford, Connecticut 06906
November 28, 1989