Receptor Mediated SPECT Imaging Of Kaposi Sarcoma With mTc Tilmanocept

DESCRIPTION provided by applicant Navidea Biopharmaceuticals has developed mTc tilmanocept as a radiopharmaceutical diagnostic imaging agent targeted to the macrophage mannose receptor CD to be used as an aid for lymphatic mapping in cancer surgeries The United States Food and Drug Administration approved Navideaandapos s new drug application NDA for mTc Tilmanocept for use in surgeries to remove melanomas and breast tumors in May of This SBIR Fast Track application proposes a highly innovative new indication for mTc tilmanocept Based on ex vivo work with mTc Tilmanocept in Kaposiandapos s sarcoma KS lesions from HIV AIDS patients Navidea in collaboration with Drs McGrath andamp Maurer of the Univ of California San Francisco have found th a t a ll KS lesion cells express CD KS lesions can occur in the lungs and along the gastrointestinal tract GI of AIDS patients where they pose a serious and life threatening risk Timely and accurate identification of these internal KS lesions is essential for delivery of therapies that may significantly extend the lives of AIDS patients wit KS Current diagnostic protocols are invasive and challenged to accurately identify internal KS lesions Our preliminary findings indicated that mTc Tilmanocept could be used to more easily less invasively and more accurately identify internal KS lesions thereby improving both the long term outcomes and quality of care for KS patients mTc Tilmanocept has an extraordinary safety record with no significant adverse events attributable to mTc tilmanocept having been observed The primary goal for the proposed efforts is to demonstrate that mTc tilmanocept when injected intravenously can be used as a single photon emission computed tomography SPECT imaging agent for visualization and identification of internal KS lesions in AIDS patients In addition despite the very significant progress that has been made over the last two decades in AIDS therapies KS remains a common serious and life threatening condition in AIDS patients worldwide Better therapies for KS are greatly needed If this project is successful and mTc tilmanocept is demonstrated to bind specifically to cells in KS lesions follow on studies will be performed not part of this application to determine if tilmanocept can be used to target delivery of therapeutics to KS lesions Targeted delivery of therapeutics may greatly improve their efficacies providing a very significant additional benefit t KS patients This Fast Track SBIR application proposes preclinical animal studies examining the safety of intravenous injection of mTc tilmanocept part followed by a clinical study providing the initial evaluation of the safety and efficacy of SPECT imaging studies with mTc tilmanocept to identify internal KS lesions in human patients part PUBLIC HEALTH RELEVANCE This project if successful has the potential to dramatically improve life expectancies quality of care and quality of life for patients suffering from Kaposiandapos s
sarcoma KS Due to the unexpected observation that KS tumor cells abundantly express the macrophage mannose receptor CD we propose to test the feasibility that Navidea Biopharmaceuticalandapos s FDA approved CD binding diagnostic radiopharmaceutical mTC tilmanocept can be used to identify internal and difficult to find KS lesions If successful follw on studies will determine if tilmanocept can be used to target delivery of therapeutics directly to
KS tumor cells