During the presentation JJ and Dr.Tullis made at University of Texas MD Anderson hospital 9-10-2012, JJ confirmed that AEMD would submit an IDE to the FDA in October to initiate U.S. clinical programs using the Hemopurifier as an adjunct treatment for HEP C. JJ then added that the IDE could be leveraged to expand indications to include single-use removal of cancer exosomes. Since the presentation was at MD Anderson Hospital considered by many to be the premier cancer hospital in the world, the implication is that MD Anderson would be most welcome to participate in studies using the HemoPurifier perhaps initially in a single arm study quantifying the removal of melanoma exosomes using the ELLSA technology followed possibly by double blind prospective studies using the HemoPurifier for removing exosomes as an adjunct treatment for melanoma. Although prospective studies would undoubtedly take years, single arm quantification studies could be done quickly in my opinion. MD Anderson has been a leader in exploring various treatments for melanoma including chemotherapy, isolation heat perfusion, and other modalities too numerous to cite. Its financial resources and interest in funding cancer research through the years have been impressive.
The presentation included references to various articles supporting certain premises:
1.) Melanoma exosomes are key delivery vehicles for spreading malignant proteins from metastatic cells to less aggressive cells. On this basis, a device strategy for removal of circulating exosomes could be implemented to slow cancer growth and metastasis in order to improve the effectiveness of standard of care treatments.
2.) There is a role for melanoma derived microvesicles in hyper-coagulation, suggesting that a device strategy for clearance of circulating exosomes/microvesicles has potential for addressing cancer-associated complications (i.e. thromboembolism) that significantly impact patient survival.
3.) There is a role for melanoma exosomes in homing to lymph nodes and conditioning lymph nodes for the subsequent seeding and growth of melanoma cells. These data support the concept that systemic clearance of exosomes could serve as a means for targeting the “messenger system” underlying cancer metastasis.
4.) There is a correlation between high concentrations of tumor-derived exosomes in plasma and cancer progression that points toward exosomes as prognostic indicators and therapeutic targets in melanoma.
5.) Removal of melanoma-derived exosomes from the blood has the potential to enhance cancer-specific immune responses and to improve the outcome of immunotherapy.
6.) Exosomes released from melanoma fuse with target cells and establish the microenvironment for metastasis. Research also reveals a correlation between exosome concentrations in circulation with disease stage, prognosis and survival, thereby reinforcing the therapeutic potential of a device strategy for eliminating cancer exosomes from circulation.
In my opinion, MD Anderson will find the potential for HemoPurifier being used as an adjunct therapy in treating melanoma too tempting to ignore and that sooner or later studies will be implemented under their important auspices. If indeed the FDA IDE application in October can be expanded so as to include trials using the HemoPurifier as an adjunct in treating melanoma, or for that matter other malignancies, at MD Anderson, I would consider that a very encouraging and important development in oncological research. I do not feel I am being too forward suggesting that other cancer centers such as Sloan Kettering and City of Hope would want to step in with studies of their own.
