Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device designed to treat infectious disease. The Hemopurifier® provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and is positioned to address the treatment of drug and vaccine resistant viruses. Aethlon has submitted a contract proposal to solicitation entitled “Application of Platform Technologies for the Development of Therapeutic Agents for Biodefense”. So far so good, now phase I human safety study within a five-year contract period needs to be submitted.
To comply with this stipulation, Aethlon’s contract response will include human safety data from clinical programs conducted at the Apollo Hospital and the Fortis Hospital, both in Delhi, India as a countermeasure against select bioterror (such as bird flu, ebola, HIV etc.,) and pandemic threats.
Luckily human efficacy studies against bioterror threats are not permissible for obvious humanitarian reasons, the demonstration of safety remains the sole regulatory challenge in humans. Aethlon plans to request permission to initiate the IDE-related human study soon after its contract response to the solicitation.
I would be really surprised if any of this study information is available public, and how participants would consent to this studies. What if the device fails or there is a unexpected biohazard ? Does not make sense to me why we are happy to host such studies.
No comments:
Post a Comment