SAN DIEGO, Jan. 3, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, disclosed today that it has submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) that requests permission to initiate a clinical feasibility study of Hepatitis-C (HCV) infected individuals enrolled to receive Hemopurifier® therapy. Upon approval by FDA, an IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application.
The Aethlon Hemopurifier® is a first-in-class medical device that targets the rapid clearance of HCV from the entire circulatory system. The goal of therapy is to improve the benefit of interferon-based or all-antiviral HCV drug regimens. Aethlon's IDE submission included clinical data from Hemopurifier® studies of HCV-infected individuals conducted at the Apollo Hospital, Fortis Hospital, and the Medanta Medicity Institute, all located in India. As requested by FDA during a Pre-IDE meeting, Aethlon also provided data that quantified the capture of HCV within the Hemopurifier® during treatment. The proposed feasibility study would enroll 10 patients with End Stage Renal Disease (ESRD) and concomitant HCV infection. The study would be conducted by the Renal Research Institute (RRI), which was established in 1997 as a partnership between Fresenius Medical Care (FMC) and Beth Israel Medical Center, New York City.
How would qualification of the device be done for other treatment options? Lets say that this gets approved for the HCV, and it proves to be successful (we would all expect/hope for that as it has been before). Certainly the safety for use on humans would be approved or not based on the outcome of this study. I would not expect the safety would have to be proven again, but do we have to submit an IDE for every disease being targeted as part of the process to allow for marketing? Thanks.
I believe AEMD has a number of options here, but the most common is to secure FDA approval for one condition and then go back to FDA with a new IDE for the remaining conditions that would be treated (or at least a subset of them). This gets the revenue pipeline established and affords the company to get funding for broader studies.
If AEMD goes that route, the IDE would be approved within a month (barring questions from FDA or a flat-out rejection) for a particular condition and the ci]linical studies of safety and effectiveness (S&E) for that condition would be used to acquire FDA approval through PMA (180 days for FDA approval). Then, with revenue coming in on THAT condition, AEMD would be in a position to fund studies that would result in additional PMA's.
Another option would be to expand the study once the IDE was started, but this requires additional approvals and there is no "interim" milestone of demonstrating S&E nor the revenue that comes with that. AEMD's announcement of a limited study (10 subjects?) would indicate that they are looking for an immediate interim milestone.
FDA has provisions for approving different types of device changes through PMA supplements, etc. but I don't think they apply here because the clinical information changes for each new condition to be treated.
Again, just my opinion...
Again, just my opinion.
Sentiment: Strong Buy
I've been watching the FDA website pretty closely to see if any information on Aethlon, HP or the IDE are posted. When I saw the Press Release, I checked again and found an Establishment Registration for Aethlon with a "site last updated" date of 14DEC. I'm fairly certain that this Establishment Registration was not on the FDA site prior and it stands to reason that it would accompany an IDE filing.
Unless FDA has concerns/questions, an IDE application SHOULD be answered within 90 days (calendar). The Agency has been under pressure over the last few years to respond quickly to all such filings by device (and drug) manufacturers. Unless Aethlon has not done its homework (and assuming that the filing was made around 14DEC), it should be a "prosperous" Spring for us Longs...
Sentiment: Strong Buy