While biotechs big and small are busy slogging through a years-to-decades long clinical trial process and burning though hundreds of millions on the way, here’s a comforting thought: There currently is no business model anywhere in biotech for dealing with a serious disease outbreak on the fly. Everything is slow in drug development. Extremely slow in fact. Only about 1 in 5,000 antiviral candidates will reach the market, and the time span from discovery to market can span decades.
Consider that the Spanish Flu pandemic of 1918 killed about as many people as World War II and the thought of agonizingly slow drug development becomes even less comforting. While GlaxoSmithKline plc (ADR) (NYSE:GSK) and Merck & Co. Inc. (NYSE:MRK) for example have promising Ebola vaccine candidates in late stage trials, there is still no assurance that they will be effective on a large scale, and besides, relying on disease-specific vaccine approaches for possible threats that have not yet even been identified is a dangerous strategy.
By the end of this year though, there may finally be a business model for dealing with a serious disease outbreak on very short notice, even one that has not even happened yet. The company is Aethlon Medical, Inc. (NASDAQ:AEMD), and it is approaching a major catalyst by year-end for its near-universal virus filter, the Hemopurifier.
The idea behind the Hemopurifier is to literally filter viruses out of the blood while leaving everything else in. While it may sound like science fiction, it is actually just a simple application of commonly used virus-purifying technology. Molecules called lectins are commonly used to isolate viruses for the purpose of creating viral cultures, similar to a petri dish in regard to bacteria. Viruses stick to lectins by their glycoprotein envelopes. While not all viruses have these envelopes, most do. Aethlon took this concept one step further by packing lectins into an external cartridge and hooking it up to a dialysis machine. The blood runs through the cartridge, leaving the virus copies behind, and the blood reenters the body sans viruses.
It was the Federal government that took notice of Aethlon’s device when then Connecticut Senator Joe Lieberman invited Aethlon CEO James Joyce to discuss the device within the context of the Project Bioshield Act. This act was passed in 2004 and authorizes Congress to spend up to $5 billion to stockpile drugs or vaccines to combat potential chemical or biological threats. Since the Hemopurifier is neither a drug nor a vaccine but a medical device, Senator Lieberman took charge to change the language of the Act to include medical devices as well, in order to include the Hemopurifier in its purview. Ironically, thanks to this change, Aethlon is now the last man standing on the list of companies actively involved in Project Bioshield.
2012 saw Aethlon make another leap forward with the Hemopurifier. That year saw Aethlon sit down with an FDA review board following a study of the device on hepatitis C patients. One member wanted to know what the evidence was that the cartridge was actually capturing viruses and not just triggering an immune response in patients. That question led to Aethlon suspending the study in order to create a protocol for measuring the viral load in the Hemopurifier itself.
What they found was that the HCV patient in question had 300 billion copies of the virus removed from the blood. A very high viral load in an HCV patient is considered to be 25,000,000 viral copies per mL of blood, roughly 117 billion copies in total for the average adult carrying 4.7 liters of blood. What this means is that the Hemopurifier reduced the viral HCV load to close to zero.
Up until now the device has been nothing more than an academic intrigue, but that may be about to change. Aethlon is at the tail end of proof of concept safety study being run by the clinical research organization of Davita Inc. (NYSE:DVA). The study is testing the Hemopurifier on patients infected with HCV with end stage renal disease. The purpose is to test the device on the most immuno-compromised and health-compromised patients in order to determine if it is safe. Results for this study should be out by year end, and will allow Aethlon to move on to the next stages of development.
Two paths could be available to the company at successful completion of this safety proof-of-concept study. The first is to approach the Federal government through Project Bioshield with evidence that the Hemopurifier works. This could lead the way to the stockpiling of the Hemopurifier by the US government in the event of viral epidemic similar to the Spanish Flu.
The second path is to test the device on a chronic viral pathogen in combination with other drugs to determine if the Hemopurifier increases the effectiveness of conventional antiviral medicines. This opens the door to partnership with HCV companies are other pharmaceutical firms focusing on antivirals.
If Aethlon decides to continue down the HCV path as it has been up to now, then there is cause for optimism. One big advantage that the Hemopurifier has over conventional antiviral HCV therapies is that it is subtractive rather than additive. This means it is much less likely to cause unwanted side effects, as some HCV drug regimens do. Particularly disturbing is the fact that Harvoni, Sovaldi, and Epclusa from Gilead Sciences, Inc. (NASDAQ:GILD), Viekira Pak and Technivie from AbbVie Inc (NYSE:ABBV), and other blockbuster hep-C drugs have all been slapped with black box warnings by the FDA due to the risk of them ironically inducing a comeback for hep-B. This may be due to hep-B opportunistically taking over the territory of a defeated hep-C, or perhaps some other reason.
Whatever it is, the Hemopurifier probably will not encounter this problem, as hepatitis B would be filtered out by the unit just as well, and it shouldn’t induce any unwanted drug interactions.
Where exactly Aethlon goes following the publication of these results remains to be seen, but if this safety trial is successful, then Aethlon is only one pivotal trial away from introducing the world’s first subtractive antiviral therapy to market, and one that could potentially be stockpiled by the US government under Project Bioshield.