In the biotechnology space, there is an acceleration of companies, both large and small, that are teetering on the brink of smashing down barriers in life-threatening diseases and shepherding in the next generation of therapeutic technologies. Indeed, there are plenty of small molecules being maneuvered down the regulatory pathway that offer promise either stand-alone or in combination therapies. Celgene Corp. (CELG) has seen shares dance upward of $100 per share as optimism builds about Abraxane, a concoction of paclitaxel and a protein called albumin, as a new therapeutic for prostate cancer. Stem cell technologies, although still volatile, seem to be finally (and deservedly) getting a firmer footing as clinical trials by companies like Athersys, Inc. (NASDAQ:ATHX) progress through mid-stage research.
Another up-and-coming technology that investors should be closely watching relates to the targeting of exosomes, little ‘bubbles’ (called vesicles) that have emerged to become novel biomarkers of disease progression as well as vital therapeutic targets. Research efforts are moving quickly as scientists now have a better understanding of how exosomes contribute to the progression of a wide spectrum of diseases. Privately held Exosome Diagnostics has partnered with Massachusetts General Hospital and University of California, San Diego to discover biomarkers transported by exosomes in cerebral spinal fluid and blood as the cornerstone of a new diagnostic platform to monitor brain cancer.
In the public sector, the forerunner in exosome research is medical device maker Aethlon Medical, Inc. (AEMD), who has created exosome diagnostic tools, and more importantly, the first therapeutic candidate to address these cancer-promoting particles. A couple steps ahead of peers, Aethlon has developed its ADAPT™ system that provides for the rapid, selective removal of disease enabling particles from the blood. At present, the ADAPT™ system generates revenues for Aethlon through a multi-million dollar contract with the Defense Advanced Research Projects Agency, or “DARPA,” where it is being advanced to reduce the incidence of sepsis in battle-injured soldiers and civilians.
However, Aethlon’s lead product is the Hemopurifier®, a medical device that targets the treatment of cancer and a variety of infectious disease conditions. The Hemopurifier® is currently in a “compassionate use” program in India where it is being utilized to accelerate the depletion of Hepatitis C Virus (HCV) to undetectable levels. An Investigational Device Exemption is also pending with the U.S. Food and Drug Administration related to the potential commencement of HCV studies in the United States.
With more than 18 million cases of sepsis diagnosed each year globally and no approved drugs demonstrating any statistical benefit for the blood infection, this single indication alone could prove a stunning boon to Aethlon’s valuation, not to mention the multi-billion-dollar HCV market that has investors cheering for Gilead Sciences’ (NASDAQ:GILD) new drug candidate, sofosbuvir.
But, that’s not the point of this article.
The point is that Aethlon has built a technology, a filter if you will, that can be formulated to extract specific matter out of the circulatory system quickly and efficiently. The aforementioned trials lend a great deal of validation to the efficacy of the ADAPT™ system.
In the cancer space, tumor-secreted exosomes have been discovered to suppress the immune system, facilitate tumor growth, seed metastasis creation and promote drug resistance. Aethlon contests that their Hemopurifier can be used synergistically with approved cancer drug therapies to enhance treatment through the elimination of tumor-secreted exosomes from the entire circulatory system.
In October, the company was issued a U.S. Patent that covers the extracorporeal removal of exosomes and other mircrovesicular particles.
Could the Hemopurifier function as an independent cancer therapy? Perhaps, but Aethlon has positioned it’s device as an adjunct therapy to improve the benefit established cancer therapies. That market opportunity alone is enormous. The company has already demonstrated the ability to capture exosomes underlying ovarian, breast, lymphoma, and metastatic melanoma.
As noted by Dr. Annette Marleau, Director of Immunology at Aethlon, “Since patients afflicted with metastatic melanoma have suppressed immune systems due to tumor- and drug-related effects, the efficacy of novel immunotherapeutic solutions is limited and only small percentages of patients experience durable responses and extended survival.”
There is clearly a cyclic pattern in the treatment of cancer that needs to be broken. The knowledge base surrounding exosomes is still emerging, but paints a powerful picture of the vital role of exosomes in cancer. What companies like Exosome Diagnostics are working on is recognizing exosomes as harbingers of more serious oncologic problems to come. Once identified, Aethlon Medical provides a therapeutic strategy to eliminate these cancer-promoting particles.
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