Investorideas.com, an investor research portal specializing in investing ideas in leading sectors including biotech and medical technology stocks, issues an exclusive Q&A with Jim Joyce, Chairman and CEO of Aethlon Medical, Inc. (OTCQB: AEMD). Mr. Joyce discusses the recent launch of its new Exosome Sciences, Inc. (ESI) and what that potentially represents to Aethlon and its shareholders.
Q: Jim on September 12th you announced the formal launch of Exosome Sciences, Inc. (ESI), a wholly-owned subsidiary previously established by Aethlon. Can you tell investors the focus behind the subsidiary and why the timing was right to launch now?
Joyce: The rationale for launching Exosome Sciences was driven by the belief we could transform an unvalued asset into a substantially valued asset that would benefit our shareholders. As the focus of Aethlon Medical is therapeutic devices, the market had little reason to assign any value to candidate diagnostic products as our resources are going to be dedicated toward clinical progression and future commercialization of the Aethlon Hemopurifier® and other pipeline therapies. Especially, now that FDA has approved an IDE that allows us to initiate the first human clinical studies of our Hemopurifier® in the United States.
Still, it became increasingly clear that we needed to leverage our proprietary techniques to isolate and quantify exosomes before the window for related diagnostic innovation began to close. It was also hard to ignore the lofty valuations being awarded to other similar-stage molecular diagnostic organizations. So, we launched Exosome Sciences as a stand-alone entity and hired the best-known researchers in the exosome field to unlock the value of our technology and build an expansive pipeline of urine and blood based diagnostic products.
Q: Can you explain to investors what Exosomes are and how they play a role in cancer diagnostics and treatment?
Joyce: Sure, but I would first like to share that when we first initiated our exosome research programs, the vast majority of the medical community considered these particles to be nothing more than cellular debris with no biological function. In fact, at the time only a handful of labs were thinking about the role of exosomes. Today, it appears our early entry into the field may pay off as the medical community clearly recognizes that exosomes are vital therapeutic and diagnostic targets. In fact, there are now industry conferences and associations dedicated solely to exosome research.
As it relates to the exosome-related objectives of Aethlon Medical, we utilize our Hemopurifier® to target the elimination of circulating tumor-secreted exosomes as an adjunct therapy to improve cancer treatment outcomes. Our strategy addresses a significant unmet medical need as researchers have discovered that exosomes suppress the immune system of cancer patients and they facilitate tumor growth, seed the spread of metastasis, and contribute to drug resistance. Our hope is that exosome elimination saves lives by tipping the therapeutic balance in favor of the patient.
In regards to the diagnostic focus of our Exosome Sciences subsidiary, we are advancing exosome-based tools to better diagnose and monitor the progression of cancer and other life-threatening disease conditions. As it turns out, exosomes transport markers specific to the origin disease into bodily fluids, including the blood and urine where they can be easily assessed. Our objective is to introduce non-invasive liquid biopsies that can provide for the earliest detection or recurrence of cancer and other diseases. Our lead product is an assay that we named ELLSA. So far, ELLSA has been validated to identify the presence of exosomes underlying the human immunodeficiency virus (HIV), tuberculosis (TB), and various forms of cancer, including ovarian, melanoma, and breast cancer.
Q: Exosome Diagnostics recently announced it entered into a collaboration agreement with Eli Lilly and Company for biomarker discovery and validation using Exosome Diagnostics proprietary EXO50 nucleic acid extraction kit. Eli Lilly will gain early access to Exosome Diagnostics technology to help identify key gene mutations and expression levels in blood that may be correlated with drug response and disease recurrence.
Your core technology, the Aethlon Hemopurifer®, targets the rapid elimination of infectious disease and cancer glycopathogens, including exosomes from circulation. Can you tell us the synergies and benefits of having both a therapeutic technology and a diagnostic division working on such an important area of cancer research? And does having a diagnostic and therapeutic division so tightly focused give your company an edge?
Joyce: Excellent question. There is tremendous synergy as the advancements of Exosome Sciences have the potential to become companion diagnostic tools that determine when Hemopurifier® therapy should be administered. As an example, an assay able to detect exosomes underlying breast cancer might define the point when it would be appropriate to initiate Hemopurifier® therapy. This same assay would then be useful in monitoring patient response to therapy and could be utilized to optimize the administration of the Hemopurifier® and other therapeutic regimens.
Q: You just reported the appointment of Dr. Douglas Taylor as Chief Scientific Officer of Exosome Sciences, Inc. What does his background bring to the table to help lead this new subsidiary?
Joyce: Dr. Taylor is the individual who first discovered tumor-secreted exosomes and is a leading published author in the field. His knowledge, expertise, and stature within the scientific community will be instrumental in developing a product pipeline and establishing strategic industry relationships.
Q: In closing, your company has achieved some significant milestones recently for Aethlon Hemopurifer®. For investors new to the company, can you give us the recent highlights?
Joyce: Since the beginning of the year, we have been extremely productive. Beyond the formal launch of Exosome Sciences, we formed a team that won a $22 million Department of Defense contract, we reported on positive Hepatitis C (HCV) treatment outcomes from studies conducted overseas, we expanded the potential indications of our Hemopurifier® in cancer, and disclosed the issuance of new patents that further protect our technologies.
However, the most significant milestone by far was FDA approval of an IDE that allows us to initiate clinical studies of HCV patients in the United States. While this took years of effort, the IDE approval unlocks the opportunity to demonstrate the value of our Hemopurifier® on the world's most important clinical stage.