Our clinical objectives are a bit more ambitious as we aim to navigate Hemopurifier® therapy into both cancer and infectious disease indications. Yes, we plan to file an investigational device exemption (IDE) to treat cancer later this year. We are also investigating Emergency Use Authorization (EUA) opportunities based on our broad-spectrum bioterror and pandemic threat data and have begun to explore Humanitarian Use Device (HUD) pathways for orphan conditions that affect fewer than 4,000 individuals in the U.S. each year.
To support the breadth of our long-term therapeutic vision, we often encounter challenging decisions. As an example, we recently disclosed a clinical relationship with DaVita Clinical Research, which required a lengthy process to establish and thus contributed to delay the initiation of our hepatitis c virus (HCV) feasibility study. However, the resulting relationship transitioned our potential clinical footprint from a single-site institute to an institute with more than 250 clinical sites to support long-term regulatory objectives.
Since crossing the threshold of having the FDA clear our candidate therapy for human studies, our therapeutic focus has been honed toward clinical progression to support future registration of Hemopurifier® therapy in the United States. The protocol of our forthcoming feasibility study calls for the enrollment of ten HCV-infected end-stage renal disease (ESRD) patients who have not received HCV drug therapy for at least 30 days. The protocol includes a control phase which consists of three consecutive standard dialysis treatments during week one followed by the inclusion of our Hemopurifier® for a total of six treatments administered during weeks two and three. The rate of adverse events observed during the Hemopurifier® treatment phase will be compared to the rate experienced during the control phase. Per-treatment changes of viral load will be observed through PCR analysis and we will also quantitate HCV viral copies captured within the Hemopurifier® during each treatment session. Successful completion of the feasibility study will set the stage for us to conduct pivotal efficacy studies required for Hemopurifier® market clearance. The study will also contribute data toward the human safety challenge requirement to advance the Hemopurifier® as a broad-spectrum countermeasure against viral bioterror and pandemic threats, whose lethality do not allow for the administration of clinical efficacy studies. Based on our experience conducting a similar protocol overseas, we are cautiously optimistic.
In closing, it is our sincere hope to reward shareholders whose support never wavered, even in the face of material setbacks and the clinical uncertainty of whether FDA would permit Hemopurifier® studies in the United States. As a result of this support, we have an opportunity to advance our therapeutic platform into a wide-range of life-threatening disease conditions.
About Aethlon Medical, Inc.
Aethlon Medical creates innovative medical devices to address life-threatening diseases. The Aethlon ADAPT™ (Adaptive Dialysis-like Affinity Platform Technology) establishes the basis for a new class of therapeutics that target the rapid elimination of disease enabling particles from the circulatory system of treated patients. The lead Aethlon ADAPT™ product is the Hemopurifier®, a device that addresses a broad-spectrum of viral pathogens as well as tumorsecreted exosomes that suppress the immune system of cancer patients. Aethlon is also operating under two government contracts with the Defense Advanced Research Projects Agency (DARPA) related the development of a medical device to reduce the incidence of sepsis. Exosome Sciences, Inc. is a majority owned Aethlon subsidiary that is advancing exosome-based strategies to diagnose and monitor cancer and infectious disease progression. Additional information can be found at www.AethlonMedical.com
Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the ESI will not be able to commercialize its future products, that the FDA will not approve the initiation of the Company's existing or future clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in the DARPA contract, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
James A. Joyce
Chairman and CEO
Chief Financial Officer
Published at Investorideas.com newswire
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