Aethlon Medical, Inc. (OTC: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, recently signed an agreement with DaVita Clinical Research (DCR) to support upcoming studies of its Aethlon Hemopurifier®. With experience conducting more than 300 early phase clinical trials through a network of more than 150 investigative physicians, DCR is uniquely positioned to help Aethlon Medical advance its unique Hemopurifier technology. DCR’s numerous locations could enable Aethlon’s trials to advance more quickly than they would if they were conducted in one clinical site.
Aethlon Medical’s Hemopurifier is a dialysis-like device with broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), hepatitis C virus (HCV) and numerous bioterror and pandemic threats. Human studies have demonstrated that Hemopurifier therapy, in combination with current standard-of-care peginterferon+ribavirin drug therapy, achieved undetectable viral load as early as day 7, which represents a significant clinical milestone in HCV care.
High demand for effective HCV treatments is evidenced by Gilead Sciences Inc.’s (NASDAQ: GILD) successful launch of Sovaldi. Early indications suggest that the drug could be the fastest drug launch ever with an estimated 3 million U.S. patients suffering from the disease. Another recent development in the space drives the point home, as Bristol-Myers Squibb (NYSE: BMY) was granted Breakthrough Therapy Designation by the FDA for its investigational DCV Dual Regimen (daclatasvir and asunaprevir).
Aethlon Medical’s Hemopurifier could offer a combination therapy with pharmaceutical drugs like these, or for patients that evolve resistance to drug therapies. With the DCR deal in place, investors may want to take a closer look at the company, particularly given the strong appetite for Gilead Sciences and other players in the HCV space.
Read the full press release discussing the deal with DCR here:
Aethlon Medical, Inc. (AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that it has reached an agreement in principle with DaVita Clinical Research® (DCR) to provide clinical management services that will support forthcoming studies of the Aethlon Hemopurifier®. The Hemopurifier® is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that suppress the immune system of cancer patients.
DCR is a specialty contract research organization (CRO) with experience in conducting more than 300 early phase clinical trials. As a subsidiary of DaVita Healthcare Partners, DCR has access to one third of the total US end-stage renal disease (ESRD) patient population and maintains a network that exceeds 150 investigative physicians practices at more than 250 clinical sites.
Aethlon previously disclosed that the United States Food and Drug Administration (FDA) had approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in the United States. Under the feasibility study protocol, Aethlon is to enroll ten ESRD patients infected with Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease indications.
"Not long after the FDA had cleared our IDE, we were presented an opportunity to advance a clinical relationship with DaVita Clinical Research," stated Aethlon Chairman and CEO, Jim Joyce. "As a result, we have transitioned our clinical plan from working with a single-site institute to working with a single institute that has a multitude of clinical sites across the United States. Beyond maintaining the resources necessary to advance our feasibility study, DaVita's proven extracorporeal expertise, patient accrual capabilities and expansive clinical infrastructure provide a foundation to support our long-term vision of treating a variety of infectious disease and cancer indications."
Aethlon further disclosed that the DCR agreement was entered into on a non-exclusive basis and is pending the completion of a definitive agreement, which will include a work order describing the full scope of services to be provided by DCR to Aethlon Medical.
DaVita Clinical Research is a wholly owned subsidiary of DaVita HealthCare Partners (DVA), a Fortune 500 company and parent company of DaVita and HealthCare Partners. DaVita is a leading provider of kidney care in the United States and abroad, delivering dialysis services to patients with chronic kidney failure and end stage renal disease. As of December 31, 2013, DaVita operated or provided administrative services at 2,074 outpatient dialysis centers in the United States serving approximately 168,000 patients, and at 73 centers in ten countries outside of the United States. HealthCare Partners(R) manages and operates medical groups and affiliated physician networks in California, Nevada, Florida, Arizona and New Mexico in its pursuit to deliver excellent-quality health care in a dignified and compassionate manner. As of December 31, 2013, HealthCare Partners provided integrated care management for approximately 765,000 managed care patients. For more information, please visit DaVitaHealthCarePartners.com.
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 tumor-secreted 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 http://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.
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