Aethlon Medical Positions to Expand Hemopurifier Clinical Trials to Include Dengue Virus Treatment

Aethlon Medical Positions to Expand Hemopurifier Clinical Trials to Include Dengue Virus Treatment

By: Dylan Sikes - AllPennyStocks.com News

Wednesday, September 24, 2014

Infections are a hot topic across the world currently. The Ebola outbreak, already the worst in history, is six months into it and still gaining steam. At its current pace, experts say that the number of Ebola cases in Liberia and Sierra Leone could top one million by the end of January, although it’s notable that the projections were calculated before a concerted response last week by the U.S. and other countries to accelerate efforts to control the outbreak. Separately, multi-drug antibiotic resistance has been streaming through headlines against the backdrop of President Obama signing an Executive Order last week to escalate efforts to develop new diagnostics and drugs to better combat the very real threat of a post-antibiotic era. On Wednesday, Aethlon Medical, Inc. (OTCQB:AEMD) released news that it is looking to provide a new treatment for dengue virus, a leading cause of death and illness carried by mosquitoes in the tropics and subtropics with no approved drugs or vaccine therapies. Currently, according to the Centers for Disease Control and Prevention, the most effective protective measures are those that avoid mosquito bites. The CDC website states that up to 400 million people annually are infected with dengue virus.


Aethlon is the maker of the Hemopurifier, a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that promote cancer progression. Think of it as a high-tech blood filter that can use different affinity agents to capture specific pathogens.

Clinical studies conducted previously in India have demonstrated the ability of the Hemopurifier to be effective in the treatment of HIV and hepatitis C. Last June, the U.S. Food and Drug Administration approved an Investigational Device Exemption (IDE) for the Hemopurifier, allowing Aethlon to move forward with human feasibility studies. Earlier this month, Aethlon announced that an independent internal review board gave approval to initiate human clinical studies of Hemopurifier therapy at DaVita (NYSE:DVA) MedCenter Dialysis located in Houston, Texas. In the coming weeks, Aethlon will begin enrolling ten end-stage renal disease patients who are infected with the hepatitis C virus to demonstrate the safety of Hemopurifier therapy.

Regarding today’s news, Aethlon announced an agreement with Qualtran, LLC that would expand human clinical studies of Hemopurifier therapy to include individuals infected with dengue virus. Qualtran is the contract research organization that originated and managed the previous clinical trials of the Hemopurifier at various sites in India. Further, Qualtran has established a collaborative relationship with India’s National Institute of Virology, resulting in research demonstrating the Hemopurifier’s ability to capture dengue virus. Moving forward, Qualtran has agreed to establish multiple treatment sites and recruit thought leaders from the dengue field to establish consensus treatment protocols in advance of the 2015 dengue outbreak season.

Aethlon intends to incorporate data from the proposed dengue treatment study into a Humanitarian Use Device (HUD) submission. A HUD program provides an alternative FDA pathway for getting market approval for medical devices that may help people with rare diseases or conditions, specifically those affecting less than 4,000 people in the U.S. each year. Efficacy studies are not feasible in the continental U.S., as dengue rarely occurs here, but it is a serious problem in Latin America, Puerto Rico, Southeast Asia and the Pacific Islands.

The IDE feasibility study in the U.S. will provide additional safety data on the Hemopurifier. This data, combined with previous clinical and pre-clinical studies is framing the robust therapeutic area where the Hemopurifier could provide a benefit for diseases and conditions of great unmet medical need, whether stand-alone or as an adjunctive therapy to improve outcomes. The company says it is seeking opportunities to expand treatment indications through HUD and Emergency Use Authorization. These pathways have a spotlight on them with the Ebola breakout, allowing some therapies that have not made it through regulatory channels yet to be used to try and fight the disease. According to Aethlon, in vitro studies of bioterror and pandemic threats conducted with domestic and international government and non-government organizations have verified the Hemopurifier capture of ebola hemorrhagic virus, dengue hemorrhagic virus, H5N1 avian influenza (bird flu), 2009 H1N1 influenza virus (swine flu), West Nile virus, and more.

Clinical validation of successfully treating deadly viruses could be the catalyst that Aethlon needs as shares are well of 27-cent highs hit in March. Shares of AEMD initially were ahead in morning trading on Wednesday, but have edged back to around even at 11.5 cents as the trading day winds towards a close. Proper due diligence is, as always, encouraged.

Copyright © 2014 AllPennyStocks.com. All rights reserved. Republication or redistribution of AllPennyStocks.com's content is expressly prohibited without the prior written consent of AllPennyStocks.com. AllPennyStocks.com shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Other Penny Stock Movers

Miner Scores with Acquisition of Promising Silver District in Mexico
Mixed Signals: Durable Goods Orders Up, But Not All Sectors Are Soaring
Biotech Steals The Show Following Pre-Clinical Data Announcement
Most Popular
5
FREE Newsletter


Back to Top