By: Dylan Sikes - AllPennyStocks.com News

Tuesday, June 25, 2013

In the biotechnology sector, achievement of milestones of varying degrees can be catalytic moments for companies. There’s the obvious market mover of a FDA approval for a new drug that can send a stock soaring, but some less-conspicuous achievements have the potential for great rewards as they can plant smaller firms on the radar of larger organizations. Examples would be inspiring clinical or pre-clinical data, commencement of clinical trials, agreements with a prominent university for research, etc. For Aethlon Medical, Inc. (OTCQB:AEMD), Tuesday’s news of receiving FDA approval of an Investigational Device Exemption, or IDE, is not being overlooked by the investment community for its potential future implications. The regulatory agency’s IDE approval allows Aethlon to initiate human feasibility studies in the U.S. for its Hemopurifier, a first-in-class device for rapidly eliminating infectious disease and pathogens from the circulatory system. For simplicity’s sake, think of the novel, disruptive technology as a filter that selectively removes disease-promoting particles as blood passes through it.

The potential uses for the Hemopurifier include a wide array of indications. Just some of the capabilities include use against viral pathogens, such as human immunodeficiency virus (HIV), hepatitis C virus (HCV) and bioterror and pandemic applications. Clinical research overseas has shown treatment with the Hemopurifier to be well tolerated and reduce viral loads in HCV and HIV patients as a stand-alone therapy by more than 50 percent with short, four-hour treatment periods. Follow-on studies combining the Hemopurifier with interferon in non-end stage renal disease (ESRD) patients resulted in undetectable HCV in only one week in hardest to treat genotype-1 patients.

Separately, additional research is being conducted via a contract with the Defense Advanced Research Projects Agency, commonly called “DARPA,” testing the Hemopurifier as a therapy to capture glycopathogen targets in sepsis, a life-threatening blood infection.

Another compelling possibility is the Hemopurifier’s ability to capture exosomes, microvescular particles underlying many strains of cancer. Exosomes are known to support tumor growth, metastasis, multi-drug resistance and suppression of the immune system. More research is needed in the blossoming area of oncology, but lab research has shown the Humopurifier to capture exosomes related to lymphoma, melanoma, breast and ovarian cancer.

As with most small biotechs, the key to meaningful awareness amongst investors and major pharma often resides in clinical research in the U.S. The IDE approval clears the path for Aethlon to attempt to validate its contentions on the prowess of the Hemopurifier in domestic clinical trials. The FDA-approved feasibility trial calls for the enrollment of 10 HCV-infected ESRD patients who have not received any drug therapy for at least one month.

According to the company, the protocol consists of a control phase of three consecutive standard dialysis treatments during week one followed by the inclusion of the Hemopurifier during a total of six dialysis sessions conducted during weeks two and three. The rate of adverse events observed during the Hemopurifier therapy phase will be compared to the rate experienced during the control phase.

"Aethlon Medical has been laying the groundwork necessary to implement the now approved clinical trial protocol for several years. We are finally able to move forward with our contract research and clinical partners in finalizing all of the activities that can now take place prior to initiating treatment of the first patient,” said Rod Kenley, president of Aethlon.

Successful completion of this brief feasibility trial will position Aethlon for a larger-scale pivotal trial necessary to apply for marketing clearance of the Hemopurifier as a new therapeutic for hepatitis C. With more than 170 million people globally being affected by HCV, the market potential is obviously large in this one indication alone.

Through Monday’s close at 10.1 cents, shares of AEMD were ahead by about 50 percent so far in 2013. In early trading action on Tuesday, shares have added on another 26 percent, advancing to 12.75 cents. Proper due diligence is, as always, encouraged.

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