SAN DIEGO, April 6, 2011 /PRNewswire/ -- Aethlon Medical, Inc., (OTCBB: AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
To our Shareholders:
On April 1st, we submitted a contract response to the Defense Advanced Research Projects Agency (DARPA) related to the Dialysis Like Therapeutics (DLT) program referenced in my last shareholder letter. In our submission, we proposed to leverage our technology platform to deliver a dialysis-like therapy that would address precursors to sepsis, including bacterial toxins, viral pathogens, and disease enhancing particles transported by exosomes. We believe our proposal meets goals underlying the DLT program as the resulting device would target to reduce the occurrence of sepsis and would provide decision-free and life saving medical care for the wounded warfighter. Additionally, we introduced an innovative strategy to deliver our dialysis-like therapy without the need for anticoagulants, as well as a novel approach to selectively clear whole bacteria from circulation.
If selected for an award, several larger organizations and industry thought leaders have agreed to partner with us to advance our program proposals. It is anticipated that the DLT program awards will be announced in the next 120 days. We are now collaborating with our advisors to determine the next contract or grant opportunity to pursue. Beyond non-dilutive bioterror and pandemic threat funding opportunities, we are also evaluating potential responses to new government programs in Hepatitis-C, HIV, and Cancer.
In addition to navigating government funding opportunities, we are actively advancing research and clinical initiatives in both infectious disease and cancer. On the clinical front, I am pleased to disclose that we our close to submitting our updated IDE to the FDA. The goal of our submission is approval from the FDA to initiate Hemopurifier® human studies in the United States. Details regarding our FDA communications and clinical site locations can be expected through forthcoming news disclosures.
In regards to our HCV treatment study in India, we initiated treatment of our first patient at the Medanta Medicity Institute, which was observed by our President, Rod Kenley. In previous studies, we demonstrated significant viral load reductions in health compromised dialysis patients that were infected with either HCV or HIV. In this study, we are leveraging those results to demonstrate that our Hemopurifier® can accelerate viral load reduction when administered to non-dialysis patients in combination with drug therapy. Based on a prior clinical validation, we are confident in our capabilities and recognize the potential significance of our Hemopurifier® as viral load depletion rates in the earliest stages of therapy are considered predictive of patients who achieve long-term clinical benefit. In the treatment of our first patient, it was recognized early on that that we needed to modify our protocol to administer anticoagulants in dosages specific to our therapy, and not in amounts normally administered to dialysis patients. Regardless, there was no harm to this patient, although the anticoagulant miscalculation did not allow him to successfully complete his entire treatment. While causing a delay of several weeks, our protocol has been formally amended and we are now ramping up patient enrollment. We are also seeking to open up our study to those residing outside of India, based on worldwide inquiries from infected individuals.
In closing, I also wish to disclose that Jeff Richardson has agreed to rejoin our team on a part-time basis. While you may or may not recall Jeff, he was responsible for originating national news coverage our technology through multiple media outlets, including Popular Science, CNN, and Readers Digest. As the former communications director at Amgen, Jeff provides tremendous insight on advancing the awareness of innovative medical therapies through the national media.
On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Certain of the 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, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, including obtaining government grants, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier® to improve the efficacy of SOC therapy against HCV, the Company's ability to manufacture its products either internally or through outside companies and to create future generations of the Hemopurifier®, the impact of government regulations, patent protection on the Company's proprietary technology, 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.
James A. Joyce
John P. Salvador
Director, Communications & Investor Relations
SOURCE Aethlon Medical, Inc.