An Update on the Clinical Status of the Aethlon Hemopurifier® in Hepatitis-C Care
Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
Through the publication of CEO notes, I seek to provide shareholders and other interested parties with a level of corporate transparency often absent in the microcap marketplace. In recent notes, I reviewed various topics, including emerging opportunities in cancer and the expansion of our government contract program to create a sepsis therapeutic.
This note is specific to our most important near-term objective: the approval of a investigational device exemption (IDE) by the U.S. Food and Drug Administration (FDA) that would allow us to initiate clinical feasibility studies of Hepatitis-C (HCV) infected individuals receiving Hemopurifier® therapy. In this regard, FDA withheld clearance of our recently amended IDE based on a single information deficiency that was deemed a safety concern. Specifically, FDA has requested that we detail our training and monitoring procedures related to heparinization, which is the primary anticoagulant utilized in dialysis and other extracorporeal therapies, including our Hemopurifier®. We are assembling the requested information and expect to have our response back in the hands of FDA in the coming week. The approval of our IDE remains a critical step in our strategy to advance a first-in-class medical device to address a major-market infectious disease condition.
HCV is a blood-borne pathogen that affects upwards of 170 million persons, or 2-3% of the world's population. It is a leading cause of liver cirrhosis and transplant and there is no pre or post infection vaccine. The magnitude of the HCV therapeutic opportunity has spawned immense competition within the drug industry. According to citeline®, there are over 200 planned and ongoing Phase I-III trials of pipeline HCV drugs as of March 1, 2013. However, it should be noted that only ten companies are responsible for 83% (165/200) of the referenced HCV studies
Bristol-Myers Squibb, Gilead, Merck & Co., AbbVie, Boehringer Ingelheim, Johnson & Johnson, Roche, Vertex, Achillion and Novartis. A primary factor for this odd statistical imbalance is the reality that these organizations often acquire candidate therapies that demonstrate clinical promise.
As a medical device, we have an enduring opportunity as our Hemopurifier® is uniquely positioned as an adjuvant to either interferon-based standard of care (SOC) or emerging all-antiviral drug regimens. And, unlike adjunct drug strategies, the Hemopurifier® performs without adding drug toxicity. In studies conducted in India, a three-treatment Hemopurifier® protocol administered in combination with interferon-based SOC resulted in undetectable HCV levels in as little at seven days in hard to treat genotype-1 patients. The studies also documented the ability of the Hemopurifier® to capture as many as 300 billion copies of HCV during a single six-hour treatment. In addition to augmenting the early viral kinetic response to drug therapy, the Hemopurifier® is a candidate solution for viral rebound patients who traditionally are forced to discontinue therapy once HCV establishes resistance to their drug regimens. Such a solution would address a significant unmet medical need in HCV care.
In closing, we are confident that we can fulfill FDA's information request. In the interim, I remain grateful to loyal shareholders that support our cause and I salute the continued perseverance of my Aethlon teammates.