Wednesday, January 06, 2010 12:55:29 PM
Press Release
Source: Aethlon Medical, Inc.
On 8:00 am EST, Tuesday December 8, 2009
To our Shareholders:
In my September 15th shareholder letter, I indicated that we initiated the program with Bioserv/NextPharma to produce our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. Today, I am pleased to report that we have now established our GMP manufacturing processes. Furthermore, we kicked-off our inaugural production run yesterday, which should allow us to commence with our first Hemopurifier® shipments in February. The task of establishing manufacturing of our Hemopurifier® under GMP was an intricate process requiring significant expertise and a focused commitment among many participants. I applaud the tireless efforts of Dr. Richard Tullis, Paul Duffin, and our colleagues at Bioserv/NextPharma.
The initial commercialization of our Hemopurifier® remains focused towards treating individuals infected with Hepatitis-C virus (HCV) at select medical centers in India. At present, fewer than half of HCV-infected individuals who initiate the 48-week interferon-ribavirin standard of care (SOC) drug regimen successfully respond to treatment. With an estimated 180 million people infected worldwide, a monumental need exists for adjunct therapies that can improve HCV cure rates without increasing the considerable toxicity already associated with SOC therapy. In this regard, we have established a data-supported strategy that provides an opportunity to play a central and enduring role in HCV care. Our strategy uniquely positions our Hemopurifier® to enhance the benefit of SOC therapy even if the drug combinations underlying SOC become redefined.
While our Hemopurifier® is the first-in-class device to selectively capture viruses and immunosuppressive proteins from circulation, the precedent for a device to treat HCV was established by Asahi Kasei Kuraray Medical (Asahi), who validated that moderate levels of viral filtration at the outset of SOC therapy improves cure rates. Asahi demonstrated that their multi-cartridge approach, which is marketed in Japan as V-RAD, was able to achieve 71.4% cure rates in HCV patients who previously failed SOC therapy. In Asahi's studies, V-RAD was administered once daily for three consecutive days at the outset of SOC therapy and provided an average viral load reduction of 26.1% during each treatment period, which averaged 3 1/4 hours in duration. Amazingly, such outcomes were achieved without a further need for viral filtration during the remaining 47+ weeks of SOC therapy.
On October 30th, we reported HCV treatment outcomes at the 42nd Annual American Society of Nephrology (ASN) Conference. When analyzing Hemopurifier® treatment data from all of our HCV human studies, we documented average per-treatment viral load reductions of 29-42%. While the length of each Hemopurifier® treatment was similar in duration to V-RAD, the Hemopurifier® did not benefit from SOC associated viral load reductions as our results were achieved in the absence of SOC therapy. We acknowledge and appreciate that V-RAD has indeed documented that viral filtration improves HCV treatment outcomes. However, we believe the Hemopurifier® delivers the necessary capabilities to establish broad-market acceptance of medical device in infectious disease care. Foremost of these capabilities is our ability to selectively capture infectious viruses and immunosuppressive proteins not addressed by V-RAD. The selective capture of deleterious agents from circulation establishes an environment that permits continuous or aggressive intermittent treatment strategies that can truly optimize patient outcomes. Whereas historic therapeutic filtration approaches, including V-RAD, are restricted in scope as they indiscriminately remove particles from blood by molecule size. As a result, the safe application of such treatments remains limited as beneficial blood components required for health are removed along with the deleterious target.
In the face of a challenging economic climate, we have reached a pivotal stage that positions us to capitalize on the sum of our efforts during the last decade. We have not deviated in our vision to evolve what once existed as a theoretical concept into the reality of a device that could change the lives of those afflicted with HCV and other infectious disease conditions. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Recent AEMD News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/19/2024 12:01:08 PM
- Aethlon Receives Ethics Committee Approval for Hemopurifier® Cancer Trial in India • PR Newswire (US) • 09/19/2024 12:01:00 PM
- Aethlon Medical Announces Activation of Royal Adelaide Hospital to Begin Patient Screening and Enrollment in Hemopurifier® Cancer Trial • PR Newswire (US) • 09/16/2024 12:01:00 PM
- Aethlon Medical to Present at the Life Sciences Investor Forum September 19th • GlobeNewswire Inc. • 09/13/2024 12:35:00 PM
- Aethlon Medical Announces Publication of Preclinical Data Showing Ability of the Hemopurifier® to Remove Extracellular Vesicles and microRNAs from Renal Perfusates Following Controlled Oxygenated Rewarming of Discarded Donor Kidneys • PR Newswire (US) • 08/27/2024 12:01:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 08/15/2024 08:34:03 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/15/2024 08:32:05 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/15/2024 08:30:33 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 08/15/2024 08:15:29 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 09:10:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 08:15:21 PM
- Aethlon Medical Announces Financial Results for the Fiscal First Quarter Ended June 30, 2024 and Provides Corporate Update • PR Newswire (US) • 08/14/2024 08:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/12/2024 12:01:08 PM
- Aethlon Medical Receives Second Ethics Committee Approval for Hemopurifier® Cancer Trial • PR Newswire (US) • 08/12/2024 12:01:00 PM
- Aethlon Medical to Release Fiscal First Quarter Financial Results and Host Conference Call on August 14, 2024 • PR Newswire (US) • 08/06/2024 01:12:00 PM
- Aethlon Medical Announces Financial Results for the Fiscal Year Ended March 31, 2024 and Provides Corporate Update • PR Newswire (US) • 06/27/2024 08:15:00 PM
- Aethlon Medical to Release Fiscal Year End Financial Results and Host Conference Call on June 27, 2024 • PR Newswire (US) • 06/21/2024 12:01:00 PM
- Aethlon Medical Receives Ethics Committee Approval for Hemopurifier® Cancer Trial • PR Newswire (US) • 06/18/2024 12:01:00 PM
- Aethlon Medical Prepares for Potentially Transformative Phase 1 Cancer Treatment Studies • PR Newswire (US) • 06/03/2024 12:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/24/2024 05:24:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/17/2024 08:05:28 PM
- Form 424B4 - Prospectus [Rule 424(b)(4)] • Edgar (US Regulatory) • 05/16/2024 08:05:23 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM