Wednesday, November 26, 2014 2:24:50 AM
http://www.specialtypharmajournal.com/medical-news/hepatitis-c/3035-aethlon-medical-reports-undetectable-hcv-in-genotypes-1-3-a-5-patients-treated-with-hemopurifier-therapy
Aethlon Medical, the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, reported today that the presence of Hepatitis C virus (HCV) is currently undetectable in all infected patients that have been treated with the Aethlon Hemopurifier® in combination with peginterferon+ribavirin (PR) drug therapy and monitored for at least ninety days.
In a study conducted at the Medanta Medicity Institute (Medicity), HCV-infected individuals were enrolled to receive up to three, six-hour Hemopurifier® treatments during the first three days of PR drug therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of HCV from the entire circulatory system to improve benefit, dose, duration and tolerability of drug therapies.
In the Medicity study, Aethlon reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in nine treated patients. Of these nine patients, six patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. Of the nine reported patients, seven have been monitored for more than ninety days. All seven currently maintain undetectable viral load, including three patients who have been monitored for 48-weeks. Two patients initiated Hemopurifier® therapy on April 18th and April 30th, and therefore have not yet been monitored for extended viral load suppression.
The Immediate Impact of Hemopurifier® Therapy
In addition to demonstrating safety and early efficacy against multiple HCV genotypes, a clinical objective of the Medicity study was to evaluate whether the Hemopurifier® could accelerate HCV eradication to levels associated with treated patients who achieve the highest rate of viral cure, including individuals that previously failed or relapsed PR drug regimens. In the study, Aethlon observed that viral load depletion during the Hemopurifier® + PR drug therapy phase was greatest in hard-to-treat genotype-1 patients with high viral load. In one treated patient, baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured after the third day of Hemopurifier® + PR therapy, representing a 3.49 log or 99.96% reduction of viral load. In another patient, baseline HCV RNA dropped from 8,760,000 IU/ml to 4,665 IU/ml when measured on day-3, representing a 3.27 log or 99.96% reduction. By contrast, a moderate viral load Hemopurifier® patient with baseline HCV RNA of 1,340,000 IU/ml dropped to 54,900 IU/ml when measured on day-3, representing a 1.38 log or 95.9% reduction.
As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that less than 5% of treated patients will achieve a 2-log or greater reduction of viral load when measured 7-days after the start of PR drug therapy. While the IDEAL study did not report day-3 viral load, a 2-log+ reduction at day-7 is a rare occurrence defined as an immediate virologic response (IVR). The IDEAL study confirms the viral cure or sustained virologic response rate of IVR patients to be greater than 90%. Based on Medicity treatment outcomes, Hemopurifier® therapy had a significant impact in accelerating HCV eradication in high viral load patients.
Capacity of the Hemopurifier® to Capture HCV During Treatment
As the result of discussions with reviewers at the Center for Devices and Radiological Health (the FDA branch responsible for approving medical devices in the US), Aethlon recently expanded the Medicity protocol to establish a data point that would quantify the amount of HCV captured within the Hemopurifier® during a single treatment. In one analyzed cartridge, researchers recovered and measured that approximately 300 billion (300,000,000,000) copies of HCV had been captured within the Hemopurifier® during a single six-hour treatment at the Medicity. Beyond the impact of inhibiting progeny virus replication, the viral capture data point defines the contribution Hemopurifier® therapy can provide to current and future antiviral drug treatment regimens. Aethlon considers this data point to be unprecedented as the previous ability to measure the benefit of HCV therapies has primarily been limited to measuring changes in the amount of virus that can be detected in circulation.
Next Steps
As a result of Hemopurifier® + PR therapy outcomes, Aethlon has requested permission from the Medicity internal review board (IRB) to begin offering Hemopurifier® therapy to HCV-infected individuals that reside outside of India. The Company has also requested IRB permission to expand the treatment protocol to allow for up to seven Hemopurifier® treatments to be administered during the first week of PR drug therapy. Based on previous three-treatment protocol outcomes, Aethlon anticipates an expanded Hemopurifier® dosing schedule could establish new milestones for early undetectable viral load achievement. The Company also disclosed it will resubmit an investigational device exemption (IDE) which incorporates the Medicity data as part of its effort to gain FDA approval to initiate clinical programs in the U.S.
It is estimated that approximately 4 million Americans and 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is the leading cause of liver transplant in the U.S. To date, almost 100 Hemopurifier® treatments have been administered in human studies. Previously, studies of the Hemopurifier® have been conducted at the Apollo, Fortis, and Sigma New Life hospitals in India. These studies demonstrated that Hemopurifier® therapy could safely reduce viral load in both HIV and HCV-infected dialysis patients without the administration of antiviral drug therapies. The Medicity study represents the first Hemopurifier® study in non-dialysis patients. In vitro studies have further validated the ability of the Hemopurifier® to capture a broad-spectrum of viral pathogens classified as bioterror or pandemic threats.
(see link for more)
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
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM