Thursday, October 29, 2020 6:45:47 PM
After receiving FDA approval of its IDE application to initiate an Early Feasibility Study (EFS) of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda), AEMD has commenced this first clinical trial in patients with advanced and/or metastatic head and neck cancer. The study is now open for enrollment. AEMD plans to enroll 10-12 subjects.
The primary endpoint of the study is safety, with exosome (see below) clearance an important secondary endpoint.
Secondary Outcome Measures:
• Levels of exosomes
• Tumor response
• Survival
Exosomes are nanosized particles released by cancer cells that promote the growth and spread of tumors, suppress the immune system and constrain the benefit of leading cancer therapies. Prior medical research and data suggest that exosomes play a key role in why some oncology patients fail to respond to treatment. Preclinical testing has demonstrated the ability of the Hemopurifier to remove tumor-derived exosomes, which could have utility in the treatment of cancer. The EFS will be the first real world-type evaluation of whether the Hemopurifier can successfully and safely remove exosomes from the blood.
AEMD’s COVID-19 EFS also is moving forward. AEMD intends to enroll up to 40 COVID-19 ICU patients at up to 20 domestic centers and is in the process of enrolling centers to participate in the study. Endpoints will include safety, reduction in circulating virus and clinical outcomes. AEMD will generate substantial data from the EFS.
Recent AEMD News
- Aethlon Medical Enters Into Materials Transfer Agreement for Santersus AG's NucleoCapture and HemoNucleoCapture Devices • PR Newswire (US) • 02/21/2024 01:01:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 10:15:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 09:15:41 PM
- Aethlon Medical Announces Fiscal Third Quarter Financial Results and Provides Corporate Update • PR Newswire (US) • 02/14/2024 09:15:00 PM
- Aethlon Medical to Release Fiscal Third Quarter Financial Results and Host Conference Call on February 14, 2024 • PR Newswire (US) • 02/07/2024 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 11:06:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 11:04:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 11:02:52 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 12/22/2023 09:01:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/27/2023 12:49:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/14/2023 09:15:39 PM
- Aethlon Medical Announces Fiscal Second Quarter Financial Results and Provides Corporate Update • PR Newswire (US) • 11/14/2023 09:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/13/2023 01:01:36 PM
- Aethlon Medical Announces Appointment of James B. Frakes, M.B.A. as Interim Chief Executive Officer and Guy Cipriani, M.B.A. as Chief Operating Officer • PR Newswire (US) • 11/13/2023 01:01:00 PM
- Aethlon Medical to Release Second Quarter Financial Results and Host Conference Call on November 14, 2023 • PR Newswire (US) • 11/06/2023 01:01:00 PM
- Aethlon Receives Clearance From Drug Controller General of India For Potential Phase 1 Trial of its Hemopurifier® in Oncology • PR Newswire (US) • 10/10/2023 12:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/04/2023 09:05:12 PM
- Aethlon Announces Reverse Stock Split • PR Newswire (US) • 10/04/2023 12:01:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/29/2023 09:57:35 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/29/2023 09:56:37 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/29/2023 09:54:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/18/2023 01:00:08 PM
- Aethlon Medical to Present at the H.C. Wainwright 25th Annual Global Investment Conference • PR Newswire (US) • 08/30/2023 12:01:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/10/2023 09:15:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/10/2023 08:20:32 PM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM