{"id":400859,"date":"2020-12-16T08:05:30","date_gmt":"2020-12-16T13:05:30","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=400859"},"modified":"2020-12-16T08:05:30","modified_gmt":"2020-12-16T13:05:30","slug":"aethlon-medical-announces-first-patient-treated-in-first-in-human-clinical-trial-of-hemopurifier-in-head-and-neck-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/aethlon-medical-announces-first-patient-treated-in-first-in-human-clinical-trial-of-hemopurifier-in-head-and-neck-cancer\/","title":{"rendered":"Aethlon Medical Announces First Patient Treated in First-in-Human Clinical Trial of HEMOPURIFIER\u00ae in Head and Neck Cancer"},"content":{"rendered":"
\n

Study is evaluating the HEMOPURIFIER\u00ae for reducing cancer-associated exosomes prior to the administration of standard-of-care KEYTRUDA\u00ae<\/h2>\n

The HEMOPURIFIER\u00ae is an FDA designated “Breakthrough Device” for depleting circulating exosomes<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n SAN DIEGO<\/span>, Dec.\u00a016, 2020 \/PRNewswire\/ —\u00a0Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the first patient has been treated in the Company’s first-in-human Early Feasibility Study (EFS) evaluating the HEMOPURIFIER\u00ae in patients with recurrent and\/or metastatic squamous cell carcinoma of the head and neck. The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA.<\/span> (Hemopurifier Plus Pembrolizumab in Head and Neck Cancer – Full Text View – ClinicalTrials.gov<\/a><\/u>). <\/p>\n

The EFS, which is the device equivalent of a Phase 1 clinical trial for a drug or biologic, is a single center, open label trial in 10 to 12 subjects. \u00a0The study is evaluating the HEMOPURIFIER\u00ae for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA\u00ae), which is a first-line therapy for patients with recurrent and\/or metastatic squamous cell carcinoma of the head and neck. The primary endpoint for the study is safety of the HEMOPURIFIER\u00ae in a clinical setting. \u00a0Secondary endpoints include efficacy based on response rates, progression-free and overall survival, and changes in exosome concentration after HEMOPURIFIER\u00ae treatment. <\/p>\n

In cancer, exosomes have been shown to participate in the development and advancement of disease. \u00a0Exosomes derived from tumor cells may promote immune suppression and seed the spread of metastasis.\u00a0These tumor derived exosomes may also inhibit the activity of immuno-oncology drugs such as\u00a0KEYTRUDA\u00ae.\u00a0Tumor derived exosomes are not currently addressed with any approved therapy.<\/p>\n

\n Dan Zandberg<\/span>, M.D., Medical Oncologist and Hematologist at UPMC Hillman Cancer Center, Associate Professor of Medicine at the University of Pittsburgh<\/span> School of Medicine and Principal Investigator of the study, stated, “We are excited to have treated the first head and neck cancer patient with the HEMOPURIFIER\u00ae.\u00a0 While KEYTRUDA\u00ae can markedly improve outcome in some head and neck cancer patients, the majority of patients still do not respond.\u00a0 If clearance of exosomes with the HEMOPURIFIER\u00ae prior to treatment with KEYTRUDA\u00ae can increase the number of patients who are able to respond to KEYTRUDA\u00ae, it could represent an important advance in the treatment of this disease. This trial represents the first step in this evaluation.”<\/p>\n

\n Charles J. Fisher, Jr.<\/span>, M.D., Chief Executive Officer of Aethlon, stated, “We are delighted to be working with Dr. Zandberg and his colleagues at the University of Pittsburgh<\/span> and UPMC Hillman to treat the first head and neck cancer patient with the HEMOPURIFIER\u00ae.\u00a0 By reducing the presence of immune suppressive exosomes from the circulatory system of head and neck cancer patients prior to treatment with KEYTRUDA\u00ae, we believe the HEMOPURIFIER\u00ae could have the potential to improve patient outcomes in this disease.\u00a0 The initiation of this first-in-human study addressing cancer-associated exosomes is a significant step towards evaluating the HEMOPURIFIER\u00ae for potentially \u00a0improving the efficacy of KEYTRUDA\u00ae in head and neck cancer.”<\/p>\n

\n About Aethlon and the Hemopurifier\u00ae<\/b>\n <\/p>\n

Aethlon is focused on addressing unmet needs in global health. The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression.<\/p>\n

The Hemopurifier\u00ae is an FDA designated “Breakthrough Device” related to the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease cancer. The Hemopurifier also holds a Breakthrough Device designation related to life-threatening viruses that are not addressed with approved therapies.\u00a0 Under the Investigational Device Exemption (IDE) application approved by FDA in October 2019<\/span> the FDA has also approved an amendment to the Company’s open IDE for the Hemopurifier in life threatening viral infections, to allow for the treatment of patients with SARS-CoV-2\/COVID-19 infection.\u00a0 This will allow for up to 40 of these patients to be treated under a New Feasibility Study protocol at up to 20 clinical sites in the U.S.<\/p>\n

Aethlon also owns 80% of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disease progression. Additional information can be found online at www.AethlonMedical.com <\/a><\/u>and www.ExosomeSciences.com<\/a><\/u>.<\/p>\n

\n Forward Looking Statements
<\/b>
\n This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “project,” “will,” “projections,” “estimate,” “potentially,” “appear” or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, Aethlon Medical, Inc.’s (the Company) ability to enroll additional patients in the Early Feasibility Study, the Company’s ability to successfully complete the Early Feasibility Study and achieve the endpoints for the study, or any future studies with its Hemopurifier or to successfully develop and commercialize the Hemopurifier. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2020<\/span>, and in the Company’s other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.<\/i>\n <\/p>\n

\n Company Contact:
<\/b>
\n Jim Frakes<\/span>
\n
Chief Financial Officer
Aethlon Medical, Inc.\u00a0
Jfrakes@aethlonmedical.com<\/a><\/p>\n

\n Media Contact:
<\/b>
\n Tony Russo<\/span>, Ph.D.
Russo Partners, LLC
tony.russo@russopartnersllc.com<\/a>
212-845-4251<\/p>\n

\n Investor Contact:
<\/b>
\n Susan Noonan<\/span>
\n
S.A. Noonan Communications, LLC
susan@sanoonan.com<\/a>\u00a0
212-966-3650<\/p>\n

\n \"Cision\" View original content:http:\/\/www.prnewswire.com\/news-releases\/aethlon-medical-announces-first-patient-treated-in-first-in-human-clinical-trial-of-hemopurifier-in-head-and-neck-cancer-301193962.html<\/a><\/p>\n

SOURCE Aethlon Medical, Inc.<\/p>\n<\/p><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

Study is evaluating the HEMOPURIFIER\u00ae for reducing cancer-associated exosomes prior to the administration of standard-of-care KEYTRUDA\u00ae The HEMOPURIFIER\u00ae is an FDA designated “Breakthrough Device” for depleting circulating exosomes PR Newswire SAN DIEGO, Dec.\u00a016, 2020 \/PRNewswire\/ —\u00a0Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the first patient has been treated in the Company’s first-in-human Early Feasibility Study (EFS) evaluating the HEMOPURIFIER\u00ae in patients with recurrent and\/or metastatic squamous cell carcinoma of the head and neck. The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA. (Hemopurifier Plus Pembrolizumab in Head and Neck Cancer – Full Text View – ClinicalTrials.gov). The EFS, … <\/p>\n

Continue reading “Aethlon Medical Announces First Patient Treated in First-in-Human Clinical Trial of HEMOPURIFIER\u00ae in Head and Neck Cancer”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-400859","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAethlon Medical Announces First Patient Treated in First-in-Human Clinical Trial of HEMOPURIFIER\u00ae in Head and Neck Cancer - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/aethlon-medical-announces-first-patient-treated-in-first-in-human-clinical-trial-of-hemopurifier-in-head-and-neck-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Aethlon Medical Announces First Patient Treated in First-in-Human Clinical Trial of HEMOPURIFIER\u00ae in Head and Neck Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Study is evaluating the HEMOPURIFIER\u00ae for reducing cancer-associated exosomes prior to the administration of standard-of-care KEYTRUDA\u00ae The HEMOPURIFIER\u00ae is an FDA designated “Breakthrough Device” for depleting circulating exosomes PR Newswire SAN DIEGO, Dec.\u00a016, 2020 \/PRNewswire\/ —\u00a0Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the first patient has been treated in the Company’s first-in-human Early Feasibility Study (EFS) evaluating the HEMOPURIFIER\u00ae in patients with recurrent and\/or metastatic squamous cell carcinoma of the head and neck. The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA. (Hemopurifier Plus Pembrolizumab in Head and Neck Cancer – Full Text View – ClinicalTrials.gov). 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(Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the first patient has been treated in the Company’s first-in-human Early Feasibility Study (EFS) evaluating the HEMOPURIFIER\u00ae in patients with recurrent and\/or metastatic squamous cell carcinoma of the head and neck. The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA. (Hemopurifier Plus Pembrolizumab in Head and Neck Cancer – Full Text View – ClinicalTrials.gov). 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