Cancer Treatment stocks to watch (NASDAQ: $AEMD) (NYSE: $MRK) (NYSE: $BMY) (NYSE: $ABBV) @Merck @bmsnews @abbvie

 

Cancer Treatment stocks to watch (NASDAQ: $AEMD) (NYSE: $MRK) (NYSE: $BMY) (NYSE: $ABBV) @Merck @bmsnews @abbvie

 

What’s next in Treatments for Cancer Patients with Solid Tumors?

June 20, 2024 - Investorideas.com, a go-to investing platform, releases an industry snapshot  looking at the future treatment of solid cancer tumors, featuring Aethlon Medical, Inc. (Nasdaq:AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.

 

Research released this year predicts, “The solid tumor therapeutics market size will grow from USD 222.71 Billion in 2023 to USD 885.44 Billion in 10 years. Increasing investments of pharmaceutical companies in Research & Development will drive the solid tumor therapeutics market's growth. North America emerged as the largest market for the global Solid Tumor Therapeutics market, accounting for 44% of the total market share globally.”

 

Current drugs available including Merck & Co., Inc.’s (NYSE:MRK) Keytruda® (pembrolizumab) and Bristol Myers Squibb’s (NYSE: BMY) Opdivo® (nivolumab), solve part of the problem but the success rates call for additional solutions.   

 

Aethlon Medical, Inc. (Nasdaq: AEMD) announced this week that, on June, 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for Aethlon’s safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier® Study). The approval is valid for three years, until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.

 

Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier® has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier® has been shown to reduce the number of exosomes from the plasma of cancer patient samples.

 

This article featuring Aethlon Medical, Inc. is paid for news dissemination

 

Read this article featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/06201Cancer-Treatment-Stocks.asp

 

"The approval from the Human Research Ethics Committee at Central Adelaide Local Health Network marks a significant milestone for Aethlon, as they deemed that our clinical study meets the requirements of the Australia’s National Statement on Ethical Conduct in Human Research,” stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “We look forward to working closely with Prof. Brown and his staff, and with our Contract Research Organizations, NAMSA and ReSQClinical Research. The next steps include submission to the Therapeutic Goods Administration, the national health regulatory agency of Australia, obtaining approval from the CALHN Research Governance Committee, and conducting a site initiation visit to facilitate patient enrollment. Following this Ethics Board approval, we plan to submit to the Ethics Committees at two additional sites in Australia and one in India.” 

 

The primary endpoint of the approximate 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitorany adverse events and clinically significant changes in lab tests of Hemopurifier® treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier® period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier® treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier® treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.

 

In May, Bristol Myers Squibb (NYSE:BMY) announced that the US Food and Drug Administration (USFDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo® plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29, 2024.

 

From news: The application is based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate non-inferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation. If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor.

 

From news: CheckMate-67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo® co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo® to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo®. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo®. Objective response rate (ORR) is a key secondary endpoint.

 

According to Merck & Co., Inc. (NYSE:MRK), “KEYTRUDA is not chemotherapy or radiation therapy-it is an immunotherapy and it works with your immune system to help fight cancer. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.”

 

Looking at key developments in the solid tumor market, BrainyInsights reported that In November 2023, AbbVie (NYSE:ABBV) acquired ImmunoGen. The main objective behind this acquisition was to build and expand a strong portfolio base for the Solid Tumor Therapeutics Market. This acquisition will further boost AbbVie’s entry into the commercial market for ovarian cancer.

 

In May, AbbVie showcased its “Robust Solid Tumor Pipeline at ASCO 2024 with New Data from Its Innovative Antibody-Drug Conjugate (ADC) Platform.”

 

From the news: "Building upon our strong commitment to patients and existing leadership in hematological malignancies, we are rapidly advancing a differentiated pipeline in solid tumors," said Daejin Abidoye, M.D., Vice President, Head of Solid Tumors, Oncology Development, AbbVie. "Our ADC platform allows us to utilize selected biomarkers such as c-Met and SEZ6 to induce targeted cancer cell death by delivering potent anti-cancer agents. The data we are presenting at ASCO demonstrate the clinical potential of this approach across a wide range of difficult-to-treat tumors."

 

From the news: Data from the dose-escalation and colorectal cancer (CRC) dose-expansion cohort of an ongoing first-in-human Phase 1 study (NCT05029882) of ABBV-400, a potential best-in-class c-Met directed ADC, will be presented in an oral presentation. The preliminary data show that among 122 heavily pre-treated advanced CRC patients, promising antitumor activity was observed at 2.4 and 3.0 mg/kg doses administered once every 3 weeks, with confirmed objective response rate (ORR) of 18% (n=40) and 24% (n=41) respectively in those groups. In patients with higher c-Met expression, ORR was enriched to >35% at doses ≥2.4 mg/kg. The most common Gr≥3 treatment-emergent adverse events (TEAEs) were anemia (35%), neutropenia (7%) and febrile neutropenia (6%). TEAEs leading to discontinuation occurred in 25 (20.5%) patients. Additional data will be presented at the meeting.

 

From the news: ABBV-400 is also being evaluated in a Phase 1b basket study (NCT06084481) in advanced solid tumors as a monotherapy and a Phase 2 study (NCT06107413) in second line metastatic CRC in combination with fluorouracil, folinic acid, and bevacizumab.

 

From their Solid Tumor market report, BrainyInsights also says, A huge chunk of pharmaceutical companies continue to make significant contributions to the development of experimental drugs and technologies. The pharmaceutical sector, for instance, is significantly invested in research and development. Pharmaceutical firms invest in future research to bring high-quality, pharmaceuticals to the marketplace. Major pharma firms are boosting their R&D efficiency by investing heavily in R&D, to ensure long returns on investments, as well as by collaborating with R&D centres worldwide. for instance: According to Statista, Roche is expected to be the world’s largest company which is investing heavily in R&D, that is, USD 14 Billion followed by Johnson & Johnson (USD 12.2 Billion), Merck & Co (USD 11.4 Billion), Pfizer (USD 10.5 Billion) and Novartis (USD 10 Billion), by the year 2026.

 

Aethlon Medical, Inc. (Nasdaq: AEMD) says it initiated its tumor-derived exosome research at a time when the medical community believed exosomes were merely cellular debris with no biological function. Today, a therapeutic to address tumor-derived exosomes represents a significant unmet need in cancer care. Aethlon has demonstrated that the affinity mechanism of the Hemopurifier® can capture tumor-derived exosomes and exosomal particles underlying several forms of cancer, including breast, ovarian and metastatic melanoma.

 

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Treatment of Blood Cancers – Stocks to watch (NYSE AMERICAN: $ATNM) (NASDAQ: $KURA) (NASDAQ: $SYRS) (NASDAQ: $SLS) @ActiniumPharma @kuraoncology @SyrosPharma @SellasLife

 

Treatment of Blood Cancers – Stocks to watch (NYSE AMERICAN: $ATNM) (NASDAQ: $KURA) (NASDAQ: $SYRS) (NASDAQ: $SLS) @ActiniumPharma @kuraoncology @SyrosPharma @SellasLife

 

Biopharma Companies Building out their Pipeline of Solutions

 

June 18, 2024 - Investorideas.com, a go-to investing platform covering biotech and medical technology stocks releases the second of a two-part series looking at developments for the treatment of blood cancers, including AML, featuring Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM). Actinium is a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies.

 

Approximately every 3 minutes, one person in the US is diagnosed with leukemia, lymphoma or myeloma. Approximately every 9 minutes, someone in the US dies from a blood cancer. This statistic represents approximately 157 people each day or more than six people every hour. This data from the Leukemia and Lymphoma Society demonstrates the growing and urgent demand for solutions.

 

Behind the scenes and the data, biopharma stocks are developing their unique approaches to treatment and building a pipeline of potential answers.    

 

Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) is building out its pipeline and has recently announced progress on several products.

 

Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies.

 

“Our Iomab-B and Actimab-A advanced product candidates fill the major unmet medical needs in relapsed or refractory AML in a complementary fashion directed at different parts of the patient journey,” they say on their website.

 

Paid news dissemination on behalf of Actinium

 

Read this article, featuring ATNM in full at https://www.investorideas.com/news/2024/biotech/06181Treatment-of-Blood-Cancers.asp

 

Actinium announced yesterday  that an abstract detailing the first ever preclinical data from the combination of menin inhibitors with Actinium’s ARC Actimab-A in acute myeloid leukemia (AML) models was presented at the 2024 European Hematology Association (EHA) Congress held June 13 – 16, 2024, in Madrid, Spain. Actinium studied Actimab-A in combination with the leading menin inhibitors, revumenib (Syndax Pharmaceuticals, Inc.) and ziftomenib (Kura Oncology, Inc.), which are being developed for patients with KMT2A rearrangements and NMP1 mutations, which are present in approximately 10% and 30% of AML patients, respectively.

 

On June 14^th, Actinium announced that results from the Phase 3 SIERRA trial of Iomab-B were presented at the 2024 European Hematology Association (EHA) Hybrid Congress being held June 13 – 16, 2024, in Madrid, Spain. The two presentations at EHA highlighted outcomes in patients with active relapsed or refractory acute myeloid leukemia (r/r AML) enrolled in the SIERRA trial who had a TP53 mutation and long-term efficacy results in this older patient population.

 

From the news: The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active r/r AML and compared outcomes of patients receiving an Iomab-B led bone marrow transplant (BMT) to those of patients receiving physician's choice of care in the control arm. Across all patients in SIERRA study, only patients receiving an Iomab-B led BMT achieved the trial's primary endpoint of durable complete remission with these patients having 92% 1-year survival and 69% 2-year survival with statistically significant higher event free survival. The SIERRA trial enrolled high-risk patients including those with one or more of the following: a TP53 mutation, advanced age up to 77 years old, complex cytogenetics and prior therapy including venetoclax and other targeted agents.

 

Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes.

 

On June 11th, Actinium highlighted data from the completed Phase 1b combination trial of Actimab-A + CLAG-M in patients with relapsed or refractory acute myeloid leukemia (r/r AML) at the 2024 Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting held June 8 – 11, 2024, in Toronto, Canada. Actimab-A is an ARC comprised of a CD33 targeting monoclonal antibody conjugated with the alpha-particle emitter Actinium-225 isotope payload. Actimab-A has been studied as a single agent and in combination with chemotherapies and targeted therapies in Phase 1 and Phase 2 trials.

 

In mid-May, Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, announced that it has completed enrollment of 85 patients in the Phase 2 portion of KOMET-001, a registration-directed clinical trial of the Company’s menin inhibitor, ziftomenib (KO-539), in patients with relapsed or refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). The Company expects to report topline data from the trial in early 2025.

 

From the news: “We are thrilled to announce this critical milestone, which brings us one step closer to delivering ziftomenib as a potentially best-in-class treatment for patients with genetically defined acute leukemias,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Our confidence is supported by our recently announced Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), which recognizes ziftomenib’s potential as an innovative medicine for patients with R/R NPM1-mutant AML and is intended to expedite review as we prepare for submission of a New Drug Application. We are grateful for the KOMET-001 investigators, patients and their families, and we look forward to sharing topline data from this pivotal study early next year.”

 

Continued: Kura announced the first patients dosed in the Phase 2 portion of KOMET-001 in February 2023. The registration-directed study is designed to assess evidence of clinical activity, safety and tolerability of ziftomenib in patients with R/R NPM1-mutant AML, with a primary endpoint of complete response. The study has completed enrollment of the 85 patients necessary to support the primary endpoint analysis.

 

“The rapid enrollment of this study reflects the urgent need for more effective treatment options in AML as well as the potential for ziftomenib to address this need,” said Eunice Wang, M.D., Chief of the Leukemia Service at Roswell Park Comprehensive Cancer Center and principal investigator of the trial. “NPM1-mutant AML represents approximately 30% of new AML cases annually and is a disease of significant unmet need for which there is no approved targeted therapy. The favorable safety profile and encouraging clinical activity demonstrated by ziftomenib to date offer the potential to transform the standard of care for these AML patients.”

 

Syros Pharmaceuticals (NASDAQ:SYRS) is developing tamibarotene, an oral selective RARα agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression.

 

Syros announced earlier this year that the United States Food and Drug Administration (USFDA) has granted Fast Track Designation to tamibarotene in combination with azacitidine and venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) with RARA overexpression as detected by an FDA approved test in adults who are over age 75 years or who have comorbidities that preclude the use of intensive induction chemotherapy. Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.

 

"We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML. This designation reflects the tremendous need for a safe and effective therapy, which can improve the clinical outcomes and prognosis among people diagnosed with AML, many of whom cannot tolerate intensive treatment," said David A. Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals. "We are particularly encouraged to secure Fast Track designation following initial randomized data from a prespecified interim analysis of our ongoing SELECT-AML-1 clinical trial, in which treatment with our RARα agonist, tamibarotene, in combination with venetoclax and azacitidine resulted in a 100% CR/CRi rate compared with a 70% CR/CRi rate for the comparator of venetoclax and azacitidine. Additionally, tamibarotene in combination with venetoclax and azacitidine demonstrated no added toxicity relative to venetoclax and azacitidine alone. We look forward to sharing additional data from SELECT-AML-1 later this year, and to potentially accelerate the delivery of tamibarotene as a new frontline option for the approximately 30% of AML patients who are positive for RARA overexpression."

 

SELLAS Life Sciences Group, Inc. (NASDAQ:SLS), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications,  announced on June 10^th  the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).

 

From the news: “We are pleased to announce the completion of enrollment in the initial portion of our Phase 2a trial representing a significant milestone in the development of SLS009 in AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “There has been a high level of enthusiasm from the clinical sites, trial investigators, and patients, reflecting the significant unmet need in the AML patient population previously treated with venetoclax-based regimens. We are extremely grateful to everyone who has helped us achieve this important milestone ahead of schedule.”

 

Continued: Dr. Stergiou continued: “In addition, we are excited to share very promising initial data from this Phase 2a trial. Efficacy was demonstrated across all cohorts far exceeding the targeted ORR of 20% and median overall survival (mOS) of 3 months. The results also showed that SLS009 was well-tolerated across all doses. These data give us increased confidence in SLS009 as a potential new treatment for AML. We remain committed to advancing the treatment landscape for this underserved patient population and we look forward to continuing the trial, mainly the expansion cohorts, and reporting additional study updates and data in Q3 of this year.”

AML is one of the most common types of leukemia and its incidence is rising globally, including in the Asia-Pacific region, says DataBridgeInsights.

 

They also reported, “According to a survey by Bristol-Myers Squibb, approximately 1.85 million new cases of blood cancer will be diagnosed worldwide in 2040, with 918,872 cases of lymphoma, 656,345 cases of leukaemia, and 275,047 cases of myeloma. Furthermore, the survey predicted that by 2040, there will be around 1,100,000 fatalities worldwide owing to blood cancer.”

 

Biopharmaceutical stocks like Actinium Pharmaceuticals, Inc. (NYSE AMERICAN:ATNM) are on the hunt for solutions. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it was studied in several Phase 1 and Phase 2 trials in almost 300 patients in multiple blood cancer indications, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin's disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM) and is currently being studied in several ongoing physician trials. Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the US Food and Drug Administration (USFDA) and the European Medicines Agency.

 

Read part one of the series on Investorideas.com

https://www.investorideas.com/news/2024/biotech/06171Biopharma-Stocks.asp

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Breaking Medical Technology News: Aethlon Medical (NASDAQ: $AEMD) Receives Ethics Committee Approval for Hemopurifier® Cancer Trial

 

Breaking Medical Technology News: Aethlon Medical (NASDAQ: $AEMD) Receives Ethics Committee Approval for Hemopurifier® Cancer Trial

 

Aethlon Medical Granted Full Ethics Approval From the Human Research Ethics Committee at Central Adelaide Local Health Network for a Safety, Feasibility, and Dose Finding Study of its Hemopurifier® in Cancer Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies

 

SAN DIEGO,CA  - June 18, 2024 (Investorideas.com Newswire) Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced that, on June, 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for Aethlon's safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for three years, until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.

 

Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.

 

This news is paid advertisement/ news disseminated on behalf of/issued on behalf of Aethlon Medical Inc.

 

Read this news, featuring AEMD in full at https://www.investorideas.com/news/2024/06181AEMD-Ethics-Committee-Approval-for-Hemopurifier-Cancer-Trial.asp

 

"The approval from the Human Research Ethics Committee at Central Adelaide Local Health Network marks a significant milestone for Aethlon, as they deemed that our clinical study meets the requirements of the Australia's National Statement on Ethical Conduct in Human Research," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We look forward to working closely with Prof. Brown and his staff, and with our Contract Research Organizations, NAMSA and ReSQ Clinical Research. The next steps include submission to the Therapeutic Goods Administration, the national health regulatory agency of Australia, obtaining approval from the CALHN Research Governance Committee, and conducting a site initiation visit to facilitate patient enrollment. Following this Ethics Board approval, we plan to submit to the Ethics Committees at two additional sites in Australia and one in India."

The primary endpoint of the approximate 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.

 

About Aethlon and the Hemopurifier®

Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for 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. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

 

Additional information can be found at www.AethlonMedical.com.

 

Forward Looking Statements

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" 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. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to successfully complete development of the Hemopurifier and to successfully demonstrate the utility of the Hemopurifier in patients with solid tumors in our planned oncology clinical trials, the Company's ability work with the requisite personnel and complete the next steps to facilitate patient enrollment, the Company's ability to submit additional studies and obtain the approval by the additional respective Ethics Boards of interested clinical trial sites in India and in Australia, the Company's ability to recruit patients for and manage its clinical trials, and other potential risks. 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, 2023, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. 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.

 

Company Contact:
Jim Frakes
Interim Chief Executive Officer and Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com

 

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
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Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com

 

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