Biotech Stock Pasithea Therapeutics Corp. (NASDAQ: KTTA) Soars on Positive Data from Phase 1 Clinical Trials

Biotech Stock Pasithea Therapeutics Corp. (NASDAQ: KTTA) Soars on Positive Data from Phase 1 Clinical Trials: Biotech Stock Pasithea Therapeutics Corp. (NASDAQ: KTTA) Soars on Positive Data from Phase 1 Clinical Trials

Seelos Therapeutics, Inc. (Nasdaq: SEEL) Soars on update for its SLS-002 (intranasal racemic ketamine) for PTSD

Seelos Therapeutics, Inc. (Nasdaq: SEEL) Soars on update for its SLS-002 (intranasal racemic ketamine) for PTSD: Seelos Therapeutics, Inc. (Nasdaq: SEEL) Soars on update for its SLS-002 (intranasal racemic ketamine) for PTSD

Wave Life Sciences Ltd. (Nasdaq: WVE) Gains on Clinical Trial News

Wave Life Sciences Ltd. (Nasdaq: WVE) Gains on Clinical Trial News: Wave Life Sciences Ltd. (Nasdaq: WVE) Gains on Clinical Trial News

Stocks to Watch Battling the Opioid Epidemic; Stocks Mentioned in this article: Greenlane Holdings, Inc. (NASDAQ: $GNLN), Safe Supply Streaming Co Ltd. (CSE: $SPLY.CN), Nutriband Inc. (NASDAQ: $NTRB), QuidelOrtho Corporation (Nasdaq: $QDEL), Emergent BioSolutions Inc. (NYSE: $EBS)

  

Stocks to Watch Battling the Opioid Epidemic; Stocks Mentioned in this article: Greenlane Holdings, Inc. (NASDAQ: $GNLN), Safe Supply Streaming Co Ltd. (CSE: $SPLY.CN), Nutriband Inc. (NASDAQ: $NTRB), QuidelOrtho Corporation (Nasdaq: $QDEL), Emergent BioSolutions Inc. (NYSE: $EBS)

 

September 20, 2024 - Investorideas.com, a go-to investing platform covering cannabis stocks releases an industry snapshot looking at the battle against dangerous drugs, including fentanyl, featuring Greenlane Holdings, Inc. (NASDAQ:GNLN), one of the premier global sellers of premium cannabis accessories, child-resistant packaging, and specialty vaporization products.

 

Stocks Mentioned in this article: Greenlane Holdings, Inc. (NASDAQ:GNLN), Safe Supply Streaming Co Ltd. (CSE: SPLY), Nutriband Inc. (NASDAQ:NTRB), QuidelOrtho Corporation (Nasdaq: QDEL), Emergent BioSolutions Inc. (NYSE: EBS)

 

According to Fact.MR ,“The global opioid overdose treatment market is expected to reach a value of US$ 1.54 billion in 2024, as revealed in a new industry analysis published by proficient researchers at Fact.MR, a market research and competitive intelligence provider. Revenue from the market is projected to increase at a CAGR of 7.2% through 2034.”

 

Cannabis company Greenlane Holdings, Inc. (NASDAQ:GNLN) has entered the battle against dangerous drugs, but not only against opioids. Greenlane announced this week its plans to launch an all-new line of fentanyl, xylazine and drink spike detection test strips under the Safety Strips, Inc.  brand of drug test strips. Products will be available to order beginning September 25^th via the Company's multiple online retail storefronts, (vapor.com, puffitup.com, and higherstandards.com/) as well as its wholesale portal (wholesale.greenlane.com). Shipments will commence October 1^st.

 

In August, Greenlane announced that it had entered into a non-binding letter of intent to be the exclusive distributor in the US of Safety Strips drug detection test strips. Greenlane has been a trusted partner for some of the most successful and well-known cannabis and lifestyle brands, such as Higher Standards, Marley Natural and K.Haring, providing full sales coverage, marketing, warehousing and logistics services.

 

Paid news dissemination on behalf of GNLN

 

Read this article, featuring GNLN in full at https://www.investorideas.com/news/2024/cannabis/09201Battling-the-Opioid-Epidemic.asp

 

"We are delighted to be working with the Safety Strips' team who share our high standards for safety and quality, and our strong focus on improving people's lives and enhancing their safety," said Barbara Sher, Chief Executive Officer for Greenlane. "By combining our extensive sales, marketing, and distribution network with Safety Strips ISO 13485 validated product line of easy, fast, and accurate test strips to detect the presence of various drugs, we can do our part to help prevent accidental overdoses as well as protecting individuals from drug-induced date rape."

 

The Opioid Epidemic in the United States

According to SHADAC.ORG, "Over the past two decades, the United States has experienced a growing crisis of substance abuse and addiction that is illustrated most starkly by the rise in deaths from drug overdoses. Since 2000, the annual number of overdose deaths from any kind of drug in the U.S. has multiplied nearly six times over, rising from 17,500 to over 106,000 people in 2021. The vast majority of these deaths (about 80,000) involved some form of opioids, including heroin, prescription painkillers, and, most prevalently in recent years, synthetic opioids such as fentanyl. Fentanyl and related synthetic opioids alone accounted for roughly 71,000 drug overdose deaths in 2021, and are also involved in most methamphetamine, cocaine, and prescription opioid overdose deaths-the next most common substances associated with overdose deaths."

 

The Rising Incidence of Drink Spiking

In a January 2023 article posted on Alcohol.org, it was reported that "According to the Office on Women's Health, date-rape drugs like Rohypnol, GHB, and ketamine are used because they are not easily detected, and victims often do not remember being drugged or assaulted until many hours later. In 2016, there were over 320,000 incidents of rape and sexual assault, and these incidents are often underreported for both women and men. According to RAINN, 11.2 percent of college students experience rape or sexual assault through force, violence, or incapacitation, and in terms of drug-facilitated sexual assault, alcohol is the No. 1 substance for assailants, next to prescription drugs with tranquilizing effects and Rohypnol, ketamine, GHB, and ecstasy."

 

In response to the rising prevalence of drink spiking, the Californian Assembly passed AB 1013, July 1, 2024. The bill mandates that approximately 2400 establishments with a Type 48 license, which allows the sale of beer, wine, and distilled spirits, must display signage informing patrons that drug testing kits are available.The new law requires businesses to display signs reading, "Don't get roofied! Drink spiking drug test kits are available here. Ask a staff member for details." Establishments must offer these drug testing devices either for sale or free of charge.

 

Additionally, news came out this week from Safe Supply Streaming Co Ltd. (CSE: SPLY) noting it has made significant progress within its portfolio through Safety Strips Inc. ("Safety Strips"), as they introduce high-performing, reliable test strips designed to combat the rising dangers of fentanyl, xylazine, and drink spiking.

 

This strategic initiative is expected to create substantial value for Safe Supply shareholders, as the demand for safety and drug testing continues to grow across North America. The product launch will enter the market through the recently announced US Expansion Agreement with Greenlane Holdings, Inc. (NASDAQ:GNLN).

 

High Performing and Reliable Testing:

Safety Strips' product launch provides consumers with an affordable, easy-to-use solution for detecting fentanyl and xylazine - two substances contributing to the escalating opioid crisis. In response to new California legislation, Safety Strips' Drink Spike Test strips meet the requirements of California Assembly Bill No. 1013, passed in July 2024, which mandates that bars and clubs offer drug testing kits to their patrons. The law is aimed at reducing incidents of drink spiking, a growing safety concern in the hospitality industry.

 

Safety Strips' detection products will be available for order starting September 25, 2024, across Greenlane's online retail platforms, with shipments commencing on October 1, 2024.

 

This week Nutriband Inc. (NASDAQ:NTRB), announced a share repurchase program to buy back up to $1,000,000 of its common stock. As of September 16, 2024, the Company had 11,106,185 shares of common stock outstanding. The stock spiked over 24% on the news.

 

From the news: Progress continues on the development of AVERSA Fentanyl, with the Company maintaining its target of submitting an NDA to the FDA in Q1/Q2 2025.

 

Nutriband Inc. is primarily engaged in the development of a portfolio of transdermal pharmaceutical products. The lead product under development is an abuse deterrent fentanyl patch incorporating our AVERSA™ abuse deterrence technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

 

Earlier this year, QuidelOrtho Corporation (Nasdaq: QDEL) reported it  has added the ARK™ Fentanyl II Assay to its U.S. Vitros® XT 7600 and 5600 Integrated Systems as well as its Vitros® 4600 Chemistry System menu of assays as a MicroTip® Partnership Assay ("MPA"). This Fentanyl assay will help hospital and emergency room customers respond to the critical demand for enhanced opioid testing, allowing on-site fentanyl testing in less than 10 minutes to aid in immediate clinical decisions.

 

From the news: According to the Centers for Disease Control and Prevention ("CDC"), the number of fatalities resulting from fentanyl overdoses has tripled from 2016 to 2021, with an ongoing upward trend. The CDC highlights California, Florida, New York, Pennsylvania and Ohio as states with the highest mortality rates attributed to fentanyl.1 Consequently, several states have responded by implementing regulations requiring fentanyl testing to be included as a required component of drugs-of-abuse test panels.

 

"This assay transforms laboratory efficiency by integrating fentanyl testing with existing protocols to eliminate the need for external screening tests, and consolidates a lab’s drugs-of-abuse panel into a singular, streamlined system, reducing intervention time and ultimately helping to save lives," said Lily Li, Senior Director of Medical and Clinical Affairs at QuidelOrtho. "Our relentless commitment to diagnostics lies in empowering our customers with impactful assays, particularly those capable of delivering rapid drugs-of-abuse detection amidst the escalating opioid crisis."

 

From the news: Ninety percent of fentanyl is excreted as norfentanyl, which is a synthetic opioid and is not detected on standard drug screening. The ARK™ Fentanyl II Assay provides preliminary analytical test results by detecting this major metabolite, reducing the risk of false negatives. As part of QuidelOrtho’s Vitros systems’ menu of assays, the test offers clinical fentanyl testing for hospitals and emergency departments, providing an effective approach to preliminary urine drug testing.

 

From the news: Drug test results obtained in emergency departments play a crucial role in addressing unique hospital challenges. When patients test positive for opioids on a standard drug test, they’re usually directed to drug treatment programs. However, these standard tests fail to identify synthetic opioids, such as fentanyl. Without specifically testing for fentanyl, instances of fentanyl exposure might be disregarded, potentially leading to missed opportunities for life-saving interventions like administering naloxone, an opioid overdose reversal medication.

 

Although the pharmaceutical played a key role in opioid addiction, companies in the sector are building out solutions.

 

Emergent BioSolutions Inc. (NYSE: EBS) announced last month, the kicking off the second year of the Ready to Rescue initiative, which will include new college football tailgate stops, in-stadium activities, Greek Life events and student wellness clinics. As part of these expanded efforts, pro football legend and campaign spokesperson, Emmitt Smith, will continue to share his story to raise awareness of opioid risks and inspire students, parents, faculty and alumni to be prepared to save a life with NARCAN® Nasal Spray, which is available over-the-counter (OTC).

 

The Centers for Disease Control and Prevention (CDC) recently announced a reduction in drug overdose deaths for the first time since 2018.1 However, opioid poisonings continue to be the leading cause of accidental death in the United States,2 with the highest rate of opioid misuse and dependency among those 18 to 25.3 What’s more, research shows less than 15 percent of college students nationwide know how to administer naloxone,4 the active ingredient in NARCAN® Nasal Spray, which can reverse the effects of an opioid overdose, including those caused by fentanyl. Education on the dangers of fentanyl, the signs of an opioid poisoning and how to both access and administer NARCAN® Nasal Spray is vital to saving lives, particularly within college communities.

 

According to Yale Medicine, “Fentanyl isn’t new; it has been used in the U.S. since 1960 as an intravenous anesthetic. It is still prescribed today by doctors, often in the form of patches and lozenges, for treating severe and chronic pain from cancer and other illnesses and injuries.”

 

“But fentanyl has shifted from exclusively being produced by pharmaceutical companies to now also coming from drug cartels and other entities, says David Fiellin, MD, a Yale Medicine primary care physician who specializes in addiction medicine.”

 

With news that the DEA proposed rules last month to reclassify cannabis from a schedule I to a schedule III substance, the shift can now really focus on dangerous drugs Greenlane Holdings, Inc. (NASDAQ:GNLN) has the built-in marketing, warehousing and logistics services to bring Safety Strips testing for dangerous substances to the market.

 

More info in Greenlane Holdings visit here

 

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Immunotherapy Clinical Trial News – Stocks to Watch; (Nasdaq: $AEMD), (NYSE: $BMY), (NYSE: $MRK), (Nasdaq: $IMRX), (NASDAQ: $IOVA), (NASDAQ: $KZIA)

 

Immunotherapy Clinical Trial News – Stocks to Watch; (Nasdaq: $AEMD), (NYSE: $BMY), (NYSE: $MRK), (Nasdaq: $IMRX), (NASDAQ: $IOVA), (NASDAQ: $KZIA)

 

September 19, 2024 - Investorideas.com, a go-to investing platform, releases the  second of a two-part series looking at news and developments for the treatment of cancer and solid tumors  focusing on immunotherapy, featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening viral infections. Aethlon’s Hemopurifier® is a clinical stage immunotherapeutic device designed to combat cancer.

 

Stocks mentioned in this article: Aethlon Medical, Inc. (Nasdaq: AEMD), Bristol Myers Squibbs (NYSE: BMY), Merck & Co. (NYSE:MRK), Immuneering Corporation (Nasdaq: IMRX), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) and Kazia Therapeutics Limited (NASDAQ: KZIA),.

 

According to News-Medical.net, “Immunotherapy, which works by enabling the body's immune system to recognize and destroy cancer cells improves long-term overall survival in patients with advanced melanoma in results from large international studies reported at ESMO 2024.  Researchers leading the longest follow-up study to date suggest that immunotherapy offers the potential for cure in patients who respond to this treatment. Further clinical trials reported at ESMO 2024 show improved long-term survival with immunotherapy given before and after surgery in women with early-stage, hard-to-treat breast cancer (triple negative breast cancer) and in patients with muscle-invasive bladder cancer.”

 

"The main message from all of these studies is that immunotherapy continues to keep its promise and hope of long-term survival for many patients with different types of cancer," said Dr. Alessandra Curioni-Fontecedro, Professor of Oncology at the University of Fribourg and Director of Oncology at the Hospital of Fribourg, Switzerland, (not involved in the study). "At ESMO 2024 we are seeing many studies in many different cancers showing that immunotherapy can work for a long time."

 

According to recent news from Aethlon Medical, Inc., “At present, approximately only 30% of cancer patients who receive pembrolizumab or nivolumab treatment for solid tumors will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in resistance to anti-PD-1 therapies as well as the spread of cancers. 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 EVs in cancer patient plasma samples.”

Paid News Dissemination of behalf of AEMD

 

Read this article featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/09191Immunotherapy-Clinical-Trials.asp

 

Following the news of cancer trials activated in Australia earlier this week, Aethlon Medical, Inc. (Nasdaq: AEMD) today announced that, on September 9, 2024, the Medanta Institutional Ethics Committee (MIEC) 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 Merck & Co., Inc.'s (NYSE:MRK) Keytruda® (pembrolizumab) or Bristol Myers Squibb's (NYSE: BMY) Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier® Study). The approval is valid for one year, followed by annual reviews. This trial has previously been reviewed by the Institutional Review Board at Medanta. Additionally, the company previously received a No Objection Certificate (NOC) from DCGI (the Indian Regulatory Authority) for the proposed oncology trial. The trial will be conducted by Dr. Ashok K. Vaid and his staff at the Department of Medical Oncology and Hematology at Medanta Medicity Hospital in Gurugram, India. The Hemopurifier® treatments will be performed by Dr. Puneet Sodhi from the Department of Nephrology, who has conducted more Hemopurifier® treatments than anyone else in the world.

 

"The approval from the MIEC, coming closely on the heels of our two ethics committee approvals in Australia, to conduct this early feasibility study, is another important step in our plan to evaluate use of the Hemopurifier as a treatment option in multiple tumor types, where cancer associated exosomes may promote immune suppression and metastasis,” stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “We are very pleased that the MIEC accepted our study protocol and look forward to working, again, with Medanta Hospital with the expectation of recruiting patients in the fourth calendar quarter of this year. We believe that the planned safety, feasibility and dose finding trial, taking place in both India and Australia, in solid tumors in patients failing treatment with anti-PD-1 antibodies, will help inform future oncology efficacy trials.”

 

The primary endpoint of the approximately nine to 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 PD-1 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.

 

Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, recently announced positive initial response data from the first five patients treated with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first line pancreatic cancer as part of its ongoing Phase 2a clinical trial.

 

Highlights:

 

- In Phase 2a arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel, complete or partial responses have been observed in the first two patients (2/5) to date, for an initial response rate of 40% and an initial disease control rate of 80%, with all five patients continuing on treatment -

 

- Initial data are at 240 mg QD (safety lead-in dose) of IMM-1-104; additional patients have now been dosed at 320 mg QD in this arm; IMM-1-104 has been well-tolerated to date in combination with gemcitabine/nab-paclitaxel -

 

- Initial data are consistent with preclinical data presented at AACR, which demonstrated that IMM-1-104 combined with chemotherapy induced deeper responses than either agent alone -

 

- Clear path forward expected for clinical development of IMM-1-104 in combination with gemcitabine/nab-paclitaxel for pancreatic cancer, assuming initial data is representative; FDA previously granted IMM-1-104 Fast Track designation for the treatment of first- and second-line pancreatic ductal adenocarcinoma -

 

- Enrollment progressing in all Phase 2a arms with further data expected by year end -

 

Continued from the news: “We are delighted to share today’s initial data on IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel. While the initial ORR of 40% and Disease Control Rate of 80% are very encouraging – and both more than would be expected for gemcitabine/nab-paclitaxel alone- we are still in the early stages of this trial, with more scans for all five of these initial patients and for additional patients planned to come. Nevertheless, it was encouraging to see a complete response in the very first pancreatic cancer patient treated with IMM-1-104 in this combination, with the patient now on treatment for over six months,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “Looking at the bigger picture, our Phase 2a trial aims to evaluate the efficacy of IMM-1-104 in multiple settings across various tumor types, to identify the highest priority opportunities for future development. If the early trends with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel continue, we will have an exciting direction for potential future development of IMM-1-104, which could greatly improve the prognosis for a drastically underserved patient population.”

 

Earlier this year, Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, announced updated clinical data for lifileucel in combination with pembrolizumab in frontline advanced melanoma, as well as translational data, from the recent 2024 ASCO Annual Meeting held earlier this year in Chicago, IL and online.

 

Clinical Data in Frontline Advanced Melanoma (Cohort 1A in IOV-COM-202 Trial)

Positive results from Cohort 1A in the IOV-COM-202 trial were published in an abstract1 and will be highlighted in an upcoming oral presentation at ASCO. Unprecedented response rates, as well as deep and durable responses, were observed in patients with frontline advanced melanoma who were naïve to immune checkpoint inhibitor (ICI) therapy. These results strongly support the ongoing Phase 3 TILVANCE-301 clinical trial.

National Cancer Institute reported ”In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that uses immune cells called tumor-infiltrating lymphocytes, or TILs. Announced on February 16, the agency’s decision also makes lifileucel the first cellular therapy to be approved for a solid tumor, the skin cancer melanoma.”

 

Continued: “The agency’s accelerated approval covers the use of lifileucel for people with advanced melanoma that has gotten worse after treatment with certain immunotherapy drugs or targeted therapies.

 

Continued: “As is the case with CAR T-cell therapy, another type of cellular therapy, lifileucel is made using a patient’s own T cells. And with both therapies, the cells are collected at the hospital where the patient is being treated but are sent away to be manufactured into the final treatment.”

 

Also seeing the potential of immunotherapy, Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company announced last week that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centres, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination).

 

From the news: Under the license agreement, Kazia receives an exclusive, worldwide, sub-licensable and royalty-bearing licence to certain intellectual property for the development of any drugs or product candidates within the PI3K inhibitor class in combination with immunotherapy or PARP inhibitors. Paxalisib, Kazia's lead product candidate, is a member of the PI3K inhibitor class.

 

Continued: The exclusive license agreement follows a collaboration between Kazia and QIMR Berghofer which began in December 2022 and has already led to the filing of supportive patents which include the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer.

 

The idea of using a patient’s immune system to battle cancer makes sense and dollars for the companies that are pioneering this approach. Let the clinical trials begin!

 

Read part one of the series of articles at Investorideas.com

https://www.investorideas.com/News/2024/biotech/09170Solid-Tumors-Market.asp

 

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

 

 

 

 

 

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

 

Aethlon Medical Granted Full Ethics Approval from the Medanta Institutional Ethics Committee 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, September 19, 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 September 9, 2024, the Medanta Institutional Ethics Committee (MIEC) 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 one year, followed by annual reviews. This trial has previously been reviewed by the Institutional Review Board at Medanta. Additionally, the company previously received a No Objection Certificate (NOC) from DCGI (the Indian Regulatory Authority) for the proposed oncology trial. The trial will be conducted by Dr. Ashok K. Vaid and his staff at the Department of Medical Oncology and Hematology at Medanta Medicity Hospital in Gurugram, India. The Hemopurifier treatments will be performed by Dr. Puneet Sodhi from the Department of Nephrology, who has conducted more Hemopurifier treatments than anyone else in the world.

Paid News Dissemination of behalf of AEMD

 

Read this news featuring AEMD in full at https://www.investorideas.com/news/2024/09191AEMD-Ethics-Committee-Approval-for-Hemopurifier.asp

"The approval from the MIEC, coming closely on the heels of our two ethics committee approvals in Australia, to conduct this early feasibility study, is another important step in our plan to evaluate use of the Hemopurifier as a treatment option in multiple tumor types, where cancer associated exosomes may promote immune suppression and metastasis,” stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “We are very pleased that the MIEC accepted our study protocol and look forward to working, again, with Medanta Hospital with the expectation of recruiting patients in the fourth calendar quarter of this year. We believe that the planned safety, feasibility and dose finding trial, taking place in both India and Australia, in solid tumors in patients failing treatment with anti-PD-1 antibodies, will help inform future oncology efficacy trails.”

 

At present, only approximately 30% of cancer patients who receive pembrolizumab or nivolumab treatment for solid tumors will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in resistance to anti-PD-1 therapies as well as the spread of cancers. 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 EVs in cancer patient plasma samples.

 

The primary endpoint of the approximately nine to 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 PD-1 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 to recruit patients for and manage its clinical trials and studies; the results of the safety, feasibility and dose finding study; unforeseen changes in regulatory requirements; 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, 2024, 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
Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com   

 

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com

 

Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com

 

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