SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced that it has initiated coverage on Aethlon Medical, Inc. (AEMD), a medical device company focused on creating innovative devices that address unmet medical needs in cancer, infectious disease and other life-threatening conditions.
"We see the core of AEMD’s developments in the Aethlon ADAPT(TM) (Adaptive Dialysis-Like Affinity Platform Technology) system, a medical device platform that forms the basis for a new class of therapeutics that target the rapid elimination of disease enabling particles from the circulatory system of treated patients. The lead Aethlon ADAPT(TM) product is Hemopurifier(R), a first-in-class device that addresses a broad spectrum of viral pathogens as well as tumor-secreted exosomes that suppress the immune system of cancer patients," commented Ajay Tandon, CEO of SeeThruEquity. "We are initiating coverage with a target price of $0.34."
To do so, the DLT program seeks to develop multiple component technologies, integrate them into a portable device, and rigorously validate device effectiveness. Key technical areas and representative technical approaches include:
Persistent interrogation of the entire blood volume via sensing technologies such as surface enhanced Raman spectroscopy (SERS). This capability may enable early identification of bacteria, viruses, toxins, and cytokines.
High-flow fluid manipulation without the use of anticoagulants via novel biocompatible/biomimetic architectures and advanced surface functionalization chemistries.
Continuous removal of pathogens, toxins, activated cells, exosomes, and cytokines via a diverse suite of "label-free" technologies such as synthetic mannose binding lectins and selective adsorption cartridges.
Closed-loop therapy with system feedback to monitor and redirect patient state based on conditional probability and reduced order techniques.
The integration and validation of these component technologies focuses on establishing a path to FDA Investigational Device Exemption (IDE) before the completion of the program. From there, the device will be available for transition to military medical commands and clinical trials required for final regulatory approval.
In addition to treating sepsis, the DLT device represents a flexible platform that may be configured to combat engineered and evolving pathogens.
Aethlon Medical, Inc. (AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions, disclosed today that the Defense Advanced Research Projects Agency (DARPA) has informed the Company that it plans to exercise an option to proceed with year four of a five-year $5.9 million contract that was awarded to Aethlon on September 30, 2011 under DARPA's Dialysis-Like Therapeutics (DLT) program.
The fourth year of Aethlon's DLT contract contains three milestones representing a potential of $669,292 in revenue opportunity. To date, Aethlon has invoiced $4,252,037 to DARPA for achieving twenty of twenty-three milestone objectives targeted in the first three years of the DLT program.
The goal of the Dialysis-Like Therapeutics (DLT) program is to develop a portable device that removes "dirty" blood from the body, separates harmful agents, and returns "clean" blood to the body in a manner similar to dialysis treatment of kidney failure. The resulting device could decrease the morbidity and mortality of sepsis, thereby saving thousands of lives and billions of dollars in the United States annually.
Other than the crickets, I may be the only other person besides you visiting this board. This company has so much potential and the owner is a good and decent person to boot. They're getting ready to uplist and they have some big backers in the health world so it wouldn't surprise me a bit to see them start to get more exposure. The Lucrazon deal should begin to gain traction soon and with a little luck economy wise, it could be off to the races soon.
Previously, we conducted studies of Hemopurifier® therapy with success in HIV and HCV-infected individuals at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity Institute, all located in India.
The goal of our FDA cleared study is to collect safety data that will allow us to advance the Hemopurifier® as a treatment against chronic viral indications and as a broad-spectrum countermeasure against emerging pandemic threats.
So, beyond our previous treatment experience overseas, you might ask what evidence do we have that our Hemopurifier® could address emerging pandemic threats. Well, previously conducted in vitro studies have verified Hemopurifier® capture of ebola hemorrhagic virus, dengue hemorrhagic virus, lassa hemorrhagic virus, H5N1 avian influenza (bird flu), the reconstructed 1918 influenza virus (r1918), 2009 H1N1 influenza virus (swine flu), West Nile virus, and monkeypox, which serves as a model for human smallpox infection. These studies were conducted with leading government and non- government research organizations, including The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), The Centers for Disease Control and Prevention (CDC), The National Institute of Virology (NIV), The Battelle Biomedical Research Center (BBRC) and The Southwest Foundation for Biomedical Research (SFBR).
Based on this collection of data, we are confident that the Aethlon Hemopurifier® is the most advanced broad-spectrum countermeasure against viral pathogens. We hope you follow our clinical efforts to advance this therapeutic technology into the marketplace. Our mission is simply to save lives.
Are pandemic viral pathogens establishing a global foothold? At present, the deadliest Ebola virus outbreak in history continues to burn through Africa. Japan is experiencing its first Dengue outbreak in 70 years, and in the U.S., twelve states have just reported clusters of Enterovirus D68 infection. Additionally, since the first documented occurrence of Chikungunya virus in the Americas late last year, 31 states have now reported infections from this debilitating viral pathogen. Worldwide outbreaks of viral pathogens will continue to be fueled by urbanization, improvements in mass transportation, global warming, and the continued evolution of new viral strains and species.
In my inaugural Chairman’s blog post, I will outline the Aethlon Medical strategy to combat chronic and emerging viral threats. In future blogs, I look forward to discussing our role in cancer immunotherapy as well as the diagnostic endeavors being advanced by our Exosome Sciences subsidiary.
Specific to viral threats, we recognized early on that there would be a continued need for a therapeutic strategy that could address antiviral drug resistance, which often occurs in chronic viral pathogens such as HIV and Hepatitis C virus (HCV). We also recognized that the vast majority of acute viral pathogens (including bioterror and pandemic threats) were not addressed with corresponding drugs or vaccines. In response, we created the Aethlon Hemopurifier® to address these unmet medical needs.
The Hemopurifier® is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes, which suppress the immune system and contribute to the spread of metastasis in cancer patients. We are now preparing to launch the first FDA approved study of Hemopurifier® therapy in the United States.
Aethlon Medical, Inc., (NASDAQ:OTCQB: AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions, announced today a suite of online corporate communication channels to maintain on-going direct communication with shareholders and other interested parties. The Company has launched official portals on social media channels including Facebook, Twitter, LinkedIn, Google+, YouTube and The Chairman's Blog.
The Chairman's Blog is an online communication portal where Aethlon Medical executives can address important topics as they relate to infectious disease, cancer and other life threatening conditions as well as specific points of discussion as they relate to key events at Aethlon Medical Chairman and Chief Executive Officer James A. Joyce penned his inaugural blog post, "The Ebola, Dengue, Enterovirus, and Chikungunya Outbreaks." The blog post can be found online at the official Aethlon Medical Chairman's Blog profile provided below.
Regarding Kevetrin, Cellceutix's lead anti-cancer compound in a dose escalation Phase 1 clinical trial, no drug-related serious adverse events or significant laboratory changes were reported in the eighth cohort in which patients were treated with 215 mg/m2 of Kevetrin. The safety committee yesterday determined that the next 9th cohort may be treated with 350 mg/m2. Patient dosing is scheduled to begin this week.
Cellceutix is also pleased to announce the submission of an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") to commence a Phase 2 clinical trial of Brilacidin-OM for the treatment of oral mucositis.
Oral mucositis is a common and often debilitating inflammation and ulceration in the mouth as a side effect of certain cancer treatments, including chemotherapy and radiation therapy that affects nearly half a million people each year. Laboratory studies of Brilacidin-OM have demonstrated antibacterial, anti-biofilm and anti-inflammatory properties of Brilacidin-OM as an oral rinse that significantly reduced the duration of oral mucositis by 90 percent or more. There are currently no FDA-approved preventative or therapeutic drugs to treat oral mucositis induced by a broad spectrum of cancer therapies.
"Oral mucositis is an extremely painful condition that often goes overlooked and unpublicized as a side effect for treating hundreds of thousands of cancer patients," commented Leo Ehrlich Chief Executive Officer of Cellceutix. "There is a tremendous market opportunity to treat this condition as it pertains to cancer, as well as in the emerging field of stem cell transplantation. We have a great deal of confidence in initiating this Phase 2 trial and hope this will lead to a drug that offers oral mucositis patients a viable treatment for their discomfort."
Cellceutix will not know the actual cure rates per treatment arm until the data is unblinded in October/November. However, the Company is very optimistic and views the high average cure rate on the blinded data as a very good sign for Brilacidin. Assuming positive results after unblinding, Cellceutix will have proven that Brilacidin is a safe and effective drug in the Phase 2 trial, and all activities will be triggered for initiation of a pivotal Phase 3 trial.
"We are very excited about the prospect of using a novel class of antibiotics to treat serious infections caused by Staph aureus, including MRSA, and potentially, with a single-dose," commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Because of the extremely unlikely chance of developing resistance, and the other benefits conferred by a short or single-dose therapy, such as near 100% compliance, we feel Brilacidin is a game-changer in the field of antibiotics for serious and resistant infections."
The initial results from the study are general observations and only considered blinded data averaged across all four treatment groups. Similar to a previously conducted Phase 2a study, Staphylococcus aureus (including MRSA) was the most common bacteria isolated at the baseline visit. The data shows that by Day 7, the average cure rate for all four treatment arms was higher than what was observed in the phase 2a study, and similar to -- if not higher than -- cure rates reported for common ABSSSI drugs, as well as those approved this year. Because 3/4 of the patients in this study were treated with Brilacidin, this high average cure rate is heavily influenced by Brilacidin, and less influenced by daptomycin, which only 1/4 patients received. This also means that the two single-dose treatment arms are providing half of the data toward this positive average cure rate; and if these data hold up, a single-dose regimen of Brilacidin would be the Company's Phase 3 study design.
cancer, plus 20 age-matched, female and male non-cancer controls. In the studies, the ESI platform was consistently able to differentiate individuals afflicted with cancer as compared to non-cancer controls. The tested serum specimens were obtained from commercial and collaborative academic biorepositories. A breakdown of the analyzed cancer specimens include:
– Glioblastoma – 5 late stage
– Metastatic Melanoma – 20 late stage
– Ovarian cancer - 31 early stage and 114 late stage
– Colorectal cancer – 7 early stage and 7 late stage
– Pancreatic cancer – 2 early stage and 12 late stage
Based on the data collected, ESI plans to establish collaborations and clinical partnerships to further validate its platform and identify specific oncology and neurodegenerative indications where the platform offers to improve upon standard of care methods to diagnose and monitor disease progression.
Additional study details will be presented at the Exosomes & Single Cell Analysis Summit to be held on September 18th and 19th, 2014.
Based on previously reported discoveries related to progressive neurodegenerative disorders, Aethlon further disclosed that the ESI team has initiated follow-on studies to advance a candidate blood test to identify and monitor the progression of Chronic Traumatic Encephalopathy (CTE). At present, CTE is only diagnosed through postmortem autopsy. CTE has been most commonly found at autopsy in former National Football League (NFL) players and has also been demonstrated to be prevalent in soldiers exposed to blast injury.
In previous disclosures, ESI researchers reported that they had successfully isolated brain-specific biomarkers that could have implications in the diagnosis, monitoring and treatment of Alzheimer's Disease (AD), CTE and Glioblastoma Multiforme (GBM). The studies provided evidence that the ESI platform could also detect exosomes as a basis for a "liquid biopsy" to diagnose neurologic conditions. While exosomes from the central nervous system had previously been identified in the cerebrospinal fluid, the ESI team identified exosomes carrying brain-specific markers tau, beta-amyloid, glycoprotein A2B5 and S100B protein that had been transported across the blood-brain barrier and into the circulatory system.
"I am immensely proud of the ESI research team as their considerable breadth of collected data reinforces the possibility that a single platform could detect and monitor a wide-range of disease conditions," stated Aethlon Medical CEO Jim Joyce, who also serves as Executive Chairman at ESI. Mr. Joyce founded ESI on behalf of Aethlon Medical shareholders as a means to explore if the lectin-affinity techniques underlying Hemopurifier® therapy could provide a basis for proprietary diagnostic applications.
In the oncology platform validation studies, 198 single point serum specimens (taken at the time of cancer diagnosis) were analyzed from patients with Glioblastoma, Metastatic Melanoma, Breast cancer, Ovarian cancer, Colorectal cancer and Pancreatic
Aethlon Medical, Inc. (NASDAQ:OTCQB:AEMD), and its diagnostic subsidiary, Exosome Sciences, Inc. (ESI), announced today that ESI researchers have developed and initially validated a lectin-based diagnostic platform that is able to isolate exosome-based biomarkers underlying a broad-spectrum of oncology indications. Aethlon Medical develops targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions. ESI develops exosome-based solutions to diagnose and monitor cancer and neurodegenerative disorders.
In the validation studies, ESI researchers provided evidence that their diagnostic platform could identify the presence of cancer in analyzed blood samples from individuals suffering from glioblastoma, metastatic melanoma, breast cancer, ovarian cancer, colorectal cancer and pancreatic cancer. Beyond the potential implications in diagnosing cancer, ESI researchers believe the high-sensitivity of the platform will allow for effective monitoring of cancer progression and response to corresponding therapies. In oncology indications, the sensitivity of the ESI platform also represents an advancement over the ELLSA assay that was originally developed by Aethlon Medical to quantify changes in circulating exosome load resulting from the administration of Aethlon Hemopurifier® therapy. The Hemopurifier® is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes, which in addition to being an oncology biomarker, suppress the immune system and contribute to the spread of metastasis in cancer patients.
Green Polka Dot defines aeroponic technology as a “vertical growing environment in which plants are grown in mist or air environments instead of soil.” Other companies say organics and living produce blend well. Vince Choate, marketing director with Hollandia Produce LP/Live Gourmet, Carpinteria, Calif., said living produce enhances organic offerings. “It’s just another addition to the living produce section,” he said. “We’ve provided some organic solutions with the butter lettuce and watercress and upland cress.”
Sales of organic living produce are bound to increase with the rest of the organic category, Choate said. “We see very good opportunities there,” he said. “There’s demand from the retailer as the consumer continues to move forward in the organic category. It’s still doing quite well. The Organic Trade Association projects the next several years will continue in that growth pattern, and I think they’re right.” “The rising retail (sales of living produce) leaves room for an organic product,” said Dean Luurtsema, vice president of Jenison, Mich.-based Luurtsema Sales Inc., which offers Living Salad Bowls among its products. Luurtsema said his company has “a fair selection” of organics. “We’re seeing organics being pretty strong,” he said. Sales increase with education, said Jim Fox, sales director with Thermal, Calif.-based North Shore Greenhouses Inc. “Organics are in demand, and the main questions are, ‘Is the living produce safe?’ and ’Are the farming methods sustainable?’” he said. “North Shore Living Herbs are both safe and certified SCS (Global Services) Sustainably Grown.”
Jim Offner - Living produce isn’t necessarily organic, but the two categories do cross paths from time to time, suppliers say. To some, they’re congruent. One example is Mount Pleasant, Utah-based Green Polka Dot Box Inc., which markets itself as a web-based “membership club for organic and non-GMO natural foods at wholesale pricing.” In September, Green Polka Dot Box announced a purchase of 40 acres of land to be devoted to greenhouses for growing systems that turn out living produce lines. The announcement followed a supply contract Green Polka Dot Box signed in August with Fresh Organics LLC, a Miami-based distributor. The 10-year deal is worth more than $616 million to Green Polka Dot Box, officials said in a news release. The first phase of the contract, which took effect in January, calls for organic colored bell peppers, red and green leaf and romaine lettuce, cucumbers and tomatoes, including heirlooms. Future phases will include a larger selection of the living produce as production increases, Green Polka Dot Box officials said. In addition to opening up a sustainable program for distribution of a steady, year-round supply of living produce and other organic products to wholesale buyers in the U.S. and around the world, the land acquisition enables Green Polka Dot Box to develop, grow and sell an array of organic produce through the company’s home delivery model to members. “This 40-acre land acquisition in Utah is another milestone that we’ve worked hard to achieve in order to launch the growing and sales of living produce,” Green Polka Dot Box CEO Rod Smith said in the news release. Varieties, often harvested while alive, can live as long as seven to 10 days, Smith said. Smith could not be reached for further comment. The site in Utah will be one of the first large-scale organic farms using “aeroponic” technology in America, Green Polka Dot Box officials said.
Upon receipt of IDE approval from FDA, Aethlon initiated discussions with various clinical partner candidates. On February 26, 2014, the Company disclosed that it had reached an agreement in principle with DaVita Clinical Research® (DCR) and subsequently disclosed that it had completed a definitive agreement with DCR on May 20, 2014. DCR is a specialty contract research organization (CRO) with experience in conducting more than 300 early phase clinical trials. As a subsidiary of DaVita Healthcare Partners Inc, DCR has access to one third of the total U.S. ESRD patient population and maintains a network that exceeds 150 investigative physicians' practices at more than 250 clinical sites.
Aethlon further disclosed that Dr. Stephen Z. Fadem had been named Principal Investigator of the IDE approved study. Dr. Fadem is Chief Medical Officer at Kidney Associates, PLLC and the Medical Director for the Houston Kidney Center Integrated Service Network at DaVita Kidney Care, a division of DaVita HealthCare Partners Inc.
Under the feasibility study protocol, Aethlon will enroll ten end-stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier® therapy in an infectious disease model. Upon successful completion of the feasibility study, Aethlon plans to conduct pivotal efficacy studies required for market clearance to treat HCV and other chronic viral indications. Previous clinical studies of Hemopurifier® therapy have been conducted in HIV and HCV-infected individuals at the Apollo Hospital, Fortis Hospital, Sigma New Life Hospital, and the Medanta Medicity Institute, all located in India.
Aethlon's feasibility study will also contribute safety data to advance the Hemopurifier® as a broad-spectrum countermeasure against high-risk bioterror and pandemic threats, which are so lethal they do not allow for the administration of clinical efficacy studies.
SAN DIEGO, Sept. 2, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (NASDAQ:OTCQB: AEMD), the pioneer in developing targeted therapeutic devices to address infectious disease, cancer and other life-threatening conditions, announced today that it has received independent internal review board (IRB) approval to initiate human clinical studies of Hemopurifier® therapy at DaVita MedCenter Dialysis located in Houston, Texas. Aethlon previously disclosed that the United States Food and Drug Administration (FDA) had approved an Investigational Device Exemption (IDE) that would allow for the initiation of Hemopurifier® feasibility studies in the United States. As a result of the independent IRB approval, the Company is now permitted to initiate the IDE approved study. Enrollment of patients who meet the study inclusion/exclusion criteria is expected to begin in the coming weeks. The Hemopurifier® is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that suppress the immune system of cancer patients.
OBI-822 is a new anti-cancer treatment that belongs to a new class of active immunotherapies. It is licensed from Memorial Sloan-Kettering Cancer Center (MSKCC). OBI-822 is a synthetic glycoprotein comprised of multiple carbohydrate tumor antigens, Globo H, on a carrier protein, Keyhole Limpet Hemocyanin. OBI-821 is a saponin-based adjuvant that is co-injected with OBI-822.
Globo H is a carbohydrate antigen expressed in high levels on the surface of malignant tumors in many epithelial cancers, such as breast, prostate, gastric, lung, colon, pancreatic, and ovarian cancer. The immunogenicity of the antigen is enhanced by conjugating Globo H to the KLH carrier protein to form OBI-822 (Globo H-KLH), and co-administered with OBI-821.
Stellarklhgold may be onto something:
OBI Pharma Announces Completion of Patient Enrollment in Phase 2/Phase 3 Clinical Trial of OBI-822 Active Immunotherapy for Metastatic Breast Cancer
TAIPEI, TAIWAN, July 22/ -- OBI Pharma, Inc., a Taiwan biotech company (GreTai 4174:TT), announced that it has completed patient enrollment in its Phase 2/3 clinical trial evaluating the safety and efficacy of its lead compound, OBI-822, an active immunotherapy for the treatment of metastatic breast cancer.
“Completing enrollment in the Phase 2/3 clinical trial is a major milestone in the development of OBI-822”, said Michael N. Chang, Ph.D., Chairman of the Board of OBI. “Our next target is a global phase 3 trial – now that there is a current IND with the US FDA and an IND application already submitted in China. We look forward to the results of this trial being confirmed once the course of treatment is completed in all enrolled patients early next year.”
“The cancer active immunotherapy, OBI-822 guides the immune system to attack breast cancer cells, with minimal side effects, [as observed in the OBI’s Phase 1 and Phase 2/3 clinical trials]” said Amy Huang, General Manager of OBI. “OBI-822’s anti-cancer potential goes beyond breast cancer. All tumor cells expressing Globo series glycan (Globo H, SSEA-3 and SSEA-4) are possible treatment targets for OBI-822. According to the latest research findings reported by Taiwan’s Academia Sinica, the Globo H vaccine can potentially treat up to 16 different types of cancer. In fact, OBI Pharma and Mackay Memorial Hospital jointly initiated a Phase 2 ovarian cancer trial in November 2013 which is currently on-going.”