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Hey Pickl,
Thanks for finding us! The board's been quiet for many months, but the same four (and now five) of us still have it boardmarked - a testament to how great a sport it is I think. Love the modified ball-golf cart idea, hah.
Welcome!
July 21st...
Hey guys I've been out of the loop and I've been trying to catch up here... what's happening on the 21st that keeps getting referenced?
Link appears to be broken, repost please?
TIA
Nice review GWMAN.. now let's see 'em :)
If not this major partnership, what WILl get us to the next level? Perhaps this is going under the radar because it's just a letter of intent so far?
What's the link to the stream? I don't see it on redchip.com
Just got a reminder about the update this afternoon.. they realllly want us to tune in to this one.
Cup and handle?
Expecting an eventful week here :)
Another solid day... with any real volume this'll go nicely
hah not necessarily mundane.. it's certainly interesting at times..just exhausting and predictable, I guess.
This board has become so tiring and tedious to read over the last year.. like watching the same episode of Days of Our Lives over and over again on repeat. Not blaming anyone in particular.. but it's just silly.
I know I never post, so perhaps I'm part of the problem... if everyone posted it'd be inherently more interesting, but still.
I'd love to see this close at .37 or .38 but I don't think we have the volume today.
Aethlon Medical Announces Corporate Update at 4pm ET on March 24, 2010
On Tuesday March 2, 2010, 8:00 am
SAN DIEGO, March 2 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board:AEMD.ob - News), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced that Jim Joyce, its Chairman and Chief Executive Officer, will present a corporate update from the NASDAQ Marketsite at the 2010 RedChip New York Equities Conference on March 24, 2010. Mr. Joyce will address a number of topics, including manufacturing, research programs and initial commercialization. The presentation will follow the market close and investors are urged to listen to the live webcast at: www.redchip.com.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b)
Aethlon also disclosed that John P. Salvador has been named as Director of Corporate Communications. Mr. Salvador, an accomplished corporate communications and investor relations professional, will act as a liaison with the medical community, candidate patients and shareholders.
Aethlon further disclosed that Mr. Joyce will present at the LDV Growth and Value Investor Conference, tomorrow, March 3rd and on the 4th at the Sheraton Suites Cypress Place in Fort Lauderdale, Florida. The presentation will begin at 6:10 pm EST on both nights.
About Aethlon Medical
Aethlon Medical, Inc. creates diagnostic and therapeutic device solutions for infectious disease and cancer. Our lead product, the Hemopurifier® is the first-in-class medical device to selectively capture circulating viruses and immunosuppressive proteins prior to cell and organ infection. Human studies have documented the ability of our Hemopurifier® to reduce viral load in patients infected with Hepatitis-C virus (HCV) and the Human Immunodeficiency Virus (HIV). Our primary clinical and commercialization focus is to establish the Hemopurifier® as an adjunct therapy to enhance and prolong the benefit of traditional infectious disease drug regimens.
The Hemopurifier® is also a broad-spectrum treatment candidate against drug resistant bioterror and pandemic threats. Third party research institutes have verified the capability of the device to capture Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) was formed in October of 2009 to leverage attributes of the Hemopurifier® in the emerging exosome research field. ESI seeks to inhibit the immune cell destruction caused by exosomes secreted by solid tumors, lymphomas, and leukemia. At present, the capture of immunosuppressive exosomes secreted from ovarian cancer tumors has been demonstrated invitro. The preservation of anti-cancer immune cells would likely improve patient responsiveness to established treatment options, including immunotherapy and chemotherapy. ESI is also analyzing exosome-related opportunities to improve early cancer detection and post-surgery surveillance of tumor growth, as well as approaches to harvest exosomes for research purposes and potential reintroduction into patients afflicted with autoimmune conditions such as Rheumatoid Arthritis and Lupus.
Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
RedChip Companies, Inc.
Jon Cunningham
1-800-733-2447, Ext. 107
Completely agree, Dennis...
or the pessimist.
Is the potential for a cup and handle formation still in play?
This consolidation, albeit healthy and to some extent even welcomed, is getting tiresome.
Good thinking Danno, but take no offense, I'd rather see them focus on HCV and HIV for now. Bioweapons in Afghanistan and Iraq are probably a more pressing issue than snake bites in the Outback ;) But good thinking.. just illustrates how many different applications there could be down the line.
Talked to a guy from RedChip on Friday. He informed me AEMD will not renew their contract with Redhcip, but that Redchip would continue to cover them on an independent basis because they still like where the company is headed.
Every time I talk to him he reiterates how awesome JJ is and how JJ's not concerned with Wall Street, but rather, getting his product to the Dr's offices on Main Street.
SAN DIEGO, Jan. 19 /PRNewswire-FirstCall/ --
Aethlon Medical, Inc. (OTC Bulletin Board: AEMD) announced today that its Chief Science Officer, Dr. Richard H. Tullis, will give a clinical presentation of the Aethlon Hemopurifier® at the 12th International Conference on Dialysis on January 22nd. The presentation will review treatment outcomes of dialysis patients infected with Hepatitis-C (HCV), and will discuss the additional use of the Hemopurifier® in HIV and Cancer care. The conference will be held at the Marriott New Orleans in New Orleans, Louisiana. Additional information, including the speaker agenda, can be accessed online at: http://www.renalresearch.com/
(Logo: http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b)
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic device solutions for infectious disease and cancer. Our Hemopurifier® represents the first-in-class medical device to selectively adsorb viruses and immunosuppressive toxins from the bloodstream. The Hemopurifier® seeks to improve Hepatitis-C treatment outcomes and serves as a broad-spectrum treatment countermeasure against bioterror and pandemic threats. Additional information regarding Aethlon Medical can be accessed online at http://www.aethlonmedical.com/
Contacts:
RedChip Companies, Inc
Jon Cunningham 1-800-733-2447, Ext. 107
Jim Joyce Chairman, CEO 858.459.7800 x301
Hey Humblehawk, boardmarked WOO board this moring... if you can find other plays like AEMD, I'm all ears.
Nice DD summary, thanks for sharing.
I am beyond 'in love' with AEMD... I think it's a real addiction for me :)
RedChip Visibility Issues Research Update on Aethlon Medical
On Wednesday January 13, 2010, 1:23 pm
ORLANDO, Fla., Jan. 13, 2010 (GLOBE NEWSWIRE) -- RedChip Visibility, a division of RedChip Companies, Inc., has issued a research update on Aethlon Medical, Inc. (OTCBB:AEMD - News), a company developing a therapeutic device to treat acute and chronic viral infections, biological warfare pathogens, and other conditions by filtering virus particles and immunosuppressive agents from the blood.
David Webber, RedChip Research Analyst, reported:
"During the final months of 2009, Aethlon continued to seek to build value with the initiation of a pilot production run of Hemopurifier cartridges using Good Manufacturing Practices, the start of work on less expensive production of the Hemopurifier's affinity agent in plants, and the establishment of a subsidiary to develop a non-core, potential use of the device in cancer."
"Based on the clinical data reported, Aethlon has made development of the Hemopurifier for the treatment of chronic hepatitis C its core program. During the final months of the year, the bulk of visible progress took place in improving manufacturing processes in ways necessary for broad commercialization."
Webber continued "We continue to rate Aethlon Medical a Speculative Buy with a 12-month price target of $1.00 per share. According to management, talks continue with potential partners. As it is not clear when to expect the next substantial increment of clinical data, we consider news of a partnership, should that occur, the potential event with the best chance of moving the stock towards our price target during 2010."
To receive a complimentary copy of the RedChip Visibility Research Update for AEMD, please visit: http://www.redchip.com/about/aboutmain.asp?rid=214
To learn more about Aethlon, visit http://www.redchip.com/visibility/investor.asp?symbol=AEMD.
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic filtration devices to improve the health of individuals afflicted with infectious disease and cancer. Aethlon's lead product, the Hemopurifier(R), is a first-in-class artificial adjunct to the immune system proven to capture infectious viruses and immunosuppressive particles from the human circulatory system. The device targets to inhibit disease progression of Hepatitis-C Virus (HCV) and Human Immunodeficiency Virus (HIV), and serves as a broad-spectrum treatment countermeasure against bioterror and emerging pandemic threats. The Hemopurifier(R) also holds promise in cancer care, as research studies verify the Hemopurifier(R) effectively captures immunosuppressive exosomes that are secreted by tumors to kill-off immune cells. At present, over 65 Hemopurifier(R) treatments (representing approximately 260 hours of treatment time) have been conducted in multi-site studies at the Apollo Hospital, Fortis Hospital, and Sigma New-Life Hospital in India. The studies enrolled end-stage renal disease (ESRD) patients infected with either HCV or HIV. In addition to establishing treatment safety, robust viral load reductions have been reported in both HCV and HIV infected individuals. Research studies have also demonstrated the Hemopurifier(R) is effective in capturing a broad-spectrum of viruses untreatable with drug therapy, including several of world's deadliest bioterror and pandemic threats. Beyond therapeutic market opportunities, Aethlon is leveraging principles underlying the Hemopurifier(R) technology platform to establish a pipeline of clinical and research diagnostic products and services. Additional information regarding Aethlon Medical can be accessed online at http://www.aethlonmedical.com.
I just reread the recent shareholder letter. I think JJ provides more insight into each of the accomplishments than he ever has, i. e. the note about the NFL/BU collaboration being watched closely by congress and major media outlets... he gives us hints at how to read between the lines and sums it up with his frustration of how undervalued he thinks we are:
He specifically compares AEMD to a company with a 7B+ market cap. For AEMD to have a similar market cap, we'd be sitting at almost $130 a share.
Do you buy 3 plasma TV's a week?
That being said, though, after doing a quick search on the costs of Chemotherapy (and the associated drugs), I rescind my original estimate. $1000 suddenly seems reasonable.
$1000 sounds like a LOT, especially for India.
I have no idea where I was coming up with this number but i kind of imagined it would be in the $50-$100 range/catridge. These are not reusable and patients will need several, if not ongoing, treatments.
$1000 per catridge seems unreasonsable to me, although I wouldn't complain from an investor perspective ;)
Could someone please give me the l2? eom
re: AEMD.. new HOD .38 with .39 ask
wow, you weren't kidding.. ask now .444!
edit... just kidding.. was there for a moment, though
good to hear, thanks!
AEMD chart looking real strong... how does the L2 look?
SAN DIEGO, Jan. 7 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc., (OTC Bulletin Board: AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b)
To our Shareholders:
The scientific accomplishments of your Aethlon Medical team in 2009 have set the stage for the initial commercialization of our Hemopurifier® as an adjunct therapy targeted to improve Hepatitis-C virus (HCV) cure rates. In addition, we strategically cultivated principles underlying our core Hemopurifier® platform technology to create an expansive yet cohesive medical product pipeline beyond infectious disease. In this regard, we positioned ourselves to advance new therapeutic and diagnostic paradigms in cancer, and also executed a collaboration that allowed us to enter the biomarker discovery marketplace. Among our reported events in 2009, we:
1. Initiated a collaborative biomarker discovery program with the Center for the Study of Traumatic Encephalopathy (CSTE) at the Boston University School of Medicine and the Sports Legacy Institute (SLI). The goal of this collaboration is to apply our proprietary techniques for selectively capturing viruses and other particles as a means to discover biomarkers that could identify athletes likely to have an increased susceptibility to Chronic Traumatic Encephalopathy (CTE) and related issues resulting from repetitive head trauma. The identification of such biomarkers could provide the basis for a test to distinguish those individuals who should be precluded from participating in football and other activities with a high risk for head trauma. CTE has recently been identified in ten deceased National Football League (NFL) players, of which most died before the age of 50. Since the announcement of our research collaboration, the NFL has established a formal relationship with the CSTE and will provide $1 million to support research. The NFL is also encouraging current and retired players to participate in CSTE brain research programs. We have subsequently received brain samples of former players identified with CTE during autopsy and have initiated our testing program. It is possible that our research becomes the story behind a story now being played out before congress and covered by major media outlets. Click here for a recent New York Times article on the topic.
2. Established Exosome Sciences, Inc. (ESI) as a wholly owned subsidiary of Aethlon Medical to leverage the discovery that our Hemopurifier® captures exosomes known to suppress the immune system in cancer patients. Inhibiting the destructive immunosuppressive activity caused by exosomes is an unmet medical need that could improve the lives of cancer patients worldwide. Addressing this need may increase patient responsiveness to chemotherapy and other treatment strategies. From a business perspective, it provides us the potential to enter the $43+ billion market for cancer therapies. While there is still much research and clinical work to be accomplished, our established collection of human Hemopurifier® data provides an advantage that could accelerate our therapeutic objectives. ESI also has the prospect of advancing exosome diagnostic and research services, and exploring recently discovered opportunities to address exosomes in disease conditions beyond cancer. Scientific publications reveal that exosomes may also have implications in inflammatory conditions including Sepsis, bacterial infections including Tuberculosis (TB), autoimmune conditions such as Rheumatoid Arthritis, and neurological and neurodegenerative diseases such as Alzheimer's disease. Regardless, the formation of ESI allows us to leverage value from a previously unrecognized asset into an entity not burdened with the status of being a publicly traded organization.
3. Completed and reported on the "first-in-man" study of a medical device to treat the Human Immunodeficiency Virus (HIV), which demonstrated a 92% reduction of viral load and improved immune function resulting from short-term intermittent application of our Hemopurifier® in the absence of any antiviral drug therapy. Similar to our treatment strategy in HCV, we believe the Hemopurifier® could significantly enhance and extend the benefit of both established and candidate drug therapies. The Hemopurifier® also offers a potential new treatment strategy for HIV-infected individuals that become fully resistant to antiviral drug regimens.
4. Entered into an agreement that extends studies of our Hemopurifier® with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) under a cooperative research and development agreement. The objectives of the USAMRIID agreement include determining the therapeutic efficacy of our Hemopurifier(R) in non-human primate studies against hemorrhagic fever viruses, including the highly virulent Zaire strain of Ebola (ZEBOV). We also disclosed that studies previously conducted by USAMRIID documented our Hemopurifier® captured approximately 50% of both wild type and mutant strains of ZEBOV from fluids during one hour in vitro studies. ZEBOV, which is untreatable with drug therapies, has the highest known virus fatality rate, up to 90% in some epidemics, with an average case fatality rate of approximately 83% in outbreaks.
5. Documented our Hemopurifier® effectively captures the current pandemic strain of the H1N1 Swine Flu Virus. During invitro studies, the Hemopurifier® removed 68% of H1N1 virus from blood plasma in 30 minutes, 80% of the virus in two hours, and a 96% reduction of H1N1 was observed at six hours. The studies were performed by third party researchers approved by the United States Department of Health and Human Services (HHS) to house and conduct research with pandemic strains of H1N1 virus. Beyond the H1N1 Swine Flu Virus data, third party researchers have now validated the ability of our Hemopurifier® to capture Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection. In addition to being the first-in-class medical device to selectively capture infectious viruses, the breadth of our collected data reinforces my belief that our Hemopurifier® is the leading and perhaps only true broad-spectrum countermeasure against drug resistant bioterror and pandemic threats.
6. Reported compelling human clinical outcomes against Hepatitis-C virus (HCV) infection; then disclosed a data supported strategy to improve HCV cure rates; and subsequently discovered a clinical validation by Asahi Kasei Kuraray Medical (Asahi) that confirms moderate levels of viral filtration at the outset of standard of care (SOC) therapy can dramatically impact HCV cure rates. Asahi reported 71.4% cure rates in patients who previously failed SOC, by applying their V-RAD filtration system (Click Here for V-RAD Website) once daily for three consecutive days at the outset of the 48-week SOC drug regimen. Cure rates of HCV patients who previously fail and then reinitiate SOC are generally reported below 20%. Viral load reductions of 26.1% were documented during each V-RAD treatment period, which averaged 3 1/4 hours in duration. These results do not bode well for drug candidates vying to become a component of SOC therapy. Especially if viral filtration achieves such results without needing to be administered during the remaining 47-weeks of SOC therapy and without stacking additional drug toxicity on top of the known toxicity of SOC therapy. However, this is good news for 180 million individuals infected with HCV worldwide. Regardless, we believe the viral filtration capabilities of our Hemopurifier® will provide even better treatment outcomes. This sentiment is reflected in the following paragraph extracted from my December 8th shareholder letter:
On October 30th, we reported HCV treatment outcomes at the 42nd Annual American Society of Nephrology (ASN) Conference. When analyzing Hemopurifier® treatment data from all of our HCV human studies, we documented average per-treatment viral load reductions of 29-42%. While the length of each Hemopurifier® treatment was similar in duration to V-RAD, the Hemopurifier® did not benefit from SOC associated viral load reductions as our results were achieved in the absence of SOC therapy. We acknowledge and appreciate that V-RAD has indeed documented that viral filtration improves HCV treatment outcomes. However, we believe the Hemopurifier® delivers the necessary capabilities to establish broad-market acceptance of a medical device in infectious disease care. Foremost of these capabilities is our ability to selectively capture infectious viruses and immunosuppressive proteins not addressed by V-RAD. The selective capture of deleterious agents from circulation establishes an environment that permits continuous or aggressive intermittent treatment strategies that can truly optimize patient outcomes. Whereas historic therapeutic filtration approaches, including V-RAD, are restricted in scope as they indiscriminately remove particles from blood by molecule size. As a result, the safe application of such treatments remains limited as beneficial blood components required for health are removed along with the deleterious target.
7. Initiated a relationship with Kentucky Bioprocessing LLC (KBP) to establish the processes necessary to support large-scale production of the active affinity agents we immobilize inside our Hemopurifier®. Such affinity agents allow our Hemopurifier® to selectively capture viruses and immunosuppressive proteins from blood and other fluids. The KBP relationship represents an important step towards establishing the long-term commercial feasibility of our Hemopurifier® in the marketplace.
8. Executed a non-exclusive agreement with NextPharma Technologies (Click Here for Website) to establish manufacturing of our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. As the result of a lengthy and dedicated effort, we established our GMP manufacturing processes and initiated our first Hemopurifier® production run. Consequently, we are primed to initiate commercialization in India and have established a manufacturing standard that exceeds the requirements for human clinical studies in the United States and the European Union. For a complete news summary of our activities in 2009, please "click here".
The productivity of our team, as referenced by our scientific advances and achievements last year are a source of great pride. I also note that in the face of one of the most challenging capital markets on record, we didn't need to put our hands out to Wall Street as both established and new shareholders stepped forth to provide sufficient investment to fund our operations. As a result, we were able to invest meaningful time into advancing potential strategic relationships that could accelerate the pace of our efforts and maximize long-term economic value for Aethlon Medical shareholders. However, until definitive agreements underlying such relationships are executed, we will continue our adherence to minimizing operating expenses.
I am challenged when authoring a shareholder letter as my passion for our endeavors often becomes muffled by the many regulatory implications of being a publicly traded company that creates medical products. However, I will confess frustration with the value assigned to our organization by the public markets. In the therapeutic world, the perception of value is often steeped in the redundancies of known and accepted treatment strategies, which in many cases are nothing more than me-too drug mechanisms that largely duplicate the action of existing drugs. These redundancies, while not scientifically meaningful, can be economically rewarding as they provide analysts and investors with a comparable guideline to judge public market value based on previously awarded values to like organizations. As we are pioneering a therapeutic device strategy to address infectious disease and potentially cancer, we don't have the collective benefit of comparable organizations as a basis for our value to be judged. However, I do believe our scientific advances will blossom into medical products that save lives.
In the HCV treatment world, considerable value is placed upon promising drug candidates. At present, there are a reported 65 drug candidates competing to become a component of standard of care (SOC) drug therapy. Yet, we are uniquely positioned to enhance the benefit of SOC therapy even if the drug combination underlying SOC becomes redefined. Thus, we have an enduring market opportunity that positions us to be an ally with drug developers, not a competitor. The most advanced HCV drug candidate is Telaprevir, which represents a significant value component of the $7+ Billion market valuation enjoyed by Vertex Pharmaceuticals (VRTX). Among the deep pipeline of HCV drug candidates, I am not aware that any has proven to reduce viral load in an HIV-infected individual. Nor am I aware that any candidate has established broad-spectrum activity against bioterror and pandemic threats. Certainly, none of these candidates represent a platform technology that can be leveraged to participate in the cancer marketplace. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements in the above Shareholder Letter may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
RedChip Companies, Inc.
Jon Cunningham
1-800-733-2447, Ext. 107
Jon@redchip.com
Jim Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Senior VP Finance
858.459.7800 x300
jfrakes@aethlonmedical.com
AEMD chart looking gorgeous and primed again... link back.
Aethlon Medical Releases Shareholder Letter (OLD)
Press Release
Source: Aethlon Medical, Inc.
On 8:00 am EST, Tuesday December 8, 2009
To our Shareholders:
In my September 15th shareholder letter, I indicated that we initiated the program with Bioserv/NextPharma to produce our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. Today, I am pleased to report that we have now established our GMP manufacturing processes. Furthermore, we kicked-off our inaugural production run yesterday, which should allow us to commence with our first Hemopurifier® shipments in February. The task of establishing manufacturing of our Hemopurifier® under GMP was an intricate process requiring significant expertise and a focused commitment among many participants. I applaud the tireless efforts of Dr. Richard Tullis, Paul Duffin, and our colleagues at Bioserv/NextPharma.
The initial commercialization of our Hemopurifier® remains focused towards treating individuals infected with Hepatitis-C virus (HCV) at select medical centers in India. At present, fewer than half of HCV-infected individuals who initiate the 48-week interferon-ribavirin standard of care (SOC) drug regimen successfully respond to treatment. With an estimated 180 million people infected worldwide, a monumental need exists for adjunct therapies that can improve HCV cure rates without increasing the considerable toxicity already associated with SOC therapy. In this regard, we have established a data-supported strategy that provides an opportunity to play a central and enduring role in HCV care. Our strategy uniquely positions our Hemopurifier® to enhance the benefit of SOC therapy even if the drug combinations underlying SOC become redefined.
While our Hemopurifier® is the first-in-class device to selectively capture viruses and immunosuppressive proteins from circulation, the precedent for a device to treat HCV was established by Asahi Kasei Kuraray Medical (Asahi), who validated that moderate levels of viral filtration at the outset of SOC therapy improves cure rates. Asahi demonstrated that their multi-cartridge approach, which is marketed in Japan as V-RAD, was able to achieve 71.4% cure rates in HCV patients who previously failed SOC therapy. In Asahi's studies, V-RAD was administered once daily for three consecutive days at the outset of SOC therapy and provided an average viral load reduction of 26.1% during each treatment period, which averaged 3 1/4 hours in duration. Amazingly, such outcomes were achieved without a further need for viral filtration during the remaining 47+ weeks of SOC therapy.
On October 30th, we reported HCV treatment outcomes at the 42nd Annual American Society of Nephrology (ASN) Conference. When analyzing Hemopurifier® treatment data from all of our HCV human studies, we documented average per-treatment viral load reductions of 29-42%. While the length of each Hemopurifier® treatment was similar in duration to V-RAD, the Hemopurifier® did not benefit from SOC associated viral load reductions as our results were achieved in the absence of SOC therapy. We acknowledge and appreciate that V-RAD has indeed documented that viral filtration improves HCV treatment outcomes. However, we believe the Hemopurifier® delivers the necessary capabilities to establish broad-market acceptance of medical device in infectious disease care. Foremost of these capabilities is our ability to selectively capture infectious viruses and immunosuppressive proteins not addressed by V-RAD. The selective capture of deleterious agents from circulation establishes an environment that permits continuous or aggressive intermittent treatment strategies that can truly optimize patient outcomes. Whereas historic therapeutic filtration approaches, including V-RAD, are restricted in scope as they indiscriminately remove particles from blood by molecule size. As a result, the safe application of such treatments remains limited as beneficial blood components required for health are removed along with the deleterious target.
In the face of a challenging economic climate, we have reached a pivotal stage that positions us to capitalize on the sum of our efforts during the last decade. We have not deviated in our vision to evolve what once existed as a theoretical concept into the reality of a device that could change the lives of those afflicted with HCV and other infectious disease conditions. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Aethlon Medical Appoints Jeff Schorey and Wayne Comper to Exosome Sciences Advisory Board
SAN DIEGO, Dec. 15 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board : AEMD) announced today that Dr. Jeff Schorey and Dr. Wayne Comper have joined the Science Advisory Board of Exosome Sciences, Inc. (ESI). Both Dr. Schorey and Dr. Comper are leading researchers in the exosome field. ESI, a wholly owned subsidiary of Aethlon Medical, was recently formed to leverage the discovery that the Hemopurifier®, a medical device being advanced as an adjunct therapy for Hepatitis-C (HCV) and other viral pathogens, is capable of capturing exosomes secreted by solid tumors, lymphomas, and leukemia to suppress the immune response in cancer patients. The targeted removal of circulating exosomes to inhibit cancer related immune suppression could increase patient responsiveness to both immunotherapy and chemotherapy
(Logo: http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b)
About Dr. Jeff Schorey
Dr. Schorey is presently an Associate Professor in the Department of Biological Sciences and Associate Director of the Eck Institute for Global Health at the University of Notre Dame. Dr. Schorey has over 15 years of experience in mycobacterial research and has published over 35 peer reviewed publications on mycobacteria pathogenesis. He presently has two NIH RO1 grants in excess of $2.5 million to study mycobacteria-host cell interaction. His recent work on exosomes has been published in such highly respected journals as the Journal of Biological Sciences, Blood and PloS ONE and in 2008 he published a review on exosomes in the journal Traffic. His work was the first to demonstrate that exosomes released from M.tb-infected macrophages can stimulate macrophage activation and more recently has shown that exosomes can promote activation of naive T cells in vivo. He is a leader in this area of research
In April 2009, he was the recipient of a Bill and Melinda Gates Foundation grant to study exosomes as a potential TB vaccine. He received one of only 81 grants funded from over 3,000 applicants. Dr. Schorey's recent work on exosomes released from TB infected macrophages has demonstrated that these exosomes containing antigenic components of tuberculosis can be utilized for efficient antigen presentation and could provide a practical strategy in the development of a vaccine for TB
About Dr. Wayne Comper
Dr. Comper is one of the founders, Director and Chief Science Officer of Exosome Diagnostics, Inc. Prior to Exosome Diagnostics, Dr. Comper was Chief Science Officer of AusAm Biotechnologies, Inc., a biotechnology company developing diagnostics and therapeutics to identify and treat kidney, cardiovascular and infectious diseases. Between 1991 and 2004, Dr. Comper was Reader of Biochemistry and Molecular Biology at Monash University, Clayton, Victoria, Australia. From 1974 to 1976, Dr. Comper was a postdoctoral fellow at Northwestern University Medical School in Chicago. From 1976 to 1978, he was a visiting scientist in the Department of Medical and Physiological Chemistry, Uppsala University, Sweden. In 1988, he was a Visiting Professor, Nephrology Section, Rush Medical School, Chicago, Illinois. He is the recipient of the 1992 Silver Jubilee Prize for Research at Monash University, where he also holds a Doctor of Science Degree. He has published over 170 research articles in peer-reviewed international journals. His research has attracted grants from the National Health and Medical Research Council of Australia, the Diabetes Foundation of Australia, The Australian Kidney Foundation and the Juvenile Diabetes Foundation International
Dr. Comper and his team at Exosome Diagnostics are studying biomarkers, including genetic signatures created by microRNAs and mRNA within exosomes isolated from cancer patients. These genetic signatures created by the cancer exosomes could be critical in developing companion molecular diagnostics tests for tailoring personalized cancer therapy
About Aethlon Medical
Aethlon Medical, Inc. creates diagnostic and therapeutic device solutions for infectious disease and cancer. Our lead product, the Hemopurifier® is the first-in-class medical device to selectively capture circulating viruses and immunosuppressive proteins prior to cell and organ infection. Human studies have documented the ability of our Hemopurifier® to reduce viral load in patients infected with Hepatitis-C virus (HCV) and the Human Immunodeficiency Virus (HIV). Our primary clinical and commercialization focus is to establish the Hemopurifier® as an adjunct therapy to enhance and prolong the benefit of traditional infectious disease drug regimens
The Hemopurifier® is also a broad-spectrum treatment candidate against drug resistant bioterror and pandemic threats. Third party research institutes have verified the capability of the device to capture Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) was formed in October of 2009 to leverage attributes of the Hemopurifier® in the emerging exosome research field. ESI seeks to inhibit the immune cell destruction caused by exosomes secreted by solid tumors, lymphomas, and leukemia. At present, the capture of immunosuppressive exosomes secreted from ovarian cancer tumors has been demonstrated invitro. The preservation of anti-cancer immune cells would likely improve patient responsiveness to established treatment options, including immunotherapy and chemotherapy. ESI is also analyzing exosome-related opportunities to improve early cancer detection and post-surgery surveillance of tumor growth, as well as approaches to harvest exosomes for research purposes and potential reintroduction into patients afflicted with autoimmune conditions such as Rheumatoid Arthritis and Lupus
Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at http://www.aethlonmedical.com/
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings
Contacts:
RedChip Companies, Inc
Jon Cunningham 1-800-733-2447, Ext. 107
Jim Joyce Chairman, CEO 858.459.7800 x301
Jim Frakes Senior VP Finance 858.459.7800 x300
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b
http://photoarchive.ap.org/
DATASOURCE: Aethlon Medical, Inc
CONTACT: Jim Joyce, Chairman, CEO, +1-858-459-7800, ext. 301,
, or Jim Frakes, Senior VP Finance, +1-858-459-7800, ext
300, , both of Aethlon Medical, Inc.; or Jon
Cunningham of RedChip Companies, Inc., 1-800-733-2447, ext. 107,
for Aethlon Medical, Inc
Web Site: http://www.aethlonmedical.com/
"In the face of a challenging economic climate, we have reached a pivotal stage that positions us to capitalize on the sum of our efforts during the last decade. We have not deviated in our vision to evolve what once existed as a theoretical concept into the reality of a device that could change the lives of those afflicted with HCV and other infectious disease conditions. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support."
Anyone who fails to understand the significance of this is blind, IMO.