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Tuesday, December 17, 2013

Exosomes; Nano-Scale Bubbles Creating Waves in Diagnostics and Therapeutics

New York, NY, Point Roberts, WA - December 17, 2013 (Investorideas.com newswire) Investorideas.com, an investor news and research portal issues an exclusive sector snapshot on the rapidly growing exosome market and opportunities with key insight from Enal Razvi, Ph.D, Biotechnology Analyst and Managing Director of SelectBio U.S.

For investors unfamiliar with exosomes, they are cell-derived vesicles that are present in most biological fluids including blood and urine, as well as other body fluids. Because the fluids are easily accessible, they can be used as markers for disease progression. Exosomes are described as tiny, nano-scale bubbles that are released from cells capable of intercellular communication.
"Only five years ago the principals of communicating within the body were hormones, immunology or neurology and now we have found another way of communicating and sending genetic signals between cells,” Life Technologies Corp (LIFE).
So why is something so small creating such a huge buzz? Two key significant areas of growth in the sector are diagnostics and therapeutics for diseases such as cancer.
According to a report earlier this year from Select Biosciences, "Exosome research is growing exponentially as researchers from several disparate disciplines are exploring the role of exosomes in inter-cellular communication, immunological responses, stem cell behavior, cancer cell communication, etc. Indeed, the potential of exosomes and other classes of microvesicles as a means of molecular cargo transport is being intensively studied. "
Enal Razvi, Ph.D, Biotechnology Analyst and Managing Director of SelectBio U.S, one of a few experts covering the space, shared insight with Investorideas.com in a recent conversation.
When we asked Enal to discuss what publicly traded companies are in this new sector for investors, he said there are only a few to watch including Life Technologies Corp (LIFE) (currently being acquired by Thermo Fisher Scientific), Eli Lilly (LLY) (due to their partnership with Exosome Diagnostics) and Aethlon Medical (AEMD).
He went on to say, "Investors need to be aware of changes exosomes allow, making companion diagnostics a reality. Exosomes can create a paradigm shift for companion diagnostics based on circulating biomarkers.
"Five years from now, or sooner, exosomes will become a key diagnostic tool for cancers. If we don’t know the origin of tumors; biomarkers can narrow down the source.
Why investors should pay attention to the space is because exosomes can significantly reduce the cost and increase the compliance, primarily for cancer, and make biopsies for personal medicine longitudinal sense. It becomes a very invasive process for a patient to get ongoing biopsies, so this new method of using exosomes for diagnostics is very exciting for patients.
Currently the research market for exosomes is about $50 million but this does not account for the opportunities in the diagnostics space which will drive market growth and value creation.”
Aethlon Medical (OTCBB: AEMD) is one of the only companies that may be able to participate in both diagnostics and therapeutics in the exosome space. The company recently announced the launch of Exosome Sciences (ESI) as a subsidiary that is advancing exosome-based strategies to diagnose and monitor the progression of cancer, infectious disease and other life-threatening conditions. Aethlon also attracted two of the best-known thought leaders in the exosome industry to play key roles in the new company.
"We are well positioned to benefit from the exosome revolution,” stated Aethlon Medical Chairman and CEO, Jim Joyce. "We are advancing patented first-in-class therapeutic technology to eliminate the presence of tumor-secreted exosomes that trigger the death of immune cells necessary for combating cancer.  On the diagnostic front, our Exosome Sciences research team pioneered the field of exosome biology and is actively advancing a pipeline of next generation diagnostic tools".
In September of this year, Exosome Diagnostics announced that it entered into a collaboration agreement with Eli Lilly & Co. (NYSE:LLY). "Exosome Diagnostics technology may provide a unique opportunity to gain insight into the biology of complex conditions such as cancer and immune disorders”, stated Andrew Schade, Senior Medical Director, Diagnostic and Experimental Pathology at Eli Lilly. He further stated that "Exosome technology enables biofluid molecular sampling and the ability to monitor disease progression in real time. As Lilly explores new ways to pursue patient tailoring, we'll continue to work with partners to expand our capabilities."
Another company in the space, stem cell therapy development company ReNeuron (LON: RENE)
reported in early December, "We have highlighted a number of key developments in the period, notably the successful and earlier-than-planned development of a second-generation cryopreserved CTX drug product for our stroke and critical limb ischaemia programmes, our planned world-class cell manufacturing facility in South Wales, the granting of Orphan Drug Designation for our retinitis pigmentosa programme and the accelerated development of our CTX cell-based exosomes therapeutic platform”.
Life Technologies Corp (LIFE) has created a mini documentary series entitled 'Exosomes-The Next Small Thing’. "Exosomes are a very powerful way, a new way of how cells communicate long distance… They are powerful mediators that carry all the signaling and machinery necessary to change the behavior of the neighboring cells". http://www.lifetechnologies.com/ca/en/home/life-science/cell-analysis/exosomes/exosomes-documentary-episode-1.html
PDF for Exosomes Market Snapshot: Enal Razvi, Ph.D.
http://www.genengnews.com/media/pdf/GEN-Biomarket-Trends-Report-Exosomes%20Market-Landscape-2013.pdf
Bio for Enal Razvi, Ph.D- Biotechnology Analyst and Managing Director of SelectBio U.S
Enal Razvi, Ph.D., conducted his doctoral work on viral immunology and subsequent to receiving his Ph.D. went on to the Rockefeller University in New York to serve as Aaron Diamond Post-doctoral fellow under Professor Ralph Steinman [Nobel Prize Winner in 2011 for his discovery of dendritic cells in the early-70s with Zanvil Cohn]. Subsequently, Dr. Razvi completed his research fellowship at Harvard Medical School. For the last two decades Dr. Razvi has worked with small and large companies and consulted for more than 100 clients worldwide. He currently serves as Biotechnology Analyst and Managing Director of SelectBio U.S. He can be reached at enal@selectbio.us
About Aethlon Medical, Inc. (AEMD)
Aethlon Medical creates innovative medical devices to address life-threatening diseases. The Aethlon ADAPT™ (Adaptive Dialysis-like Affinity Platform Technology) establishes 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™ product is the Hemopurifier®, a device that addresses a broad-spectrum of viral pathogens as well as tumor-secreted exosomes that suppress the immune system of cancer patients. Aethlon is also operating under two government contracts with the Defense Advanced Research Projects Agency (DARPA) related the development of a medical device to reduce the incidence of sepsis. Exosome Sciences, Inc. is a majority owned Aethlon subsidiary that is advancing exosome-based strategies to diagnose and monitor cancer and infectious disease progression. Additional information can be found at www.AethlonMedical.com
News source: http://www.hispanicbusiness.com/2013/12/4/reports_from_dalian_medical_university_advance.htm
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Wednesday, December 4, 2013

Biopharma Stock News Alert: SUNSHINE BIOPHARMA (OTCQB: SBFM) EXPANSION AND FINANCING OPPORTUNITIES FOR Adva-27a CANCER DRUG CANDIDATE: Company to RE-DOMICILE IN CANADA

Montreal, Quebec, Canada - December 4, 2013 (Investorideas.com Biotech Newswire) Sunshine Biopharma Inc. ( OTCQB: SBFM ), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it is re-domiciling the Company in Canada for expansion through acquisitions and to gain access to various financing opportunities available to Canadian corporations. To this end, The Company filed a Schedule 14-C Information Statement on September 16, 2013 and an S-4 Registration Statement on October 23, 2013.

"We are very pleased that the re-domiciling process is going smoothly", said Dr. Steve N. Slilaty, Chief Executive Officer of Sunshine Biopharma. "Re-domiciling the Company in Canada will give us access to a more favorable fiscal environment and provide with greater flexibility to execute our business plan. This will better position our Company for expansion and allow us to capitalize on growth opportunities as our Adva-27a drug candidate enters the clinic."
About Adva-27a
Adva-27a is Sunshine Biopharma’s lead anticancer compound, a small molecule that has recently been shown to be effective at killing multidrug resistant breast cancer cells, small-cell lung cancer cells, uterine sarcoma cells and pancreatic cancer cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). Adva-27a is currently in the IND-Enabling stage of development. The original U.S. patent covering Adva-27a was issued on August 7, 2012 under US patent number 8,236,935.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.
For Additional Information Contact:
Camille Sebaaly, CFO
Sunshine Biopharma Inc.
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com
www.sunshinebiopharma.com
Disclaimer/ Disclosure:The Investorideas.com newswire is a third party publisher of news and research as well as creates original content as a news source. Original content created by investorideas is protected by copyright laws other than syndication rights. Investorideas is a news source on Google news and Linkedintoday plus hundreds of syndication partners. Our site does not make recommendations for purchases or sale of stocks or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated by featured companies, news submissions, content marketing and online advertising. Contact each company directly for press release questions. Disclosure is posted on each release if required but otherwise the news was not compensated for and is published for the sole interest of our readers. Disclosure: SBFM has renewed effective December 3,2013 with Investorideas for six months of news publication and general public awareness of the company news and technologies and products in the biopharma markets ( one hundred thousand shares of 144 stock per 3 month period for a total of six months ) More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp
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Thursday, November 7, 2013

Medical Technology Breaking News: Aethlon Medical (OTCQB: AEMD) to Present at SeeThruEquity Investor Conference

SAN DIEGO - November 7, 2013 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB:AEMD), announced today that Company Chairman and CEO, Jim Joyce will present a corporate overview at the SeeThruEquity Investor Conference on November 12th at 10:30 am Eastern Standard Time (EST). Mr. Joyce's presentation will be webcast via the following link: http://wsw.com/webcast/seethru5/AEMD. The conference will be held at Convene Midtown East (730 Third Avenue), New York City. Additional details can be accessed online at: www.seethruequity.com

Aethlon is currently preparing to launch the first U.S. studies of Hemopurifier® therapy based on the recent approval of an Investigational Device Exemption (IDE) by the United States Food and Drug Administration (FDA) to initiate feasibility studies in Hepatitis C (HCV) infected individuals.
On the evening of November 12th, Mr. Joyce will also co-host a grand opening event for the Company's Exosome Sciences, Inc. (ESI) subsidiary at 6:30pm EST. Individuals that wish to attend the event should RSVP by email to Chris Wetzel (ESI Director of Operations) by the end of the business day on Friday November 8th. Chris's email address is: cwetzel@exosomesciences.com. The event will be held at the recently established ESI lab located within the Princeton Research Center. The address is 11 Deer Park Drive, Suite 103, Monmouth Junction, NJ 08852. Directions can be accessed online at: www.princetoncorporateplaza.com/contact.html.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
Certain 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, that the company can successfully protect its intellectual property, that removal of exosomes from the human body will impact or lead to successful treatment of cancer, or that exosomes are the cause of tumor growth and progression, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies 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. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com newswire
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This site is currently compensated by featured companies, news submissions and online advertising.
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar

Monday, November 4, 2013

Medical Technology Breaking News: Aethlon Medical (OTCQB: AEMD) Note: Grand Opening of Exosome Sciences Subsidiary on November 12th at 6:30pm Eastern

SAN DIEGO - November 4, 2013 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB:AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.

As a follow-up to my October 15th note, I am pleased to inform shareholders and other interested parties that we will host a grand opening event for our Exosome Sciences, Inc. (ESI) subsidiary on November 12th at 6:30pm eastern. Individuals that wish to attend the event should RSVP by email to Chris Wetzel (ESI Director of Operations) by the end of the business day on Friday November 8th. Chris's email address is: cwetzel@exosomesciences.com. The event will be held at our new ESI lab located within the Princeton Research Center. The address is 11 Deer Park Drive, Suite 103, Monmouth Junction, NJ 08852. Directions can be accessed online at: www.princetoncorporateplaza.com/contact.html.
We established Exosome Sciences as a stand-alone subsidiary to pursue exosome-based strategies to diagnose and monitor the progression of cancer, infectious disease and other life-threatening conditions. We believe exosomes are an optimal diagnostic target as diseased cells release them into bodily fluids such as urine and blood where they can be accessed. Our ESI subsidiary is developing non-invasive liquid biopsies based on the knowledge that these exosomes transport disease-origin markers underlying a wide-range of disease conditions. In regards to ESI's leadership, we have retained two of the best-known thought leaders in the exosome industry. Dr. Douglas Taylor as ESI's Chief Scientific Officer and Dr. Cicek Gercel-Taylor as ESI's Clinical Research Director. In closing, I look forward to introducing our ESI team on the 12th.
About Dr. Douglas Taylor
Dr. Taylor discovered and pioneered the field of exosome biology and their role in intercellular communication and immune regulation. He has been in the Department of Obstetrics, Gynecology and Women's Health at the University of Louisville School of Medicine since 1992. Dr. Taylor published the initial article describing circulating tumor exosomes/microvesicles in 1979 (Anal. Biochem. 98:53-59, 1979). The research in his laboratory has primarily focused on the release and consequences of exosomes from gynecologic cancer and lung tumors. Over the past 30+ years, Dr Taylor has pioneered the isolation and characterization of circulating tumor-derived exosomes. His work has focused on characterization of circulating exosomes released by tumor cells for their role in immune regulation and induction of a pro-inflammatory tumor microenvironment. His work has demonstrated that the presence of specific circulating exosomal components have potential use as biomarkers for cancer patients.
About Dr. Gercel-Taylor
Dr. Cicek Gercel-Taylor has been a pioneer in the field of exosome biology and in defining their nucleic acid and protein cargoes. She previously has worked at the Department of Obstetrics, Gynecology and Women's Health at the University of Louisville School of Medicine since 1992, and also is the Resident Research Coordinator. Her main research interest is in gynecological cancers, where she investigates the consequences of exosomes on genetic and epigenetic alterations induced in normal host target cells. She has explored the role of endogenous and exogenous hormones in modulating exosomal cargoes and the resulting effects on pathologic processes. A significant part of these investigations includes the identification and characterization of clinically relevant biomarkers, specifically proteomic and miRNA content of pathology-derived exosomes.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
Certain 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, that the company can successfully protect its intellectual property, that removal of exosomes from the human body will impact or lead to successful treatment of cancer, or that exosomes are the cause of tumor growth and progression, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies 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. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com newswire
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This site is currently compensated by featured companies, news submissions and online advertising.
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Friday, October 25, 2013

Aethlon Medical (OTCBB: AEMD) Gains 14.17% Following Note Authored by Chairman and CEO, Jim Joyce; Cancer Immunotherapy Article, Introduction to Dr. Douglas Taylor

New York, NY, Point Roberts, WA - October 25, 2013 (Investorideas.com newswire) Investorideas.com staff: Investorideas.com, an investor research portal specializing in sector research for independent investors reports on trading for medical technology stock Aethlon Medical, Inc. (OTCBB :AEMD), closing at $0.1450, gaining $ 0.0180 or 14.17% as of the close Oct 24 th, on volume of 878,373 shares.

Yesterday the Company issued a note authored by Chairman and CEO, Jim Joyce. The stock traded higher than normal volume and had a high of $0.1470.
Investorideas.com Newswire Excerpt:
Last week, the Wall Street Journal published an informative article on the emergence of cancer immunotherapies designed to augment the immune system's ability to recognize and combat malignant tumors. The oncology community is embracing this new treatment paradigm based on mounting clinical evidence that immunotherapies can produce long-term responses across multiple tumor types when combined with traditional therapies. As per the article, industry analysts project that immunotherapies could represent half of all cancer treatments within the next 10 years. The opportunity in lung cancer alone was referenced as a $6 billion opportunity.
At least five major drug companies are advancing candidates, including Bristol-Myers Squibb, whose drug Yervoy is already approved for melanoma. Drug mechanisms that inhibit the PD-1 molecular pathway, which cancer cells hijack to evade destruction by the body's immune system, are a primary target in the emerging immunotherapy pipeline. The article also balanced the compelling promise of these candidates with the reality that PD-1 inhibitors and other immunotherapies face significant administration and cost hurdles. Much of the concern is associated with the challenge of stacking an immunotherapeutic drug on top of the toxicity of established therapies such as radiation, chemotherapy, targeted cancer agents or other PD-1 inhibitors. Beyond this challenge, the cost of combining such therapies could prove to be prohibitive considering that Yervoy alone costs $120,000 for four doses administered over 12 weeks.
From an Aethlon Medical perspective, the Wall Street Journal article serves to reinforce our vision that a medical device can deliver immunotherapeutic benefit to both established and candidate cancer therapies, and do so economically and without added drug toxicity.
Full news:http://www.investorideas.com/CO/AEMD/news/2013/10241.asp
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
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Disclaimer/ Disclosure: The Investorideas.com newswire is a third party publisher of news and research as well as creates original content as a news source. Original content created by investorideas is protected by copyright laws other than syndication rights. Investorideas is a news source on Google news and Linkedintoday plus hundreds of syndication partners. Our site does not make recommendations for purchases or sale of stocks or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investment involves risk and possible loss of investment. This site is currently compensated by featured companies, news submissions, content marketing and online advertising. Contact each company directly for press release questions. Disclosure is posted on each release if required but otherwise the news was not compensated for and is published for the sole interest of our readers. More disclaimer info: http://www.investorideas.com/About/Disclaimer.asp Disclosure: Investorideas has been compensated by AEMD for news distribution and content publishing: three thousand per month effective June 2013
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894. Global investors must adhere to regulations of each country.
800-665-0411 - Source - www.Investorideas.com

Thursday, October 24, 2013

Medical Technology Breaking News: Aethlon Medical (OTCQB: AEMD) Note: Cancer Immunotherapy Article, Introduction to Dr. Douglas Taylor

SAN DIEGO - October 24, 2013 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB:AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.

Last week, the Wall Street Journal published an informative article on the emergence of cancer immunotherapies designed to augment the immune system's ability to recognize and combat malignant tumors.  The oncology community is embracing this new treatment paradigm based on mounting clinical evidence that immunotherapies can produce long-term responses across multiple tumor types when combined with traditional therapies.  As per the article, industry analysts project that immunotherapies could represent half of all cancer treatments within the next 10 years. The opportunity in lung cancer alone was referenced as a $6 billion opportunity. 
At least five major drug companies are advancing candidates, including Bristol-Myers Squibb, whose drug Yervoy is already approved for melanoma.  Drug mechanisms that inhibit the PD-1 molecular pathway, which cancer cells hijack to evade destruction by the body's immune system, are a primary target in the emerging immunotherapy pipeline. The article also balanced the compelling promise of these candidates with the reality that PD-1 inhibitors and other immunotherapies face significant administration and cost hurdles. Much of the concern is associated with the challenge of stacking an immunotherapeutic drug on top of the toxicity of established therapies such as radiation, chemotherapy, targeted cancer agents or other PD-1 inhibitors.  Beyond this challenge, the cost of combining such therapies could prove to be prohibitive considering that Yervoy alone costs $120,000 for four doses administered over 12 weeks.
From an Aethlon Medical perspective, the Wall Street Journal article serves to reinforce our vision that a medical device can deliver immunotherapeutic benefit to both established and candidate cancer therapies, and do so economically and without added drug toxicity.
Our device strategy targets a survival mechanism deployed by tumors to evade and defeat the immune system of cancer patients.  This mechanism, which is not addressed by drug therapies, is the seretion of exosomes by cancerous tumors.  Researchers have discovered that tumors release these particles to trigger the death of cancer fighting immune cells and facilitate the spread of metastasis.  Additionally, the systemic elimination of exosomes may represent a novel strategy to inhibit the PD-1 molecular pathway.  To date, researchers have demonstrated that the Aethlon Hemopurifier® can capture exosomes underlying lymphoma, melanoma, ovarian, and breast cancer. If you are not familiar with the Hemopurifier®, it is a first-in-class medical device that targets the rapid elimination of life-threatening infectious viruses and tumor-secreted exosomes from circulation.  
Based on the recent approval (after 5+ years of effort) of an investigational device exemption (IDE) by FDA, we are preparing to initiate the first U.S. studies of Hemopurifier® therapy in Hepatitis-C (HCV) infected individuals. In studies previously conducted overseas, Hemopurifier® therapy was demonstrated to accelerate viral load depletion in hardest-to-treat HCV patients receiving standard-of-care drug therapy.
As a result of crossing the IDE approval threshold, we opened the door to advance relationships with medical institutes that have clinical interest in expanding Hemopurifier® indications to include various forms of cancer.
When we initiated our first cancer research activities, we were making two intuitive yet forward-looking bets.  The first was that exosomes would emerge to become a vital therapeutic target.  The second was a belief that novel immunotherapies would rethink the landscape for treating cancer.  Today, tumor-secreted exosomes are well-documented therapeutic targets and cancer immunotherapies are expected to take center stage in the cancer treatment arena. There is growing hope that the marriage of traditional cancer therapies with next-generation immunotherapies may someday allow cancer to become a manageable condition much like HIV-infection is managed through a cocktail of treatment mechanisms.  At Aethlon Medical, our role is to provide the oncology community with a therapeutic tool that counters the immunosuppressive impact of exosomes without adding drug toxicity to companion cancer therapies.  
In closing, I am providing the scientific viewpoint of Dr. Douglas Taylor on the potential implications of Hemopurifier® therapy in cancer care.  Dr. Taylor is credited with the discovery of tumor-secreted exosomes and is a leading published author on the topic.  He is also one of the newest members of the Aethlon family as he has accepted the position of Chief Scientific Officer at our Exosome Sciences diagnostic subsidiary. The following is a statement from Dr. Taylor:
Evidence indicates that molecules, such as programmed cell death-1 (PD-1) and CTLA-4, are exploited by tumors to suppress patient immune surveillance, allowing the progression of cancers. These molecules and their ligands negatively regulate anti-tumor immune responses, particularly CD8+ effector T cells. Treatment of activated T cells with anti-PD-L1 antibodies reduce T cell proliferation, which correlates with attenuated IL-2 secretion. In vitro cytotoxicity studies and in vivo growth inhibition can be restored utilizing anti-PD-L1 antibodies or by genetic silencing of PD-1.  The expression of PD-L1 on tumor cells inhibits anti-tumor immunity through engagement of PD-1 on effector T cells. Expression of PD-L1 on tumors is correlated with reduced survival in many tumor types.
Due to the role of these molecules in immune regulation and correlation with cancer outcomes, these pathways are being targeted for immunotherapy. Bristol Myers' experimental PD-1 inhibitor Nivolumab and Merck's candidate, MK-3475, block the PD-1/PD-L1 interaction, allowing the immune system to react with the tumor cells. Yervoy targets a similar checkpoint, inhibiting the CTLA-4 pathway. Unlike genetically targeted drugs, which disrupt mutations that fuel tumor growth, the new agents treat the immune system. Current interest in targeting these molecular pathways raises a concern that their normal function acts as to modulate the immune system to prevent attacks on healthy cells. Studies in murine models deficient for PD-1 developed dilated cardiomyopathy and congestive heart failure and that expression of PD-1 may also prevent autoimmune diseases. Based on the critical role of PD-1 and CTLA-4, targeting their expression may be problematic resulting in serious side effects on the host. However, an essential component of the activity of such molecules may be due to their presence on exosomes released by tumor cells. We previously demonstrated the presence of these immunoregulatory molecules on tumor-derived exosomes and their ability to suppress T cell activation and proliferation ( Taylor et al. Clinical Cancer Research , 9: 5113-5119, 2003). Thus, a reasonable approach that does not result in systemic toxicity would be the removal of these immunoregulatory molecules. Consequently, the ability of the Hemopurifier® to remove these circulating exosomes may provide a superior approach to treat these patients without the generalized inhibition of the respective molecular pathways. About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
Certain 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, that the company can successfully protect its intellectual property, that removal of exosomes from the human body will impact or lead to successful treatment of cancer, or that exosomes are the cause of tumor growth and progression, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies 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. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com newswire
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BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar

Tuesday, October 15, 2013

Medical Technology Breaking News: Aethlon Medical (OTCQB: AEMD) Note: Clinical Partnering Programs, Manufacturing Optimization and Ramp-Up, Exosome Sciences Grand Opening

SAN DIEGO - October 15, 2013 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB:AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.

In recent months, we launched and staffed a diagnostic subsidiary, expanded our intellectual property portfolio, and continued to generate revenues from established and newly awarded government contracts. More importantly, we achieved the most significant milestone in the history of our organization, FDA approval of an investigational device exemption (IDE) that allows us to initiate the first human Hemopurifier® therapy studies in the United States. As a result, we have an opportunity to reward our stakeholders though the established Wall Street model of demonstrating U.S. clinical progression. For those not familiar with our Hemopurifier®, it is a first-in-class medical device that targets the rapid elimination of life-threatening infectious viruses and cancer glycopathogens from circulation.
As per the IDE approved protocol, we 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. Successful completion of the protocol, which we previously conducted with success in India, will set the stage for pivotal studies required for market clearance in the U.S. The approval of our IDE has also unlocked the ability to advance clinical partnering programs with medical institutes that are pursuing indications of our Hemopurifier® in cancer care.
Manufacturing Optimization and Ramp-up
In the coming weeks, we are scheduled to initiate Hemopurifier® manufacturing to support our FDA approved study as well as our continued treatment endeavors overseas. In this regard, I am pleased to share that our researchers along with collaborative assistance have discovered a processing technique that significantly optimizes the ability of the affinity agent immobilized within the Hemopurifier® to bind viruses and other glycopathogen targets. As you may recall, we previously reported that intermittent Hemopurifier® administration during the first three days of interferon-based therapy resulted in undetectable viral load in as little as seven days in hard-to-treat HCV genotype-1 patients. Based on a review of clinical literature, we believe such outcomes reflect a significant advancement in HCV care. By incorporating our new processing techniques into our manufacturing protocol, we expect the optimized capture capabilities of the Hemopurifier® will further augment the benefit of standard-of-care drug therapies. We anticipate Hemopurifier® manufacturing to be complete by year-end and then expect to begin treating patients in the first quarter of 2014.
Exosome Sciences Follow-up
Last month, we announced the launch of Exosome Sciences (ESI) as a subsidiary that is advancing exosome-based strategies to diagnose and monitor the progression of cancer, infectious disease and other life-threatening conditions. We also disclosed that we staffed ESI with two of the best-known thought leaders in the exosome industry.
Additionally, we referenced a plan to establish the ESI labs in a research facility located in Langhorne, Pennsylvania. We reconsidered the Langhorne option and instead made the decision to execute a lease and are now building out ESI lab facilities at the Princeton Research Center (www.princetoncorporateplaza.com). This 260,000 square foot facility is ideally situated on the Princeton-Rutgers Route 1 Corridor ("Einstein Alley"), which provides easy access to both New York City and Philadelphia. We are planning a small grand opening event for Aethlon shareholders in early November and will let you know once a date has been set. Regardless, our goal is to transform ESI from a previously unvalued asset into a stand-alone organization that contributes measurable asset value on the balance sheet of Aethlon Medical.
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
Certain 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, that the company can successfully protect its intellectual property, that removal of exosomes from the human body will impact or lead to successful treatment of cancer, or that exosomes are the cause of tumor growth and progression, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies 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. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com newswire
Sign up for the free investor news and stock alerts
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer / Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. Disclosure: Investorideas has been compensated by AEMD for news distribution and content publishing: three thousand per month effective June 2013
http://www.investorideas.com/About/Disclaimer.asp
This site is currently compensated by featured companies, news submissions and online advertising.
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar