Investorideas.com Newswire

Investorideas.com Newswire
Be one of the most talked about companies (stocks) on social media

Thursday, December 20, 2012

Defense Stock Trading Alert: PositiveID (OTCBB: PSID) Trades Up on News of Boeing (NYSE:BA) Licensing Deal of $2.5 million for M-BAND systems

Point Roberts, WA - December 20, 2012 (Investorideas.com Newswire, www.biodefensestocks.com) Investorideas.com, a leader in sector research for independent investors issues a trading alert for biodefense stock, PositiveID Corporation(OTCBB: PSID). The stock jumped over 50 % in early morning trading following news of a license agreement and a teaming agreement with The Boeing Company (NYSE:BA), including a license fee to PositiveID of $2.5 Million.

William J. Caragol, Chairman and CEO of PositiveID, stated, "We are very proud to team with Boeing on the BioWatch opportunity and look forward to being a part of a strong team that exceeds the expectations of our customers."
A unit of The Boeing Company, Boeing Defense, Space & Security is one of the world's largest defense, space and security businesses specializing in innovative and capabilities-driven customer solutions, and the world's largest and most versatile manufacturer of military aircraft. Headquartered in St. Louis, Boeing Defense, Space & Security is a $32 billion business with 60,000 employees worldwide. Follow us on Twitter: @BoeingDefense.
Full news: http://www.investorideas.com/CO/PSID/news/2012/12201.asp
About PositiveID Corporation
PositiveID Corporation is an emerging growth company and developer of airborne bio-threat detection systems for America's homeland defense industry as well as advanced technologies for rapid medical testing and diabetes management. Its wholly-owned subsidiary, Microfluidic Systems, is focused on the development of microfluidic systems for the automated preparation of and performance of biological assays in order to detect biological threats at high-value locations, as well as analyze samples in a medical environment. For more information on PositiveID, please visit http://www.PositiveIDCorp.com .
Published at Investorideas.com News wire
More info on PSID
http://www.investorideas.com/CO/PSID/
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector, featuring stock news, commentary and trading alerts in leading sectors including biotech, tech, mining, energy, water, renewable energy, beverage stocks and more.
Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
Follow Investorideas.com on Facebook http://www.facebook.com/Investorideas
Follow Investorideas.com News on Linkedin.com/today at http://www.linkedin.com/today/investorideas.com
Sign up for the free investor news and stock alerts http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising . Disclosure PSID is a featured company on Investorideas.com and has compensated the company in the past. Investorideas.com is currently long PSID shares. www.InvestorIdeas.com/About/Disclaimer.asp
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
800-665-0411 - Source - www.Investorideas.com

Biodefense Stock Breaking News: PositiveID (OTCBB:PSID) Enters into License Agreement and Teaming Agreement with The Boeing Company; License Fee of $2.5 million

DELRAY BEACH, Fla. - December 20, 2012 (Investorideas.com Newswire) PositiveID Corporation (OTCBB: PSID) ("PositiveID" or "Company"), an emerging growth company and developer of airborne bio-threat detection systems for America’s homeland defense industry as well as advanced technologies for rapid medical testing and diabetes management, today announced it has entered into a license agreement and a teaming agreement with The Boeing Company (“Boeing”), including a license fee to PositiveID of $2.5 million.

The license agreement provides Boeing the exclusive license to manufacture and sell PositiveID's M-BAND (Microfluidics-based Bioagent Networked Detector) airborne bio-threat detector for the U.S. Department of Homeland Security's ("DHS") BioWatch Generation 3 opportunity, as well as other opportunities (government or commercial) that may arise in the North American market. Under the teaming agreement, PositiveID will retain exclusive rights to serve as the reagent and assay supplier of the M-BAND systems to Boeing in the U.S. market. PositiveID will also retain the right to sell M-BAND units, reagents and assays in international markets.
PositiveID's M-BAND, developed under contract for DHS Science and Technology Division, is a bioaerosol monitor with fully integrated systems with sample collection, processing and detection modules that continuously analyze air samples for the detection of bacteria, viruses, and toxins. Results from individual M-BAND instruments are reported via a secure wireless network in real time to give an accurate and up to date status for fielded instruments in the aggregate.
William J. Caragol, Chairman and CEO of PositiveID, stated, "We are very proud to team with Boeing on the BioWatch opportunity and look forward to being a part of a strong team that exceeds the expectations of our customers."
A unit of The Boeing Company, Boeing Defense, Space & Security is one of the world's largest defense, space and security businesses specializing in innovative and capabilities-driven customer solutions, and the world's largest and most versatile manufacturer of military aircraft. Headquartered in St. Louis, Boeing Defense, Space & Security is a $32 billion business with 60,000 employees worldwide. Follow us on Twitter: @BoeingDefense.
About PositiveID Corporation
PositiveID Corporation is an emerging growth company and developer of advanced technologies for diabetes management and rapid medical testing, as well as airborne bio-threat detection systems for America's homeland defense. Its wholly-owned subsidiary, Microfluidic Systems, or MFS, is focused on the development of microfluidic systems for the automated preparation of and performance of biological assays in order to detect biological threats at high-value locations, as well as analyze samples in a medical environment.www.PositiveIDCorp.com.
For more information on PositiveID, please visit http://www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that it has made significant progress realigning its business with a focus on its molecular diagnostics platform; the likelihood that the Company also continues to make strong progress in the diabetes management segment of its business; the likelihood that the Company will enter into strategic partnerships and/or teaming agreements with large government contractors for M-BAND manufacturing and system integration for BioWatch Gen-3; the likelihood that the Company will submit a proposal upon release of the final BioWatch Gen 3 RFP, currently scheduled for release in the fourth quarter of calendar 2012, from Department of Homeland Security for the $3.1 billion BioWatch Gen-3 procurement; the likelihood that the Company will commence the second stage of Easy Check clinical study at Schneider Children's Medical Center in Israel; the likelihood that the Company will complete a bench-top unit of the GlucoChip glucose-sensor and initiate strategic partnerships; the likelihood that the Company will continue development of its Dragonfly Rapid MDx Cartridge-based diagnostic system for point-of-care diagnostics; the likelihood that the Company will complete the license and/or sale of the VeriChip and iglucose product lines to position them with the best partners for market exploitation and monetization; the likelihood that the Company will complete a strategic financing to capitalize the Company to execute on these opportunities; the likelihood that significant opportunities that lie ahead, including BioWatch Gen 3 and the continued development of the Company's innovative Dragonfly system; the likelihood that the Company will continue to execute its plan, described above; the likelihood that the Company is well positioned to capitalize on the BioWatch Gen 3 opportunity and to make meaningful steps in the commercialization of our diabetes management products; the likelihood that that progress, in conjunction with a strategic financing to fully capitalize the Company, will allow the Company to unlock value for stockholders; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize its M-BAND system and Dragonfly system, as well as its diabetes management products; the Company's ability to complete the license and/or sale of the VeriChip and iglucose product lines to position them with the best partners for market exploitation and monetization; the Company's ability to attract strategic partners; the Company's ability to complete a strategic financing; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 28, 2012, and 10-Qs filed on August 20, 2012, May 14, 2012, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
CONTACT:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
Published at Investorideas.com News wire
More info on PSID
http://www.investorideas.com/CO/PSID/
Sign up for the free investor news and stock alerts http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising . Disclosure PSID is a featured company on Investorideas.com and has compensated the company in the past . Investorideas.com is currently long PSID shares. www.InvestorIdeas.com/About/Disclaimer.asp
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

Wednesday, December 12, 2012

Biotech Stock News; Aethlon Medical (OTCBB: AEMD) Announces Expansion of Compassionate-Use Program To Treat Hepatitis C Virus (HCV)

SAN DIEGO - December 12, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, announced today that a compassionate-use clinical program that provides HCV-infected individuals with access to the Hemopurifier� therapy, has been expanded to include individuals who experience a viral breakthrough during standard-of-care drug therapy.
Investorideas.com Newswire
The Aethlon Hemopurifier� is a first-in-class medical device that selectively targets the rapid clearance of HCV from the entire circulatory system to improve benefit, dosing, duration and tolerability of drug therapies. A virologic breakthrough occurs when infected individuals achieve undetectable HCV levels after drug therapy initiation, but then experience a rebound in HCV levels prior to completion of therapy. Researchers often attribute viral breakthroughs to the development of drug resistance or the emergence of HCV subtypes that are less sensitive to drug therapy.
"It is immensely disheartening when HCV-infected individuals initially respond but are then forced to discontinue their drug therapy as the result of a viral breakthrough," stated Aethlon Chairman and CEO, Jim Joyce. "Whether it be interferon-based or future all-antiviral drug strategies, there is an enduring opportunity for our Hemopurifier� to help individuals salvage benefit from their HCV drug regimen."
Aethlon previously disclosed that the compassionate-use program, which was approved by the Institutional Review Board at the Medanta Medicity Institute (Medicity), would allow individuals who previously failed or subsequently relapsed standard-of-care drug regimens with treatment access to the Aethlon Hemopurifier�. Individuals who fail drug therapy maintain detectable HCV levels throughout the course of drug therapy, whereas a treatment relapse is defined when HCV levels decrease and remain undetectable during treatment, but become detectable after cessation of therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. Additional details about the Medicity can be found online at www.medanta.org. Under the compassionate-use program, the Medicity is offering Hemopurifier� therapy to HCV-infected individuals that reside in India or travel from other regions and meet the inclusion/exclusion criteria that have been established for participation.

The Treatment Protocol
The Medicity is offering compassionate-use access to Hemopurifier� therapy on a minimum three-day treatment regimen with the option for patients to extend treatment to a maximum period of seven consecutive days. During each treatment day, Hemopurifier� therapy is administered for a duration of up to six-hours. In HCV-infected individuals who previously failed or subsequently relapsed drug therapy, the goal of Hemopurifier� therapy is to accelerate the early viral kinetic response to drug therapy without adding drug toxicity or interaction risks. More specifically, Hemopurifier� therapy targets to increase immediate and rapid virologic response rates, which correlate with high clinical cure rates. In viral breakthrough patients, the goal of Hemopurifier� therapy is to reset viral load to undetectable levels as a strategy to salvage the continuance and benefit of drug therapy.
Medicity is offering the three-day treatment regimen at $7,235.00 (USD), which includes Hemopurifier� therapy, physician and support fees, hospital lodging, catheter and other consumables. The cost for each treatment day beyond the minimum three-day regimen is $2,295.00. Pre-treatment consult and post treatment monitoring is charged at $200/day and includes transportation to and from hotel.
The Medicity has established the following inclusion and exclusion criteria for candidate patient consideration:
Inclusion Criteria
  • Males or females 18 years of age and older testing positive for any HCV genotype
  • Patients who initially responded to standard-of-care drug therapy, but have since suffered a virologic breakthrough
  • Patients who relapsed after completing a previous course of standard-of-care drug therapy
  • Null responders or patients who previously were unable to achieve > 2 log viral load reduction at month three of standard of care drug therapy
  • Candidate patients must be willing to submit to temporary vascular access catheterization
  • Ability to tolerate blood volume losses of up to 150 ml per week
  • Stable clinical condition, including stable hematocrit
  • Patients on ACE inhibitors must suspend ACE inhibitor administration for a minimum of six days prior to initiating therapy.
  • Karnofsky score ≥ 60
  • A more detailed list of inclusion criteria, including blood chemistry requirements will be provided to candidate patients who meet the above criteria
  • The subject must be informed of the investigational nature of this study and written informed consent obtained prior to enrollment in this study
Exclusion Criteria
  • Clinically significant infection, other than HCV, defined as any acute viral, bacterial, or fungal infection, which requires specific therapy (Anti-infectious therapy must have been completed at least 14-days before entry into study).
  • Co -infections with Hepatitis B virus and Human immunodeficiency virus ( HIV )
  • Received any investigational agent(s) within 28-days of entry into study
  • Any known pre-existing medical condition that could interfere with the subject's participation in the protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly controlled diabetes mellitus, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypotension, or significant arrhythmia)
  • Subjects with ECG showing clinically significant abnormalities
  • Need for frequent blood transfusions.
  • Recent History of bleeding or bleeding disorders requiring the restriction in use of anticoagulants during study treatments.
  • Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis).
  • Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immunoregulatory medications
  • Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months. Subjects receiving methadone within the past year are also excluded.)
  • Any cancer requiring systemic chemotherapy
  • Any other condition that, in the opinion of the Principal Investigators, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
Individuals interested in the study are encouraged to contact:
Dr Puneet Sodhi
Mail ID: puneet.sodhi@Medanta.org
Contact No.: +91-9910002681
Jitendra Kumar Gupta
Mail ID: jitendra@qualtran.com
Contact No.: +91-9313365371
Information requests can also be sent directly to Aethlon Medical at: info@aethlonmedical.com
Current HCV Studies
Aethlon has previously reported data from a clinical program at the Medicity that is evaluating the capability of the Aethlon Hemopurifier� to accelerate HCV RNA depletion at the outset of standard of care peginterferon+ribavirin (PR) therapy. In this study, HCV-infected individuals are enrolled to receive up to three, six-hour Hemopurifier� treatments during the first three days of PR drug therapy. Aethlon recently reported that two HCV-infected patients who received Hemopurifier� therapy in combination with PR drug therapy achieved undetectable viral load at day-7, which is rarely reported in drug therapy alone.
The primary clinical endpoint of this study protocol has been to increase the incidence of rapid virologic response (RVR), defined as undetectable HCV RNA at day 30 of therapy. RVR represents the clinical endpoint that best predicts treatment cure, otherwise known as sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after the completion of PR drug therapy. As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that only10.35% (n=318/3070) of PR treated patients achieved a RVR. However, patients that achieved a RVR had SVR rates of 86.2% (n=274/318) versus SVR rates of 32.5% (n=897/2752) in non-RVR patients. While the incidence of undetectable HCV RNA at day-7 is not reported in the IDEAL study, the study did reveal that just 4.3% (n=131/3070) of patients achieved undetectable HCV RNA at day-14, which equated to a 91% (n=118/131) SVR rate.
To date, Aethlon has reported that Hemopurifier� therapy has been well tolerated and without device-related adverse events in the first ten treated patients. Of these ten patients, seven patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. Aethlon previously reported undetectable HCV RNA in eight of the 10 treated patients. Of the two patients reported to have detectable HCV RNA, one had discontinued PR therapy as a result of a diabetes related condition. HCV RNA is undetectable in all patients (n=4) that have been monitored for 48 weeks since receiving Hemopurifier� therapy. Among the 10 treated patients, Aethlon reported that six genotype-1 patients received the three treatment Hemopurifier� protocol, which resulted in four (67%) patients achieving a RVR. The IDEAL study predicts it would normally require approximately 40 PR treated patients to achieve 4 RVR outcomes. Both patients who achieved undetectable HCV RNA at day-7 also achieved a RVR. Beyond the high likelihood of a SVR, genotype-1 patients that achieve a RVR also have the opportunity to reduce the duration of PR drug therapy from 48 weeks to 24 weeks.
Aethlon expects to report updated results, including new patient data from this study in the near future. The Company also disclosed it is presently incorporating new patient data within investigational device exemption (IDE) that is expected to be submitted to FDA by year-end in an effort to gain approval to initiate HCV clinical programs in the United States.
About Aethlon Medical
The Aethlon Medical mission is to create 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 therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. 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
More info on AEMD at Investorideas.com Visit: http://www.investorideas.com/CO/AEMD/
Disclaimer: 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. This site is currently compensated by featured companies, news submissions and online advertising. If you have any questions regarding information in this press release please contact the company listed in the press release. Aethlon Medical, Inc. is currently an annual news release client at Investorideas.com and compensates Investorideas.com $2425 quarterly to publish and distribute news with Investorideas and its syndication partners
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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

Friday, December 7, 2012

Biotech Stock News; Aethlon Medical (OTCBB: AEMD) Note: A Medical Device Strategy to Address Metastatic Melanoma

SAN DIEGO - December 7, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
At Aethlon Medical, our focus is to create revolutionary medical devices that save lives. In the treatment of Hepatitis C (HCV) infected individuals, we have demonstrated that our Hemopurifier® synergistically combines with drug therapy to accelerate the achievement of undetectable viral load. In cancer, I envision our opportunity to save lives will be driven by the discovery that our Hemopurifier® can addresses a therapeutic target that plays a pivotal role in cancer progression, yet remains beyond the reach of drug therapies. The target? Microvesicles known as exosomes, which are particles secreted by tumors underlying a wide-range of cancers.
Investorideas.com Newswire

When we first initiated our tumor-derived exosome research, it was based on a belief that these particles were immunosuppressive, much like glycoproteins that shed from HIV and other viral pathogens. However, the medical community consensus at the time was that exosomes had no biological function other than to discard cellular debris. Today, tumor-derived exosomes are known to suppress the immune response in cancer patients. Beyond possessing immunosuppressive properties, tumor-derived exosomes facilitate tumor growth, metastasis, and the development of drug resistance. Such deleterious effects underlie the pathogenesis of cancer, and as a result of our early research we have been able to obtain broad patent protection in the field. By addressing this unmet medical need, our objective is to deliver a medical device that improves the benefit of cancer therapies without adding drug resistance or interaction risks.
As more and more medical institutes establish exosome research programs, we benefit from new discoveries that will help us to understand which forms of cancer are most likely to benefit from our technology. In this regard, Dr. Annette Marleau (our Director of Tumor Immunology) provides the following review on recent discoveries that describe the implication of exosomes in metastatic melanoma, a form of cancer whose 5-year survival rate is less than 20%.
Exosomes As Therapeutic Targets In Metastatic Melanoma
Exosomes are nano-sized microvesicles released in large quantities by cancer cells that are key culprits in the pathogenesis of several cancer types. Exosomes are now recognized as biological delivery vehicles for communication between cells in almost every system of the body investigated to date. In the area of oncology, cancer derived exosomes are highly stable "packages" released from tumors that transport proteins and genetic material from their originating tumor cells to distant sites throughout the body to accelerate tumor progression. In melanoma patients, tumor-secreted exosomes serve as carriers of malignant proteins and their levels in circulation correlate with the aggressiveness of the cancer1. To date, cancer exosomes have been implicated in: a) immune suppression; b) enhancement of angiogenesis; and c) promotion of metastasis, which will be discussed below.
Owing to several recent publications that have defined their pathological roles in metastatic disease, melanoma exosomes are emerging as candidate therapeutic targets. Metastatic (stage 4) melanoma, the most aggressive form of skin cancer, has a five-year survival rate of only 15-20%2. This disease continues to be a challenge to treat, as the current standard treatments have proven to be ineffective and/or highly toxic. Since patients afflicted with metastatic melanoma have suppressed immune systems due to tumor- and drug-related effects, the efficacy of novel immunotherapeutic solutions is limited and only small percentages of patients experience durable responses and extended survival. Thus, the development of novel treatments to reliably bolster anti-cancer immune responses remains an urgent clinical objective.
Recent scientific studies have defined the importance of melanoma exosomes in the progression of cancer, thereby providing the rationale for targeting tumor-derived nano-vesicles therapeutically. In a 2012 publication in the prestigious journal Nature Medicine, Dr. David Lynden's group at Weill Cornell Medical College and their colleagues reported that melanoma tumors release exosomes that condition metastatic sites for growth of tumors and their supporting blood vessels3. This publication also identifies a correlation between high exosome concentrations in circulation with advanced disease and poor prognosis of patients. This knowledge reinforces the concept that a strategy for eliminating circulating exosomes could be beneficial for addressing metastatic disease.
A pivotal publication by Dr. Joshua Hood and colleagues at Washington University School of Medicine showed that melanoma exosomes migrate to lymph nodes and alter the biochemical milieu to allow lodging of cancer cells in the establishment of metastatic foci4. Once again, this study suggests that systemic clearance of melanoma exosomes could interrupt the "messenger system" underlying metastasis. Along these same lines, a study by Parolini and colleagues in The Journal of Biological Chemistry demonstrated that melanoma exosomes serve as delivery vehicles for spreading malignant proteins from high aggressive metastatic cells to less aggressive cancer cells5.This article raises the concept that exosomes from a primary tumor can transfer their cargo to distant organs, thereby allowing the malignancy to spread.
Experiments have also demonstrated that the functions of immune cells are impaired by melanoma exosomes6. Since the immune system is responsible for recognizing and destroying cancer cells, exosomes thereby manipulate immunity to allow tumors to grow unchecked. Additionally, since immunotherapy is administered to bolster the patient's endogenous immune response, melanoma exosomes impair the effectiveness of these treatments. On this basis, a device strategy for removal of circulating exosomes could be implemented to reverse immune dysfunction in order to improve the effectiveness of standard of care treatments against metastatic melanoma.
Given these recent scientific developments that reveal broad tumor growth promoting and immune inhibitory effects of melanoma exosomes, there is a strong impetus for moving forward with therapeutic targeting options, which do not exist to date. Clinical studies are needed to define the impact of exosomes in metastatic melanoma and to offer promising new treatment solutions that are urgently needed.
References
1 Logozzi M, De Milito A, Lugini L, Borghi M, Calabrò L, Spada M, Perdicchio M, Marino ML, Federici C, Iessi E, Brambilla D, Venturi G, Lozupone F, Santinami M, Huber V, Maio M, Rivoltini L, Fais S. High levels of exosomes expressing CD63 and caveolin-1 in plasma of melanoma patients. PLoS One. 2009;4(4):e5219.
2 http://www.cancer.org/cancer/ skincancer-melanoma/detailedguide/ melanoma-skin-cancer -survival-rates
3 Peinado H, Aleckovic M, Lavotshkin S, Matei I, Costa-Silva B, Moreno-Bueno G, Hergueta-Redondo M, Williams C, GarcĂ­a-Santos G, Ghajar C, Nitadori-Hoshino A, Hoffman C, Badal K, Garcia BA, Callahan MK, Yuan J, Martins VR, Skog J, Kaplan RN, Brady MS, Wolchok JD, Chapman PB, Kang Y, Bromberg J, Lyden D. Melanoma exosomes educate bone marrow progenitor cells toward a pro-metastatic phenotype through MET. Nat Med. 2012 Jun;18(6):883-91.
4 Hood JL, San RS, Wickline SA. Exosomes released by melanoma cells prepare sentinel lymph nodes for tumor metastasis. Cancer Res. 2011 Jun 1;71(11):3792-801.
5 Parolini I, Federici C, Raggi C, Lugini L, Palleschi S, De Milito A, Coscia C, Iessi E, Logozzi M, Molinari A, Colone M, Tatti M, Sargiacomo M, Fais S. Microenvironmental pH is a key factor for exosome traffic in tumor cells. J Biol Chem. 2009 Dec 4;284(49):34211-22.
6 Marton A, Vizler C, Kusz E, Temesfoi V, Szathmary Z, Nagy K, Szegletes Z, Varo G, Siklos L, Katona RL, Tubak V, Howard OM, Duda E, Minarovits J, Nagy K, Buzas K. Melanoma cell-derived exosomes alter macrophage and dendritic cell functions in vitro. ImmunolLett. 2012 Nov;148(1):34-8.
About Aethlon Medical
The Aethlon Medical mission is to create 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 therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. 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
More info on AEMD at Investorideas.com Visit: http://www.investorideas.com/CO/AEMD/
Disclaimer: 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. This site is currently compensated by featured companies, news submissions and online advertising. If you have any questions regarding information in this press release please contact the company listed in the press release. Aethlon Medical, Inc. is currently an annual news release client at Investorideas.com and compensates Investorideas.com $2425 quarterly to publish and distribute news with Investorideas and its syndication partners
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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

Tuesday, December 4, 2012

Medical Device Stock Trading Alert: Aethlon Medical (OTCBB: AEMD) Closes up 11.9% on News

Point Roberts WA - December 4, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, today announced the initiation of a compassionate-use clinical program to treat individuals infected with Hepatitis C virus (HCV). The compassionate-use program, which has been approved by the Institutional Review Board at the Medanta Medicity Institute (Medicity), will provide individuals who previously failed or subsequently relapsed standard-of-care drug regimens with treatment access to the Aethlon Hemopurifier®. The Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of HCV from the entire circulatory system to improve benefit, dosing, duration and tolerability of drug therapies.
Investorideas.com staff: Investorideas.com, an investor research portal specializing in sector research for independent investors including biotech and medical technology stocks issues a trading alert for Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions. The stock closed up Monday 11.9% on over 720,000 shares volume following news of the initiation of a compassionate-use clinical program to treat individuals infected with Hepatitis C virus (HCV).
Investorideas.com Newswire Full news: http://www.investorideas.com/CO/AEMD/news/2012/12031.asp
About Aethlon Medical

The Aethlon Medical mission is to create 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 therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector, featuring stock news, commentary and trading alerts in leading sectors including biotech, tech, mining, energy, water, renewable energy, beverage stocks and more .
Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
Follow Investorideas.com on Facebook http://www.facebook.com/Investorideas
Follow Investorideas.com News on Linkedin.com/today at http://www.linkedin.com/today/investorideas.com
Sign up for the free investor news and stock alerts at Investorideas.com
http://www.investorideas.com/Resources/Newsletter.asp
Published at Investorideas.com Newswire
More info on AEMD at Investorideas.com Visit: http://www.investorideas.com/CO/AEMD/
Disclaimer: 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. This site is currently compensated by featured companies, news submissions and online advertising. If you have any questions regarding information in this press release please contact the company listed in the press release. Aethlon Medical, Inc. is currently an annual news release client at Investorideas.com and compensates Investorideas.com $2425 quarterly to publish and distribute news with Investorideas and its syndication partners
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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
Source Investorideas.com 800 665 0411

Medical Technology Stock Research Alert for Decision Diagnostics (OTCBB: DECN)

Point Roberts, WA - December 4, 2012 (Investorideas.com Newswire) Investorideas.com, an investor research portal specializing in sector research for independent investors publishes CFA commentary on Decision Diagnostics Corp. (OTCBB: DECN), by Patrick J. Murphy of Murphy Analytics LLC, a provider of sponsored research coverage on smallcap stocks.

Decision Diagnostics Corp. (OTCBB: DECN)
Patrick J. Murphy
Decision Diagnostics Corp. is developing products that offer unique solutions in medical care. The Shasta GenStrip® is an at home diagnostic for testing blood glucose designed to run on the Johnson & Johnson's (NYSE: JNJ) LifeScan LifeFirst™ OneTouch® family of meters, which are used by over 5 million people in the U.S. alone and for which JNJ estimates 97% of patients, including those with Medicare, are insured.
Of the products developed by DECN, the Company's Shasta GenStrip® in particular has significant potential for helping the rapidly growing diabetic population. DECN reports that the application for the Shasta GenStrip® was submitted to the FDA in December of 2010, and although the approval process typically now takes in excess of two years, DECN is now responding to a short series of follow up questions from the FDA, subsequent to recent meetings.
Select Stock Trading Data
Recent Stock Price: $0.17
Shares Outstanding: 11.48 million
Float 8.4 million
Recent Market Cap: $1.95 million
52 Week Range: $0.05 - $0.65
Exchange: OTCBB
Ticker: DECN
URL: http://www.decisiondiagnostics.com/
Data sourced from Yahoo! Finance; otcbb.com; Company filings
In terms of the overall market opportunity, a report from Research and Markets estimates that the global blood glucose monitoring market was estimated to be worth $8.9 billion in 2010 and is expected to grow 4.5% annually to reach $12.2 billion, with blood glucose test strips representing nearly 90% of the market at $10.9 billion. The report also cites International Diabetes Federation that diabetes affected 366 million people in 2011, or 8.3% of the global population, and that this is projected to increase to 9.9% of the population by 2030.
Trends in the U.S. serve to illustrate what is driving the increase in diabetes - the rise in obesity. According to the American Diabetes Association , approximately 26 million people in the U.S. have diabetes, representing 8.3% of the population, with 1.9 million new cases in 2010. The high prevalence of diabetes is not surprising in light of the data from the Centers for Disease Control (CDC) , which reports that during the past 20 years, there has been a dramatic increase in obesity in the United States and rates remain high at nearly 36% of U.S. adults and approximately 17% of children and adolescents aged 2—19. Similarly, metabolic syndrome affects nearly 50 million people in the U.S. Alone: As addressed by the National Institute of Health:
"Metabolic syndrome is a name for a group of risk factors that occur together and increase the risk for coronary artery disease, stroke, and type 2 diabetes. Metabolic syndrome is becoming more and more common in the United States. Researchers are not sure whether the syndrome is due to one single cause, but all of the risks for the syndrome are related to obesity.”
Unlike many competing product offerings, Genstrip employs a razor blade only model, a diagnostic test strip, and DECN has stated that the product is likely to cost less than 50% of the branded product without sacrificing quality. As an illustration of the potential appetite for the Genstrip product, DECN's 10-Q notes that the Company was approached by the largest retailer in the world, recently revealed to be Wal-Mart by DECN President and CFO Keith Berman, regarding the sale of Genstrip at its 5,000+ stores globally. DECN reports that a contract was negotiated in September 2010 and subsequently renegotiated and renewed in April 2011. However, while conducting market research during this time and seeking pre-orders, DECN reports that initial market interest was greater than the product capacity of the Company's contract manufacturer, and the Company ended the pre-order initiative while remaining confident there is a very large opportunity for Genstrip in a market dominated by four large pharmaceutical manufacturers which DECN reports sell similar products at similar pricing.
It seems reasonable to speculate increasing prosperity around the world is creating greater disposable income for increasing segments of the population, with increasing leisure time and presumably less manual labor. Whatever the cause or causes may be, the trend towards an increase in obesity and a resulting increase in the diabetes population seems clear, as does the potential opportunity for products that serve that market. Although FDA approval is of course not a certainty, DECN seems to have developed a product with significant potential if approval is obtained.
DECN also has developed a line of medical IT products for the rapidly expanding EMR/HER market. Unlike other medical information systems using standard computer terminals, Decision Diagnostics Corp. uses smart phones, which allow physicians to carry, access and update their patients' histories, medication data, and best care guidelines - all at the point of care. Decision Diagnostics Corp. is a provider of prescription drugs, home testing products for the chronically ill, a fulfillment provider of direct to patient diabetes programs, and a developer of cutting edge cell phone centric e-health products and technologies.
Patrick Murphy Bio:
Patrick J. Murphy is the owner of Murphy Analytics LLC, a provider of sponsored research coverage on smallcap stocks. Mr. Murphy has nearly 20 years of capital markets experience providing institutional investment and transaction analysis across a range of asset classes including microcap equities, commercial real estate debt and equity, municipal derivatives and public finance, venture capital, fixed income, CMBS and mortgage REIT's. In addition to his work with Murphy Analytics, Mr. Murphy also serves as a consultant to a municipal derivatives advisory firm. Mr. Murphy is an alumnus of the University of Notre Dame (1991), with an undergraduate degree in Economics, and earned a Masters Degree in Finance from St. Louis University in 1997. Mr. Murphy is a CFA Charterholder and a member of the CFA Society of St. Louis.
Patrick Murphy Disclaimer:
Readers are advised that the above article is solely for information purposes and should not to be construed as an offer to sell or the solicitation of an offer to buy any security. The views expressed herein are based upon the author's analysis of the issuer's public disclosures, and assumes both their accuracy and completeness. The opinions and statements included herein are based on sources (including the companies discussed and public sources) believed to be reliable and in good faith, but no representation or warranty, express or implied, is made as to their accuracy, completeness or correctness. The author has not independently verified the information contained herein. This information is not intended to be used as the sole basis of any investment decisions, nor should it be construed as advice designed to meet the investment needs of any particular investor. You should review a complete information package on all companies, which should include, but not be limited to, the Company's annual report, quarterly reports, press releases and all regulatory filings. The foregoing discussion contains statements which are based on current expectations, estimates and projections, and differences from such expectations, estimates and projections can be expected. The author, Patrick Murphy, was compensated $500 by InvestorIdeas.com for writing this article. Murphy does not own shares of any of the companies mentioned in this article. Mr. Murphy's research firm, Murphy Analytics, may be engaged for the provision of a research report on the Company in the future.
Decision Diagnostics Company websitehttp://www.decisiondiagnostics.com/
DECN SEC quarterly file
http://biz.yahoo.com/e/120820/decn10-q.html
More info on DECN at Investorideas.com http://www.investorideas.com/CO/DECN/
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector, featuring stock news, commentary and trading alerts in leading sectors including biotech, tech, mining, energy, water, renewable energy, beverage stocks and more.
Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
Follow Investorideas.com on Facebook http://www.facebook.com/Investorideas
Follow Investorideas.com News on Linkedin.com/today at http://www.linkedin.com/today/investorideas.com
Sign up for the free investor news and stock alerts at Investorideas.com
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. This site is currently compensated by featured companies, news submissions and online advertising.
Disclosure: Investorideas.com has been compensated one hundred fifty thousand shares for news and content publication and distribution for 45 days
http://www.investorideas.com/About/Disclaimer.asp
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
800-665-0411 - Source - www.Investorideas.com
http://www.lifescan.com/about-us
http://www.onetouch.com/onetouch-diabetes-testing-supplies
http://www.pharmpro.com/News/2011/05/Animas-and-LifeScan-Strengthen-Strategic-Focus-to-Better-Serve-People-Living-with-Diabetes/
http://www.investorideas.com/CO/DECN/news/2012/11211.asp
http://www.businesswire.com/news/home/20120111006216/en/Research-Markets-Blood-Glucose-Test-Strips-Market
http://www.diabetes.org/diabetes-basics/diabetes-statistics/?loc=DropDownDB-stats
http://www.cdc.gov/obesity/data/facts.html
http://www.ncbi.nlm.nih.gov/pubmed/17893688
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004546/
http://www.investorideas.com/CO/DECN/news/2012/11281.asp

Monday, December 3, 2012

Biotech Stock News; Aethlon Medical (OTCBB: AEMD) Announces Initiation of Compassionate-Use Program to Treat Hepatitis C Virus (HCV)

SAN DIEGO - December 3, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, today announced the initiation of a compassionate-use clinical program to treat individuals infected with Hepatitis C virus (HCV). The compassionate-use program, which has been approved by the Institutional Review Board at the Medanta Medicity Institute (Medicity), will provide individuals who previously failed or subsequently relapsed standard-of-care drug regimens with treatment access to the Aethlon Hemopurifier®. The Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of HCV from the entire circulatory system to improve benefit, dosing, duration and tolerability of drug therapies.
Investorideas.com Newswire

The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. Additional details about the Medicity can be found online at www.medanta.org.
It is estimated that approximately 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is a leading cause of liver transplantation. The opportunity to address infected individuals who fail or subsequently relapse drug therapy is significant as retreatment prognosis with drug therapy alone is often poor. Under the compassionate-use program, the Medicity is offering Hemopurifier® therapy to HCV-infected individuals that reside in India or travel from other regions and meet the inclusion/exclusion criteria that have been established for participation.
"We are grateful to the Medicity for providing us the opportunity to improve Hepatitis C treatment outcomes," stated Aethlon Chairman and CEO, Jim Joyce. "While we plan to be cautious in our initial ramp-up, we do look forward to augmenting our established contract revenue stream with Hemopurifier® product sales."
The Treatment Protocol
The Medicity is offering compassionate-use access to Hemopurifier® therapy on a minimum three-day treatment regimen with the option for patients to extend treatment to a maximum period of seven consecutive days. During each treatment day, Hemopurifier® therapy is administered for a duration up to six-hours. In HCV, the goal of therapy is to accelerate the early viral kinetic response to standard-of-care drug therapy without adding drug toxicity or interaction risks. More specifically, Hemopurifier® therapy targets to increase immediate and rapid virologic response rates, which correlate with high clinical cure rates.
Medicity is offering the three-day treatment regimen at $7,235.00 (USD), which includes Hemopurifier® therapy, physician and support fees, hospital lodging, catheter and other consumables. The cost for each treatment day beyond the minimum three-day regimen is $2,295.00. Pre-treatment consult and post treatment monitoring is charged at $200/day and includes transportation to and from hotel.
The Medicity has established the following inclusion and exclusion criteria for candidate patient consideration:
Inclusion Criteria
  • Males or females 18 years of age and older testing positive for any HCV genotype
  • Patients who relapsed after completing a previous course of standard-of-care drug therapy
  • Null responders or patients who previously were unable to achieve > 2 log viral load reduction at month three of standard of care drug therapy
  • Candidate patients must be willing to submit to temporary vascular access catheterization
  • Ability to tolerate blood volume losses of up to 150 ml per week
  • Stable clinical condition, including stable hematocrit
  • Patients on ACE inhibitors must suspend ACE inhibitor administration for a minimum of six days prior to initiating therapy.
  • Karnofsky score ≥ 60
  • A more detailed list of inclusion criteria, including blood chemistry requirements will be provided to candidate patients who meet the above criteria
  • The subject must be informed of the investigational nature of this study and written informed consent obtained prior to enrollment in this study
Exclusion Criteria
  • Clinically significant infection, other than HCV, defined as any acute viral, bacterial, or fungal infection, which requires specific therapy (Anti-infectious therapy must have been completed at least 14-days before entry into study).
  • Co -infections with Hepatitis B virus and Human immunodeficiency virus ( HIV )
  • Received any investigational agent(s) within 28-days of entry into study
  • Any known pre-existing medical condition that could interfere with the subject's participation in the protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly controlled diabetes mellitus, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypotension, or significant arrhythmia)
  • Subjects with ECG showing clinically significant abnormalities
  • Need for frequent blood transfusions.
  • Recent History of bleeding or bleeding disorders requiring the restriction in use of anticoagulants during study treatments.
  • Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis).
  • Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immunoregulatory medications
  • Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months. Subjects receiving methadone within the past year are also excluded.)
  • Any cancer requiring systemic chemotherapy
  • Any other condition that, in the opinion of the Principal Investigators, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
Individuals interested in the study are encouraged to contact:
Dr Puneet Sodhi
Mail ID: puneet.sodhi@Medanta.org
Contact No.: +91-9910002681
Jitendra Kumar Gupta
Mail ID: jitendra@qualtran.com
Contact No.: +91-9313365371
Information requests can also be sent directly to Aethlon Medical at: info@aethlonmedical.com
Current HCV Studies
Aethlon has previously reported data from a clinical program at the Medicity that is evaluating the capability of the Aethlon Hemopurifier® to accelerate HCV RNA depletion at the outset of standard of care peginterferon+ribavirin (PR) therapy. In this study, HCV-infected individuals are enrolled to receive up to three, six-hour Hemopurifier® treatments during the first three days of PR drug therapy. Aethlon recently reported that two HCV-infected patients who received Hemopurifier® therapy in combination with PR drug therapy achieved undetectable viral load at day-7, which is rarely reported in drug therapy alone.
The primary clinical endpoint of this study protocol has been to increase the incidence of rapid virologic response (RVR), defined as undetectable HCV RNA at day 30 of therapy. RVR represents the clinical endpoint that best predicts treatment cure, otherwise known as sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after the completion of PR drug therapy. As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that only10.35% (n=318/3070) of PR treated patients achieved a RVR. However, patients that achieved a RVR had SVR rates of 86.2% (n=274/318) versus SVR rates of 32.5% (n=897/2752) in non-RVR patients. While the incidence of undetectable HCV RNA at day-7 is not reported in the IDEAL study, the study did reveal that just 4.3% (n=131/3070) of patients achieved undetectable HCV RNA at day-14, which equated to a 91% (n=118/131) SVR rate.
To date, Aethlon has reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in the first ten treated patients. Of theseten patients, seven patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. Aethlon previously reported undetectable HCV RNA in eight of the 10 treated patients. Of the two patients reported to have detectable HCV RNA, one had discontinued PR therapy as a result of a diabetes related condition. HCV RNA is undetectable in all patients (n=4) that have been monitored for 48 weeks since receiving Hemopurifier® therapy.Among the 10 treated patients, Aethlon reported that six genotype-1 patients received the three treatment Hemopurifier® protocol, which resulted in four (67%) patients achieving a RVR. The IDEAL study predicts it would normally require approximately 40 PR treated patients to achieve 4 RVR outcomes. Both patients who achieved undetectable HCV RNA at day-7 also achieved a RVR. Beyond the high likelihood of a SVR, genotype-1 patients that achieve a RVR also have the opportunity to reduce the duration of PR drug therapy from 48 weeks to 24 weeks.
Aethlon expects to report updated results, including new patient data from this study in the near future. The Company also disclosed it is presently incorporating new patient data within investigational device exemption (IDE) that is expected to be submitted to FDA by year-end in an effort to gain approval to initiate HCV clinical programs in the United States.
About Aethlon Medical
The Aethlon Medical mission is to create 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 therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. 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
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page on Investorideas.comDisclosure/Disclaimer: AETHLON MEDICAL INC (OTC BB: AEMD) Investorideas.com is paid by AEMD to publish news and distribute content through Investordeas.com Newswire and its syndicated partners and blogs