SAN DIEGO - June 12, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
Last week, Medical News Today reported on a cancer research discovery
that reinforces the potential importance of our therapeutic endeavors.
For more than a century, cancer researchers have understood that certain
forms of cancer only spread to specific, preferred organs. However, the
mechanism underlying the spread of organ specific metastasis (the "soil
and seed" theory of 1889) had remained unknown. Based on new findings
published and now available online in the journal Nature, researchers
have identified that circulating cancer-secreted particles known as
"exosomes" play a significant role in fueling the metastatic invasion of
preferred organs. The paper concludes that exosomes offer promise for
new therapeutic directions in the metastatic process.
We applaud and appreciate this ground breaking research as our
Hemopurifier� has been validated to capture the form of cancer-secreted
exosomes referenced in the publication. The same Hemopurifier� that we
have been advancing with promising results in the treatment of hepatitis
c (HCV) infected individuals.
In the study, researchers were interested to see if exosomes budding
from melanoma actually participated in the course of the cancer. The
answer was yes, and to a great extent. The researchers identified that
melanoma cancer cells released "exosome" vesicles (microscopic particles
like "bubbles" that are filled with many different molecules such as
proteins and nucleic acids) that travel
to the bone, liver, lung and brain. This cellular material fuses with
targeted organs and establishes the environment to spread tumor cells.
The researchers also reported that cancer-secreted exosomes triggered
inflammation, promoted leaky blood vessels and educated bone marrow
progenitor cells to participate in the metastatic cascade. The
discoveries were led by a team from the Weill Cornell Medical College,
Memorial Sloan-Kettering Cancer Center, with collaborative support from
researchers at MD Anderson Cancer Center, Lawrence Berkeley National
Laboratory, the National Cancer Institute, and the US National
Institutes of Health.
Dr. Hector Peinado, the lead author of the study was quoted to say:
"If, in the future, we were able to find a way to control the education
of bone marrow cells, as well as the release and content of tumor
exosomes in cancer patients, we would be able to curtail and reduce the
spread of cancer, and improve the patient's quality of life and
survival." At present, I am not aware of another therapeutic strategy
beyond our Hemopurifier� that offers to inhibit or eliminate the
presence of cancer-secreted exosomes.
The Weill-Cornell researchers also identified that exosome protein
levels in circulation predicted disease stage, prognosis, and survival
in subjects with metastatic disease. When they compared circulating
exosomes taken from patients with different stages of melanoma, they
found that stage IV patients displayed much higher exosome protein
levels as compared with earlier stage melanoma patients. If disease had
not yet metastasized, exosomes were not present in circulation. The
researchers also noted that stage IV patients with a lower presence of
exosomes tended to have longer survival than stage IV patients with
higher exosome protein content. Again, reinforcing the therapeutic
potential of a device that could inhibit or eliminate exosomes from
circulation.
Our first research into cancer-secreted exosomes was driven by the
curiosity that exosomes seemed to carry a unique high mannose signature
that is found on the surface of glycoproteins that coat infectious viral
pathogens. This signature happened to be the targeted binding site of
the affinity agent immobilized in our Hemopurifier�, and provides the
basis for our ability to selectively capture HCV, HIV, and a
broad-spectrum of other viruses. In well-studied viruses such as HIV, we
knew that surface glycoproteins can shed to trigger apoptosis or
programmed cell death of immune cells. Therefore, it made sense to us
that exosomes might have these same immunosuppressive properties.
However, at the time we initiated our research, the medical community
consensus was that exosomes were nothing more than cellular trash bags
with no meaningful biologic function. In fact, there were only a handful
of researchers with exosome focused research programs. This is no
longer the case. Many cancer research institutes are now pursuing
exosome driven initiatives as cancer-secreted exosomes have since been
verified to play a significant role in the invasion of the immune system
in cancer patients. Additionally, researchers now understand how
exosomes contribute to the development of tumor angiogenesis as a
mechanism for cancer to survive. The harmful role of exosomes is also
being identified in other life threatening conditions, including sepsis,
a disease we are studying under contract with the Defense Advanced Research Projects Agency (DARPA).
To date, we have demonstrated the ability to capture exosomes
underlying a variety of cancers. As related to the discoveries by the
Weill Cornell team, we fortuitously disclosed in September of 2010 that
our Aethlon Hemopurifier� was able to capture exosomes derived from
individuals with metastatic melanoma in a pre-clinical study. At
present, we are fully focused on participating in a response to a new
DARPA contract opportunity, expanding our HCV treatment studies, and
preparing the resubmission of a investigational device exemption to FDA.
Once these objectives have been advanced, we plan to discuss a
potential melanoma treatment study that a U.S. based cancer research
institute has proposed to conduct as a result of the Weill Cornell
discoveries.
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 the Defense Advanced Research Projects
Agency (DARPA) that would reduce the incidence of sepsis in
combat-injured soldiers and civilians. For more information, please
visit www.aethlonmedical.com.
All financial
disclosures, anticipated revenue recognition amounts and other
information related to the financial results and operations of the
Company set forth above are unaudited and are subject to year-end audit
adjustments and footnote disclosures.
Certain of the statements herein may be forward-looking and involve
risks and uncertainties. Such forward-looking statements involve
assumptions, known and unknown risks, uncertainties and other factors
which may cause the actual results, performance
or achievements of Aethlon Medical, Inc. to be materially different
from any future results, performance, or achievements expressed or
implied by the forward-looking statements. Such potential risks and
uncertainties include, without limitation, the ability for the Company
to derive business partnerships or future revenue streams using the
Aethlon ADAPT™ system including the ability to introduce a targeted
breast cancer therapy known as HER2osome™, there is no assurance that
FDA will approve the initiation of the company's clinical programs or
provide market clearance of the company's products, the ability to
achieve the goals set out in the DARPA contract, future human studies of
the Aethlon Hemopurifier® as an adjunct therapy to improve patient
responsiveness to established cancer therapies, 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.
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
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Tuesday, June 12, 2012
Monday, June 4, 2012
Biotech Stock to Watch; Cleveland BioLabs (Nasdaq:CBLI) Big Moves on News of GLP Efficacy Study With Radiation Countermeasure CBLB502
New York, New York –June 4, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for
Cleveland BioLabs, Inc. (Nasdaq:CBLI), making gains of $0.68 or (53.54%) to trade at $1.95 12:36PM EDT on over 2.5 Million shares. The stock has a day’s high of $2.40.
The Company reported today
strong survival results for its randomized, blinded, placebo-controlled
efficacy study of CBLB502 in 179 non-human primates (NHPs) conducted
under Good Laboratory Practice (GLP) with elements of Good Clinical
Practice (GCP), as required by the U.S. Food and Drug Administration's
(FDA) Animal Rule. The study demonstrated with a high degree of
statistical significance the dose-response relationship between the
administration of CBLB502 and the survival of lethally irradiated
animals, the study's primary endpoint.
About Cleveland BioLabs, Inc.
Cleveland
BioLabs, Inc. is a clinical-stage biotechnology company leveraging deep
mechanistic understanding of the cell death process, apoptosis, to
develop a robust pipeline of compounds primarily focused on oncology
applications and mitigation of radiation injury. The Company's lead
compound is being developed as both a radiation countermeasure and a
direct acting anticancer agent. The Company has two operating
subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic
relationships with the Cleveland Clinic, Roswell Park Cancer Institute,
the Children's Cancer Institute of Australia
and the Armed Forces Radiobiology Research Institute. To learn more
about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.
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Friday, May 25, 2012
Biotech Stock Alert; Complete Genomics (NasdaqGM: GNOM) Gains over 30% in Morning Trades
New York, NY - May 25, 2012 - www.InvestorIdeas.com, a global
investor research specializing in sector research including China
stocks, issues an investor alert for Complete Genomics, Inc. (NasdaqGM: GNOM),
continuing on yesterday’s gains, trading up at $3.03, up 0.70 (30.04%)
10:30AM EDT on over 9 Million shares . GNOM is the top percentage gainer
on NASDAQ as of the time of this report.
The Company announced earlier this month that it had sequenced the genomes of 600 individuals from 20 Mexican-American families from San Antonio in what is thought to be the largest whole genome sequencing family study conducted to date and the first such study of its kind in a Latino population.
About Complete Genomics
Complete Genomics is the whole human genome sequencing company that has developed and commercialized an innovative DNA sequencing service. The Complete Genomics Analysis Platform (CGA(TM) Platform) combines Complete Genomics' proprietary human genome sequencing technology with advanced informatics and data management software. Additional information can be found at http://www.completegenomics.com
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The Company announced earlier this month that it had sequenced the genomes of 600 individuals from 20 Mexican-American families from San Antonio in what is thought to be the largest whole genome sequencing family study conducted to date and the first such study of its kind in a Latino population.
About Complete Genomics
Complete Genomics is the whole human genome sequencing company that has developed and commercialized an innovative DNA sequencing service. The Complete Genomics Analysis Platform (CGA(TM) Platform) combines Complete Genomics' proprietary human genome sequencing technology with advanced informatics and data management software. Additional information can be found at http://www.completegenomics.com
Research more biotech and pharma stocks with Investorideas.com global stock directory :
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Tuesday, May 15, 2012
Biotech Stock Alert; Aethlon Medical (OTC: AEMD) to Present at Today's Security Research Associates 8th Annual Growth Conference
SAN DIEGO - May 14, 2012 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD),
announced that Chairman and CEO James A. Joyce will present at today's
Security Research Associates (SRA) 8th Annual Growth Stock Conference.
The Conference will be held at the Le Meriden Hotel in San Francisco. A
live webcast of the presentation will begin at 1:30 p.m. Pacific time
(4:30 p.m. Eastern time) and can be accessed online at: http://wsw.com/webcast/sra13/aemd/
The webcast and archived replay of the company's presentation may be accessed in the Investor Relations section of the Company's website at www.aethlonmedical.com.
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 the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, 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.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@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
The webcast and archived replay of the company's presentation may be accessed in the Investor Relations section of the Company's website at www.aethlonmedical.com.
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 the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, 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.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@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
Friday, May 11, 2012
Biopharmaceutical Stock to Watch; Arena Pharmaceuticals (NASDAQ:ARNA) Big Moves on Lorcaserin Obesity Drug
New York, New York - May 11, 2012 - Investorideas.com, an investor
research portal specializing in sector research including biotech and
pharma stocks, issues a trading alert for Arena Pharmaceuticals, Inc. (NasdaqGS:ARNA)
making big moves, gaining $5.82 2.16(59.02%) 10:51AM EDT on over 40
million shares in morning trading . The stock was up over 80% during
earlier trading.
Arena Pharmaceuticals, Inc. (ARNA) and Eisai Inc. reported yesterday, the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management. In addition to the United States, the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil. This expansion builds on the agreement executed by Eisai and Arena in July 2010 for Eisai's exclusive rights to market and distribute lorcaserin in the United States, subject to lorcaserin's approval by the US Food and Drug Administration (FDA).
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
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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. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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Arena Pharmaceuticals, Inc. (ARNA) and Eisai Inc. reported yesterday, the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management. In addition to the United States, the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil. This expansion builds on the agreement executed by Eisai and Arena in July 2010 for Eisai's exclusive rights to market and distribute lorcaserin in the United States, subject to lorcaserin's approval by the US Food and Drug Administration (FDA).
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; water and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, natural gas stocks, tech (includes cloud and social networking), defense stocks, nanotech, China stocks and agriculture.
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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. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411
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Tuesday, May 8, 2012
Biotech Stock Alert; Aethlon Medical (OTC: AEMD) Reports Undetectable Hepatitis C Virus (HCV) in Genotype 1, Genotype 3, and Genotype 5 Patients Treated with Hemopurifier® Therapy
SAN DIEGO - May 8, 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, reported today that the presence of Hepatitis C virus (HCV)
is currently undetectable in all infected patients that have been
treated with the Aethlon Hemopurifier® in combination with
peginterferon+ribavirin (PR) drug therapy and monitored for at least
ninety days.
In a study conducted at the Medanta Medicity Institute (Medicity), HCV-infected individuals were enrolled to receive up to three, six-hour Hemopurifier® treatments during the first three days of PR drug therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. 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, dose, duration and tolerability of drug therapies.
In the Medicity study, Aethlon reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in nine treated patients. Of these nine patients, six patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. Of the nine reported patients, seven have been monitored for more than ninety days. All seven currently maintain undetectable viral load, including three patients who have been monitored for 48-weeks. Two patients initiated Hemopurifier® therapy on April 18th and April 30th, and therefore have not yet been monitored for extended viral load suppression.
The Immediate Impact of Hemopurifier® Therapy
In addition to demonstrating safety and early efficacy against multiple HCV genotypes, a clinical objective of the Medicity study was to evaluate whether the Hemopurifier® could accelerate HCV eradication to levels associated with treated patients who achieve the highest rate of viral cure, including individuals that previously failed or relapsed PR drug regimens. In the study, Aethlon observed that viral load depletion during the Hemopurifier® + PR drug therapy phase was greatest in hard-to-treat genotype-1 patients with high viral load. In one treated patient, baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured after the third day of Hemopurifier® + PR therapy, representing a 3.49 log or 99.96% reduction of viral load. In another patient, baseline HCV RNA dropped from 8,760,000 IU/ml to 4,665 IU/ml when measured on day-3, representing a 3.27 log or 99.96% reduction. By contrast, a moderate viral load Hemopurifier® patient with baseline HCV RNA of 1,340,000 IU/ml dropped to 54,900 IU/ml when measured on day-3, representing a 1.38 log or 95.9% reduction.
As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that less than 5% of treated patients will achieve a 2-log or greater reduction of viral load when measured 7-days after the start of PR drug therapy. While the IDEAL study did not report day-3 viral load, a 2-log+ reduction at day-7 is a rare occurrence defined as an immediate virologic response (IVR). The IDEAL study confirms the viral cure or sustained virologic response rate of IVR patients to be greater than 90%. Based on Medicity treatment outcomes, Hemopurifier® therapy had a significant impact in accelerating HCV eradication in high viral load patients.
Capacity of the Hemopurifier® to Capture HCV During Treatment
As the result of discussions with reviewers at the Center for Devices and Radiological Health (the FDA branch responsible for approving medical devices in the US), Aethlon recently expanded the Medicity protocol to establish a data point that would quantify the amount of HCV captured within the Hemopurifier® during a single treatment. In one analyzed cartridge, researchers recovered and measured that approximately 300 billion (300,000,000,000) copies of HCV had been captured within the Hemopurifier® during a single six-hour treatment at the Medicity. Beyond the impact of inhibiting progeny virus replication, the viral capture data point defines the contribution Hemopurifier® therapy can provide to current and future antiviral drug treatment regimens. Aethlon considers this data point to be unprecedented as the previous ability to measure the benefit of HCV therapies has primarily been limited to measuring changes in the amount of virus that can be detected in circulation.
Next Steps
As a result of Hemopurifier® + PR therapy outcomes, Aethlon has requested permission from the Medicity internal review board (IRB) to begin offering Hemopurifier® therapy to HCV-infected individuals that reside outside of India. The Company has also requested IRB permission to expand the treatment protocol to allow for up to seven Hemopurifier® treatments to be administered during the first week of PR drug therapy. Based on previous three-treatment protocol outcomes, Aethlon anticipates an expanded Hemopurifier® dosing schedule could establish new milestones for early undetectable viral load achievement. The Company also disclosed it will resubmit an investigational device exemption (IDE) which incorporates the Medicity data as part of its effort to gain FDA approval to initiate clinical programs in the U.S.
It is estimated that approximately 4 million Americans and 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is the leading cause of liver transplant in the U.S. To date, almost 100 Hemopurifier® treatments have been administered in human studies. Previously, studies of the Hemopurifier® have been conducted at the Apollo, Fortis, and Sigma New Life hospitals in India. These studies demonstrated that Hemopurifier® therapy could safely reduce viral load in both HIV and HCV-infected dialysis patients without the administration of antiviral drug therapies. The Medicity study represents the first Hemopurifier® study in non-dialysis patients. In vitro studies have further validated the ability of the Hemopurifier® to capture a broad-spectrum of viral pathogens classified as bioterror or pandemic threats.
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 the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, 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.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@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
In a study conducted at the Medanta Medicity Institute (Medicity), HCV-infected individuals were enrolled to receive up to three, six-hour Hemopurifier® treatments during the first three days of PR drug therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. 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, dose, duration and tolerability of drug therapies.
In the Medicity study, Aethlon reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in nine treated patients. Of these nine patients, six patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. Of the nine reported patients, seven have been monitored for more than ninety days. All seven currently maintain undetectable viral load, including three patients who have been monitored for 48-weeks. Two patients initiated Hemopurifier® therapy on April 18th and April 30th, and therefore have not yet been monitored for extended viral load suppression.
The Immediate Impact of Hemopurifier® Therapy
In addition to demonstrating safety and early efficacy against multiple HCV genotypes, a clinical objective of the Medicity study was to evaluate whether the Hemopurifier® could accelerate HCV eradication to levels associated with treated patients who achieve the highest rate of viral cure, including individuals that previously failed or relapsed PR drug regimens. In the study, Aethlon observed that viral load depletion during the Hemopurifier® + PR drug therapy phase was greatest in hard-to-treat genotype-1 patients with high viral load. In one treated patient, baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured after the third day of Hemopurifier® + PR therapy, representing a 3.49 log or 99.96% reduction of viral load. In another patient, baseline HCV RNA dropped from 8,760,000 IU/ml to 4,665 IU/ml when measured on day-3, representing a 3.27 log or 99.96% reduction. By contrast, a moderate viral load Hemopurifier® patient with baseline HCV RNA of 1,340,000 IU/ml dropped to 54,900 IU/ml when measured on day-3, representing a 1.38 log or 95.9% reduction.
As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that less than 5% of treated patients will achieve a 2-log or greater reduction of viral load when measured 7-days after the start of PR drug therapy. While the IDEAL study did not report day-3 viral load, a 2-log+ reduction at day-7 is a rare occurrence defined as an immediate virologic response (IVR). The IDEAL study confirms the viral cure or sustained virologic response rate of IVR patients to be greater than 90%. Based on Medicity treatment outcomes, Hemopurifier® therapy had a significant impact in accelerating HCV eradication in high viral load patients.
Capacity of the Hemopurifier® to Capture HCV During Treatment
As the result of discussions with reviewers at the Center for Devices and Radiological Health (the FDA branch responsible for approving medical devices in the US), Aethlon recently expanded the Medicity protocol to establish a data point that would quantify the amount of HCV captured within the Hemopurifier® during a single treatment. In one analyzed cartridge, researchers recovered and measured that approximately 300 billion (300,000,000,000) copies of HCV had been captured within the Hemopurifier® during a single six-hour treatment at the Medicity. Beyond the impact of inhibiting progeny virus replication, the viral capture data point defines the contribution Hemopurifier® therapy can provide to current and future antiviral drug treatment regimens. Aethlon considers this data point to be unprecedented as the previous ability to measure the benefit of HCV therapies has primarily been limited to measuring changes in the amount of virus that can be detected in circulation.
Next Steps
As a result of Hemopurifier® + PR therapy outcomes, Aethlon has requested permission from the Medicity internal review board (IRB) to begin offering Hemopurifier® therapy to HCV-infected individuals that reside outside of India. The Company has also requested IRB permission to expand the treatment protocol to allow for up to seven Hemopurifier® treatments to be administered during the first week of PR drug therapy. Based on previous three-treatment protocol outcomes, Aethlon anticipates an expanded Hemopurifier® dosing schedule could establish new milestones for early undetectable viral load achievement. The Company also disclosed it will resubmit an investigational device exemption (IDE) which incorporates the Medicity data as part of its effort to gain FDA approval to initiate clinical programs in the U.S.
It is estimated that approximately 4 million Americans and 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is the leading cause of liver transplant in the U.S. To date, almost 100 Hemopurifier® treatments have been administered in human studies. Previously, studies of the Hemopurifier® have been conducted at the Apollo, Fortis, and Sigma New Life hospitals in India. These studies demonstrated that Hemopurifier® therapy could safely reduce viral load in both HIV and HCV-infected dialysis patients without the administration of antiviral drug therapies. The Medicity study represents the first Hemopurifier® study in non-dialysis patients. In vitro studies have further validated the ability of the Hemopurifier® to capture a broad-spectrum of viral pathogens classified as bioterror or pandemic threats.
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 the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company's clinical programs or provide market clearance of the company's products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, 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.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@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
Friday, April 27, 2012
All the JAZZ; Biotech/Pharma Stock alert for Jazz Pharmaceuticals (JAZZ)
New York, NY - April 27, 2012 - www.InvestorIdeas.com, a global
investor research portal for independent investors, specializing in
sector research, issues a trading alert for Jazz Pharmaceuticals plc (NasdaqGS: JAZZ). The stock is trading at $52.69, up $ 7.49(16.58%)as of 1:54PM EDT on over 3 Million shares.
Yesterday Jazz Pharmaceuticals reported it has agreed to acquire EUSA Pharma, a privately-held, specialty pharmaceutical company with headquarters in the United States and United Kingdom, for $650 million in cash and a potential $50 million milestone payable in cash based upon its lead product, Erwinaze(TM) (asparaginase Erwinia chrysanthemi), achieving a specified U.S. net sales target in 2013.
Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, pain, psychiatry and women's health. The company's marketed products in these areas include: Xyrem® (sodium oxybate), Prialt® (ziconotide intrathecal infusion), FazaClo® (clozapine USP) HD and LD, Luvox CR® (fluvoxamine maleate) and Elestrin® (estradiol gel 0.06%).
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Yesterday Jazz Pharmaceuticals reported it has agreed to acquire EUSA Pharma, a privately-held, specialty pharmaceutical company with headquarters in the United States and United Kingdom, for $650 million in cash and a potential $50 million milestone payable in cash based upon its lead product, Erwinaze(TM) (asparaginase Erwinia chrysanthemi), achieving a specified U.S. net sales target in 2013.
Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, pain, psychiatry and women's health. The company's marketed products in these areas include: Xyrem® (sodium oxybate), Prialt® (ziconotide intrathecal infusion), FazaClo® (clozapine USP) HD and LD, Luvox CR® (fluvoxamine maleate) and Elestrin® (estradiol gel 0.06%).
Research biotech stocks at Investorideas.com with the global stock directory of biotech and pharma stocks on the TSX, OTC, NASDAQ, NYSE and other leading exchanges http://www.investorideas.com/ BIS/Stock_List.asp
Get Free investor news and stock alerts at Investorideas.com
Sign Up: http://www.investorideas.com/Resources/ Newsletter.asp
Join Investor Ideas Get 13 of the best stock directories online;
Research oil and gas stocks, gold stocks, water stocks, renewable energy stocks Join: http://www.investorideas.com/ membership/
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; water and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, natural gas stocks, tech (includes cloud and social networking), defense stocks, nanotech, China stocks and agriculture.
Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
Follow Investorideas.com on Facebook http://www.facebook.com/Investorideas
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.
From time to time Investorideas.com buys shares in companies it features. As a policy, Investorideas.com does not short stocks
www.InvestorIdeas.com/About/Disclaimer.asp
800-665-0411
Source - www.Investorideas.com
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