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Exosomics blog (mentions AEMD)
http://sites.google.com/site/cdktest1/exosomics-blog
Exosomes and Microvesicles 2011
http://www.exosomeandmicrovesicle.org/
The conference begins on the 15th of October with a Welcome Reception held at the hotel from 7pm onwards. We anticipate the sessions to be 9am till 5pm on the 16th and the 17th. This is subject to change.
This conference will bring together researchers in Exosomes and Microvesicles with the topics including:
Basic cell biology/biochemistry of vesicle biogenesis
Vesicle purification/characterization/analysis/composition
• Characterization or the resulting vesicle populations
• Are characteristic definitions "real" or out-dated
Use of vesicles in clinical applications
• Microvesicles as diagnostic tools
• mRNA profiles
• miRNA signature
Development of microvesicle based technologies
• Application in regenerative medicine
• Drug and gene delivery
Vesicle functions in normaly physiological processes
• Immune cell-derived vesicles
• Platelet derived microvesicle
• Stem cell-derived vesicles
• Embryonic-derived vesicles
Role of vesicles in human disease
• Cancer-derived
• Autoimmune associated
• Microvesicles in infections
• HIV
• Transfer of prions
Recent developments and remaining challenges:
Many types of vesicles released by cells including those coming from multivesicular bodies, shedding microvesicles, HERV retrovirus particles, blebs, apoptotic bodies, nanotubes etc.
New analysis techniques are emerging which cast doubts upon some of the old definitions that we use. They also show that the standard preparation methods do not result in pure exosomes, but a mixture of exosomes and microvesicles, which the current dogma tells us should have very different properties.
PSI-7977 with Standard Therapy Produces 91% Sustained Response
Details Category: Experimental HCV Drugs Published on Friday, 09 September 2011 00:00 Written by Press Release HCV © Russell Kightley
The experimental hepatitis C virus (HCV) nucleotide analog polymerase inhibitor PSI-7977, used in combination with pegylated interferon and ribavirin, demonstrated a 12-week sustained virological response rate of 91% for previously untreated genotype 1 chronic hepatitis C patients in the ongoing PROTON trial.
Below is an edited excerpt from a Pharmasset press release describing the study and its findings.
Pharmasset Announces 91% SVR12 From the PROTON Trial in Subjects With Hepatitis C Genotype 1
-- Intent-to-treat SVR12 of 91% (43 of 47) following a 24-week treatment regimen incorporating 12 weeks of PSI-7977 400 mg QD
Princeton, N.J. --September 6, 2011 -- Pharmasset, Inc. (Nasdaq: VRUS), announced today sustained virologic response (SVR) results from its phase 2b PROTON study with PSI-7977 400 mg dosed once daily in combination with peginterferon alfa 2a and ribavirin (Peg-IFN/RBV) in subjects with hepatitis C virus (HCV) genotype 1 who have not been treated previously. 43 out of 44 (98%) evaluable subjects achieved an SVR12, defined as HCV RNA below the limit of detection (<15 IU/mL) 12 weeks after the completion of treatment. All enrolled subjects will be followed to determine SVR24, the primary efficacy endpoint of the study.
Ninety five treatment-naive patients with HCV genotype 1 were enrolled into two open-label arms of the PROTON trial, receiving either PSI-7977 200 mg QD [once-daily] (N=48) or 400 mg QD (N=47) for 12 weeks. Individuals in both arms received Peg-IFN/RBV for 24 weeks and were followed post-treatment to assess SVR12. Twenty-six subjects were enrolled in a placebo control arm and are receiving 48 weeks of Peg-IFN/RBV. Results from this study through the SVR12 endpoint are scheduled to be presented as part of a Presidential Plenary Session at the American Association for the Study of Liver Diseases (AASLD) meeting on Tuesday, November 8, 2011.
"I am very pleased with the results of this study which clearly demonstrate the benefit of the 400 mg dose of PSI-7977 with only 24 weeks of interferon for all subjects," stated Dr. Eric Lawitz, the study's principal investigator. "HCV therapy is becoming overly complex, and the elimination of 24 weeks of interferon and ribavirin as well as all response guided criteria for patients with HCV genotype 1 would be a welcomed simplification."
At the European Association for the Study of the Liver (EASL) in April 2011, Dr. David Nelson presented interim results from the PROTON trial showing that 43 out of 47 subjects receiving the 400 mg dose of PSI-7977 achieved an eRVR, defined as HCV RNA below the limit of detection (<15 IU/ml) at week 4 through week 12. Of those not achieving eRVR, 3 discontinued therapy early due to unrelated adverse events and 1 was lost to follow-up, as previously reported. Notably, one of these individuals went on to achieve an SVR12 in spite of the shortened course of therapy. The combination of PSI-7977, pegylated interferon and ribavirin was generally safe and well tolerated.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in four Phase 2b trials in patients with HCV genotypes 1 through 6, including abbreviated duration interferon and interferon-free regimens. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, recently reported safety and efficacy data from 14 days of monotherapy as well as 14 days in combination with the pyrimidine, PSI-7977. An SVR-endpoint study of the Pharmasset purine-pyrimidine combination is anticipated to begin in the third quarter of 2011. Mericitabine (RG7128) continues in three Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.
9/9/11
Source
Pharmasset, Inc. Pharmasset Announces 91% SVR12 From the PROTON Trial in Subjects With Hepatitis C Genotype 1. Press release. September 6, 2011.
I never got a link to the first message.
Implementation Science Research to Support Programs under the President's Emergency Plan for AIDS Relief (PEPFAR)
http://www.grants.gov/search/search.do?mode=VIEW&oppId=114673
W81XWH-11-DMRDP-MID-ARA
http://www.grants.gov/search/search.do?mode=VIEW&oppId=115354
Military Infectious Diseases Applied Research Award W81XWH-11-DMRDP-MID-ARA
http://www.grants.gov/search/search.do?mode=VIEW&oppId=115373
Research Answers to NCI’s Provocative Questions (R21)
http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-11-012.html
Research Answers to NCI’s Provocative Questions (R01)
http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-11-011.html
Yes. I got your message.
Results of world-first viral therapy trial in cancer patients published in Nature
http://www.eurekalert.org/pub_releases/2011-08/ohri-row082511.php
Roche Drug for Unapproved Use May Save $1 Billion, U.S. Says (Hopefully the HHS realizes the cost saving potential of the HP for HCV, HIV, sepsis, H1N1, other viral disease and pushes for use of the HP
by the medical community - that is the only reason for this post)
http://www.bloomberg.com/news/2011-09-07/roche-drug-for-unapproved-use-may-save-1-billion-u-s-says-1-.html
Aethlon’s Hemopurifier
removes H1N1 from blood (Revisiting from MEDICAL DEVISE DAILY - 2010)
By LYNN YOFFEE
Medical Device Daily Staff Writer
Aethlon Medical’s (San Diego) blood filtration device,
the Hemopurifier, has successfully removed 96% of H1NI in
blood plasma samples as reported from an emergency
study authorized by the U.S. Department of Health and
Human Services (HHS).
“At this point we’re in discussions as to what the potential
next steps might be in terms of clinical programs with
HHS. We’re watching how H1N1 evolves and there are certainly
different opportunities in terms of getting approval
via emergency use authorization or humanitarian use.
Should H1N1 become virulent, then we think it should be
something seriously considered,” Aethlon’s chairman/CEO,
Jim Joyce, told Medical Device Daily.
Joyce said the tipping point for an early emergency use
authorization of any type will be if the virus mutates.
“There are no reports of mutation yet, but you’re seeing
that the hard-hit population has been people under 25,
which is concerning because there’s a certain portion of
that population that should have a robust immune
response. Researchers are now trying to understand how it
goes from infection to death in a very short time in children.
Given these events, there are some initial indications
[that H1N1 could be mutating], but nothing solid yet.”
Joyce explained that the Hemopurifier isn’t just a filtration
device; he calls it as an adjunct and treatment enhancement
device because it can be used in conjunction with
common antiviral medication to rid the body of the virus.
“The concept of enhancing the ability of a drug to be
effective is no longer theoretical,” Joyce said. “It’s proven.
There’s a very strong precedent now. Not only can the
Hemopurifier enhance outcomes, it can do so dramatically.”
He refers to studies and subsequent data related to the
Hemopurifier’s use to fight hepatitis-C (HCV), the company’s
original indication. Potential applications and related
studies focus on a variety of pathogens that infect the
blood including HIV, hemorrhagic fever and
cytomegalovirus.
But heightened concerns over the H1N1 pandemic led to
the U.S. government’s move to start testing the filter
against this new influenza. Joyce said Aethlon was asked to
ship an undisclosed number of the devices to “a research
institute” for testing by third-party researchers.
Why all the secrecy?
“As this disease has grown, there’s sensitivity to organizations
that are housing the virus, especially if they’re in
geographically centralized areas,” Joyce said, adding that
further details of the study are confidential until the HHS
signs off.
Researchers involved are expected to publish their
results in a peer-reviewed journal in the near future.
What Joyce was able to disclose are some top line data
results that show the longer the device is used, the more
effective it is at removing a virus from blood. Hemopurifier
removed 68% of H1N1 virus from blood plasma in 30 minutes,
80% of the virus in two hours, and there was a 96%
reduction of H1N1 observed at six hours.
Joyce said it’s this feature that will set the Hemopurifier
apart from its closest competitors, whether used against
H1NI or HIV.
“There’s a very important mechanism of how our cartridge
works,” he said. “It’s selective for removing the virus
and doesn’t indiscriminately remove particles in the blood
that are needed. The other factor that’s advantageous is
that it removes proteins that shed from virus, so we can
preserve immune cells. We see the benefit in use with
antivirals because we think it enhances the ability for
antivirals to work, but we also see it as immunotherapeutic.”
Asahi Kasei Medical (Tokyo) has developed a similar
blood filtration device called Planova filters, and the company
has even launched a direct-to-consumer website touting
its benefits in chronic hepatitis treatment as approved
in Japan. But Joyce points out that this device’s potential
applications are limited because it strips the blood of too
many components, limiting the amount of time a patient
could endure the blood cleansing.
“But what Asahi has done is to validate the concept of a
treatment enhancement device and we’re looking to follow
along and improve on that,” he said.
Hemopurifier employs hollow-fiber dialysis along
with affinity chromatography to selectively bind envelope
viruses. The filtration cartridge is able to capture circulating
viruses, viral proteins and toxins in an effort to
reduce viral load so that the patient’s natural immunity
can recover to effectively kill off the infection. But
Hemopurifier can also be used in conjunction with drugs
and vaccines.
Earlier this year, Aethlon reported results of the first
human study of Hemopurifier to treat HIV. Viral load was
reduced by 92% in an HIV-infected individual who received
a total of 12 Hemopurifier treatments administered three
times a week over the span of one month.
But the majority of research has been focused on HCV
with results from various studies that demonstrate robust
viral load reductions.
In addition to tackling numerous viral indications,
Joyce pointed out that Hemopurifier could aid drug
research because the filter isolates live viruses from the
blood.
“Normally researchers are challenged because they
don’t have the quantities of virus they need,” he said.
“Usually when it grows in culture, it evolves differently than
in the body. We could provide quantities of virus from
patients so that drug companies could examine the various
strains which would provide better insight into how the
virus is evolving.”
(This story originally appeared
TMC435 for Hepatitis C Phase 3 Studies Fully Enrolled, Company Says
http://hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/3214-tmc435-for-hepatitis-c-phase-3-studies-fully-enrolled-company-says
If one were to assimilate the info from the previous 7-8 posts and knowing how the HP works, would that be another theoretical evidence for the HP against certain cancers ?
I have purposely posted message # 2340 on Lectins because that is the basis for the HP.
Cell receptor could allow measles virus to target tumors
http://www.sciencecodex.com/cell_receptor_could_allow_measles_virus_to_target_tumors
Nectins - Overview
http://www.ihop-net.org/UniPub/iHOP/bng/103564.html
Nectin-4 is a new histological and serological tumor associated marker for breast cancer. [2007]
Nectin-4 is a new bio-marker whose use could help refine breast cancer taxonomy and improve patients' follow-up. [2007]
Nectin-4 emerges as a potential target for breast cancer immunotherapy. [2007]
In vivo, Nectin-4 is re-expressed in breast carcinoma, and a circulating form of Nectin-4 is detected in the sera of patients with metastatic breast cancer. [2005]
Nectin-4, a new serological breast cancer marker, is a substrate for tumor necrosis factor-alpha-converting enzyme (TACE)/ADAM-17. [2005]
Nectin 4 overexpression in ovarian cancer tissues and serum: potential role as a serum biomarker. [2010]
Previously, we found expression of nectin 4 to be increased in ovarian cancer compared with normal ovaries. [2010]
Reverse transcriptase-polymerase chain reaction (RT-PCR) and quantitative RT-PCR validated the overexpression of nectin 4 messenger RNA in ovarian cancer compared with normal ovarian cell lines and tissues. [2010]
Protein levels of nectin 4 were elevated in ovarian cancer cell lines and tissue compared with normal ovarian cell lines as demonstrated by Western immunoblotting, flow cytometry, and immunohistochemical staining of tissue microarray slides. [2010]
In patients with benign gynecologic diseases with high serum CA125 levels, nectin 4 was not detected in the majority of cases, suggesting that nectin 4 may serve as a potential biomarker that helps discriminate benign gynecologic diseases from ovarian cancer in a panel with CA125. [2010]
Identification of nectin-4 oncoprotein as a diagnostic and therapeutic target for lung cancer. [2009]
Treatment of lung cancer cells with small interfering RNAs against Nectin-4 suppressed its expression and cell growth. [2009]
Nectins in Lung Cancer
http://cancerres.aacrjournals.org/content/69/16/6694.full
Identification of Nectin-4 Oncoprotein as a Diagnostic and Therapeutic Target for Lung Cancer
Atsushi Takano1,2, Nobuhisa Ishikawa1, Ryohei Nishino1, Ken Masuda1, Wataru Yasui3, Kouki Inai4, Hitoshi Nishimura5, Hiroyuki Ito6, Haruhiko Nakayama6, Yohei Miyagi7, Eiju Tsuchiya7, Nobuoki Kohno2, Yusuke Nakamura1, and Yataro Daigo1
+ Author Affiliations
Abstract
Gene expression profile analysis of lung cancers revealed the transactivation of an immunoglobulin-like molecule Nectin-4 in the majority of non–small cell lung cancers (NSCLC). Immunohistochemical staining of 422 NSCLCs showed that a high level of Nectin-4 expression was associated with poor prognosis for NSCLC patients [/b](P < 0.0001), and multivariate analysis confirmed its independent prognostic value (P < 0.0001). We established an ELISA to measure serum Nectin-4 and found that serum Nectin-4 levels were significantly higher in NSCLC patients than in healthy volunteers. The proportion of the serum Nectin-4–positive cases was 88 of 164 (53.7%) NSCLCs, whereas only 3 of 131 (2.3%) healthy volunteers were falsely diagnosed as positive, which was superior to carcinoembryonic antigen (CEA) and cytokeratin 19-fragment (CYFRA21-1) in sensitivity and specificity. A combined ELISA for both Nectin-4 and CEA increased sensitivity and classified 65.0% of lung adenocarcinomas as positive with false-positive rate of 4.6%. The use of both Nectin-4 and CYFRA21-1 classified 68.3% of lung squamous cell carcinomas as positive with false-positive rate of 6.1%. Treatment of lung cancer cells with small interfering RNAs against Nectin-4 suppressed its expression and cell growth. In addition, exogenous expression of Nectin-4 increased the lamellipodia formation and the invasive ability of mammalian cells through activation of small GTPase Rac1. Nectin-4 might play a significant role in lung carcinogenesis, and it should be a new candidate serum and tissue biomarker, as well as a therapeutic target. [Cancer Res 2009;69(16):6694–703]
Nectin 4 overexpression in ovarian cancer tissues and serum: potential role as a serum biomarker.
http://www.ncbi.nlm.nih.gov/pubmed/20959669
NECTINs
Clinical relevance
Even though no pharmaceutical products released so far target any nectins or Necls, some discoveries have intensified the clinical relevance of these proteins.
Nectin-1 and nectin-3 have been shown to be involved in cellular adhesion in some neuronal synapses. Unlike many other cellular adhesion molecules they do not distribute evenly on axonal and dendritic side of the synapse. Instead, Nectin-1 is primarily found on the axonal side and nectin-3 primarily on the dendritic side.
Recently, it has been found that nectin-4 can be found in the serum of patients suffering from lung cancer. This has led to speculations that this protein might be involved in some developing cancers and might even have a pharmaceutical potential.
Also, it has been well known for some time now, that necl-2 is down regulated in a variety of cancers. This is why necl-2 is also known as Tumor suppressor in lung cancer 1 (TSLC1).
[edit]
Nectin-4
View Nectin-4 IHC images.
Nectins are type I transmembrane glycoproteins that are calcium-independent immunoglobulin (Ig)-like cell adhesion molecules (CAMs). Homology has led to their designation as poliovirus receptor-related (PRR) proteins, but nectins do not bind poliovirus. The extracellular domains of the nectin family form cis-homodimers (same cell), followed by homophilic or heterophilic trans-dimers (across cells) that organize intercellular junctions. Nectin-1, also known as CD111, PRR1 and herpes virus entry mediator C (HVEC) has a secreted splice variant. Nectin-1, Nectin-2 (CD112, PRR2, HVEB) and Nectin-3 (PRR3) are concentrated in adherens junctions and exist on neurons, endothelial cells, epithelial cells and fibroblasts.
Nectin-4 is a type I transmembrane glycoprotein belonging to the Nectin family of Ig superfamily proteins. It is both a homophilic and heterophilic (with Nectin-1) cell adhesion molecule that is expressed in the placenta, the embryo, and in breast carcinoma. A soluble form of Nectin-4 is generated from the membrane protein via the action of TACE/ADAM-17.
Viral envelope
From Wikipedia, the free encyclopedia
Schematic of a Cytomegalovirus
Many viruses (e.g. influenza and many animal viruses) have viral envelopes covering their protein capsids.[1] The envelopes typically are derived from portions of the host cell membranes (phospholipids and proteins), but include some viral glycoproteins. Functionally, viral envelopes are used to help viruses enter host cells. Glycoproteins on the surface of the envelope serve to identify and bind to receptor sites on the host's membrane. The viral envelope then fuses with the host's membrane, allowing the capsid and viral genome to enter and infect the host.
Usually, the cell from which the virus itself buds will often die or be weakened, and shed more viral particles for an extended period. The lipid bilayer envelope of these viruses is relatively sensitive to desiccation, heat, and detergents, therefore these viruses are easier to sterilize than non-enveloped viruses, have limited survival outside host environments, and typically must transfer directly from host to host. Eveloped viruses can cause persistent infections.
http://en.wikipedia.org/wiki/Viral_envelope
Lectins are glycoproteins that recognize and bind to specific oligosaccharides.
Concanavalin A and wheat germ agglutinin are plant lectins that have been useful research tools (discussed p. 363).
The C-type lectin-like domain is a Ca++-binding carbohydrate recognition domain present in many animal lectins. Recognition and binding of carbohydrate moieties of glycoproteins, glycolipids, and proteoglycans by animal lectins is a factor in cell-cell recognition, adhesion of cells to the extracellular matrix, interaction of cells with chemokines and growth factors, recognition of disease-causing microorganisms, and initiation and control of inflammation. For example:
Mannan-binding lectin (MBL) is a glycoprotein found in blood plasma. It binds cell surface carbohydrates of disease-causing microorganisms and promotes phagocytosis of these organisms as part of the immune response.
Selectins are integral proteins of mammalian cell plasma membranes with roles in cell-cell recognition and binding. The C-type lectin-like domain is at the end of a multi-domain extracellular segment extending outward from the cell surface. A cleavage site just outside the transmembrane a-helix provides a mechanism for regulated release of some lectins from the cell surface. A cytosolic domain participates in regulated interaction with the actin cytoskeleton.
http://www.grandchallenges.org/Explorations/Pages/TopicsOverview.aspx
Explorations Round 8 Topics
Topics for Grand Challenges Explorations Round 8 are:
Protect Crop Plants from Biotic Stresses From Field to Market
Design New Approaches to Optimize Immunization Systems
Explore New Solutions for Global Health Priority Areas
Explore Nutrition for Healthy Growth of Infants and Children
Apply Synthetic Biology to Global Health Challenges
How Topics are Chosen
Each round of the Grand Challenges Explorations initiative awards grants against a set of specific topics. In general, topics are chosen according to three major criteria:
The topic fits within the goals and disease priorities of the Bill & Melinda Gates Foundation
The topic contains a roadblock where radical, new thinking is needed for the discovery of an effective health solution
Potential projects within the topic are likely to be well suited for the phased structure of the initiative
In addition, we consider whether a topic will engage the participation from scientists outside traditional global health disciplines, as well as researchers working in the developing world.
Focusing Proposals on Current Topics
For each round of Grand Challenges Explorations, applicants are asked to focus their proposals on specific topics where creative, unorthodox thinking is most urgently needed. Interested applicants should:
Review the current topic descriptions (links on right when award Round is open) to determine which subject best suits your idea
Visit the Application Instructions page to understand how to submit your proposal
Past Topics
To read topics for past Grand Challenges Explorations rounds, please click here.
Bill and Melinda Gates Foundation Grants
http://www.grandchallenges.org/Explorations/Topics/Pages/NewGHSolutions.aspx
You are welcome!
Pharmasset hepatitis drug may get faster review
http://www.businessweek.com/ap/financialnews/D9PAHRT01.htm
"Alarming" Rate of Hepatitis C Re-infection among HIV+ Gay Men ( The HP should be one of the most effective mechanisms in this group of patients as it would decrease the viral count of HIV & HCV. Of course studies need to be done - ANESRI)
Published on Wednesday, 24 August 2011 00:00 Written by Liz Highleyman
HIV and HCV © Russell Kightley
One-third of HIV positive men who have sex with men (MSM) who were treated for acute hepatitis C virus (HCV) infection in Amsterdam became re-infected within 2 years, indicating a need for improved prevention efforts, according to a recent report.
Femke Lambers from the Amsterdam Public Health Service and colleagues with the MOSAIC (MSM Observational Study of Acute Infection with Hepatitis C) study group assessed the incidence of re-infection among HIV positive gay and bisexual who cleared HCV following treatment of acute primary (first case) hepatitis C. They presented their findings at the 18th Conference on Retroviruses and Opportunistic Infection (CROI 2011) and in the August 19, 2011, advance online edition of AIDS.
Starting around the year 2000, clinicians began reporting cases of apparently sexually transmitted acute HCV infection among HIV positive gay and bisexual men, first in the U.K. and then in major cities in Europe, Australia, and the U.S.
Overall, HIV positive people are more likely to develop chronic HCV infection (that is, they are less likely to clear spontaneously without treatment), experience more rapid liver disease progression, and do not respond as well to interferon-based therapy as people with HCV alone; treatment is considerably more effective, however, if started during acute infection. Unlike many diseases, HCV infection does not confer immunity and people can become infected multiple times.
The researchers analyzed 56 HIV positive MSM at 2 large HIV outpatient clinics in Amsterdam who were previously diagnosed with presumed sexually transmitted acute HCV infection, were treated between 2003 and 2011, and had undetectable HCV RNA at the end of therapy.
HCV re-infection was defined as detectable HCV viral load with a switch in HCV genotype or clade, indicating new infection rather than potential late post-treatment relapse. This method would not count men who were infected a second time with the same type of HCV, thus possibly underestimating the re-infection rate.
Results
From 2006 through 2009, 5 of the 56 participants experienced presumed HCV relapse and were not included in further analysis.
11 of the remaining 51 participants were found to be re-infected with a different type of HCV during a median follow-up period of 1.3 years.
The median time until re-infection was 8.4 months.
The incidence of HCV re-infection in this group was 15.2 per 100 person-years.
The cumulative incidence of re-infection was 33% within 2 years.
Most men switched from HCV genotype 4 to genotype 1.
3 men were re-infected with the same genotype but a different clade.
CD4 counts did not differ between participants with and without HCV re-infection, and all re-infected patients on antiretroviral therapy had undetectable HIV viral load.
Among 21 men with available data on behavior, those who were re-infected were significantly more likely to report non-injection recreational drug use, but no statistically significant differences in sexual activity were observed in this small population.
4 re-infected men were treated a second time: 2 achieved sustained virologic response (SVR), 1 relapsed, and 1 was still undergoing follow-up at the time of the report.
"An alarmingly high incidence of HCV re-infection was found in this group," the study authors concluded. "This high re-infection rate indicates that current prevention measures should be discussed, frequent HCV RNA testing should be continued after successful treatment and in case of possible relapse, clade typing should be performed to exclude re-infection."
Given the lack of association between CD4 T-cell count and re-infection, they recommended that more research is needed of the relationship between HIV infection and acquisition of HCV.
Most importantly, they elaborated in their discussion, "these findings stress the importance of repeated risk counseling for HCV transmission, which should be provided not only before and during treatment but also after its completion."
Investigator affiliations: Department of Research, Cluster infectious diseases, Public Health Service of Amsterdam, Netherlands; Department of Internal Medicine, Division of Infectious Diseases, Tropical Medicine and AIDS, CINIMA, Academic Medical Center, Amsterdam, Netherlands; Department of Medical Microbiology, Section of Clinical Virology, Academic Medical Center, Amsterdam, Netherlands; Department of Microbiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands; Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.
8/23/11
Reference
FAE Lambers, M Prins, X Thomas, et al on behalf of the MOSAIC (MSM Observational Study of Acute Infection with hepatitis C) study group. Alarming incidence of hepatitis C virus (HCV) reinfection after treatment of sexually acquired acute HCV infection in HIV-infected men having sex with men in Amsterdam. AIDS (abstract). August 19, 2011 (Epub ahead of print).
A Novel Therapeutic Strategy to attack Cancer -
http://www.slideshare.net/Aethlon/a-novel-therapeutic-strategy-to-address-cancer
Investor Summary for AEMD
http://www.slideshare.net/Aethlon/aemd-aethlon-medical-investor-summary-8511
Aethlon Medical Announces Sarcoma, Lung Cancer, Prostate Cancer, Metastatic Melanoma, and Head and Neck Cancer Studies
http://finance.yahoo.com/news/Aethlon-Medical-Announces-prnews-4192906986.html?x=0&.v=1
Hi Lee,
Thank you for the kind words.
I have been invested in AEMD for at least 2-3 years.
I used to mainly follow this thread on IHUB and it was a solid source of information about the company. I never had much to contribute (at least that is what I used to think at the time!) or lack of time prevented me from doing more DD and contributing to this board. For a long time before I became the moderator there was no moderator and hardly any postings. I decided to be one for 2 solid reasons :
- When any PR comes out a decent amount of people look up discussion boards to learn more or to get a feel for the stock. AEMD is gathering steam and I wanted the IHUB thread to be current for people who visit the site. A lot of people refrain from visiting the Yahoo web sites for stocks for reasons we all know (although the AEMD board is still very informative).
- Also, I was worried about a basher taking over as a moderator which would hurt the company. This thought is not baseless as I have this with a company on IHUB - I do not want to go into the details.
I do not post on Yahoo. I do visit the site though. My hope is to get more discussion here also for potential investors.
Hi Don,
Welcome to the board. The 10Q does not look good at face value - I am by no means an expert on reading financial reports but looks like there is going to be more dilution. However the time for all the positive catalysts is drawing nearer day by day.
The CEO has already announced that AEMD has been chosen for the DARPA award. No more details are available currently. But the final contract should be available sometime in Sept., 2011. This would be a major validation for the company. Although we know that that there is a great potential for the HP, the premise for it is substantially different from anything currently available in the medical field. For the medical profession or the pharmas to accept such a new groundbreaking technology there has to be a lot of strong evidence for the product. Currently not many people would take DLT seriously. DARPA recognition would give AEMD a major springboard for recognition.
The AEMD HCV trial with the HP is currently ongoing in India. This is a 30 patient study. To my knowledge the study is not complete yet. So for getting the SVR (Sustained Virologic Response - also considered virologic "cure") the wait period is 24 weeks after discontinuation of therapy. In this study the plan is to have 15 patients receiving multiple HP treatments followed by SOC therapy and 15 patients as control. As we know the SOC therapy by itself is over many weeks. So even if AEMD has already enlisted 15 patients for HP/SOC arm of the trial you have to factor in 6-9 months for the SVR numbers to come out . This is what the med. community will look at. Having said that, the company will be looking into the RVR( Rapid virologic response - if undetectable HCV at week 4 of treatment this is highly predictive of the SVR) and the EVR(Early Virologic Response - at week 12 of therapy. Failure to achieve the EVR is the most accurate predictor that the SVR will not be achieved). If the company posts favorable RVR and EVR numbers that would open up the MDs towards the HP and thus start bringing in more income. My feeling is that besides India the Asian market is huge for HCV. Even before FDA approval for use within the US for HCV, the Asian market can bring in substantial revenues. The cost of the recently approved new anti HV drugs would still be prohibitive in most places in the world. The HP does not only have a unique mechanism but it also works extremely fast in terms of reducing the viral count. I think that is a huge factor in its favor.
Going back to DARPA - you should see post number 2256 by ping_pow_princess and open the link.
Dr. T. Broderick has given an amazing presentation on DARPA's vision with DLT. One of the many slides which impressed me is the one which says Program Impact. At the bottom it says in bold - [b]Save at least 43,000 US lives and $3.3B annually. So it made me think that the gov. is looking at DLT from a civilian aspect and not just a military viewpoint.
Also, I have read (for this I do not have a source) that DARPA approval helps for FDA approval.
These are the short term catalysts for AEMD. The company has a strong product which works but needs clinical proof for the mainstream medical use.
A Novel Therapeutic Strategy to Address Cancer - Presentation Transcript
1.A Novel Therapeutic Strategy to Address Cancer September 2011
2.Cancer is the leading cause of deathworldwide and accounted for 7.6 million deaths in 2008 alone
3.There were 12.7 million new cases of Cancer in 2008
4.Cancer deaths in the United States are expected to exceed 570,000 in 2011
5.In 2011, new cases of Cancer are expected to exceed 1,500,000 in the U.S.
6.Innovative strategies are needed to address Cancer progression mechanisms that are beyond the reach of current drug therapies
7.A therapeutic strategy that could inhibit the proliferation of immunosuppressive exosomes released by solid tumors, lymphomas and leukemias would fill a significant unmet medical need in cancer care
8.What are Exosomes?• Cancer cells, both in vivo and in vitro, have been demonstrated to release membranous structures, de?ned as exosomes
9.Researchers have recently unveiled several roles that exosomes play in accelerating cancer progression
10.The resulting research publications are reporting that................
11.Exosomes cause apoptosis or programmed cell death of immune cells
12.Exosomes disrupt signaling of anti-cancer T cells
13.Exosomes contribute to tumor angiogenesis
14.Exosomes enhance the spread of tumor metastasis
15.The quantity of exosomes in circulation is indirect correlation with cancer progression
16.What if exosomes could be eliminated from circulation?
17.The Aethlon Hemopuri?er® The ?rst therapeutic candidate to eliminate cancer exosomes from circulation
18.The Aethlon Hemopuri?er®• Provides a therapeutic ?ltration mechanism to remove cancer exosomes from the circulatory system• Allows selective exosome capture via unique high-mannose signatures resident on exosome surfaces
19.Providing access to the entire circulatory system• Exosomes can be accessed from entire circulatory system, which can pass through the Hemopuri?er® in as little as 15 minutes
20.Hemopuri?er® therapy has the advantage of beingdelivered through the global infrastructure of dialysismachines that are already located in hospitals in clinics
21.Our goal is to improve patient responsiveness to traditional chemotherapies and emerging classes of immune based therapies
22.To improve patient responsiveness without additional drug toxicity or interaction risks
23.In vitro binding of exosomes underlying the following cancers has been demonstrated• Breast• Ovarian• Colorectal• Lymphoma• Melanoma
24.Human Hemopuri?er® treatment experience already exists
25.The Hemopuri?er® has previously demonstrated the ability to reduce viral load in HIV and hepatitis C (HCV) infected individuals without the administration of antiviral drugs
26.A clinical study to evaluate the ability of the Hemopuri?er® to improve HCV drug therapy benefit is currently being conducted
27.The clinical application of the Hemopuri?er® in Cancer?
28.We are currently collaborating with candidate investigators to develop a clinical protocol to demonstrate the ability of our Hemopuri?er® to eliminate circulating cancer exosomes
29.We invite you to follow our efforts to improve cancer care AethlonMedical.com
30.Our mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions Thank You
31.ContactJim Joyce
Chairman, CEO8910 University Center Lane
San Diego , California92122jj@aethlonmedical.com
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and Aethlon Medical intends that such forward-looking statements be subject to the safe harbor created thereby. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including the company's ability to successfully obtain FDA and other regulatory approvals for the sale of its products, the capability of the Hemopuri?er® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, and the company's ability to raise capital when needed. Some information in this presentation, or on which this presentation is based, has been obtained from sources that Aethlon Medical, Inc., believes to be reliable and accurate. However, it has not been independently verified and no representation or warranty, express or implied, is made as to the accuracy or completeness of any information obtained from third parties. Such risks and uncertainties, including those discussed above, are more fully described in the Securities and Exchange Commission (SEC) reports ?led by Aethlon Medical, Inc., including its most recent annual report on Form 10-K. This presentation speaks only as of its date, and the company disclaims any duty to update the information herein. Further information is avail able by contacting the company or at the company's website at www.aethlonmedical.com.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Top-Quality Clinical Studies For Medical Devices, FDA Seeks Feedback On Proposed Guidelines
http://www.medicalnewstoday.com/articles/232840.php
Viruses causing cancer ! (Another potential for the HP)
Key Oncoprotein Discovered In Merkel Cell Carcinoma By Pittsburgh Researchers
http://www.medicalnewstoday.com/articles/232828.php
National HIV Prevention Conference – Highlights of Day 3
http://blog.aids.gov/2011/08/national-hiv-prevention-conference-%e2%80%93-highlights-of-day-3.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+aids%2Fgov+%28Blog.AIDS.gov%29&utm_content=Yahoo%21+Mail
NHPC: Gap Seen Between HIV Diagnosis and Care- I know AEMD is rightfully focused on HCV currently but the HP may be the fastest means to get the viral load down esp. in people diagnosed late with the disease)
http://www.medpagetoday.com/clinical-context/HIVAIDS/28074?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=ET&userid=335313