Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
rmzport,
thank you. AEMD is a co. with a tremendous potential - lets hope it gets recognized for what it is worth.
Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, including First in Human (FIH) Studies
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm279459.htm
AASLD: African Americans Face Hep C "Triple Whammy" (CME/CE)
http://www.worldbookandnews.com/medical-news/gastroenterology/200931-AASLD-African-Americans-Face-Hep-C-Triple-Whammy-CMECE.html
SAN FRANCISCO -- African Americans face a "triple whammy" when it comes to the hepatitis C virus, a researcher said here.
Two aspects of this triple threat are well known: the high prevalence of the virus in the African-American community and the lower response to therapy of infected individuals, according to Zobair Younossi, MD, of Inova Fairfax Hospital in Fairfax, Va.
But there's a third threat: African Americans don't spontaneously clear the virus as often as other racial and ethnic groups, Younossi reported at the annual meeting of the American Association for the Study of Liver Diseases.
"I would call it a triple whammy -- high prevalence, lower chance of spontaneous clearance, and then the lower chance of sustained virologic response," Younossi told MedPage Today.
"This is the population that we really need to focus on and develop something that will help," he said during a poster presentation.
Younossi and colleagues analyzed data collected from 2005 to 2008 by the National Health and Nutrition Examination Survey (NHANES), which included clinical and laboratory data on nearly 15,000 participants.
Included in the data were results for tests for hepatitis C antibodies and RNA, Younossi said, which allowed the researchers to look at rates of spontaneous clearance of the virus.
All told, they found that 192 of the 14,750 participants had antibodies to the virus. Also, 149 of the participants had hepatitis C RNA, indicating they remained infected. The other 43 had cleared the virus naturally.
In a univariate analysis, the only factor that was significantly different between the groups was the proportion of African Americans who remained infected versus those who had cleared the virus (P=0.0163), Younossi said.
The rate of clearance among African Americans in the cohort was 9.25%, compared with 27.2% among Caucasians and 31.2% among Hispanics.
In a multivariate analysis, Younossi said, the only independent predictor of not being able to clear the virus was African-American race. The odds ratio for non-clearance for African Americans, compared with Caucasians, was 3.80, with a 95% confidence interval from 1.31 to 11.36, which was significant at P=0.015.
The finding is, "not unexpected," according to Gary Davis, MD, of Baylor College of Medicine in Houston, who was not involved in the study.
Davis told MedPage Today that analysis of smaller cohorts had suggested the disparity and the confirmation in such a large group is useful and important.
The explanation may lie in a genetic factor: a single nucleotide polymorphism in the IL28b gene that has been shown to reduce the response to therapy, and may also cut the rate of spontaneous clearance, he added.
People with the two copies of the C allele of the gene respond best to treatment, while those with two copies of the T allele are most resistant. Those with one copy of each allele fall in the middle.
There is evidence that the same is true for the ability to clear the virus naturally, Davis said, and since the T allele is more common in African Americans, it would explain the findings of Younossi and colleagues.
Younossi told MedPage Today it's likely that the genetics plays an important role, but he said he believes that genetics is only a component and not the main reason for the response rates.
The researchers did not report external support for the study. Younossi reported financial links with Vertex, Biolex, Tibotec, and Salix.
Davis reported financial links with Vertex, Tibotec, Genentech, Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Novartis, and Pharmasset.
http://www.q1productions.com/medicaldeviceapprovals/Index.php
Providing Clarity & Definition to New & Existing FDA Regulatory Pathways to Ensure Medical Device Approvals in a Timely & Cost Efficient Manner
December 8-9, 2011
Baltimore, MD
ABOUT THE CONFERENCE
The medical device industry is experiencing greater regulatory scrutiny from FDA; several instances of device failures and high profile recalls have resulted in the agency looking closer at devices on the market and their approval processes. Changes to popular approval routes such as the 510(k) are up for reconsideration. With budgets throughout the industry already stretched, changes to regulatory directives are causing confusion and concern, as indications point to more clinical research data being required, longer trials being conducted and longer times to market. This conference will provide clarity to new regulatory pathways for device approvals and regulatory oversight.
| More Info |
TOPICS TO BE COVERED
Understanding Changes to the 510(k) Regulatory Process
Improving Transparency & Communication from the Agency to the Public
Achieving a Better Understanding of how FDA Scrutinizes Predicate Devices
Assurance Case Reports & its Impact on 510(k) Submissions
Comprehending FDA's Regulatory Approval Process for Combination Products
Using Pre-IDE Meetings to Streamline the IDE Process
Panel Discussion: Q&A Sessions with FDA Representatives
Evaluating Recent FDA Approvals
Exploring the Usefulness of the De Novo Process
Case Study: A Look at the Modular PMA Process
Navigating the Regulatory Process in Europe
Examining FDA Rules Governing Social Media
Reviewing Recent Enforcement Actions Regarding Off-Label Use
Examining the Latest Recall Cases in the Medical Device Industry
Investigating Trends in Warning Letters Issued by the FDA
Albert Einstein College of Medicine receives $8 million from NIH to study how cancer spreads
Bronx, NY -- The National Cancer Institute (NCI) has awarded Albert Einstein College of Medicine of Yeshiva University two grants totaling $8 million to study the microenvironments that drive the spread of cancer from the primary tumor to other parts of the body in the process known as metastasis.
"Although metastasis is responsible for the vast majority of cancer-related deaths, our understanding of this complex process is extremely limited and so are the opportunities for preventing metastatic disease," said John Condeelis, Ph.D., professor and co-chair of anatomy and structural biology, co-director of the Gruss Lipper Biophotonics Center, director of the program in microenvironment and metastasis in the Albert Einstein Cancer Center, and holder of the Judith and Burton P. Resnick Chair in Translational Research at Einstein. Dr. Condeelis is a principal investigator on both grants.
The first grant, for $4 million over five years, will establish a tumor microenvironment research center (TMEN Center) at Einstein, one of 11 new national centers created by NCI's Tumor Microenvironment Network. The Einstein center will be led by principal investigator Dr. Condeelis and co-principal investigator Vladislav Verkhusha, Ph.D., professor of anatomy and structural biology.
The scientists will study two types of primary-tumor microenvironments. The first type programs cancer cells to disseminate from the primary tumor as dormant tumor cells. These cells eventually awaken after many years and give rise to recurrent cancers at distant sites—a condition currently not possible to detect and treat. Also under investigation is the type of microenvironment that controls whether disseminating tumor cells will grow immediately upon arrival at distant sites and are therefore sensitive to treatment.
The research will focus on breast and head and neck tumors, but the results should be applicable to a wide variety of solid tumors. Other investigators on this grant are from Mount Sinai School of Medicine, New York; College of Nanoscale Science & Engineering, University at Albany, State University of New York; and the University of Wisconsin-Madison.
In a second $4 million NCI grant, titled "In vivo multiphoton based imaging of complex cancer cell behavior," Einstein investigators will study the spread of breast tumor cells from the primary tumor using cutting-edge research methods including: high-resolution multiphoton microscopy (capable of imaging breast tumors at the single-cell level), advanced fluorescent proteins (which allow multicolor deep-tissue imaging and studies of dynamics of metastasis), and a novel methodology that uses computer modeling to analyze cancer (which may be able to identify the genes that propel cell migration, dissemination and other tumor-cell behaviors involved in metastasis).
One important factor in securing the grants is the advanced imaging capacity of the Gruss Lipper Biophotonics Center, which was established through the generous support of Evelyn Gruss Lipper, M.D., an Einstein alumna, former faculty member and former member of the Board of Overseers. "Due to her generosity, this combination of technologies is unique to Einstein," said Dr. Condeelis.
###
The three principal investigators on the second grant are Dr. Verkhusha, Dr. Condeelis, and Aviv Bergman, Ph.D., professor and founding chair of systems & computational biology.
About Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University is one of the nation's premier centers for research, medical education and clinical investigation. During the 2010-2011 academic year, Einstein is home to 724 M.D. students, 256 Ph.D. students,122 students in the combined M.D./Ph.D. program, and 375 postdoctoral research fellows. The College of Medicine has 2,770 full time faculty members located on the main campus and at its clinical affiliates. In 2010, Einstein received nearly $200 million in support from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Through its extensive affiliation network involving five medical centers in the Bronx, Manhattan and Long Island – which includes Montefiore Medical Center, The University Hospital and Academic Medical Center for Einstein – the College of Medicine runs one of the largest post-graduate medical training programs in the United States, offering approximately 150 residency programs to more than 2,500 physicians in training. For more information, please visit http://www.einstein.yu.edu.
Mayo Clinic Researchers Discover Why Measles Spreads so Quickly (See the bottom -Please see posts 2341- 2348. This has some implications for AEMD. Maybe people from these institutions should be made aware of AEMD as an antiviral/exosome filter - some of these institutions have deep pockets for cancer research)
Wednesday, November 02, 2011
ROCHESTER, Minn. — Mayo Clinic researchers have discovered why measles, perhaps the most contagious viral disease in the world, spreads so quickly. The virus emerges in the trachea of its host, provoking a cough that fills the air with particles ready to infect the next host. The findings may also help in the fight against ovarian, breast and lung cancers.
The findings, published online Nov. 2 in the journal Nature, give researchers insight into why some respiratory viruses spread more quickly and easily than others: They found the measles virus uses a protein (called nectin-4) in the host to infect and then leave from the strategic location of the throat.
Despite the development of a measles vaccine, the virus continues to affect more than 10 million children each year and kills about 120,000 worldwide. In recent years, the spread of the virus has increased due to lack of people being vaccinated, and measles is still a significant public health problem in the United States.
But why is the measles virus so much more contagious than other respiratory viruses?
"The measles virus has developed a strategy of diabolic elegance," says Roberto Cattaneo, Ph.D., principal investigator of the study and Mayo Clinic molecular biologist. "It first hijacks immune cells patrolling the lungs to get into the host. It then travels within other immune cells everywhere in the body.
"However, the infected immune cells deliver their cargo specifically to those cells that express the protein nectin-4, the new receptor. Remarkably, those cells are located in the trachea. Thus, the virus emerges from the host exactly where needed to facilitate contagion."
The researchers were also excited about another aspect of these findings.
Nectin-4 is a biomarker of several types of cancer such as ovarian, breast and lung. Clinical trials are under way that use measles and other viruses to attack cancer — including current ovarian, glioma and myeloma clinical trials at Mayo Clinic.
Because measles actively targets nectin-4, measles-based cancer therapy may be more successful in patients whose cancer express nectin-4. Many researchers believe that modified viruses could be a less toxic alternative to chemotherapy and radiation.
Dr. Cattaneo worked with colleagues at the Paul Ehrlich Institute in Germany; Mathieu Mateo, Ph.D., and Chanakha Navaratnarajah, Ph.D., at Mayo Clinic; and other colleagues at the University of Iowa; the Armand Frappier Institute in Montreal, Canada; Inserm/CRCM/University of Aix-Marseille in France; and the National University of Singapore/Duke University.
The research was funded by the National Institutes of Health and by grant agencies in Germany, France, Canada and Singapore.
HIV-Related Measure Included Among New Leading Health Indicators Announced by HHS
Posted: 03 Nov 2011 11:51 AM PDT
By Ronald Valdiserri, M.D., M.P.H., Deputy Assistant Secretary for Health, Infectious Diseases, and Director, Office of HIV/AIDS Policy, U.S. Department of Health and Human Services
This week, Dr. Howard Koh, our Assistant Secretary for Health, unveiled critical health priorities for the nation known as “Leading Health Indicators” (LHIs). I am very pleased to point out that these important national indicators include an HIV-related measure. Announced at the 138th Annual Meeting of the American Public Health Association, the LHIs are a smaller set of Healthy People 2020 objectives selected to communicate high-priority health issues and actions that can be taken to address them. Among the 26 prioritized LHIs organized under 12 topics is this measure: Persons living with HIV who know their serostatus.
“The LHIs are a call to action in critical public health areas that demand our immediate attention,” said Dr. Koh. “We can solve the most pressing health problems in this country, and the LHIs prioritize our actions for a healthier future.”
The LHIs will be used to assess the health of the U.S. population over the next decade, to facilitate collaboration among diverse groups, and to motivate individuals and communities to take action to improve their health. The LHIs also will be used by policymakers and public health professionals to track progress in local communities as they work toward meeting these key national health goals.
Our efforts to work towards the National HIV/AIDS Strategy’s goals are strengthened and reinforced by the inclusion of this measure among the LHIs because the indicators help communicate high-priority health issues to the public and actions that can be taken to address them. The indicator sets a target of 90 percent of persons aged 13 years and older living with HIV who are aware of their HIV infection, working from a baseline of 79 percent in 2006. The nation’s efforts will be monitored by CDC’s HIV surveillance system.
The Healthy People 2020 Federal Interagency Workgroup worked in collaboration with the Institute of Medicine of the National Academy of Sciences and the Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 to develop the LHIs. They also align with and further promote key priorities across the Department and Federal government, including the National HIV/AIDS Strategy, HHS Action Plan to Reduce Racial and Ethnic Health Disparities, and National Prevention Strategy.
Read the full press release about the Leading Health Indicators.
Visit the Healthy People 2020 website for more details.
UV light controls antibodies, improves bio-sensors
From detecting pathogens in blood samples to the study of protein synthesis, Quartz Crystal Microbalance (QCM) sensors have many uses in modern biology. In this technique, antibodies anchored to gold electrodes on a piece of quartz crystal act like the "hooks" on the sticky side of a Velcro strap, grabbing molecules of interest as they pass by. The more molecule-sensing antibodies on the surface of the sensor, the more sensitive the QCM device's detection capabilities.
Unfortunately, some of the antibodies typically anchor themselves to the gold plate "hook"-side-down, rendering them useless as bio-receptors and dampening the sensor's sensitivity. Now researchers from the University of Naples "Federico II" and the Second University of Naples in Italy have found a way to increase the number of right-side-up antibodies in this well-established molecule detection process – using light. In a paper recently published in the Optical Society's open-access journal Biomedical Optics Express, the team of scientists irradiated antibodies with ultra-short pulses of ultraviolet (UV) light. The UV light is absorbed by the amino acid tryptophan, which breaks the disulfide bridges holding parts of the antibody together and causes a particular part of the amino acid cysteine, called a thiol group, to become exposed at the tail end of the antibody. Because thiol groups are more strongly attracted to the gold electrodes than other parts of the antibody, the bottom sides of these irradiated antibodies become much more likely to adhere to the gold electrodes than the "hook" ends. Using this method, the researchers were able to more than double the sensitivity of the QCM device, opening up new possibilities for research using this type of sensor, the researchers say.
Paper: "Light assisted antibody immobilization for bio-sensing," Biomedical Optics Express, Della Ventura et al., Vol. 2, Issue 11, pp. 3223-3231 (2011).
Viral Hepatitis Action Plan Update
Posted: 02 Nov 2011 12:00 AM PDT
By Ronald Valdiserri, M.D., M.P.H., Deputy Assistant Secretary for Health, Infectious Diseases, and Director, Office of HIV/AIDS Policy, U.S. Department of Health and Human Services
Dr. Ronald Valdiserri
Recently, I had the pleasure of participating in the National Viral Hepatitis Technical Assistance Meeting where there was significant focus on realizing the potential of the Viral Hepatitis Action Plan. Organized by the National Alliance for State and Territorial AIDS Directors and the National Viral Hepatitis Roundtable , the meeting brought together Adult Viral Hepatitis Prevention Coordinators from state health departments across the nation with hepatitis advocates, community leaders and representatives from Federal government and industry.
Overview of Implementation and HHS Commitment
During a plenary session, I shared an update on Federal actions underway to implement the Viral Hepatitis Action Plan. I focused on our efforts to better coordinate viral hepatitis programs and activities across Federal government, which are being advanced with the support of a cross-government working group known as the Viral Hepatitis Implementation Group (VHIG). Comprised of representatives of agencies and offices from across the Department of Health and Human Services (HHS) as well as colleagues from the Department of Veterans Affairs and the Department of Justice’s Bureau of Prisons, the VHIG is charged with improving coordination, identifying opportunities for new collaborations, and making the best use of all the available resources to achieve better outcomes related to the prevention, diagnosis and treatment of viral hepatitis.
In another session, Dr. Howard Koh, Assistant Secretary for Health, discussed highlights of the progress made since the release of the Action Plan almost six months ago, highlighting the World Hepatitis Day event held at the White House. Dr. Koh also reaffirmed the commitment of his office—which includes, among others, my office as well as the Office on Minority Health and National Vaccine Program Office—to pursuing the Plan’s goals. Dr. Koh thanked the participants for their efforts in support of the Plan and the essential work they do in states and communities to help advance it.
Hepatitis Priorities of Federal Agencies
During another session, colleagues from several agencies within HHS shared highlights of the efforts underway to implement the Action Plan, including:
Health Resources and Services Administration—Dr. Sarah Linde-Feucht, Chief Public Health Officer, discussed how the Health Resources and Services Administration’s (HRSA) is supporting implementation of the Action Plan in several ways, particularly by facilitating access to health care through the health center and Ryan White programs, and operating training programs for the health care workforce. She noted that HRSA’s HIV/AIDS Bureau recently updated its resource guide Hepatitis and HRSA’s Ryan White HIV/AIDS Care and is now administering the $1.6 million Hepatitis C Treatment Expansion Initiative which supports 15 projects around the nation in implementing effective, focused interventions designed to increase access to and completion of Hepatitis C (HCV) treatment for HIV-positive patients.
HRSA’s Bureau of Primary Health Care—Addressing how HRSA’s health center program supports implementation of the Viral Hepatitis Action Plan, Dr. Seiji Hayashi, Chief Medical Officer of HRSA’s Bureau of Primary Health Care (BPHC), noted that the program serves over 19 million patients at over 8,100 service sites across the nation providing significant capacity for prevention, diagnosis and treatment of viral hepatitis. BPHC supports and promotes the use of evidence-based guidelines and practices including hepatitis B screening and immunizations, HCV testing guidelines, harm reduction efforts, and hepatitis treatment guidelines. Dr. Hayashi also highlighted several BPHC-supported national technical assistance centers available to assist health centers with improving their services for specific populations disproportionately impacted by viral hepatitis such as Asian and Pacific Islander Americans, persons with a history of drug use, and the lesbian, gay, bisexual and transgender populations.
Centers for Disease Control and Prevention—Dr. John Ward, Director of CDC’s Division of Viral Hepatitis (DVH), reported that CDC is continuing to develop its “Know More Hepatitis” education campaign and is in discussions with partners about the development of a National Hepatitis Testing Day that would be observed in May. He also shared that DVH is examining the evidence base for a recommendation for one-time universal HCV testing of all “Baby Boomers” (i.e., those born between 1946 and 1964) because of the higher prevalence among that population. Finally, Dr. Ward reminded us that despite declines in transmission of hepatitis C since the 1990s, HCV transmission “is alive and well in the United States.” He pointed, in particular, to a concerning resurgence in new infections among young people (15-24 years old) documented by several state surveillance programs and supported by data from the Youth Risk Behavior Survey that shows a significant increase over time in injection drug use among that demographic in several states and cities.
Substance Abuse and Mental Health Services Administration—Mr. Warren Hewitt of SAMHSA’s Center for Substance Abuse Treatment (CSAT) discussed efforts underway within the agency to support implementation of the Action Plan including work by the Addiction Technology Transfer Centers to update their viral hepatitis continuing education curriculum and intensify dissemination of evidence-based viral hepatitis prevention, testing, and treatment practices among providers of substance abuse treatment services. SAMHSA is also exploring ways to place greater emphasis on viral hepatitis prevention, intervention and treatment with grantees in both their block and discretionary grant programs. Finally, Mr. Hewitt shared that CSAT’s Division of Pharmacologic Therapies is distributing the Action Plan to its grant program officers and will be providing training about it in 2012 so that these key liaisons are able to encourage and support grantees in working to better integrate viral hepatitis into their work.
As these several updates illustrate, agencies across the government are actively working to pursue the positive health goals of the Viral Hepatitis Action Plan. I look forward to continuing the collaborations with my Federal and non-Federal colleagues as we work in the months and years ahead to become a nation fully committed to combating the silent epidemic of viral hepatitis.
Combating the Silent Epidemic of Viral Hepatitis
Action Plan for the Prevention, Care and Treatment of Viral Hepatitis
http://www.aids.gov/hepatitis/
DARPA-SN-12-05
DARPA MTO
Dialysis Like Therapeutics (DLT)
Technology Exchange
Arlington, VA
The Defense Advanced Research Projects Agency (DARPA) Microsystems Technology Office (MTO) will conduct a briefing in support of the anticipated Broad Agency Announcement (BAA) for the integration portion of the Dialysis Like Therapeutics (DLT) program. When released, the BAA will be posted on the Federal Business Opportunities (FBO) website, http://www.fedbizopps.gov and the Grants.gov website, http://www.grants.gov. This Technology Exchange workshop is unclassified.
Attendance at the DLT Technology Transfer Day is voluntary and is not required to propose to subsequent BAAs (if any) on this topic. The Technology Exchange Day workshop does not constitute a formal solicitation for proposals or abstracts. This announcement is issued solely for information and program planning purposes and is not a Request for Information (RFI). Since this is not an RFI, no submissions against this notice will be accepted by the Government. DARPA will not provide reimbursement for costs incurred to participate in this workshop. Interested parties to this notice are cautioned that nothing herein obligates the Government to issue a solicitation.
BACKGROUND
The goal of DARPA’s Dialysis Like Therapeutics program is to develop a portable device that removes “dirty” blood from the body, separates harmful agents, and returns “clean” blood to the body in a manner similar to dialysis treatment of kidney failure. While the device could have an impact across multiple areas of medicine, the target application for this device is sepsis.
The envisioned system will be capable of removing at least 90% of unknown pathogens, cytokines, toxins, and activated cells from a patient in one day with the objective of significantly reducing patient mortality. At the completion of the program the device will be submitted to the Food and Drug Administration (FDA) for possible Investigational Device Exemption (IDE) status.
In the initial DLT solicitation, DARPA-BAA-11-30, DARPA sought innovative proposals to develop and apply scientific advances in the design of system components for a blood sensing and purification device. Fundamental to the success of DLT is the integration of the system components currently being developed into a portable device. As stated in the initial DLT solicitation, system integrators will be responsible for managing the life-cycle system integration process that includes system design, integration, validation, regulatory approval, and demonstrations throughout the program. It also stated that proposers for system integration are required to develop intellectual property agreements with component developers. Therefore, meeting participants could include technical, business development, and contracting personnel from teams considering submission to potential future solicitations.
This Special Notice serves as an announcement for a Technology Exchange workshop. The objective of the workshop will be to familiarize interested parties with the DLT component technologies, discuss potential scientific requirements for integration proposals, and examine award instrument types and funding options for the forthcoming Integration Broad Agency Announcement (BAA).
PURPOSE
The purpose of the DLT Technology Transfer workshop is threefold:
1. To familiarize participants with DARPA’s interest in integrating DLT related component technologies into a device.
2. To identify potential proposers and promote understanding of the anticipated DLT BAA proposal requirements; and
3. To promote discussion of synergistic capabilities among potential program participants.
It is DARPA’s desire to receive comprehensive, quality responses to the anticipated DLT BAA. To assist those wanting to form strong, collaborative teaming efforts and business relationships, a teaming website (http://teaming.sysplan.com/BAA-11-30/) exists to facilitate formation of teaming arrangements between interested parties. Specific content, communications, networking, and team formation are the sole responsibility of the participants. Neither DARPA nor the Department of Defense endorses the destination website or the information and organizations contained therein. This website is provided consistent with the stated purpose of the anticipated DLT BAA.
Additional information regarding the DLT BAA will be available at http://www.darpa.mil/Opportunities/Solicitations/DARPA_Solicitations.aspx#MTO following the publication of the BAA on FBO. It is anticipated that the DLT BAA will be released in early April 2012. If a BAA is released, materials presented at the workshop, as well as a frequently asked questions (FAQ) document compiling questions and answers received to date, may be made available at the website mentioned above.
TENTATIVE AGENDA
Registration: 0800-0900 EDT
Presentations/Discussions: 0900-1700 Eastern
*Date of the meeting is to be determined; plan for March 28 or 29, 2012.
REGISTRATION INFORMATION
• Interested parties must register for the Technology Transfer workshop at https://safe.sysplan.com/mto/dlt_transfer. This website will not be operational until 2012.
• Registration must be completed by COB March 9, 2012.
• Non-U.S. citizens are required to submit a DARPA Form 60 to the registration website no later than COB March 9, 2012. Submission instructions will be sent in the registration receipt e-mail.
• All attendees will be required to present Government-issued photo identification upon entry to the event.
• There will be a registration fee for this event.
AEMD is presenting here.
http://www.sracap.com/events.html
Early natural killer cell counts in blood predict mortality in severe sepsis
Andaluz–Ojeda D et al. –
The results demonstrate the prognostic role of NK cells in severe sepsis, evidencing a direct association of early blood counts of these cells with mortality.
Results
Twenty-one patients died; 10 of them in the 72 hours following admission to the ICU.
The most frequent cause of death (n=12) was multi-organ dysfunction syndrome.
At day one, survivors showed significantly higher levels of IgG and C4 than those who finally died.
On the contrary, NK cell levels were significantly higher in the group of patients with fatal outcome.
Survivors exhibited a progressive increase from day one to day 10 of most of the immunological parameters evaluated (IgG, IgA, IgM, C3, CD4 (+), CD8 (+) T cells and NK cells).
Multivariate Cox regression analysis including age, sex, APACHE II, severe sepsis/septic shock status and each one of the immunological parameters showed that NK cell counts at day 1 were independently associated with increased risk of death at 28 days [hazard ratio (95%CI), p]: [3.34 (1.29 -8.64), 0.013].
Analysis of survival curves evidenced that levels of NK cells at day 1 (>83cel /mm3) were associated with early mortality.
SURGEONS DEVELOP A FASTER, LESS EXPENSIVE TECHNIQUE TO IDENTIFY
BACTERIAL INFECTIONS AND DETERMINE ANTIBIOTIC RESISTANCE
Raman spectroscopy technique may lead to more effective treatment for
patients with Staph infections
SAN FRANCISCO—Surgeons at Detroit Medical Center and Wayne State University in Detroit are developing a faster, less expensive method of identifying bacterial infections and determining their antibiotic resistance. Surgeons used a technology known as Raman spectroscopy to look at the bacteria’s infrared wavelengths and pinpoint unique patterns of molecular vibration in blood samples inoculated with Staphylococcus aureus, the bacteria that causes Staph infections. Their findings were reported today at the 2011 Annual Clinical Congress of the American College of Surgeons.
The study, led by Amy Riley Spencer, MD, general surgery resident at Detroit Medical Center and Wayne State University, observed 120 spectral patterns from four strains of antibiotic resistant S. aureus: two that were sensitive to the antibiotic methicillin, one that was resistant to methicillin, and a more stubborn form of Staph infection that has a reduced susceptibility to a last-resort antibiotic called vancomycin (RVS-MRSA).
Raman spectroscopy enabled the researchers to distinguish the methicillin sensitive S. aureus (MSSA) from methicillin resistant S. aureus (MRSA) with 90.2 percent accuracy. They also could tell the difference between MRSA and its more stubborn form, RVS-MRSA, with 96.3 percent accuracy. The S. aureus profiles were then entered into a statistical program to create a preformed model of the Raman spectra. When the surgeons tested new spectra, the program was 98 percent accurate in classifying the bacteria as one of the four strains.
Based on these results, the researchers believe the Raman spectroscopy technique could lead to the development of faster, more effective treatment for people with Staph infections. Currently, emergency room patients may have to wait about six hours before diagnostic tests can identify a Staph infection and another 24 to 72 hours to determine which antibiotics could treat it, said Dr. Spencer. In the meantime, “you treat these very sick patients with the antibiotics you have and hope that will control it. The overuse of such antibiotics has been blamed for the rise of antibiotic resistance. This scenario could lead to a situation where the bacterial infection can’t be treated. Our findings suggest that Raman spectroscopy can identify the infection earlier and save money by treating the infection quicker instead of hoping an antibiotic is working and then switching when it doesn’t,” Dr. Spencer explained.
The S. aureus profiles generated by Raman spectroscopy are among dozens of pathogen profiles being added to a database of other bacteria, viruses, malignant tumors, and fungi. “Our goal is to map out as complete a number of pathogens and pathogenic organisms as we can, starting with the most pertinent ones first and, as we get further into it, the ones you don’t see very often,” Dr. Spencer said. In early 2012, Dr. Spencer and her team expect to launch a clinical trial comparing Raman spectroscopy with traditional identification techniques with funding from the National Institutes of Health and Wayne State University.
Researchers are simultaneously developing a technology to integrate the pathogen database and the Raman spectroscopy technique into a hand-held device that would cut turnaround times for diagnostic test results from several hours to about 10 minutes. Currently, Raman spectroscopy is deployed through costly table-top devices and portable robots, said Gregory Auner, PhD, a professor in the department of electrical and computer engineering and founder and director of the Smart Sensors and Integrated Microsystems Program at Wayne State University.
“We are miniaturizing it even further, down to the size of two or three cell phones,” said Dr. Auner, who has led the hand-held device’s development for the last five years with grants from the U.S. Department of Defense and the National Institutes of Health. “Also, the price would be two orders of magnitude less, in the thousands of dollars,” he concluded.
Michael D. Klein MD, FACS; Jocelyn Y. Ang, MD; Tara A. Twomey, MS; David J. Sant, BSc; Chantelle N. Chinkhota, PhD; and Rachel E. Kast, PhD, also participated in the study.
# # #
Researchers identify potential molecular target to prevent growth of cancer cells
http://www.eurekalert.org/pub_releases/2011-09/uotm-rip091611.php
Fortilin is another synonym for TPT1 - see link below
http://www.ihop-net.org/UniPub/iHOP/gismo/92819.html
TPT1 is secreted in exosomes! Link above, also -
http://www.nature.com/cdd/journal/v15/n11/full/cdd2008104a.html
Early HIV Treatment Dramatically Increases Survival In Patients Co-Infected With Tuberculosis
Timing is everything when treating patients with both HIV and tuberculosis. Starting HIV therapy in such patients within two weeks of TB treatment, rather than two months as is the current practice, increases survival by 33 percent, according to a large-scale clinical trial in Cambodia led by researchers at Children's Hospital Boston and the Immune Disease Institute (IDI).
The study's results reported by Anne Goldfeld, MD, of the IDI and the Program in Cellular and Molecular Medicine at Children's Hospital Boston, and the CAMELIA (Cambodian Early versus Late Introduction of Antiretrovirals) study team in the October 20 issue of the New England Journal of Medicine definitively show that immunosuppressed HIV-TB co-infected patients should be started on ART rapidly at two weeks after beginning TB therapy. At the same time, the results strongly suggest that the World Health Organization (WHO) should be more aggressive in its recommendations for treating such patients.
A collaboration of Cambodian, French, and American physicians and researchers, the CAMELIA trial set out to settle a long-standing debate in the medical community over the relative timing of antiretroviral (ART) and anti-TB treatment regimens in co-infected patients. Some have advocated for delaying ART for upwards of two months after initiating anti-TB treatment, arguing that the toxicity of and difficulties in adhering to the two regimens (which together require patients to take seven pills every day), as well as the risk of severe inflammation as the immune system rebounds from HIV's suppressive influence, create undue burden on patients. Those supporting early initiation of ART note that rapid restoration of immune function bolsters the effects of anti-TB treatment.
"Tuberculosis claims the lives of more than half a million people with HIV worldwide every year," said Goldfeld, who holds professorships in medicine at Harvard Medical School and immunology and infectious diseases at Harvard School of Public Health and is co-founder of the Cambodian Health Committee. "This is a tragedy, because TB is completely curable when diagnosed and treated properly even in a patient with advanced HIV, especially if the patient also receives anti-retroviral therapy."
The WHO, in its most recent guidelines, recommended that co-infected patients start ART as soon as possible within eight weeks of initiating anti-TB treatment, but at the time lacked any evidence-based research to provide more fine-grained guidance.
Upon enrollment in the CAMELIA trial, all participants started standard treatment for TB, followed either two weeks or two months later by ART. Patients, all of whom had very weak immune systems, were seen at one of five study sites across Cambodia and followed for as long as four and a half years. By the time enrollment closed, 661 patients had been recruited into the study.
The study's results make a very strong case for starting ART treatment as early as two weeks after initiating treatment for TB. At the end of the study, the survival rate in the early ART arm was 33 percent greater than that in the late ART arm.
The study was also remarkable for its successful level of follow up: Of the trial's 661 participants, only 12 were lost to follow-up over the study period, and participants only missed less than one percent of the study's 8,955 scheduled visits.
"When we started, there was no research infrastructure for conducting such a trial in Cambodia. ART was just being introduced into the country, and HIV and TB were not being treated in an integrated fashion," Goldfeld said. "As side benefits, over the course of the study we helped to establish a center of excellence for HIV and TB care, and a center for treating children with HIV. We also created a national framework in Cambodia for treating patients with multi-drug resistant TB, which is now being replicated in Ethiopia.
"We also want to understand how the immune system is restored when you give HIV drugs while treating TB at the same time," Goldfeld continued. "This trial has created an unprecedented opportunity to gain fundamental insights into the workings of the immune system in the context of HIV and TB. It has many fruits yet to bear."
The study, which was previously reported at the 18th Annual AIDS Meeting in Vienna in 2010, was supported by the National Institute of Allergy and Infectious Diseases and the French National Agency for Research on AIDS and Viral Hepatitis.
Mortality of HIV-infected patients starting potent antiretroviral therapy: comparison with the general population in nine industrialized countries Full Text
International Journal of Epidemiology,
In industrialized countries, the mortality experience of HIV–infected patients who start ART and survive the first 6 months continues to be higher than in the general population, but for many patients excess mortality is moderate and comparable with patients having other chronic conditions. Much of the excess mortality might be prevented by earlier diagnosis of HIV followed by timely initiation of ART
Innovation Institute Debuts At Henry Ford Hospital (One of the projects includes Dialysis like therapeutics for treating sepsis!!! I wonder who is involved in this. This is actually good for AEMD - more research will only make DLTs acceptable, as this is a very new concept in clinical medicine. When the DARPA product comes out and works as envisioned, the market will be huge. Also, many hospitals would have multiple units to prevent sepsis in potential patients.)
http://www.fox14tv.com/story/15676752/innovation-institute-debuts-at-henry-ford-hospital?clienttype=printable
PR Newswire
10/12/11 - 12:06 PM EDT
DETROIT, Oct. 12, 2011 /PRNewswire/ -- A $12-millionDetroit project aimed at shaping the future of medicine – the Innovation Institute at Henry Ford Hospital – officially opened its doors today."Our vision is to grow a robust new industry within the region with the potential to create new jobs. By doing so, we can improve the health, economy and living standards of our community," says Madhu Prasad, M.D., director of the Innovation Institute at Henry Ford and a surgeon.The Institute, located on the campus of Henry Ford Hospital, is a partnership that includes Henry Ford Medical Group, the College for Creative Studies (CCS), the Smart Sensors and Integrated Microsystems (SSIM) Program at Wayne State University and The Henry Ford."We were surprised to discover that imaginative thinkers, who had little experience with doctors or hospitals, were able to partner in unique and synergistic ways with Henry Ford engineers and scientists. We have assembled a remarkable set of intellectual assets here in Southeast Michigan that promises to transform care," says Dr. Prasad.The Institute already has launched several dozen projects, including:
•Virtual breast biopsy.
•Knifeless surgery.
•Rapid diagnosis of viruses and cancers.
•Surgical probes that can instantly differentiate malignant versus normal cells.
•Endotracheal equipment products that allows any user, trained or untrained, to intubate a neonatal patient quickly, easily and precisely.
•A surgical retractor system that enables transition from laparoscopic surgery to open surgery.
•An ergonomic operating room chair for physicians.
•A waiting room communications system that keeps patients' families informed through every step of a loved one's surgery.
•Dialysis-like therapeutics to treat sepsis.
•A blood test to objectively identify traumatic brain injury.
•A portable "environment-of-care" cabinet which provides soothing music, light, and aroma therapy to enhance patient recovery.
•A Health Kiosk which provides empowering medical information.
Blood Infection Costliest U.S. Hospital Condition: Report
Septicemia treatment totaled $15.4 billion in 2009, agency says
http://consumer.healthday.com/Article.asp?AID=657661
Scripps Florida Scientist Awarded $2.2 Million Grant to Study Hepatitis C
http://www.scripps.edu/news/press_releases/20111010tellinghuisen.html
Up to 40% of cancers 'are caused by viruses': Discovery offers hope of vaccines and new therapies
http://www.dailymail.co.uk/health/article-2049775/Cancer-vaccine-step-closer-viral-infections-linked-40-cent-cases.html
EASL: Antiretroviral Therapy Reduces Liver Fibrosis Progression in HIV/HCV Coinfected People
Earlier initiation of antiretroviral therapy (ART) and spending more time on HIV treatment may help slow liver disease progression in HIV/HCV coinfected patients, according to an Italian study using non-invasive methods presented at the 13th European AIDS Conference (EACS 2011) last week in Belgrade.
An Update on Treatment of Genotype 1 Chronic Hepatitis C Virus Infection: 2011 Practice Guideline by the American Association for the Study of Liver Diseases
http://www.aasld.org/practiceguidelines/Pages/NewUpdatedGuidelines.aspx
HIV CDC FOA
The Council was briefed on the Center for Disease Control and Prevention’s recent funding opportunity announcement (FOA) for funding opportunity announcement (FOA) for HIV prevention programs for health departments. First, the council heard from Ms. Eva Margolies, Associate Director for Planning and Policy Coordination in the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, who explained that CDC revised the funding requirements to align with the NHAS. The FOA, she explained, responded to the Strategy’s call for CDC to refocus its funded prevention programs for maximum effect on reducing new HIV infections and address any misalignment of HIV prevention resource allocations, ensuring that funding follows the epidemic. In developing the revised requirements, CDC consulted with a variety of stakeholders and made several revisions based on their input. The requirements embody CDC’s commitment to high impact prevention using scalable, cost-effective interventions with demonstrated potential to reduce new infections and yield a major impact on the HIV epidemic. The applications are currently under review at CDC with funding awards anticipated in January 2012. Ms. Margolies shared that CDC is currently planning for capacity building assistance to help grantees adapt to the changes in funding levels that will be phased in over five years. Next, Ms. Julie Scofield, Executive Director of the National Alliance of State and Territorial AIDS Directors (NASTAD), shared some concerns that her members have about the revisions reflected in the FOA and their potential impact on future HIV prevention efforts across the Nation. These include the fact that NASTAD believes HIV prevention has been and continues to be “woefully underfunded,” reflecting only four percent of Federal domestic HIV investments. NASTAD urged examination of whether all other Federal domestic HIV resources are being used to better purpose than prevention. She noted that a number of State health departments will experience substantial reductions in the levels of funding they receive for HIV prevention activities under this new funding opportunity. This is cause for concern among many States, particularly those with relatively low HIV incidence since the reductions will impair their ability to maintain the HIV prevention infrastructure that they have developed over the years. In addition, Ms. Scofield urged restoration of funding that has been reduced to the pool of resources available to the health departments.
Halozyme Announces Positive Results From Roche's Subcutaneous Herceptin Phase 3 Trial
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, announced that the Phase 3 HannaH trial, conducted by Roche, showed that women with HER2-positive early breast cancer who received a new, investigational subcutaneous (SC) injection of Herceptin® (trastuzumab), experienced comparable results to Herceptin given as an intravenous (IV) infusion. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required.
"We are very pleased to see this important program achieve success in a Phase 3 pivotal clinical trial," said Gregory Frost, Ph.D., Halozyme's president and CEO. "The convenience of subcutaneous administration may provide another option for women living with early breast cancer."
No new safety signals were observed and adverse events were overall consistent with Herceptin IV. Data from the trial will be submitted for presentation at an upcoming medical meeting and will support a marketing application to regulatory authorities in the European Union in 2012.
Roche has additional ongoing trials of a subcutaneous formulation of MabThera® (rituximab), using Enhanze™ Technology in patients with CD20+ non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukaemia (CLL).
About the HannaH trial
HannaH is a Phase III, open-label trial involving 596 women with HER2-positive early breast cancer. The trial was designed to compare trastuzumab concentration in the blood (pharmacokinetics), efficacy (pathologic complete response) and safety of Herceptin SC to that of Herceptin IV.
The trial met its co-primary endpoints that were trastuzumab concentration in the blood (serum concentrations) and efficacy. Secondary endpoints included event-free survival and overall survival. In the trial the most common side effects seen were infections and abnormal blood counts (anaemia and low white blood count) similar to other trials with chemotherapy and Herceptin IV.
About Herceptin subcutaneous delivery
Herceptin SC uses Enhanze™ Technology, developed by Halozyme(R) which enables the injection of large volumes of a medication under the skin (subcutaneous) and enhances pharmacokinetics. It works by reversibly breaking down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin.
About Breast Cancer
Breast cancer is the most common cancer among women worldwide. Each year about 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 people will die of the disease annually.
In HER2-positive breast cancer, increased quantities of the HER2 receptor are present on the surface of the tumour cells. This is known as 'HER2 positivity' and affects approximately 15-20 percent of people with breast cancer.
Treating TB, HIV Co-Infections Early, Aggressively Can Save Lives, Multiple Studies Show
http://globalhealth.kff.org/Daily-Reports/2011/October/20/GH-102011-TB-HIV-Coinfection-Study.aspx
lowman, Herrm, Conix - welcome.
abc1938,
I have been very busy the past few days with the family and am opening my laptop after 4 days!
To my knowledge AEMD is not selling any products anywhere currently. It should not be long though as they should announce some results of the HCV trial soon and then slowly start using it on the general population in India, even before they have the complete results of the trial. This is my hunch.
I am glad you asked about GMPs - I looked it up and learned a lot myself. This is a good link -
http://en.wikipedia.org/wiki/Good_manufacturing_practice
Mobilizing Public and Private Sector Investments to Support Critical HIV Services
Posted: 07 Oct 2011 07:42 AM PDT
By Joan Romaine and James Albino* (Cross-posted from The White House Office of National AIDS Policy Blog)
The White House Office of Social Innovation and Civic Participation and the Office of National AIDS Policy held a joint meeting on Friday, September 9th on “Mobilizing Public and Private Sector Investments to Support the Goals of the National HIV/AIDS Strategy,” in which 25 members from the private sector and philanthropic community gathered to discuss ways to enhance existing support and investments targeted at HIV/AIDS prevention, care and treatment, as well as to strategize on ways to bring new people to the table to foster new investments and commitments.
Office of National AIDS Policy (ONAP) Director, Jeffrey Crowley welcomed guests and reiterated the President’s message that the Federal government cannot do this essential work alone. At this “all-hands-on-deck” moment, we must work together in new ways to make lasting progress on persistent social problems. Marta Urquilla, Senior Policy Advisor in the Office of Social Innovation and Civic Participation, explained how the Social Innovation Fund (SIF), which invested in AIDS United as part of its inaugural portfolio in 2010, reflects a new way of doing business for the federal government. The SIF invests in intermediaries to identify promising community solutions that are achieving results and support the growth, validation and scale of those innovations. A vehicle for public-private investment, the SIF leverages 3 private dollars for every 1 Federal dollar, and drives capital to communities in need, including those that are historically under-resourced.
Mark Ishaug, President and CEO of AIDS United (AU) presented AIDS United’s new “Make It Grow” campaign and gave an update from AU’s Access to Care (A2C) Initiative. He talked about the importance of the commitments and investments they’ve received from the private sector to do their work – which is leading thousands of people with HIV to have improved access to doctors and case management services. Terry McGovern, Senior Program Officer, HIV/AIDS Human Rights, Ford Foundation and Raymond Sacchetti, Senior Vice President, U.S. Virology, Bristol-Myers Squibb, both of whom have been critical partners in working with ONAP to stimulate private sector support for HIV programs, talked passionately about the importance of their commitments to this effort…providing the “why they need to do this,” as well as the importance of why they need to do this now, and describing why they feel it is a corporate responsibility to do this work. These discussions were followed by a presentation on the value of the data and national evaluation and outcomes to date by Johns Hopkins University professor and chair of the Department of Health, Behavior and Society, Dr. David Holtgrave.
Many participants recognized that this is an opportune time in the United States to support HIV programs, and there are many ways to become engaged. The bulk of the meeting time was given to a roundtable discussion where participants talked about successes and challenges, as well as effective solutions. Several participants discussed ways that they could work in new ways to support the engagement of other participants.
This meeting is one of a series focused on Public-Private Partnerships that ONAP will be hosting this fall.
Birmingham Kicks Off First of Five Fall Implementation Dialogues on the NHAS
Posted: 07 Oct 2011 09:07 AM PDT
By Joan Romaine, Policy Advisor, Office of National AIDS Policy, on detail from the National Institutes of Health (NIH) (Cross-posted from The White House Office of National AIDS Policy Blog)
The first of a series of five Implementation Dialogues was held on September 27 in Birmingham, Alabama, at the University of Alabama at Birmingham’s Alys Robinson Stephens Preforming Arts Center. The meeting focused on “Incorporating Prevention and Care Research Into HIV Programs” brought together speakers and panelists from across federal, state and local government, as well as experts from the HIV/AIDS community and research areas. Jeffrey S. Crowley, Director of the Office of National AIDS Policy (ONAP) welcomed the more than 150 guests, and thanked them for their work in support of the National HIV/AIDS Strategy. UAB President Carol Garrison, and Dr. Howard Koh, Assistant Secretary for Health, U.S. Department of Health and Human Services also spoke. Dr. Koh encouraged participants to make the National HIV/AIDS Strategy real in the southeast and around the country. He recalled the early days of the AIDS epidemic thirty years ago, and the extreme fear and stigma surrounding the treatment of the first patients, and the challenge of providing care with no plan or coordinated approach in place. He noted that while there is still a great deal of stigma and health disparities around HIV/AIDS, there is now a plan of action in the National HIV/AIDS Strategy, which he said has, “catalyzed the country”.
Attendees heard a presentation of research updates from UAB Associate Professor of Medicine and Project Director, UAB 1917 Clinic Cohort, Dr. Michael J. Mugavero. This baseline information of the latest HIV/AIDS research findings from the field (including HPTN 052 and CAPRISA 004) set the stage for the panel and community discussions, which were moderated by Dr. Michael Saag, Jim Straley Chair in AIDS Research and Director, Center for AIDS Research at UAB. The panelists included: Dr. Gina Brown, from the National Institutes of Health, Dr. Peter Leone, from the North Carolina Department of Health and Human Services, Dr. Deborah Parham Hopson, from Health Resources and Services Administration, Mr. Steve Wakefield from the Fred Hutchinson Cancer Research Center and Ms. Tiffany West, from the District of Columbia Department of Health.
Many important themes and suggestions came out of the meeting, including the need to do more HIV/AIDS testing, and the importance of linking and retaining more people into care. In addition, the need to address the health disparities that exist and the barriers to identifying people early. Some discussion was had around the difficulty people and communities have talking about sex, which makes it challenging to address sexually transmitted infections. Additional discussions stemmed around the need to understand better what puts people at risk for HIV, what will keep them in treatment , and how to integrate policies and programs at federal, state and local levels. Recommendations included focusing on what people and groups can do that are scalable and figuring out what prevention and education messages work for which communities. Policies, such as opt-out testing were discussed as well in terms of their impact, as well evaluating what’s working, tailoring interventions and sharing information. These and other important ideas and recommendations were brought forward and the ONAP will be developing a brief synthesis of the implementation dialogue that will be made available to the public. All of the Implementation Dialogues will be videocast on the ONAP website.
Treatment Compliance A Problem For Hepatitis C Patients (This is where the HP factors in - reduce the viral load acutely early in the disease and therefore possibly shorten the time required to be on oral meds. This becomes a win win situation for the patient , the drug companies and AEMD! We need FDA approval to start trials soon - ANESRI)
Patients being treated for chronic hepatitis C become less likely to take their medications over time, according to a new study from the Perelman School of Medicine at the University of Pennsylvania. Since the study also showed better response to the drugs when they're taken correctly, the researchers say the findings should prompt clinicians to assess patients for barriers to medication adherence throughout their treatment, and develop strategies to help them stay on track. The study is published online this month in Annals of Internal Medicine.
"Our findings are particularly timely since many chronic hepatitis C patients are now being prescribed direct-acting antiviral drugs, which have a complex dosing regimen that may be even harder for patients to maintain than the two-drug standard therapy," said lead author Vincent Lo Re, MD, MSCE, an assistant professor of Infectious Disease and Epidemiology. "These data show us that we need to develop and test interventions to help patients be more successful at taking their medicine and have the best chance at being cured."
Literacy issues, financial hurdles, and socioeconomic problems such as unstable living situations can all hamper patients' abilities to properly maintain their drug regimen. The authors suggest that refilling patients' pill boxes for them, creating easy-to-follow dosing and refill schedules, and helping them set alarms to remind them to take their medicine may all help improve adherence.
The Penn researchers studied 5,706 chronic hepatitis C patients who had been prescribed the standard treatment for the virus - pegylated interferon (given as a single weekly shot) and ribavirin (a twice-daily oral medicine) -- using pharmacy refill data and test results for virologic response during treatment. They found that patients who refilled their prescriptions on time had a higher likelihood of being cured of the infection. However, over the course of patients' treatment, adherence waned, and more often for ribavarin. That pattern, Lo Re notes, is similar to that among patients taking drugs for other chronic conditions, during which patients often develop so-called "pill fatigue."
The newer, more powerful direct-acting antiviral drugs, which must be taken every 8 hours, will add to the complexity, and cost, of chronic hepatitis C treatment. In addition, if the newer direct-acting antiviral drugs aren't taken properly, the hepatitis C virus may become resistant to treatment, compromising the chance of cure. Hepatitis C is a communicable disease spread via blood, from needle-sharing during IV drug use, tattooing or piercing, or even from more casual contact like sharing razors and toothbrushes. Worldwide, approximately 180 million people have the disease, about 4 million of them in the United States.
Monitoring for and treating drug-related side effects may also be a key factor in boosting adherence, Lo Re says. The study results showed that patients who received medication for thyroid dysfunction, anemia, or low white blood cell counts - common side effects associated with hepatitis C drugs - were more likely to remain adherent to their antiviral therapy. Although those drugs added more steps into their self care, Lo Re said the resulting relief for symptoms, including depression, fatigue and irritability, and more frequent visits to health care providers typically required with administration of these drugs, may play a role in patients' ability to maintain the regimen overall.
"We know that a major barrier to adherence is side effects of these drugs. People don't feel good when they're on them," he said. "If we can identify those problems and treat them when they occur, patients may be more motivated and feel well enough to continue with their prescribed regimen."
abc1938
Thank you very much for those sincere words. It does help to know that my efforts are not going wasted.
With the recent good news, one can view AEMD with a different perspective. I do feel that good days are ahead for the investors as well as for people who can benefit from the HP as a medical device.
Do keep posting on the board.
Viremia Copy-Years Predicts Mortality Among Treatment-Naive Human Immunodeficiency Virus–Infected Patients Initiating Antiretroviral Therapy (The HP from AEMD has to be one of the most potent available mechanisms to decrease the viral load acutely in HIV and HCV)
Clin Infect Dis. (2011) doi: 10.1093/cid/cir526 First published online: September 2, 2011
Conclusions. Viremia copy-years predicted all-cause mortality independent of traditional, cross-sectional VL measures and time-updated CD4+ T-lymphocyte count in ART-treated patients, suggesting cumulative HIV replication causes harm independent of its effect on the degree of immunodeficiency.
HHS Awards $1.89 Billion in Grants for HIV/AIDS Care and Medications
The U.S. Department of Health and Human Services (HHS) today announced the release of more than $1.89 billion to ensure that people living with HIV/AIDS continue to have access to life-saving health care and medications. The grants are funded through the Ryan White HIV/AIDS Program, which helps more than half a million individuals each year obtain clinical care, treatment and social support services.
“These grants will help make a real difference in the lives of Americans living with HIV/AIDS, especially those in underserved rural and urban communities, ensuring they get access to quality health care and support systems,” Secretary Kathleen Sebelius said. “The care and services these grants support will help Americans living with HIV/AIDS to live longer, healthier lives.”
The Health Resources and Services Administration (HRSA), an agency within HHS, oversees the Ryan White HIV/AIDS Program, which provides funding for health services for people who lack sufficient health care coverage or financial resources to cope with HIV disease.
Approximately $1.21 billion will be sent to states and territories under Part B of the Ryan White Program. In FY 2011, $885 million was appropriated for the AIDS Drug Assistance Program (ADAP). Part B awards also include formula base grants that can be used for home and community-based services, insurance continuation, ADAP assistance, and other direct services. Sixteen states will also receive Emerging Community grants based on the number of AIDS cases over the most recent 5-year period. Moreover, a total of $8,386,340 in Part B Supplemental grants was awarded to 36 states and territories that demonstrated need based on the severity of the HIV/AIDS epidemic in the state/ territory, including service needs of emerging populations, unmet need for core medical services, and unique service delivery challenges. These grants provide supplemental funding to address specific needs, including projected ADAP shortfalls and additional core medical services. For a list of Part B awards, visit: www.hrsa.gov/about/news/2011tables/110926hivaids.html#finalpartb.
From the ADAP appropriation, 30 Part B States and Territories will receive $40 million in ADAP Emergency Relief Funding (ERF) for the purpose of eliminating or reducing ADAP waiting lists and/or supporting cost containment strategies to prevent implementation of a waiting list. For a list of ADAP ERF awards, visit: www.hrsa.gov/about/news/2011tables/110926hivaids.html#partbadap.
A total of $645 million was awarded to 52 cities to provide core medical and support services for individuals living with HIV/AIDS under Part A of the Ryan White Program. These awards go to eligible metropolitan areas with the highest number of people living with HIV/AIDS and to transitional grant areas experiencing increases in HIV/AIDS cases and emerging care needs. The Part A awards include $49.6 million for the Minority AIDS Initiative to improve access to care in disproportionately impacted communities. For a list of Part A awards, visit: www.hrsa.gov/about/news/2011tables/110926hivaids.html#finalparta.
Seventy-five percent of Part A and B funds must be spent on “core medical services,” which include outpatient HIV/AIDS primary medical care services, prescription drug assistance, health insurance assistance and medical nutrition therapy. The remaining 25 percent pays for support services that help people living with HIV/AIDS achieve desired medical outcomes. These services include but are not limited to respite care, medical transportation and linguistic services.?“The Ryan White Program plays an important role in the fight against HIV/AIDS,” said HRSA Administrator Mary Wakefield, PhD, RN. “These funds will help link those affected by HIV/AIDS to the continuous and coordinated quality care they need.”
These funds also will support states and communities in their ongoing efforts to pursue the goals of the National HIV/AIDS Strategy, particularly efforts to increase access to HIV care and reduce HIV-related health disparities.
For information about HIV/AIDS prevention, testing, treatment, research, and use of new media in response to HIV/AIDS visit AIDS.gov.
9/27/11
Source
U.S. Department of Health and Human Services. HHS Awards $1.89 Billion in Grants for HIV/AIDS Care and Medications. Press release. September 26, 2011.
Impact of hepatitis C triple therapy availability upon the number of patients to be treated and associated costs in France: a model-based analysis
Gut doi:10.1136/gutjnl-2011-300586
Objective The combination of pegylated interferon (PEG-IFN), ribavirin (RBV) and a protease inhibitor (PI) has been approved in summer 2011 for the treatment of genotype 1 (G1) hepatitis C virus (HCV)-infected patients, with a substantially improved efficacy. The aim of this study was to estimate the number of G1 patients to be treated in France in 2012 and associated costs.
Results Compared with the 5100 G1 patients treated in 2010, the number of G1 patients receiving treatment in 2012 would be 15?000 in scenario 1, 18?300 in scenario 2 and 19?400 in scenario 3, among whom 2.5–3.7% may receive PEG-IFN/RBV and 96.3–97.5% PEG-IFN/RBV+PI. Costs associated with this regimen use ranged from 497 to 638 million Euros.
Conclusion These model-based estimates indicate that new anti-HCV treatments may result in a three- to fourfold increase in the number of G1 patients to be treated in France in 2012.
Hepatitis C virus infection in USA: an estimate of true prevalence (This is strong material for AEMD)
Authors: Chak, Eric1; Talal, Andrew H.2; Sherman, Kenneth E.3; Schiff, Eugene R.4; Saab, Sammy5
Source: Liver International, Volume 31, Number 8, 1 September 2011 , pp. 1090-1101(12
The recent National Health and Nutrition Examination Survey (NHANES) sampled only the civilian, non-institutionalized population of USA and may have underestimated the prevalence of hepatitis C virus (HCV) in this country. We searched the database MEDLINE, the Bureau of Justice Statistics, Center for Medicare and Medicaid and individual states Department of Corrections for all epidemiological studies regarding the prevalence of HCV in populations not sampled by the NHANES survey namely the incarcerated, homeless, nursing home residents, hospitalized and those on active military duty. Because of their relatively low frequency in the NHANES sample, we also expanded our search to include healthcare workers and long-term dialysis patients. Although included in the NHANES sample, we also performed searches on drug users (injection and non-injection) and veterans to confirm the findings of the NHANES study. Based on the prevalence of studies identified meeting our inclusion criteria, our most conservative estimates state that there at least 142 761 homeless persons, 372 754 incarcerated persons and 6805 persons on active military duty unaccounted for in the NHANES survey. While the NHANES estimates of drug users (both injection and non-injection) appear to be reasonable, the survey seems to have underestimated the number of HCV-positive veterans. Our most conservative estimates suggest that there are at least 5.2 million persons living with HCV in USA today, approximately 1.9 million of whom were unaccounted for in the NHANES survey
Aethlon Medical Announces Hemopurifier® and HER2osome™ Cancer Therapy Presentation at Exosomes and Microvesicles 2011
SAN DIEGO, Oct. 5, 2011 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that the Aethlon Hemopurifier® and HER2osome™ cancer therapy will be the subject of a presentation at the Exosomes and Microvesicles 2011 conference on October 17th. The event is being held at the Wyndham Lake Buena Vista Resort located in Walt Disney World, Florida. Dr. Annette Marleau, Director of Tumor Immunology at Aethlon Medical will give the presentation. Both the Aethlon Hemopurifier® and HER2osome™ represent novel exosome-targeted strategies to improve cancer treatment outcomes. Exosomes released by cancers have recently emerged to become therapeutic targets in cancer care, as they are implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes assist tumors in evading the response of the immune system.
ibox updated eom
Aethlon Medical Receives Government Contract Award from DARPA
http://aethlonmedical.investorroom.com/index.php?s=43&item=96