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.
From the 6/21 workshop -
SPECIAL NOTICE DARPA-SN-11-37: DARPA and FDA Workshop on Preclinical Platforms for Evaluating Medical Countermeasure Efficacy and Toxicity
WORKSHOP DATE: June 21, 2011
REGISTRATION DEADLINE: June 15, 2011, 4:00pm ET
TECHNICAL POCs: Dr. Barry Pallotta, DARPA DSO, and Dr. Suzanne Fitzpatrick, FDA OCS
E-MAIL: DARPA-SN-11-37@darpa.mil
Registration URL: http://www.sa-meetings.com/DARPA_FDAWorkshop
Teaming Site URL: https://team.sainc.com/DARPA_FDA
Description
The Defense Advanced Research Projects Agency (DARPA) Defense Sciences Office (DSO) and the U.S. Food and Drug Administration (FDA) Office of Chief Scientist (OCS) are hosting an informational workshop on June 21, 2011 at the Executive Conference Center (ECC) at Liberty Center in Arlington, VA. The purpose of the workshop is to discuss the scientific advancements that are needed, and the technical and regulatory challenges that must be overcome, for the development of human-relevant preclinical platforms for efficacy and toxicology testing.
A critical part of the United States’ response to emerging infectious diseases or chemical/biological attack is the rapid development of medical countermeasures including vaccines, pharmaceuticals, and medical devices. Recently, DARPA demonstrated that vaccine manufacturing, up to several million doses, can be greatly accelerated through novel plant-based methods. However, the use of any medical product in humans first requires preclinical evidence of efficacy and full understanding of toxicity before it can be marketed. Current methods for obtaining this information rely primarily on animal models that may have limited relevance to humans and/or poorly predict clinical effects. In addition, traditional testing consumes significant time that might not be available in a national emergency. Consequently, DARPA and FDA seek in vitro platforms that will rapidly assess efficacy, toxicity, and pharmacokinetics in a way that is relevant to humans and suitable for regulatory review of such medical countermeasures.
The goals of the workshop are: a) to introduce the biomedical and regulatory science communities to DARPA and FDA interest in modernizing regulatory science, particularly with respect to preclinical testing platforms for medical countermeasures, b) to solicit from participants ideas for technologies and/or scientific studies that promise to accelerate approval of safe and effective medical countermeasures, c) to acquaint participants with DARPA and FDA processes and programs, and d) to facilitate a dialog between the scientific/technical innovators and the FDA regarding the use of novel technologies and their potential impact on the regulatory process.
The workshop will start with an overview presentation by DARPA outlining the agency’s role in funding innovative science and technology, and interest in applying new technologies to develop medical countermeasures and accelerate their regulatory approval. FDA staff will then describe that agency’s role in the development and approval of medical products in the context of nascent projects or initiatives that anticipate the impact of new science and technologies on regulatory science and process.
Given the long-term vision of an in vitro platform that provides human-relevant assays of countermeasure efficacy, toxicity, and pharmacokinetics, the workshop will be designed to foster interactions and exchanges of information among all participants and government representatives. During breakout sessions participants will be asked to identify the scientific and technical obstacles that stand in the way of the envisioned platform. Participants will also be asked to outline multi-year research and development efforts that will result in realization of the
2
envisioned platform. These sessions will be moderated by DARPA and FDA personnel and organized along the following broad and overlapping subject areas:
1. Platforms – Can a single platform do everything or do we need/prefer several/many? How do we design the platform to be flexible, user-friendly, and readily commercialized? How will it be controlled? Can you estimate how much it might cost to manufacture?
2. In vitro tissues – what is the optimal structure/design for human-relevant in vitro tissues and organs? Which tissues/organs do we need? Which of these are currently under development? How will they be qualified?
3. Viability and Function – what screens or assays should we use for monitoring cytotoxicity or organ failure? What can/should we do in real time? How do we identify and monitor toxicity/efficacy pathways? Is the concept of discrete molecular pathways too limiting?
4. Disease models – can we use an in vitro platform to model human diseases? Which ones? Would a “cure” that was efficacious on the platform have any relevance to actual humans? How would the model be validated?
5. Extrapolation – how do we extrapolate the results from in vitro tissues and organs to whole organism effects? Can we predict rare adverse events? Can we make predictions regarding the effects of medical countermeasures on a genetically diverse human population, pregnant women, or children? How can systems be qualified for use in FDA regulated product development beyond countermeasures?
Following the breakout sessions the proposed R&D plans will be presented to the entire group for comment and discussion. Breakout groups will be permitted to present as many ideas as time permits.
Participants are encouraged to visit https://team.sainc.com/DARPA_FDA to discuss subject areas and provide their areas of expertise for potential teaming opportunities.
There are no registration fees to attend the workshop.
DARPA Arm Fast Tracked By FDA -
Posted on February 16, 2011 by jmmeijer
The FDA has inaugurated a new program called the Innovation Pathway to usher breakthrough medical technology through their approval process on a fast track. The first technology to take advantage of this program is the so called DARPA arm. This technology breakthrough is a potential precursor to a wide new range of products requiring a man machine interface.
The FDA provided a brief overview of the Innovation Pathway as follows;
“The proposed Innovation Pathway program includes the following features:
• products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;
• selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and
• products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.”
The Darpa Arm already has a lot of press. Here are a few interesting videos. The arm is controlled by a brain implanted electrode array which provides the signals which are interpreted by a sophisticated translation program to activate the appropriate actuators in the arm. The macaque monkeys were initially trained in a virtual environment and then graduated to a real environment.
http://www.emergogroup.com/blog/term/darpa
http://jmmeijer.wordpress.com/2011/02/16/darpa-arm-fast-tracked-by-fda/
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242629.htm
Was away on vacation this past week - did see the presentation on the web site. Very promising & impressive. Good job JJ and team. All the pieces are falling together.
U.S. Department of Health and Human Services
Assistant Secretary for Preparedness and Response
The Public Health Emergency Medical
Countermeasures Enterprise Review Fact Sheet
Emerging infectious diseases, pandemics, and bioterrorism
carry the potential for catastrophic impact, and the U.S. Government has faced chronic challenges in producing
medical countermeasures against such threats, as exemplified during the recent 2009-H1N1 pandemic. The President called out the renewed need for a national capability to respond to these threats in the State of the Union, and the Secretary of HHS stepped forward to address this need. The vision to combat such threats is simple: our nation must have the nimble, flexible capability
to produce medical countermeasures rapidly in the face of any attack or threat, whether known or unknown, novel or reemerging, natural or intentional.
The business model of the current medical countermeasure
development enterprise requires new, innovative approaches to meet this vision. The HHS Assistant Secretary
for Preparedness and Response led an extensive review of all aspects of product development from concept
to approval, calling on the scientific leaders from all federal agencies that work with medical countermeasures,
the National Security Staff, state and local health departments, the National Biodefense Science Board, the President’s Council of Advisors on Science and Technology),
industry, and the Institute of Medicine.
The new strategy envisions a capabilities-based approach and a much more active role by the U.S. Government in forging partnerships, attacking constraints, modernizing
regulatory oversight, and supporting transformative technologies. It also addresses leadership and management
practices that must be addressed to produce an integrated and successful program.
The new strategy contains initiatives that focus on products,
platforms and technologies with multi-use potential to transform how the Enterprise makes investments and enhances its performance by providing stronger support to our partners:
• Emphasizing translation of medical countermeasures
concepts and research produced by the National
Institutes of Health (NIH) programs through new approaches to scout for promising efforts and accelerating candidate product maturity by using the full range of NIH resources;
• Removing barriers to innovation and reducing the opportunity costs for the private sector by providing a full suite of testing, evaluation, product development,
and manufacturing services in concert with mature pharmaceutical partners;
• Promoting regulatory innovation and investment in regulatory science in order to provide private sector partners with more access to regulators and greater clarity about the pathways to product approval;
• Addressing capacity to respond quickly with products
for pandemic diseases as informed from the extensive experience gained during the 2009 H1N1 pandemic, and
• Repositioning the U.S. Government as a strategic partner and investor and providing meaningful financial
incentives and rewards to private sector partners who succeed in developing the medical countermeasures we need.
The review findings and resulting strategy are informed by findings of the pandemic influenza review by the President’s Council of Advisors on Science and Technology.
We will achieve greater productivity from our investments
in biodefense and better protection from emerging
infectious diseases by reducing or eliminating the inefficiencies and chokepoints that impede progress. The five elements will be pursued simultaneously, implemented
in an enterprise-wide manner, and embodied
in discrete but synergistic initiatives that will be announced
shortly.
The strategy outlined above represents a significant departure
from the U.S. Government’s previous approach, and recognizes that incremental improvements will not achieve our goals. Only by taking bold steps and implementing
this new transformative strategy, comprehensively
and broadly, will we achieve the return on investment
for which many in the Medical Countermeasure Enterprise have worked tirelessly. Our return will be measured not in dollars and cents but in the protection of the safety and security of the American people
DARPA and FDA Workshop on Preclinical Platforms for Evaluating Medical Countermeasure Efficacy and Toxicity
6/21/11
ECC at the Liberty Center, Arlington, VA
DARPA is hosting; DSO Deputy Office Director Jon Mogford and DARPA PM Barry Pallotta are speaking
Device Makers Grumble over FDA Processes
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: June 13, 2011
WASHINGTON -- When Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health (CDRH) addressed a conference of small device companies recently, he assured them, "We get it."
But the audience was not convinced.
Of late, device makers have become increasingly vocal about problems with the FDA approval process, claiming long delays, and little consistency in FDA decisions.
For example, a recent survey of device makers found most think the FDA is unpredictable, and many seek approval for new products in Europe before coming to U.S. regulators.
One small device company was so frustrated by what it characterized as FDA foot-dragging and vacillating on the company's study design that it filed a Citizen Petition with the agency demanding answers from FDA Commissioner Margaret Hamburg, MD, within 180 days.
A More "Adversarial" Environment
Shuren, speaking at a conference of the Medical Device Manufacturers Association (MDMA) said he was aware of the more adversarial relationship between FDA and device makers, which he said included "a lot of finger-pointing."
When pressed on what, exactly, has become more "adversarial," about the relationship between medical device companies and the agency that regulates them, Shuren declined to mention specifics.
But industry representatives said they feel the tension.
"I think patients are always better served when industry and FDA work together, "said Mark Leahey, President and CEO of MDMA, which bills itself as the "voice for smaller" medical technology companies. "I think, unfortunately, there have been instances in the past couple years where FDA is being more confrontational with industry than collaborative."
David Nexon, senior executive vice president of AdvaMed, the largest medical device lobbying group, stopped short of characterizing the current relationship between industry and the agency that regulates it as adversarial, but he admitted device groups are increasingly agitated with the FDA.
"We really feel we want to be a partner with the FDA, we really want to produce improved treatments and cures," said Nexon. "At the same time, people are very frustrated with FDA's performance."
The "performance" Nexon references appears to be the most common complaint in the device industry: approval decisions take too long, and the review process has too many bumps along the way.
Much of the recent criticism of the FDA was aimed at the agency's fast-track 510(k) approval process for devices, which is the process used for 90% of the devices considered by the agency.
The finger-pointing noted by Shuren was especially rampant at a recent congressional hearing called "FDA Medical Device Approval: Is there a Better Way?" during which Republican members of Congress voiced the concerns of device companies. In Congress, the practice of seeking approval outside the U.S. before approaching the FDA is considered a worrisome sign.
Shuren was the star witness at that hearing, and he defended FDA's process. The agency was not perfect, he said, but it shouldn't look to the European system as a guide. He explained Europe chooses to overlook efficacy and instead requires device companies to only prove their devices are safe.
"If we have good technologies that are safe and effective, we want to get them to patients," Shuren told the healthcare subcommittee of the House Committee on Oversight and Government Reform during a June 3 hearing. "We don't do our healthcare system justice if we're getting out devices that aren't effective."
The week before that hearing, Shuren defended the agency after a new report from Northwestern University that found device companies are frustrated by the unpredictable nature of the FDA's fast-track 510(k) approval process.
The study was funded by the Institute for Health Technology Studies, a nonprofit group that is funded by medical device companies and the Advanced Medical Technology Association.
Diana Zuckerman, PhD, president of the National Research Center for Women and Families keeps a very close eye on FDA approvals and is a common presence at FDA and congressional hearings. She, too, said she noticed a more adversarial tone at hearings.
She was a witness in a recent Senate Special Committee on Aging hearing, during which the Government Accountability Office (GAO) released a report criticizing the way in which recalls of devices approved through the 510(k) process are handled.
At that hearing, it was particularly clear that there are those who feel FDA's fast-track process doesn't do enough to guarantee patient safety. By speeding up approval, the FDA runs the risk of approving dangerous devices, witnesses told the committee.
One example of a fast track approval that ran into safety problems is the DePuy ASR prosthetic hip. That hip replacement device was approved in 2006 through the 510(k) process but recalled in 2010 after it was found to malfunction at a much higher rate than expected.
But there are also those who say the FDA's fast-track approval process is a very safe route for devices to come to the market. According to figures from the Institute of Medicine (IOM), only 1.5% of all devices approved through the 510(k) process are recalled.
Zuckerman (who authored a study with Cleveland Clinic cardiologist Steve Nissen, MD, that called into question those IOM numbers) told MedPage Today that the FDA's device-approval standards have improved, but they still aren't good enough.
"As a nonprofit organization that pays a lot of attention to medical devices, we have noticed -- it would be hard to miss -- that the FDA [has begun] ... holding devices to standards that are slightly more rigorous," she said, adding that the standard is still "much less rigorous than the requirements for prescription drugs."
Longer Wait Times Irk Device Companies
Premarket approvals take 28% longer now than they did during the 2003-2007 time period, and 510(k) approvals have slowed by 43%, according to a study by the California Health Institute, an organization that advocates for California's device industry.
The average time from submission to FDA approval for devices is a little less than five months in Europe, and about 13 months in the U.S., the Northwestern study found.
Shuren told the congressional panel that the agency is pretty much hitting its marks for approval times.
For instance, under the 510(k) program, which is used for nine out of 10 devices examined by the agency, 90% of the agency's reviews are completed in 90 days or less, and 98% of reviews were completed in 150 days or less. But that was just for the devices whose makers pay a tax to the FDA (which was mandated by the Medical Device User Fee and Modernization Act -- or MDUFMA for short).
Shuren told the panel the average time for all 510(k) submissions stands at about 140 days.
Nexon of AdvaMed said the FDA is meeting its own time goals, but overall time for approval is growing.
"FDA recognizes that it can do a better job at managing its premarket review programs," Shuren said.
Changes Needed
Part of the problem is the case load, Shuren said. CDER's workload has increased by 26% since 2007, driven by a significant increase in requests from device makers, Shuren said.
Nexon said it has become increasingly difficult to get a meeting at the FDA, which many companies see as one of the most important first steps toward device approval.
Device companies also criticize the FDA's reviewers, and Shuren will admit that the reviewers need better training. Device companies have complained that reviewers will tell them one thing, and then come back asking for something totally different.
In the Northwestern University survey, more than half of respondents said it's "somewhat unclear or uncertain" what the FDA wants in terms of preparing for a 510(k) submission, and 72% said there is a difference between what guidance documents say and what FDA reviewers say during the review process.
Nearly half of the reviewers in the CDRH have four years or less of reviewing experience, and the majority of the front line supervisors have three years or less, Shuren said.
Shuren recently announced that every new reviewer at the agency will have to undergo training, rather than cutting their teeth on a device application, which was the old approach.
Shuren would like to hire more experienced reviewers, preferably physicians who have a better understanding of the human body and how medical devices work, but hiring doctors is very expensive, he said, particularly when the agency is competing with device companies, some of which can afford to pay physician reviewers a hefty salary.
He said it's difficult to compete with the private sector when the FDA is very limited in what it can pay its reviewers.
While FDA appropriations have increased in recent years, the money was for other areas of the agency and device pre-market approval operations didn't see that money, Shuren said.
The drug approval operation at FDA is much more well-funded because it collects about 10 times more in user fees from pharmaceutical companies.
When asked if increasing user fees on device companies might help pay for better trained reviewers and speed up the process of device approvals, Janet Trunzo, executive vice president of technology and regulatory affairs at AdvaMed, said the company couldn't discuss user fees because it is in the midst of negotiations on MDUFMA, which is up for reauthorization in 2012.
That reauthorization is also a likely contributor to the tension between industry and FDA.
Money aside, reviewers get burned out at the FDA, because of a very high workload and the increased criticism of the department, Shuren said.
"Just being beaten on is draining," he told reporters.
Shuren consistently talks about the changes that are coming in device approval, including better trained reviewers, more guidance documents, and better communication with companies. He recently announced 25 changes the FDA would make to its device approval process. But the agency is holding off on big changes until the Institute of Medicine issues a report on device approvals this summer.
Too Cozy With Industry
It's no secret that many at the FDA leave the agency, opting for the heftier paychecks that come along with working in the private sector. And that has raised some eyebrows.
For instance, former FDA Commissioner Andrew von Eschenbach, Dan Schultz, the former head of CDRH, and Heather Rosecrans, the former director of the FDA's 510(k) program all work for Washington-based Greenleaf Health, a firm that consults for device companies.
"Almost everyone who headed up CDRH left to work for device companies," Zuckerman said. "It's not surprising that it feels more adversarial, because it was so cozy before."
Zuckerman said companies are complaining about how long the FDA is taking "compared to the good old days." She said the FDA during the Bush administration had a "lack of rigor" in approving devices.
But Nexon dismissed allegations that industry was happier with the device approval climate during the previous administration.
"That doesn't ring true to us," Nexon said. "The decline in FDA performance began in 2007, and it's continuing to decline under this administration. It's not really a partisan issue."
http://www.darpa.mil/Our_Work/MTO/Programs/Dialysis_Like_Therapeutics_(DLT).aspx
Continuous removal of pathogens, toxins, activated cells, exosomes, and cytokines via a diverse suite of "label-free" technologies such as synthetic mannose binding lectins, custom aptamers, selective adsorption, acoustophoresis, dielectrophoresis, and inertial separation.
Oncologists React to Cost-Cutting Editorial
Download Complimentary Source PDF
By Kristina Fiore, Staff Writer, MedPage Today
Published: May 28, 2011
One way to curb rising cancer costs may be to cut back on chemotherapy regimens -- specifically if they're producing no effects after three consecutive rounds.
That's one of 10 recommendations put forth in a New England Journal of Medicine commentary by Thomas Smith, MD, and Bruce Hillner, MD, of Virginia Commonwealth University -- who may be trying to spark debate just ahead of this year's annual meeting of the American Society of Clinical Oncology.
Smith and Hillner argue that spending on cancer treatment must be curbed because it is spiraling out of control, predicted to rise from $104 billion in 2006 to $173 billion in 2020 -- largely driven by rises in the cost of therapy and the extent of care.
"We must find ways to reduce the costs of everyday care to allow more people and advances to be covered without bankrupting the healthcare system," they wrote.
To achieve that, the researchers outlined 10 recommendations for oncologists: five regarding behavior and five focusing on attitudes and practice.
Perhaps their most contentious point was limiting chemotherapy regimens to only three if the patient does not respond well -- restricted, of course, to those with incurable solid tumors.
The idea evoked a strong response from several clinicians contacted by MedPage Today and ABC News.
While some said this recommendation largely reflects the way they've already been practicing, others argued that cancer treatment cannot be so generalized, since there are multiple variables including the type of disease, the available treatments, and the patient's response.
"Reasonable people could accept an approach that allocated resources where they were likely to be effective and withheld resources when they were not likely to be effective," Rosamond Rhodes, PhD, of Mount Sinai School of Medicine in New York City, said in an email.
"In the circumstance in which a person has shown no benefit from three consecutive regimens of chemotherapy, and offering another regimen is not likely to be effective, withholding further ineffective interventions could be acceptable," she added. "A rationing scheme based on a low efficacy standard and applied to all patients with all diseases, could be just, fair, and reasonable."
On the other hand, Bayard L. Powell, MD, of Wake Forest University in Winston-Salem, N.C., warned that treatment decisions are complex, and physicians should make decisions on an individual basis.
"Chemotherapy can be expensive and can be toxic, but it can improve both the quality and duration of life for many patients," Powell said in an email. "It would be very difficult, and inappropriate, to make broad generalizations about how to best use these therapies in a diverse group of patients with cancer."
And being denied treatment -- even if it may not be effective -- is not something patients want to hear, experts said. Herbert Kressel, MD, of Beth Israel Deaconess Medical Center in Boston, relayed the experience of his mother-in-law, who had failed three regimens.
"Her oncologist recommended no further treatments," Kressel said in an email. "Her son, a physician, argued vehemently against this and persuaded the oncologist to go one more round. Needless to say, she was totally cured and lived over 10 additional disease-free years."
Among the other recommendations regarding oncologists' behaviors were getting with the guidelines to cut out surveillance testing with serum tumor markers, and using sequential monotherapy instead of combination regimens for recurrent disease.
They also called for limiting chemotherapies on the basis of patient performance (they should be able to walk themselves into the clinic, Smith and Hillner wrote) and for reducing chemotherapeutic dose as an alternative to giving expensive hematopoietic colony-stimulating factors afterwards, which have shown little benefit.
In terms of physician attitudes and practice, the editorialists called for more talks with patients about end-of-life care, offering better informed consent regarding their expectations, and improved integration of palliative care.
As well, governments and payers should have more discussions about cost-effectiveness and comparative effectiveness, and there should be a change reimbursement so that payments aren't so tied to chemotherapy, they said.
Hillner has received grants frm the National Cancer Institute and the Academy for Molecular Imaging.
Smith reported consulting for the Agency for Healthcare Research and Quality.
This article was developed in collaboration with ABC News.
Primary source: New England Journal of Medicine
Source reference:
Smith TJ, Hillner BE "Bending the cost curve in cancer care" N Engl J Med 2011; 364: 2060-2065.
This is in San Diego - Are we here? Should we be here?
https://www.medicalcountermeasures.gov/BARDA/PHEMCE/Workshop/2011/workshop.aspx
Interesting -
http://www.ciloaweb.com/how-ciloa-helps
Exosomes - very technical, but strong research!
http://yale.pubget.com/paper/21514161
20th International Vicenza Course of Hemodialysis and Chronic Kidney Disease
http://aethlonmedical.investorroom.com/index.php?s=19#
Aethlon Aims To Lure Drug Makers To Device Biz
With Disease-Filtering Technology
Aethlon Medical is looking to repurpose the disease-filtering technology behind its investigational
Hemopurifier device to attract drug company partnerships.
The company's pitch to pharmaceutical firms: Instead of taking on the substantial regulatory and
commercialization burdens of developing a systemically delivered medicine, reach market much
quicker and at a lower cost by attaching your drug candidates to a dialysis-type device designed to
filter disease agents from the blood.
Compared to drug development, the device route "can be a very efficient pathway,” Aethlon
Chairman and CEO Jim Joyce said in an interview.
While the revenue potential of taking the device route may not be as high as in the pharmaceutical
space, Aethlon says its proposed model could be ideal for certain situations, particularly if a drug
developer is running into safety issues with the systemic delivery of a promising therapy.
Also, the strategy may be viewed as a stepping stone to the larger drug market, the San Diego-based
firm suggests. By partnering with Aethlon on device development, a drug company could start
earning revenue earlier, "perhaps allowing them to access the resources to meet longer-term
objectives of having that same compound move forward in the market as a systemically injected
compound," Joyce explained.
The CEO says his firm is in early discussions with several drug companies about prospects to partner
on product development with the newly introduced Aethlon ADAPT filtration platform technology,
but it is too soon to name names.
“We seek collaborative relationships that provide us with near-term development revenues in
addition to potential long-term royalty streams from commercialized products,” Joyce said.
"The timing for introducing our platform could not be better considering the scope of increasing and
unpredictable regulatory challenges faced by therapeutic drug developers."
Genesis Is Hemopurifier Viral Filtration Device
The genesis of the ADAPT platform is Aethlon's development-stage Hemopurifier viral filtration
system, which employs an “affinity treatment cartridge” that rapidly separates and captures
infectious viruses and toxins from a patient’s blood as it circulates outside of the body.
The single-use cartridge is designed to work in
conjunction with portable pumps or dialysis
machines already in the hospital or clinic. Blood
circulation is established into the system via a
catheter or other blood access device, and the
entire circulatory system can pass through the
device in as little as 15 minutes, the company
says.
Internally, Aethlon is developing it as therapy for
"category A" bioterrorism threats and the
hepatitis C virus, among other infectious diseases.
It is also hoping to win a government contract to
develop its system to treat sepsis.
But the device maker is trying to sell drug
developers on the prospect of swapping out inhouse
Aethlon affinity agents with compounds
owned by the pharmaceutical firm, which could
either be clinical-stage drugs, already marketed products or agents that have previously failed clinical
drug studies.
Aethlon sees potential for the system in treating a large variety of high-risk diseases, and would ink
agreements in clinical areas that won't compete with what the company is developing internally.
Selling Point: Avoid Toxicity, Adverse Interactions
A principal selling point to drug firms, according to Joyce, is the prospect of bypassing serious safety
issues for candidates with promising efficacy profiles.
For instance, he pointed to a theoretical case of a cancer drug candidate that has demonstrated
safety on its own but exhibits troubling interactions with other drugs likely to be part of a
chemotherapy regimen.
“The combined toxicity becomes problematic for advancing the compound,” Joyce noted.
But if you attach the drug candidate to the filtration system instead of delivering it systemically, it
inherently eliminates the risks of drug toxicity and drug-drug interactions, Aethlon points out.
It also can provide a way around certain contraindications of medications. For instance, the antivascular
endothelial growth factor cancer drug Avastin can't be used in patients from about one
month prior through about one month following surgery due to bleeding risks, among other issues.
"An extracorporeal device that could selectively be clearing VEGF, or perhaps other growth factors,
out of the circulatory system might prove to be very beneficial, especially during that [pre- and postsurgical]
window," Joyce said.
Aethlon also points to the potential to employ larger quantities of an affinity agent than could safely
be delivered into the body, and to prevent resistance to certain types of drug therapies that build up
over time, such as in the case of HIV therapies. (See “ Expanding HIV Therapy: Will Devices Pick Up
Where Drugs Leave Off? ” – “The Gray Sheet” Sept. 4, 2006.)
In addition, the company says its technology can be used to target a variety of drug agents within a
single device "to address multiple factors underlying a single disease condition.”
Aethlon Medical’s Hemopurifier filtration
technology employs a cylinder-shaped “affinity
treatment cartridge” that captures infectious
viruses and toxins from blood circulated
outside of the body.
In-House Projects Continue; Sepsis Eyed
It remains to be seen how much partnership activity Aethlon generates from the pharmaceutical
industry. Joyce says he hopes to be able to talk about new opportunities for the ADAPT platform in
the coming months.
Regardless, the ADAPT project is intended to supplement, not substitute for, internal development of
the Hemopurifier system.
Under an investigational device exemption, Aethlon is studying Hemopurifier in the U.S. to filter out
bioterrorism agents such as smallpox and Ebola.
It is also conducting a 30-person study in India to test the device's ability to improve clinical
outcomes as adjunct therapy for hepatitis C. The company plans to meet with FDA this summer to
discuss the HCV indication, with hopes of gaining an IDE in July.
Additionally, the firm has submitted a response to a contract opportunity with the Defense
Department’s Defense Advanced Research Projects Agency to develop a "dialysis-like therapeutic"
for sepsis, a serious condition that develops from an overactive immune response to a blood
infection.
Aethlon is proposing to attach multiple agents intended to bind precursors to sepsis.
“We wouldn’t be trying to treat sepsis,” Joyce explained. “We’d be looking to reduce the incidence of
it.”
The sepsis program could turn out to be Aethlon's first big partnering opportunity.
"If selected for an award, several larger organizations and industry thought leaders have agreed to
partner with us to advance our program proposals," Joyce noted in a recent letter to shareholders.
By Zach Miners
Can we use Methotrexate as a part of ADAPT and improve efficacy?
http://www.medpagetoday.com/MeetingCoverage/ASCO/26846?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&userid=335313
New Melanoma treatment - Again, we ned research with the HP
http://www.medpagetoday.com/MeetingCoverage/ASCO/26853?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&userid=335313
Interesting article - I can see the HP being used to decrease the viral load/count of HIV/HCV and then ADAPT being used for giving chemo drug combination with antivirals to eliminate the rest of the virus - farfetched because research needs to be done, but definitely possible.
http://news.yahoo.com/s/ap/20110603/ap_on_he_me/us_med_aids_anniversary_7
Live From ASCO: Time To Cool Down?
http://us.mg4.mail.yahoo.com/dc/launch?.gx=1&.rand=frqa67loakqpt
It's great to see researchers and industry execs coming out of the convention with excitement about promising new pathways and the potential for combinations. But they should also start thinking harder about raising the bar. Otherwise climate change (of a reimbursement and/or regulatory nature) could spark a cool down in one of the hottest therapeutic areas of the industry.
http://invivoblog.blogspot.com/2011/06/deals-of-week-asco-edition.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+invivoblog+%28The+IN+VIVO+Blog%29&utm_content=Yahoo%21+Mail
Some highlights which possibly pertain to AEMD -
-But as big pharmas have set their sights on oncology as the therapeutic area of choice -- given its high unmet medical need and, historically, generous reimbursement, there's no doubt ASCO is now a critical meeting for even the biggest players in the industry.
-Like last year, the particular tumor type driving a lot of investor interest at this year's Chicago confab is melanoma
-The reality is organizations like US Oncology, Cardinal's P4 Healthcare, and Via Oncology are going beyond traditional treatment guidelines recommended by the likes of ASCO and the National Comprehensive Cancer Network, working with payers to provide "clinical pathways" that aim to standardize treatment for a specific disease or tumor type. Aimed for now at treating the most costly cancers, these programs, which are still in pilot mode at major players like Aetna, Blue Cross Blue Shield and Highmark, reduce the wide latitude US doctors have historically enjoyed when prescribing oncologics.
-The ultimate impact of these pathways on the biopharma industry isn't yet known, but as we write in this IN VIVO feature, their advent has real consequences for how companies should approach drug development. And while it's very early days to be talking about a melanoma pathway, doing clinical trials to show the merit of your drug in conjunction with a competitor, when it's highly likely to see real-world use in such a combination, just makes sense. (We also wonder how this impacts GSK's Phase III melanoma drugs, its MEK1/2 inhibitor and its BRAF protein kinase inhibitor. Can these earlier stages medicines get traction in the current competitive marketplace? GSK certainly hopes so, and has its own combo trials ongoing.)
-Despite the increasing complexity of the oncology market, one in which payers are taking a more active role in controlling costs, such cross-collaboration remains the exception rather than the rule. There are plenty of reasons why: issues around control, valuation, and overlap with other non-partnered products mean it can be tough for two large companies to come to agreement on how to share knowledge and find ways to work together.
-
http://www.medscape.com/viewarticle/743098?src=emailthis
So, maybe the infected HCV donors can be treated with the HP first to bring down their viral load before they can donate!
http://www.mdlinx.com/family-medicine/news-article.cfm/3620863/hepatitis?sms_ss=yahoomail
Results
242 and 339 HCC cases linked to HBV (n = 43,892) and HCV (n = 83,817) notifications, respectively.
For both HBV and HCV groups, being male and increasing age were significantly associated with risk of HCC.
Increasing comorbidity score indicated high risk while living outside urban areas was associated with lower risk.
Hazard ratios for males were two to three times those of females.
For both HBV and HCV groups, cirrhosis, alcoholic liver disease and the interaction between the two were associated with significantly and considerably elevated risk.
http://www.mdlinx.com/gastroenterology/news-article.cfm/3610049/hepatitis-c?sms_ss=yahoomail
The HP can play a substantial role in this population.
Can antiviral therapy for hepatitis C reduce the prevalence of HCV among injecting drug user populations? A modeling analysis of its prevention utility
Journal of Hepatology, 05/27/2011
Martin NK et al. – Despite the possibility of re–infection, modest rates of hepatitis C treatment among active injecting drug users could effectively reduce transmission. Evaluating and extending strategies to treat hepatitis C among active injectors are warranted.
The field is ready for the HP ADAPT as a combination therapy!
http://www.cancernetwork.com/news/display/article/10165/1856235?GUID=3DAC7709-3491-41EA-A5E5-AB50867ADB6A&rememberme=1&ts=06052011
Janet Woodcock spoke about recent progress of the targeted therapy approach to cancer with the major hope of successful treatment lying in combination treatments. She emphasized the need for predictability in treatment developments and testing agents in well-developed assays before exposing patients in first in-human trials. Dr. Woodcock also gave drug developers and researchers an agenda for better understanding the mechanisms of toxicity of new agents in order to have a more "systems" perspective of treatments.
Her presentation emphasized the many aspects of development that are currently lacking: a lack of classification assays to identify subpopulations of patients and a lack of pharmacodynamic assays for many agents. In terms of logistics, Dr. Woodcock acknowledged that ongoing trials need to have agents fed into them rather than having a single agent as the center of a trial. Two other major barriers that the new guidance will aim to overcome are competition between pharmaceutical companies in co-developing two agents as well as the regulation hurdle. She reassured the audience that the FDA is indeed supporting the need for innovative combination treatments and new roads to attain these treatments.
HCV linked to heart disease!
http://www.mdlinx.com/infectious-disease/news-article.cfm/2748505/hepatitis?sms_ss=yahoomail
Another potential use for the HP?
http://online.wsj.com/public/search?article-doc-type=%7BBusiness%7D&HEADER_TEXT=Business
BUSINESS MAY 31, 2011
Throat Cancer Linked to Virus
By LAURA LANDRO
A sharp rise in a type of throat cancer among men is increasingly being linked to HPV, the sexually transmitted human papillomavirus that can cause cervical cancer in women.
A new study from the National Cancer Institute warns that if recent trends continue, the number of HPV-positive oral cancers among men could rise by nearly 30% by 2020. At that rate, it could surpass that of cervical cancers among women, which are expected to decline as a result of better screening.
The study is to be presented this week at the annual American Society of Clinical Oncology meeting.
Between 1988 and 2004, the researchers found, the incidence of HPV-positive oropharynx cancers—those that affect the back of the tongue and tonsil area—increased by 225%. Anil Chaturvedi, a National Cancer Institute investigator who led the research, estimates there were approximately 6,700 cases of HPV-positive oropharynx cancers in 2010, up from 4,000 to 4,500 in 2004, and cases are projected to increase 27% to 8,500 in 2020.
HPV Facts
Human papillomavirus is the most common sexually transmitted virus in the U.S.
More than half of sexually active men and women are infected with HPV at some time in their lives.
About 20 million Americans are currently infected and about six million more get infected each year.
HPV can cause cervical cancer in women, which is the second-leading cause of cancer deaths in women world-wide.
HPV is linked to a four- to five-fold increase in certain oral cancers, especially in men; about 25% of mouth and 35% of throat cancers are caused by HPV.
There are more than 100 different types of HPV virus. Some are low-risk while highrisk types can cause several cancers, including head and neck cancer, which is becoming more prevalent.
Source: Centers for Disease Control and Prevention; American Academy of Pediatrics
Recent studies show about 25% of mouth and 35% of throat cancers are caused by HPV, according to the Centers for Disease Control and Prevention.
Men account for the majority of cases, and currently the highest prevalence is in men 40 to 55, says Eric Genden, chief of head and neck oncology at Mount Sinai Medical Center in New York. Studies have shown that the cancer can show up 10 years after exposure to HPV, which has become the most common sexually transmitted virus in the U.S.
"We are sitting at the cusp of a pandemic," says Dr. Genden.
Dr. Chaturvedi says more studies are needed to evaluate whether a vaccine now used to prevent HPV for genital warts and genital and anal cancers can prevent oral HPV infections.
The HPV vaccine, Gardasil, made by Merck & Co., was approved in 2006 for girls and young women up to age 26, but while it is routinely recommended, only about 27% of girls have received all three doses needed to confer protection.
The FDA in 2009 approved the vaccine for males ages 9 through 26 to reduce the risk of genital warts, and in 2010 approved it for both sexes for the prevention of anal cancers. However, the CDC has only a "permissive" recommendation for boys, rather than a routine recommendation, meaning doctors generally will only administer it if parents or patients ask for it, says Michael Brady, chairman of the American Academy of Pediatrics infectious disease committee.
Lauri Markowitz, a CDC medical epidemiologist, says the CDC advisory committee that sets vaccine recommendations will review new data related to the issue at a meeting next month. However, at present there aren't any clinical-trial data showing the effectiveness of the vaccine against oral infections, she says.
A Merck spokeswoman says the company has no plans to study the potential of Gardasil to prevent these cancers.
Researchers say it isn't clear why men are at higher risk for HPV-positive oral cancers. But for both men and women a high lifetime number of sex partners is associated with the cancer.
Changes in sexual behaviors that include increased practice of oral sex are associated with the increase, but a 2007 New England Journal of Medicine article also said engagement in casual sex, early age at first intercourse, and infrequent use of condoms each were associated with HPV-positive oropharyngeal cancer. Mouth-to-mouth contact through kissing can't be ruled out as a transmission route.
Most infections don't cause symptoms and go away on their own. But HPV can cause genital warts and warts in the throat, and has been associated with vaginal, vulvar and anal cancers.
Anna Giuliano, chairwoman of the department of cancer epidemiology at the Moffitt Cancer Center in Tampa, Fla., who studies oral HPV infections of men in several countries, says the rise in cancers among men shows it is important for males, as well as girls, to be vaccinated.
Doctors typically don't test for HPV-positive oral cancers. But Jonathan Aviv, director of the voice and swallowing center at New York's ENT and Allergy Associates, says his group looks through a miniature camera inserted through the nose at the back of the throat and tongue, and can biopsy suspicious warts or tumors.
In addition to being asked about symptoms such as hoarseness, difficulty swallowing, a neck mass or mouth sore that won't heal, patients are asked to fill out a risk-assessment sheet that includes the number of lifetime oral-sex partners. "People do get upset sometimes, but if your sexual history puts you at an increased risk for HPV, you should go and see an ear, nose and throat doctor," says Dr. Aviv.
Fortunately, says Mount Sinai's Dr. Genden, those with HPV-positive oral cancers have a disease survival rate of 85% to 90% over five years, higher than those with oral cancers that aren't linked to HPV, but are more commonly linked to alcohol use, tobacco, and radiation exposure.
Philip Keane, a 52-year-old photographer and partner in a marketing firm, found a lump on his neck while shaving, which was initially misdiagnosed as an infection. A scope of his throat showed it was HPV-positive throat cancer. Dr. Genden removed it last July using minimally invasive robotic surgery, and Mr. Keane had 6½ weeks of daily radiation after that, which left him cancer-free.
At first surprised and embarrassed, Mr. Keane says he has no reason to think he was at high risk; while he has young daughters who have been immunized, "I didn't know about HPV in men." He plans to have his 12-year-old son immunized as well.
Write to Laura Landro at laura.landro@wsj.com
HIV prevalence in the US -http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6021a2.htm