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Ampligen Treatment Study (AMP 511) starting in San Francisco Bay Area

Discussion in 'Active Clinical Studies' started by Doogle, Jun 9, 2011.

  1. Doogle

    Doogle Senior Member

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    We are a group of ME/CFS patients coordinating contact information for those interested in receiving Ampligen in the San Francisco Bay Area in California.

    Sites administering the drug under the FDA approved open label AMP 511 study protocol have dwindled to Dr. Peterson in Incline Village, NV and Dr. Lapp in Charlotte, NC. An expansion of Ampligen sites has begun, including Dr. Enlander's site, and the reactivation of Dr. Batemans site in Salt Lake City, UT.

    A local physician that has experience administering the drug has contacted Dr. David Strayer at Hemispherx Biopharma, manufacturer of Ampligen, and has received the OK to start an open label Ampligen treatment protocol in the lower Peninsula Bay Area. The doctor needs a minimum of two participants for the study to be economically viable.

    * The physician is a fee-for-service provider. Patients pay the doctor directly for services at the time services are rendered, and submit his/her own claims to insurance.

    * Before being enrolled in the treatment protocol, patients will be tested for biomarkers to determine the likely response to Ampligen.

    * After the doctor determines the patient is appropriate for the study, they must remit a $1,000 deposit to the physician, after which the paperwork will be started for the study. The paperwork takes approximately two months to complete and approve before Ampligen is administered.

    * Patients withdrawing during the paperwork period will forfeit their $1,000. Patients who continue will have the deposit applied to their cost of Ampligen administration.

    * The total cost of the administration of Ampligen to each participant is approximately $2,500/month.

    * The physician estimates for many patients itll take 18 months to achieve the full therapeutic and stabilization effects of Ampligen. Participants should plan for that timeframe.

    * Two Bay Area ME/CFS patients have already started the process to qualify to receive Ampligen under the open label treatment protocol.

    Ampligen has a controversial history, including refusal of the FDA to approve retail marketing of the drug due to efficacy questions. Also, some patients state theyve become worse on the drug. However, Ampligen has been clearly beneficial for a subset of ME/CFS patients. Some of the clinical factors that may identify these patients:

    * Acute Viral Onset
    * 2-5A Synthetase/RNase L Up Regulation
    * Depressed Natural Killer Cell Cytotoxicity
    * Persistent Herpes Virus Infections (EBV, HHV-6, CMV, etc)

    Ampligen often initially causes dose dependent flu-like symptoms that can be significant. This has contributed to patient reports of Ampligens adverse effects. These are not the only health risks from Ampligen. Titrating the Ampligen dose may help minimize side effects. Ampligen is administered intravenously twice per week, so people with fragile veins may have difficulty with infusions. IV ports are sometimes installed.

    Ampligen is administered under an experimental drug treatment protocol, and may be discontinued at any time without penalty by the participant, the FDA, the manufacturer, or the study principal investigator (usually the administering doctor). Before a person enrolls in the drug treatment protocol, the risks will be explained, and participants must sign a consent form. Persons that improve and consequently stop Ampligen for an extended period may eventually relapse after a unpredictable length of time. Some patients restart Ampligen if they start to relapse.

    While many ME/CFS patients have an interest in Ampligen, the AMP 511 Cost-Recovery treatment protocol requirements are expensive:

    *Ampligen is administered from 200mg or 400mg vials. The cost of the Ampligen alone, at the usual therapeutic dose of 400mg twice per week, is $1,200 per month, and is rarely covered by medical insurance. Some patients, however, may require a lesser dose.

    *Infusion costs, administrative costs, and testing are extra, are generally not covered by insurance, and will cost approximately $1,300 a month.

    This notice is for informational purposes, and is not intended to be an offer or guarantee of any sort.

    Persons interested in Ampligen treatment in the San Francisco Bay Area, and have the resources to pay for the costs involved, please contact: samp511@comcast.net

    Permission granted to repost
  2. mojoey

    mojoey Senior Member

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    Just started a public ampligen spreadsheet so that we can better monitor the progress of patients on amp. http://tinyurl.com/3zly3ks This crowdsourcing approach has been very helpful for providing a firsthand perspective at the usefulness of GcMaf for ME/CFS.

    Please fill it out if you have been on amp or are on amp, and please spread the word to any other patients you know that are the same.
  3. LaurelW

    LaurelW Senior Member

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    Utah
    I tried that link and it says that document doesn't exist.
  4. mojoey

    mojoey Senior Member

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  5. aquariusgirl

    aquariusgirl Senior Member

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    Laurel... or anyone else...
    am I right in thinking that Medicare will cover infusion costs?

    Thanks
  6. Doogle

    Doogle Senior Member

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    They have at some sites. The costs have to be coded and submitted properly but I don't know what the procedures are.

  7. vli

    vli

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    CA
    I just called Derek Enlander's NYC office and the nurse coordinator told me that the cost of doing amp through them for 6 mos incl. doctor's consults, blood tests and the drug $11,600.
  8. mellster

    mellster Marco

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    San Francisco
    I replied to the email address given but so far haven't gotten a response.
  9. Doogle

    Doogle Senior Member

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    Hi,

    I replied today. Again, sorry it took so long. I will be updating more information on the study shortly.

    Thanks.


  10. dannybex

    dannybex Senior Member

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    Seattle
    Does Ampligen speed up cancer rates?

    I have no idea of course, but just stumbled across this on the NCF site, while googling Dr. DeMeirlier:

    "It is known, from patents owned by the manufacturer of Ampligen, Hemispherx BioPharma, that Ampligen contributes to apoptosis (cell death) causing the road to malignancies to be far shorter."

    http://www.ncf-net.org/forum/CallForResignation.htm

    Doesn't really make any sense to me, but thought others might want to investigate it if this is possible. (Sounds more like an opinion/theory, rather than a fact.)
  11. AndrewB

    AndrewB Senior Member

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    England, UK
    If it WERE true that the drug highly increased my chances of getting cancer, id still take it. Because there's evidence to suggest ME itself causes t a higher risk anyway.
    Plus, id rather be well for say, only another 10 years then get cancer and die, then live like this for another 40. I watched my mother pass away from cancer in 2007 and it was horrific, but i would prefer that, to a life of pain, fatigue, breathing problems, and no treatment.
    vli likes this.
  12. Doogle

    Doogle Senior Member

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    Update: 09-13-2011

    We are a group of ME/CFS patients coordinating contact information for those interested in receiving Ampligen in the San Francisco Bay Area in California.

    According to the Hunter-Hopkins Center Ampligen, an experimental drug manufactured by Hemispherx Biopharma, is an anti-viral and immune modulator used to treat CFS. In a 1990-1992 U.S. placebo controlled study, approximately 80% of 45 CFS patients improved, and 50% improved significantly. A similar study in Belgium reported similar results. Several hundred persons have been treated with Ampligen, and thousands of doses of have been administered safely. Patient experiences with Ampligen can be read at:
    http://ampligen-treatment.blogspot.com/2010/01/my-ampligen-treatment-begins.html
    http://www.cfids-me.org/marys/ampcoda.html
    http://www.cfids-me.org/aacfs/ampligen.html
    https://docs.google.com/spreadsheet...FBkSHRPdkhZblRobzVWUTZUY3JGQ0E&hl=en_US#gid=0

    Sites administering the drug under the FDA approved open label AMP 511 study protocol have dwindled to Dr. Peterson in Incline Village, NV and Dr. Lapp in Charlotte, NC. An expansion of Ampligen sites has begun, including Dr. Enlander's site, and the reactivation of Dr. Bateman's site in Salt Lake City, UT.

    A local SF Bay area physician with experience administering the drug has contacted Dr. David Strayer at Hemispherx Biopharma, and has received the OK to start an open label Ampligen treatment protocol in the lower Peninsula Bay Area. The study needs one additional participant to be economically viable.

    * The physician is a fee-for-service provider. Patients pay the doctor directly for services at the time services are rendered, and submit his/her own claims to insurance.

    * Before being enrolled in the treatment protocol, patients will be tested for biomarkers to determine the likely response to Ampligen.

    * After a patient is determined appropriate for the study, they must remit a $1,000 deposit to the physician, for paperwork to be started. The paperwork takes approximately two months to complete and approve before Ampligen is administered.

    * Patients withdrawing during the paperwork period will forfeit their deposit. Patients who continue will have the $1,000 applied to their cost of Ampligen administration.

    * The total cost of Ampligen to each participant is approximately $2,500/month.

    * The physician estimates itll take 18 months for most patients to achieve the full therapeutic and stabilization effects of Ampligen, and they should plan for that timeframe.

    * Two Bay Area ME/CFS patients have qualified to receive Ampligen under the open label treatment protocol, submitted deposits, and the study paperwork will be starting soon.

    Ampligen has a controversial history, including refusal of the FDA to approve retail marketing of the drug due to efficacy questions. Also, some patients state theyve become worse on the drug. However, Ampligen has been clearly beneficial for a subset of ME/CFS patients. Some of the clinical factors that may identify these patients are:

    * Acute Viral Onset
    * 2-5A Synthetase/RNase L Up Regulation
    * Depressed Natural Killer Cell Cytotoxicity
    * Persistent Herpes Virus Infections (EBV, HHV-6, CMV, etc)

    Ampligen often initially causes dose dependent flu-like symptoms that can be significant. This has contributed to patient reports of Ampligens adverse effects. These are not the only health risks from Ampligen. Titrating the Ampligen dose may help minimize side effects. Ampligen is administered intravenously twice per week, so people with fragile veins may have difficulty with infusions. IV ports are sometimes installed.

    Ampligen is administered under an experimental drug treatment protocol, and may be discontinued at any time without penalty by the participant, the FDA, the manufacturer, or the study principal investigator (usually the administering doctor). Before a person enrolls in the drug treatment protocol, the risks will be explained, and participants must sign a consent form. Persons that improve and consequently stop Ampligen for an extended period may eventually relapse after a unpredictable length of time. Some patients restart Ampligen if they start to relapse.

    While many ME/CFS patients have an interest in Ampligen, the AMP 511 Cost-Recovery treatment protocol requirements are expensive:

    *Ampligen is administered from 200mg or 400mg vials. The cost of the Ampligen alone, at the usual therapeutic dose of 400mg twice per week, is $1,200 per month, and is rarely covered by medical insurance. Some patients, however, may require a lesser dose.

    *Infusion costs, administrative costs, and testing are extra, are generally not covered by insurance, and will cost approximately $1,300 a month.

    Persons interested in Ampligen treatment in the San Francisco Bay Area, and have the resources to pay for the costs involved, please contact: samp511@comcast.net

    This notice is for informational purposes, and is not an offer or guarantee.
    Permission granted to repost
  13. JohnnyD

    JohnnyD Senior Member

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    Hemispherx participated in an investor conference on Monday and said they will unveil a new CFS diagnostic test at IACFS/ME Conference next week. Carter said this diagnostic is at the genetic level, hot spots in the genetic code that potentially identify those with CFS and also those who are the hyper-responders to ampligen. This is based on Chronix analysis of Hemispherx's pivotol AMP-516 trial study.

    A recording of the Rodman and Renshaw investor conference talk is available here: http://www.wsw.com/webcast/rrshq20/heb or on the hemispherx.net website. You'll need a Windows Media Player plugin for your browser and they ask for your name and email address.

    OR a complete transcript of the presentation is available here: http://imeassoc.com/New_test_from_Hemispherx.html

    There is some discussion of this on mecfs forum here: http://www.mecfsforums.com/index.php/topic,9390.0.html

    Since this is Chronix NGS analysis at the genetic level, I would think it would be of interest to most cfs/me sufferers despite prejudices held against: hemipherx, mecfs forum, ampligen etc etc :) In fact, this post probably deserves it's own topic.

    Peace,
    Johnny
  14. Doogle

    Doogle Senior Member

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    Updated Study

    Updated Study

    Two Bay Area ME/CFS patients have qualified to receive Ampligen under the open label treatment protocol, submitted deposits, and the study paperwork will be starting soon.
  15. barbc56

    barbc56 Senior Member

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    If you have to pay to be in a study, wouldn't that skew the results or would it? So far two patients doesn't seem like enough for a study. Too bad there isn't someway around the money angle.
  16. Doogle

    Doogle Senior Member

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    This is an open label study going on at other centers so the data will pooled between many patients not just two. This data is used to develop better methods of endpoint measurement and drug knowledge rather than evaluation of effectiveness which is usually based on double blind placebo controlled studies. I agree, it would be wonderful to make the treatment more affordable.
    Ocean likes this.
  17. barbc56

    barbc56 Senior Member

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    Good to know there will be more than 2. I can see many complications with conclusions, one being if you have to pay money you are more likely to think you will get better? Maybe not?

    I could be wrong about this. Anyone know of other studies where people have had to pay?

    Something about this seems unsettling but maybe it's the pizza I ate last night, LOL
    Ocean likes this.
  18. NotAllInMyHead

    NotAllInMyHead

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    Kogelnik's Rituxan/Valcyte study (also very expensive) requires patients to pay also.
  19. Doogle

    Doogle Senior Member

    Messages:
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    Update: 02-11-2012

    A San Francisco Bay Area area physician with experience administering Ampligen is working with Hemispherx Biopharma to start an open label Ampligen treatment protocol in the lower Peninsula Bay Area. According to Hemispherx Biopharma the paperwork should be ready for approval by the local IRB board in two weeks, and the study should start in approximately a month.

    We are a group of ME/CFS patients coordinating contact information for those interested in receiving Ampligen in this study.

    According to the Hunter-Hopkins Center, Ampligen an experimental drug manufactured by Hemispherx Biopharma, is an anti-viral and immune modulator used to treat CFS. In a 1990-1992 U.S. placebo controlled study, approximately 80% of 45 CFS patients improved, and 50% improved significantly. A similar study in Belgium reported similar results. Several hundred persons have been treated with Ampligen, and thousands of doses of have been administered safely. Patient experiences with Ampligen can be read at:
    http://ampligen-treatment.blogspot.com/2010/01/my-ampligen-treatment-begins.html
    http://www.cfids-me.org/marys/ampcoda.html
    http://www.cfids-me.org/aacfs/ampligen.html
    https://docs.google.com/spreadsheet...FBkSHRPdkhZblRobzVWUTZUY3JGQ0E&hl=en_US#gid=0

    Sites administering the drug under the FDA approved open label AMP 511 study protocol have dwindled to Dr. Peterson in Incline Village, NV and Dr. Lapp in Charlotte, NC. An expansion of Ampligen sites has begun, including Dr. Enlander's site, and the reactivation of Dr. Bateman's site in Salt Lake City, UT.

    * The San Francisco Bay Area physician is a fee-for-service provider. Patients pay the doctor directly for services at the time services are rendered, and submit his/her own claims to insurance.

    * Before being enrolled in the treatment protocol, patients will be tested for biomarkers to determine the likely response to Ampligen.

    * After a patient is determined appropriate for the study, they must remit a $1,000 deposit to the physician, for paperwork to be started.

    * Patients withdrawing during the paperwork period will forfeit their deposit. Patients who continue will have the $1,000 applied to their cost of Ampligen administration.

    * The total cost of Ampligen to each participant is approximately $2,500/month.

    * The physician estimates itll take 18 months for most patients to achieve the full therapeutic and stabilization effects of Ampligen, and they should plan for that timeframe.

    Ampligen has a controversial history, including refusal of the FDA to approve retail marketing of the drug due to efficacy questions. Also, some patients state theyve become worse on the drug. However, Ampligen has been clearly beneficial for a subset of ME/CFS patients. Some of the clinical factors that may identify these patients are:

    * Acute Viral Onset
    * 2-5A Synthetase/RNase L Up Regulation
    * Depressed Natural Killer Cell Cytotoxicity
    * Persistent Herpes Virus Infections (EBV, HHV-6, CMV, etc)

    Ampligen often initially causes dose dependent flu-like symptoms that can be significant. This has contributed to patient reports of Ampligens adverse effects. These are not the only health risks from Ampligen. Titrating the Ampligen dose may help minimize side effects. Ampligen is administered intravenously twice per week, so people with fragile veins may have difficulty with infusions. IV ports are sometimes installed.

    Ampligen is administered under an experimental drug treatment protocol, and may be discontinued at any time without penalty by the participant, the FDA, the manufacturer, or the study principal investigator (usually the administering doctor). Before a person enrolls in the drug treatment protocol, the risks will be explained, and participants must sign a consent form. Persons that improve and consequently stop Ampligen for an extended period may eventually relapse after a unpredictable length of time. Some patients restart Ampligen if they start to relapse.

    While many ME/CFS patients have an interest in Ampligen, the AMP 511 Cost-Recovery treatment protocol requirements are expensive:

    *Ampligen is administered from 200mg or 400mg vials. The cost of the Ampligen alone, at the usual therapeutic dose of 400mg twice per week, is $1,200 per month, and is rarely covered by medical insurance. Some patients, however, may require a lesser dose.

    *Infusion costs, administrative costs, and testing are extra, are generally not covered by insurance, and will cost approximately $1,300 a month.

    Persons interested in Ampligen treatment in the San Francisco Bay Area, and have the resources to pay for the costs involved, please contact: samp511@comcast.net

    This notice is for informational purposes, and is not an offer or guarantee.
  20. Doogle

    Doogle Senior Member

    Messages:
    196
    Likes:
    28
    Update: 03-20-2012

    A San Francisco Bay Area area physician (Dr. Raj Patel) with experience administering Ampligen will very shortly be starting open label Ampligen treatment in Los Altos, CA according to Hemispherx Biopharma. The study paperwork has been approved by the IRB board except for minor changes to patient consent wording for California regulations. Hemispherx said the process had been delayed due to the effort of getting a different study ready. Hemispherx has just published a new study on the beneficial effects of Ampligen.

    This is good news for persons in the bay area as the medication hasn't been available for over 7 years in this area and preparation for this treatment study has been in the works for almost a year.

    According to the Hunter-Hopkins Center, Ampligen an experimental drug manufactured by Hemispherx Biopharma, is an anti-viral and immune modulator used to treat CFS. In a 1990-1992 U.S. placebo controlled study, approximately 80% of 45 CFS patients improved, and 50% improved significantly. A similar study in Belgium reported similar results. Several hundred persons have been treated with Ampligen, and thousands of doses of have been administered safely. Patient experiences with Ampligen can be read at:
    http://ampligen-treatment.blogspot.com/2010/01/my-ampligen-treatment-begins.html
    http://www.cfids-me.org/marys/ampcoda.html
    http://www.cfids-me.org/aacfs/ampligen.html
    http://theglassmountain.wordpress.com/category/ampligen/
    https://docs.google.com/spreadsheet...FBkSHRPdkhZblRobzVWUTZUY3JGQ0E&hl=en_US#gid=0

    Other sites administering the drug under the FDA approved open label AMP 511 study protocol include Dr. Peterson in Incline Village, NV, Dr. Lapp in Charlotte, NC, Dr. Enlander in NYC, Dr. Klimas in Miami, and Dr. Bateman in Salt Lake City.

    * The San Francisco Bay Area physician is a fee-for-service provider. Patients pay the doctor directly for services at the time services are rendered, and submit his/her own claims to insurance.

    * Before being enrolled in the treatment protocol, patients will be tested for biomarkers to determine the likely response to Ampligen.

    * After a patient is determined appropriate for the study, they must remit a $1,000 deposit to the physician, for paperwork to be started.

    * Patients withdrawing during the paperwork period will forfeit their deposit. Patients who continue will have the $1,000 applied to their cost of Ampligen administration.

    * The total cost of Ampligen to each participant is approximately $2,500/month.

    * The physician estimates itll take 18 months for most patients to achieve the full therapeutic and stabilization effects of Ampligen, and they should plan for that timeframe.

    Ampligen has a controversial history, including refusal of the FDA to approve retail marketing of the drug due to efficacy questions. Also, some patients state theyve become worse on the drug. However, Ampligen has been clearly beneficial for a subset of ME/CFS patients. Some of the clinical factors that may identify these patients are:

    * Acute Viral Onset
    * 2-5A Synthetase/RNase L Up Regulation
    * Depressed Natural Killer Cell Cytotoxicity
    * Persistent Herpes Virus Infections (EBV, HHV-6, CMV, etc)

    Ampligen often initially causes dose dependent flu-like symptoms that can be significant. This has contributed to patient reports of Ampligens adverse effects. These are not the only health risks from Ampligen. Titrating the Ampligen dose may help minimize side effects. Ampligen is administered intravenously twice per week, so people with fragile veins may have difficulty with infusions. IV ports are sometimes installed.

    Ampligen is administered under an experimental drug treatment protocol, and may be discontinued at any time without penalty by the participant, the FDA, the manufacturer, or the study principal investigator (usually the administering doctor). Before a person enrolls in the drug treatment protocol, the risks will be explained, and participants must sign a consent form. Persons that improve and consequently stop Ampligen for an extended period may eventually relapse after a unpredictable length of time. Some patients restart Ampligen if they start to relapse.

    While many ME/CFS patients have an interest in Ampligen, the AMP 511 Cost-Recovery treatment protocol requirements are expensive:

    *Ampligen is administered from 200mg or 400mg vials. The cost of the Ampligen alone, at the usual therapeutic dose of 400mg twice per week, is $1,200 per month, and is rarely covered by medical insurance. Some patients, however, may require a lesser dose.

    *Infusion costs, administrative costs, and testing are extra, are generally not covered by insurance, and will cost approximately $1,300 a month.

    Persons interested in Ampligen treatment in the San Francisco Bay Area, and have the resources to pay for the costs involved, contact: Dr. Raj Patel. Please contact him only if you are seriously interested in participating. Thank you.

    This notice is for informational purposes, and is not an offer or guarantee.

    Permission granted to repost.

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