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Dec 20th: High Noon for Ampligen! FDA Advisory Committee Decides Ampligens fate in live webcast

urbantravels

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Los Angeles, CA
I wonder though, why did the FDA accept their application for review again this year knowing that they had not done the study that had been requested at the last denial.

I had assumed that the FDA had changed their views, it seems to be the same problems as before - am I wrong?

That part is a bit hard to understand for me too. It's evident that the FDA has made a serious new commitment to ME/CFS in this past year, and that they've allowed Ampligen to advance to the point of having an advisory panel review, which is farther than it's ever gotten before. Maybe they wanted to show due diligence in allowing Ampligen an open hearing by the independent experts, even if they kinda suspected what the outcome was going to be. If nothing else, this hearing aired the important issues for the pharma community - the FDA is expressing that they DO feel a sense of urgency about the need to find treatments, and would welcome other sponsors to come forward - Unger said this at the end, in so many words.
 

dannybex

Senior Member
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3,561
Location
Seattle
I blame alot of these problems on Hemispherix not the FDA. I wonder though, why did the FDA accept their application for review again this year knowing that they had not done the study that had been requested at the last denial.

I had assumed that the FDA had changed their views, it seems to be the same problems as before - am I wrong?
I too blame Hemispherx and not the FDA. I think Carter and Co assumed that the FDA may have been willing to look at their "new" (old) data, and they were, but they never did the larger and longer study that the FDA requested THREE years ago.
 

urbantravels

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Los Angeles, CA
My (very incomplete) impression is that this is an 'advisory recommendation' that is usually followed.

Yes, this is an independent panel that is formed to make recommendations to the FDA based on an independent review of the evidence. The recommendations are not binding on the FDA, although I do think they are followed in the vast majority of cases.

Notoriously, there was an FDA review panel in 2009 that called for Vicodin and Percocet to be taken off the market - banned completely - along with other drugs in their class (narcotic pain relievers that also contain acetaminophen.) The reasoning was that acetaminophen can easily cause liver toxicity, so you don't want to routinely throw it in with another drug when it's not necessarily needed.

However, for some reason the FDA never acted on this recommendation, and Vicodin and Percocet remain on the market. Could have something to do with the enormous market share and profitability of Vicodin...
 

SOC

Senior Member
Messages
7,849
So is the upshot here that no smallish pharmaceutical company is going to get a significant drug past the FDA and we have to get big pharma interested? Heck, that will only take another 10-20 years. :rolleyes:
 

Dolphin

Senior Member
Messages
17,567
The big question in my mind is how do we get funding from any source for clinical trials of any drug.
In the mid-2000s, I heard* that the makers of Imunovir/Isoprinosine started planning a multi-site study of the drug in the US. Then the NICE guidelines came out recommending CBT and GET and this changed their minds against spending all the $ required on a trial.:(

* Can't remember where I read/heard the latter part but know the trial had been planned.
 

heapsreal

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In the mid-2000s, I heard* that the makers of Imunovir/Isoprinosine started planning a multi-site study of the drug in the US. Then the NICE guidelines came out recommending CBT and GET and this changed their minds against spending all the $ required on a trial.:(

* Can't remember where I read/heard the latter part but know the trial had been planned.

Probably have a better chance then ampligen as it already has a good safety profile and its effects can be monitored through Nk function testing and should be alot cheaper and easier to administer then ampligen??
 

snowathlete

Senior Member
Messages
5,374
Location
UK
Although I am disappointed, in fairness to the FDA, Hemispherx Biopharma didn't do a good job with their trials and data. It simply was not good enough and the panel clearly were not confident that they could rely on the data being correct. So although I would be happy, as a patient, taking a risk to take this drug, I can understand why a member of the panel without the disease, even after hearing the moving testimonies they heard, didn’t feel able to vote Yes on the drugs approval.

On a positive note, the message, if true, is that the FDA are keen to find and approve drugs for ME/CFS. The impression I got was that they would even do this if a drug doesn't even look that good, or even that safe, but they need to know where they stand with those facts based on good trials and reliable data. This is the good news.

I hope this encourages drugs companies to invest in developing drugs for the illness, but my guess is that there just aren't any others even close to be ready, if they even exist at all. The best chance would seem to come from Rituximab, but even a promising drug like that can't get enough funding for trials (that may be to do with patent stuff, I'm not really clear on that, but have read its run out / running out).

The thing is if you're a drugs company, it's not easy to develop a drug when you don't know the cause of the illness, and when there are sub groupings that you can't tie down. Your starting point is not good because you have to develop a drug that works so well that it is seen to work even when the results are negatively skewed by some subgroups not responding.

Our best hope still looks to be discovering the pathogenic cause(s) and/or developing solid tests for the disease. Once that is in place, I can see drugs companies investing a lot in developing drugs for the disease, but until then...
 

urbantravels

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Los Angeles, CA
According to some reports in the financial press, Hemispherx misrepresented the likelihood of Ampligen getting approved in this review, by not disclosing to investors and the public back in June that the FDA had allowed the review based on re-analysis of previous studies, but only while cautioning that "It would be unusual for this type of data to provide adequate evidence of efficacy." The full language of the FDA's message apparently wasn't disclosed until this week's release of background information, and before that HEB was supposedly over-hyping the possibility of approval.
 

Dolphin

Senior Member
Messages
17,567
Dolphin said:
In the mid-2000s, I heard* that the makers of Imunovir/Isoprinosine started planning a multi-site study of the drug in the US. Then the NICE guidelines came out recommending CBT and GET and this changed their minds against spending all the $ required on a trial.:(

* Can't remember where I read/heard the latter part but know the trial had been planned.​

Probably have a better chance then ampligen as it already has a good safety profile and its effects can be monitored through Nk function testing and should be alot cheaper and easier to administer then ampligen??
Yes. Unfortunately drug company is relatively small also, like HEB.
 

heapsreal

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Yes. Unfortunately drug company is relatively small also, like HEB.
we just need something to get approved to open the flood gates on other treatments. I dont think immunovir is a 'cure' but it would help certain sub groups and maybe other similar drugs could be approved like interferons used in MS. Maybe we need to support something that is easier to get approved??
 

user9876

Senior Member
Messages
4,556
I see an inherent problem in studying the "subgroup" that seems to respond to Ampligen because we apparently don't have any other way to define this subgroup besides "responds to Ampligen." A bit of circular logic there. As far as I know there are plenty of drugs that only x% of patients respond to, so what's the special problem here?

Has anyone carried out a detailed look at the immune system of those who respond. For example looking at the different types of b cells such as the study that found high numbers of nieve and transitional b cells. Or looking in detail at the NK cells based on the work in Australia.
 

Dolphin

Senior Member
Messages
17,567
we just need something to get approved to open the flood gates on other treatments. I dont think immunovir is a 'cure' but it would help certain sub groups and maybe other similar drugs could be approved like interferons used in MS. Maybe we need to support something that is easier to get approved??
I think this study shows an interesting effect, or side effect, of a drug becoming available for CFS

Effect of physician-recommended treatment on mental health practitioners' attributions for chronic fatigue syndrome.

By Taylor, Renee R.; Jason, Leonard A.; Kennedy, Cara L.; Friedberg, Fred

Rehabilitation Psychology. Vol 46(2), May 2001, 165-177.

Abstract

Objective: To evaluate whether differing treatment recommendations for chronic fatigue syndrome (CFS) by physicians influence attributions about CFS among mental health practitioners.

Participants and Study Design: 93 mental health practitioners were randomly assigned to 1 of 3 conditions. All groups read the same case study of a person diagnosed with CFS, with the only difference between groups being the type of treatment recommended by a physician. The treatment conditions included a drug trial (Ampligen) or 1 of 2 differing psychotherapy approaches, cognitive behavior therapy with graded activity or cognitive coping skills therapy.

Results: Ss in the 3 groups did not differ with respect to their prior familiarity with CFS. Ss who read the case study proposing treatment with Ampligen were more likely to report that the patient was correctly diagnosed and more likely to perceive the patient as disabled than those whose case study described cognitive behavioral therapy with graded activity as the treatment.

Conclusion: Results of this investigation support the hypothesis that physician recommendations for CFS treatment can influence subsequent attributions about a patient's illness among mental health practitioners.

(PsycINFO Database Record (c) 2009 APA, all rights reserved)

Thread at: http://forums.phoenixrising.me/inde...n-mental-health-practitioners-attributns.2898
 

jimells

Senior Member
Messages
2,009
Location
northern Maine
Notoriously, there was an FDA review panel in 2009 that called for Vicodin and Percocet to be taken off the market - banned completely - along with other drugs in their class (narcotic pain relievers that also contain acetaminophen.)

I recall this. Of course, they couldn't possibly recommend simply removing the acetaminophen, because that would've put the drugs in a different class of narcotics, and made these Evil Pain Pills even *more* evil. As I understand it, the main purpose of the acetaminophen is to 'denature' the narcotic by making it dangerous to crush then snort or inject the drug.

I am feeling particularly bitter today about the way chronic pain patients are left untreated due to the fact that this is the fourth day of an unrelenting migraine attack, and I have zero access to any medication that might help, even though many such drugs are in stock at the pharmacy 12 miles away. :ill:
 

urbantravels

disjecta membra
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1,333
Location
Los Angeles, CA
I was never real clear about why they couldn't just formulate a narcotic with ibuprofen or naproxen or something else that wasn't acetaminophen - could never find reliable info about whether there was some pharmaceutical reason why that wouldn't work.
 

heapsreal

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Has anyone carried out a detailed look at the immune system of those who respond. For example looking at the different types of b cells such as the study that found high numbers of nieve and transitional b cells. Or looking in detail at the NK cells based on the work in Australia.

Thats what we would like to see done but again its about research dollars that our illness doesnt get. Im sure a group of us could put our heads together and come up with some good things to research in cfs but its all about dam money. klimas has shown that immunovir helps cfsers improve nk function but i suppose theres no money it approving immunovir??
 

waiting

Senior Member
Messages
463
I recall this. Of course, they couldn't possibly recommend simply removing the acetaminophen, because that would've put the drugs in a different class of narcotics, and made these Evil Pain Pills even *more* evil. As I understand it, the main purpose of the acetaminophen is to 'denature' the narcotic by making it dangerous to crush then snort or inject the drug.

I am feeling particularly bitter today about the way chronic pain patients are left untreated due to the fact that this is the fourth day of an unrelenting migraine attack, and I have zero access to any medication that might help, even though many such drugs are in stock at the pharmacy 12 miles away. :ill:
So sorry to hear about your migraine, jimells. You've likely already thought of this but is here any chance they deliver? Sometimes they don't advertise this service and sometimes it's free if it's within a certain area.
 

Hope123

Senior Member
Messages
1,266
1) People should not assume that the data that is availabel publicly is ALL the data that is available. FDA can request data from the drug companies but by business laws concerning confidentiality/ patents/ etc., neither FDA nor drug companies are required to release all information to the public. There have been some big scandals in recent years with drug companies witholding data on adverse effects, the drug being approved, and lots of patients being harmed. Some drugs have been pulled off the market or had a big warning label slapped on them because of this.

As a healthcare professional, I used to get mailings almost every week from pharma about new side effects, indications, warnings, etc. These were from drug companies and required by FDA when something new came up.

2) One thought is Hemispherix could have looked at who responded to Ampligen and then work backwards to see what, if any, of their blood tests were different from the people who did not respond. I believe they did a fair amount of bloodwork to screen who qualified for the drug initially and to rule out other causes of disease.

3) An Immunovir study would likely be much les expensive than an Ampligen study. partly because the drug is orally taken, doesn't need a lot of safety monitoring (decades long good safety profile), and is not overly expensive ($100/ month US currently vs. $2,000 or more for Ampligen, not counting infusion cost).
 

heapsreal

iherb 10% discount code OPA989,
Messages
10,086
Location
australia (brisbane)
1) People should not assume that the data that is availabel publicly is ALL the data that is available. FDA can request data from the drug companies but by business laws concerning confidentiality/ patents/ etc., neither FDA nor drug companies are required to release all information to the public. There have been some big scandals in recent years with drug companies witholding data on adverse effects, the drug being approved, and lots of patients being harmed. Some drugs have been pulled off the market or had a big warning label slapped on them because of this.

As a healthcare professional, I used to get mailings almost every week from pharma about new side effects, indications, warnings, etc. These were from drug companies and required by FDA when something new came up.

2) One thought is Hemispherix could have looked at who responded to Ampligen and then work backwards to see what, if any, of their blood tests were different from the people who did not respond. I believe they did a fair amount of bloodwork to screen who qualified for the drug initially and to rule out other causes of disease.

3) An Immunovir study would likely be much les expensive than an Ampligen study. partly because the drug is orally taken, doesn't need a lot of safety monitoring (decades long good safety profile), and is not overly expensive ($100/ month US currently vs. $2,000 or more for Ampligen, not counting infusion cost).

hope,
that just makes too much sense. All the patients seem to have too much sense lol
 

Dolphin

Senior Member
Messages
17,567
In the mid-2000s, I heard* that the makers of Imunovir/Isoprinosine started planning a multi-site study of the drug in the US. Then the NICE guidelines came out recommending CBT and GET and this changed their minds against spending all the $ required on a trial.:(

* Can't remember where I read/heard the latter part but know the trial had been planned.

Just did a quick search of some info I had. Here is a sample piece showing they were interested.

https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0410A&L=CO-CURE&P=R1802&I=-3

Date:
b-blank.gif

Sun, 3 Oct 2004 11:42:40 -0400




From Pamela Wong <[log in to unmask]>:

Source: http://pharmalicensing.com/company/dispcompany/8953

Newport Pharmaceuticals Ltd

Profile
Newport Pharmaceuticals Ltd was established in 1996 to focus on the
pharmaceutical interests of the Newport holding company, following the
acquisition of Newport Synthesis from the American parent Systemed Inc, in
March 1995. Newport continues to grow as a profitable pharmaceutical
company focussed on products for the treatment of infectious diseases,
immunological diseases and related conditions.

Newport's lead product is inosine pranobex/Isoprinosine, a synthetic purine
derivative. It is an immunopharmacologic agent with both immunomodulatory
and antiviral properties.

Isoprinosine has been licensed since 1971 for the treatment of cell
mediated immune deficiencies associated with various viral infections. It
has been on the market for over 30 years and is currently registered in 43
countries world wide for a variety of indications. These include the
treatment of HPV, HSV, VZV, CMV, EBV, measles virus infections and SSPE.

Newport has been pursuing a program for the development of Isoprinosine as
a treatment for chronic fatigue syndrome (CFS) since 1999. The company conducted its first Phase II trial in Canada and the results are summarised in Diaz- Mitoma, F et al. 'Clinical improvement in chronic fatigue syndrome is associated with enhanced natural killer cell- mediated cytotoxicity: the results of a pilot study with Isoprinosine' JCFS 2003; 11(2): 71-95. In addition, Newport has been actively collaborating with investigators in the UK (Pinching AJ. 'Inosine Pranobex In The Treatment Of Chronic Fatigue Syndrome - a pilot study' Fatigue 2002, London, 2002)

After Newport's pre-IND meeting with the FDA in March 2004, Newport now wishes to enter into partnership with a matching biopharmaceutical company, which has the capability to assist Newport in the development program and to bring the drug to the US market. The unmet therapeutic need in chronic fatigue syndrome is well recognised


Formation and ownership
Company formed in 1996. Privately owned.


Annual turnover
EUR € 2,000,000 (2003)


Number of employees
10

Also


https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0511A&L=CO-CURE&P=R2&I=-3

http://www.primezone.com/newsroom/news.html?d=88857

Source: Bioaccelerate, Inc.

Newport Pharmaceuticals Ltd. Announces Update on Co-Development Program For Isoprinosine DUBLIN, Ireland, Oct. 31, 2005 (PRIMEZONE) -- Newport Pharmaceuticals Ltd (NPL), a privately owned company focusing on immunological disorders, commented today on its phase II clinical development program for lead product Isoprinosine(r) (Inosine Acetoben Dimepranol) (IAD) for the treatment of chronic fatigue syndrome (CFS) in the United States.

"The unmet therapeutic need in CFS is well recognised," said James O'Daly, Managing Director of Newport. "According to the American Chronic Fatigue and Immune Dysfunction Society (CFIDS), there may be 800,000 people in the U.S. suffering from the illness. One of the key competitive advantages at this stage of the development of Isoprinosine is the proven safety record in licensed indications in many countries. Secondly, there is an increasing level of awareness of Isoprinosine as a potential treatment for CFS within the medical and patient communities. This level of awareness is particularly high amongst U.S. CFS doctors."

Newport's co-development partner, Amilar Pharmaceuticals, is a speciality pharmaceutical company with development stage compounds in women's health. Amilar is a wholly owned subsidiary of Bioaccelerate Holdings Inc. (OTCBB:BACL).

"We believe Isoprinosine has significant commercial potential in the treatment of chronic fatigue syndrome, and we are excited to be working with Newport Pharmaceuticals to advance this program through late-stage clinical development and commercialization," stated Christopher O'Toole, Head of Specialty Pharmaceuticals for Bioaccelerate.

Newport has been pursuing a program for the development of Isoprinosine(r) as a treatment for CFS since 1999. The company conducted its first Phase II trial in Canada and the results are summarised in Diaz-Mitoma, F et al. 'Clinical improvement in chronic fatigue syndrome is associated with enhanced natural killer cell-mediated cytotoxicity: the results of a pilot study with Isoprinosine(r)' JCFS 2003.

About Newport Pharmaceuticals Ltd.

Newport Pharmaceuticals Ltd was established in 1996 to focus on the pharmaceutical interests of the Newport holding company, following the acquisition of Newport Synthesis from the American parent Systemed Inc, in March 1995. Newport continues to grow as a profitable pharmaceutical company focussed on products for the treatment of infectious diseases, immunological diseases and related conditions. IAD (Isoprinosine/Imunovir) is a synthetic purine derivative. It is an immunopharmacologic agent with both immunomodulatory and antiviral properties. IAD has been licensed since 1971 for the treatment of cell mediated immune deficiencies associated with various viral infections. It has been on the market for over 30 years and is currently registered in 43 countries world wide for a variety of indications.

About Bioaccelerate

Bioaccelerate Holdings Inc. (OTCBB:BACL) is a pharmaceutical development organization ("PDO") that seeks to acquire, develop and commercialize novel pharmaceutical compounds in an efficient, cost-effective way. Bioaccelerate uses its broad network of academic, industry and capital market relationships to expedite drug development and raise capital to create and fund its subsidiary companies, which are organized by vertical portfolios in five therapeutic areas: oncology, specialty pharmaceuticals, central nervous system disorders (CNS), cardiovascular disease and anti-infectives.

Bioaccelerate conducts its business directly and through its subsidiaries. The company holds majority equity interests in 10 biopharmaceutical companies, three of which are public, and holds minority interests in four biopharmaceutical companies, two of which are public. The company also holds a minority equity interest in a public nanotechnology company. Bioaccelerate's strategy relies on its development network for research, clinical development and project management to guide early-stage compounds from the discovery process through to Phase II/III development where incremental value can be created. Bioaccelerate Holdings is listed on the Over-The-Counter Bulletin Board under the symbol "BACL." For more information on Bioaccelerate, visit the company's website at http://www.bioaccelerate.com.

Bioaccelerate Safe Harbor Statement

Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with pre-clinical and clinical developments in the biopharmaceutical industry in general and in Bioaccelerate's compounds under development in particular; the potential failure of Bioaccelerate's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioaccelerate's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioaccelerate's business, structure or projections; the development of competing products; uncertainties related to Bioaccelerate's dependence on third parties and partners; and those risks described in the filings with the SEC, all of which are under Bioaccelerate's prior name Mobile Design Concepts, Inc. Bioaccelerate disclaims any obligation to update these forward-looking statements.

CONTACT: Bioaccelerate Holdings Inc. Christopher O'Toole (212) 332-4387 [log in to unmask] www.bioaccelerate.com

Newport Pharmaceuticals Ltd James O'Daly +353 (1) 8903011 [log in to unmask] www.newport-pharma.com