Ampligen
Encyclopedia
Rintatolimod is an experimental immunomodulator
y double stranded RNA drug
developed by Hemispherx Biopharma
of Philadelphia, Pennsylvania. Rintatolimod was first synthesized in the 1970s and has been proposed and tested as a treatment for illness
es including chronic fatigue syndrome
(CFS) and acquired immunodeficiency syndrome
(AIDS).
Hemispherx reports that it completed a Phase III clinical trial
for CFS in 2004 and filed a new drug application
(NDA) with the U.S. Food and Drug Administration (FDA) to market and sell rintatolimod for the treatment of CFS, but this was rejected in December 2009 because the FDA concluded that the two RCTs "did not provide credible evidence of efficacy."
synthesized a double-stranded RNA
compound composed of inosinic and cytidylic acid residues (poly I:poly C or poly I:C). Poly I:C inhibited tumor growth by inducing interferon
production. In the mid-1970s, William A. Carter, a post-doctoral researcher at Johns Hopkins University
, modified the dsRNA molecule by adding uridylic acid molecules at specific interval along the RNA chain. The new compound, called Ampligen (for AMPLIfied GENetic activity) stimulated interferon production like poly I:C, but was less toxic.
A new research project is about to commence on the use of rintatolimod in the treatment of ME/CFS (chronic fatigue syndrome ). Key physicians have been recruited in this treatment project, Derek Enlander MD, New York, Charles Lapp MD, Carolina, Lucinda Bateman MD , Salt Lake City, Nancy Klimas MD Miami, and Dr Peterson MD Reno.
The project is due to start in May 2011.
Carter founded a company based upon the compound and licensed it from Johns Hopkins. By the late 1980s, Carter and his company, HEM Research, Inc., were pursuing human therapeutic uses for rintatolimod, as well as non-therapeutic uses, such as diagnostic testing for HIV
and protecting plants from pathogens.
Rintatolimod was tested in clinical trials in America beginning in 1988, after DuPont
invested $
30 million in Hemispherx. Initial success in a small trial for AIDS
treatment was followed by difficulties in persuading the FDA to permit large scale trials. By 1991, it was thought that the chance of approval for a large trial being conducted in the USA had gone. Hemispherx then began to move clinical trials to Canada
and Belgium
.
In Belgium, rintatolimod has been available for use since the drug's trial beginning in May 1996. It has also been available under Canada's Emergency Drug Release Program for both chronic fatigue syndrome
(CFS) and HIV treatment since 1996, with marketing rights controlled by Biovail Corporation International. An agreement between the Spanish company Esteve and Hemispherx in 2002 gave Esteve the rights to perform clinical trials at their own cost in Spain
, Portugal
, and Andorra
. Bioclones (PTY) Ltd, a UK based company, was granted the exclusive marketing rights to rintatolimod in the United Kingdom
, Ireland
, and several countries in the Southern Hemisphere.
The marketing agreement with Bioclones was terminated in 2005.
Over its developmental history, rintatolimod has received various designations, including “orphan drug product” and “emergency compassionate cost recovery sales authorization” both from the FDA and "promising" clinical outcome recognition based on the evaluation of certain summary clinical reports (AHRQ, Agency Health Research Quality).
On December 3, 2007, the FDA deemed the NDA submitted by the company on October 10, 2007 to be incomplete. Specifically, eleven deficiencies were noted in the Clinical Section and three in the Pre-Clinical Section.
In 2009, William Carter said that rintatolimod could be a booster for a flu vaccine to the H1N1
flu and fight the 2009 swine flu outbreak.
The FDA postponed an announcement about rintatolimod scheduled for May 25, 2009 for "one to two weeks." In July, 2009, a report said that the FDA's decision would not be announced until later in 2009. Critics said that Hemispherx is regularly using "an eight year old government report to assure investors the company's chronic fatigue syndrome drug will be approved soon."
The drug was rejected by FDA in December 2009.
es. A receptor on the cell surface called Toll-like receptor 3 (TLR3) is part of an evolutionarily conserved family of “pattern recognition” receptors that detect pathogens immediately, even those the body has not yet encountered, long before adaptive immunity can intervene against foreign invaders. These molecules are critical to the first line of immunological defense against a broad range of pathogens, such as viruses, and even various forms of cancer.
When TLR3 senses a dsRNA, it relays a message to the cell to produce interferon, a small protein that serves as a signal. Interferon alerts other cells that an infection is present and produces a series of responses in nearby cells and the interferon-producing cell. These include changes in gene regulation, for example stimulating production of the 2'-5' oligoadenylate synthetase-dependent enzyme RNase L
(Ribonuclease, latent). This protein degrades viral RNA. It can also degrade the cell's own RNA, leading to the apoptosis
(programmed cell death) of virally compromised cells.
The mechanism of rintatolimod in relation to CFS is not known but it is thought to involve RNase L
. Accumulation of an inactive form of RNase L may be associated with CFS. According to a Hemispherx press release summarizing findings published in the Journal of Immunology
, rintatolimod requires TLR-3 to work, in contrast to other synthetic dsRNA molecules that are detected by multiple cellular sensors.
for treatment of CFS) in the USA was completed in 2004. The AMP 511 open-label study of rintatolimod in CFS is still recruiting participants. Open-label studies are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the benefits of the investigational drug until marketing approval is obtained. Hemispherx management had missed several target deadlines for new drug application (NDA) filing in the past, including the end of 2005, the third quarter of 2006, and the first quarter of the year 2007. In October 2007, the US Food and Drug Administration
(FDA) Ampligen NDA was filed. In December 2009 the FDA issued a CRL refusing Hemisherx's new drug application for rintatolimod's treatment of CFS. The FDA concluded that the two RCTs "did not provide credible evidence of efficacy." The agency recommends a minimum of one additional six month 300 patient study, and rodent carcinogenicity studies. The company reports it is currently working with the FDA to address these concerns.
Rintatolimod is received intravenously. It is generally administered twice weekly for periods of one year or greater. Two toxicology studies were recently completed that establish the safety of intranasal and intramucosal methods of rintatolimod administration. Hemispherx states it is currently researching an oral drug that uses nucleic acid technology related to rintatolimod.
reaction has occurred in about 15% of patients, and other reported side effects
include chills, fever
, malaise
, leukopenia
, neutropenia
and leukocytosis
. A full list is available on the Hemispherx website. The extent of these side-effects is unknown. According to Hemispherx, side-effects usually subside within "several months".
Manuel Asensio
, an investment adviser who reports on companies he considers to be overvalued, has criticized Hemispherx and its rintatolimod results, alleging a variety of misdemeanors including accusations of refusing to supply rintatolimod after clinical trials have ended, and issuing misleading results to widen markets for rintatolimod.
In 1998, Hemispherx Biopharma filed a complaint against Asensio and his company, alleging defamation, conspiracy and interference with its business relations through a short selling
plot. After a jury rejected the defamation claims against Asensio, a mistrial was declared. Hemispherx announced in 2006 that they anticipated a new trial date to be set.
On November 2, 1999, Mary Schweitzer, a chronic fatigue syndrome patient who had been treated with rintatolimod, raised the question of why rintatolimod had never been fast-tracked by the US public health authorities at the Chronic Fatigue Syndrome Co-ordinating Committee of the U.S. Department of Health and Human Services.
In June 2009, The Street
alleged Hemispherx was "seeking to divert investors' attention away from the delayed approval of rintatolimod as a treatment for chronic fatigue syndrome" by issuing three press releases in seven days about research from 2007 into possible applications for rintatolimod as a flu vaccine booster. Hemispherx stated that rintatolimod could be used against the H1N1 swine flu. The Street also alleged the Hemispherx press releases were misleading because they imply the research had been done in 2009. Hemispherx's attempts to put rintatolimod in the H1N1 market were unsuccessful. The company stated they were "shut out of the U.S. government's efforts to stockpile vaccine against the H1N1 flu."
and AIDS
, although studies have been limited. Other suggested uses include Ebola
and Smallpox
.
Immunomodulator
An immunomodulator, also known as an immunotherapy is a substance which has an effect on the immune system.- Immunosuppressants :Inhibits immune response in organ transplantation and autoimmune diseases.- Immunostimulants :...
y double stranded RNA drug
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
developed by Hemispherx Biopharma
Hemispherx Biopharma
Hemispherx Biopharma is a biopharmaceutical company based in Philadelphia, Pennsylvania. Founded in 1990, the company has 32 employees.The company has created a immunomodulatory double stranded RNA drug called Ampligen. The company is developing Ampligen to use as a treatment for chronic fatigue...
of Philadelphia, Pennsylvania. Rintatolimod was first synthesized in the 1970s and has been proposed and tested as a treatment for illness
Illness
Illness is a state of poor health. Illness is sometimes considered another word for disease. Others maintain that fine distinctions exist...
es including chronic fatigue syndrome
Chronic fatigue syndrome
Chronic fatigue syndrome is the most common name used to designate a significantly debilitating medical disorder or group of disorders generally defined by persistent fatigue accompanied by other specific symptoms for a minimum of six months, not due to ongoing exertion, not substantially...
(CFS) and acquired immunodeficiency syndrome
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
(AIDS).
Hemispherx reports that it completed a Phase III clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
for CFS in 2004 and filed a new drug application
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
(NDA) with the U.S. Food and Drug Administration (FDA) to market and sell rintatolimod for the treatment of CFS, but this was rejected in December 2009 because the FDA concluded that the two RCTs "did not provide credible evidence of efficacy."
History
Rintatolimod was developed in the 1960s after Merck & Co.Merck & Co.
Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. The Merck headquarters is located in Whitehouse Station, New Jersey, an unincorporated area in Readington Township...
synthesized a double-stranded RNA
RNA
Ribonucleic acid , or RNA, is one of the three major macromolecules that are essential for all known forms of life....
compound composed of inosinic and cytidylic acid residues (poly I:poly C or poly I:C). Poly I:C inhibited tumor growth by inducing interferon
Interferon
Interferons are proteins made and released by host cells in response to the presence of pathogens—such as viruses, bacteria, or parasites—or tumor cells. They allow communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors.IFNs belong to...
production. In the mid-1970s, William A. Carter, a post-doctoral researcher at Johns Hopkins University
Johns Hopkins University
The Johns Hopkins University, commonly referred to as Johns Hopkins, JHU, or simply Hopkins, is a private research university based in Baltimore, Maryland, United States...
, modified the dsRNA molecule by adding uridylic acid molecules at specific interval along the RNA chain. The new compound, called Ampligen (for AMPLIfied GENetic activity) stimulated interferon production like poly I:C, but was less toxic.
A new research project is about to commence on the use of rintatolimod in the treatment of ME/CFS (chronic fatigue syndrome ). Key physicians have been recruited in this treatment project, Derek Enlander MD, New York, Charles Lapp MD, Carolina, Lucinda Bateman MD , Salt Lake City, Nancy Klimas MD Miami, and Dr Peterson MD Reno.
The project is due to start in May 2011.
Carter founded a company based upon the compound and licensed it from Johns Hopkins. By the late 1980s, Carter and his company, HEM Research, Inc., were pursuing human therapeutic uses for rintatolimod, as well as non-therapeutic uses, such as diagnostic testing for HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
and protecting plants from pathogens.
Rintatolimod was tested in clinical trials in America beginning in 1988, after DuPont
DuPont
E. I. du Pont de Nemours and Company , commonly referred to as DuPont, is an American chemical company that was founded in July 1802 as a gunpowder mill by Eleuthère Irénée du Pont. DuPont was the world's third largest chemical company based on market capitalization and ninth based on revenue in 2009...
invested $
United States dollar
The United States dollar , also referred to as the American dollar, is the official currency of the United States of America. It is divided into 100 smaller units called cents or pennies....
30 million in Hemispherx. Initial success in a small trial for AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
treatment was followed by difficulties in persuading the FDA to permit large scale trials. By 1991, it was thought that the chance of approval for a large trial being conducted in the USA had gone. Hemispherx then began to move clinical trials to Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
and Belgium
Belgium
Belgium , officially the Kingdom of Belgium, is a federal state in Western Europe. It is a founding member of the European Union and hosts the EU's headquarters, and those of several other major international organisations such as NATO.Belgium is also a member of, or affiliated to, many...
.
In Belgium, rintatolimod has been available for use since the drug's trial beginning in May 1996. It has also been available under Canada's Emergency Drug Release Program for both chronic fatigue syndrome
Chronic fatigue syndrome
Chronic fatigue syndrome is the most common name used to designate a significantly debilitating medical disorder or group of disorders generally defined by persistent fatigue accompanied by other specific symptoms for a minimum of six months, not due to ongoing exertion, not substantially...
(CFS) and HIV treatment since 1996, with marketing rights controlled by Biovail Corporation International. An agreement between the Spanish company Esteve and Hemispherx in 2002 gave Esteve the rights to perform clinical trials at their own cost in Spain
Spain
Spain , officially the Kingdom of Spain languages]] under the European Charter for Regional or Minority Languages. In each of these, Spain's official name is as follows:;;;;;;), is a country and member state of the European Union located in southwestern Europe on the Iberian Peninsula...
, Portugal
Portugal
Portugal , officially the Portuguese Republic is a country situated in southwestern Europe on the Iberian Peninsula. Portugal is the westernmost country of Europe, and is bordered by the Atlantic Ocean to the West and South and by Spain to the North and East. The Atlantic archipelagos of the...
, and Andorra
Andorra
Andorra , officially the Principality of Andorra , also called the Principality of the Valleys of Andorra, , is a small landlocked country in southwestern Europe, located in the eastern Pyrenees mountains and bordered by Spain and France. It is the sixth smallest nation in Europe having an area of...
. Bioclones (PTY) Ltd, a UK based company, was granted the exclusive marketing rights to rintatolimod in the United Kingdom
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
, Ireland
Republic of Ireland
Ireland , described as the Republic of Ireland , is a sovereign state in Europe occupying approximately five-sixths of the island of the same name. Its capital is Dublin. Ireland, which had a population of 4.58 million in 2011, is a constitutional republic governed as a parliamentary democracy,...
, and several countries in the Southern Hemisphere.
The marketing agreement with Bioclones was terminated in 2005.
Over its developmental history, rintatolimod has received various designations, including “orphan drug product” and “emergency compassionate cost recovery sales authorization” both from the FDA and "promising" clinical outcome recognition based on the evaluation of certain summary clinical reports (AHRQ, Agency Health Research Quality).
On December 3, 2007, the FDA deemed the NDA submitted by the company on October 10, 2007 to be incomplete. Specifically, eleven deficiencies were noted in the Clinical Section and three in the Pre-Clinical Section.
In 2009, William Carter said that rintatolimod could be a booster for a flu vaccine to the H1N1
H1N1
'Influenza A virus is a subtype of influenza A virus and was the most common cause of human influenza in 2009. Some strains of H1N1 are endemic in humans and cause a small fraction of all influenza-like illness and a small fraction of all seasonal influenza. H1N1 strains caused a few percent of...
flu and fight the 2009 swine flu outbreak.
The FDA postponed an announcement about rintatolimod scheduled for May 25, 2009 for "one to two weeks." In July, 2009, a report said that the FDA's decision would not be announced until later in 2009. Critics said that Hemispherx is regularly using "an eight year old government report to assure investors the company's chronic fatigue syndrome drug will be approved soon."
The drug was rejected by FDA in December 2009.
Hypothesized mechanism of action
The manufacturer says rintatolimod acts by stimulating the innate immune system. Cells normally encounter double-stranded RNA molecules like rintatolimod and poly I:C only during infection with RNA virusVirus
A virus is a small infectious agent that can replicate only inside the living cells of organisms. Viruses infect all types of organisms, from animals and plants to bacteria and archaea...
es. A receptor on the cell surface called Toll-like receptor 3 (TLR3) is part of an evolutionarily conserved family of “pattern recognition” receptors that detect pathogens immediately, even those the body has not yet encountered, long before adaptive immunity can intervene against foreign invaders. These molecules are critical to the first line of immunological defense against a broad range of pathogens, such as viruses, and even various forms of cancer.
When TLR3 senses a dsRNA, it relays a message to the cell to produce interferon, a small protein that serves as a signal. Interferon alerts other cells that an infection is present and produces a series of responses in nearby cells and the interferon-producing cell. These include changes in gene regulation, for example stimulating production of the 2'-5' oligoadenylate synthetase-dependent enzyme RNase L
RNAse L
RNase L is an interferon-induced ribonuclease which, upon activation, destroys all RNA within the cell .- Production and Activation :...
(Ribonuclease, latent). This protein degrades viral RNA. It can also degrade the cell's own RNA, leading to the apoptosis
Apoptosis
Apoptosis is the process of programmed cell death that may occur in multicellular organisms. Biochemical events lead to characteristic cell changes and death. These changes include blebbing, cell shrinkage, nuclear fragmentation, chromatin condensation, and chromosomal DNA fragmentation...
(programmed cell death) of virally compromised cells.
The mechanism of rintatolimod in relation to CFS is not known but it is thought to involve RNase L
RNAse L
RNase L is an interferon-induced ribonuclease which, upon activation, destroys all RNA within the cell .- Production and Activation :...
. Accumulation of an inactive form of RNase L may be associated with CFS. According to a Hemispherx press release summarizing findings published in the Journal of Immunology
Journal of Immunology
The Journal of Immunology is a peer-reviewed academic journal that publishes basic and clinical studies in all aspects of immunology. It was founded by Arthur Fernandez Coca in 1915 . It is the official journal of The American Association of Immunologists and published by The American Association...
, rintatolimod requires TLR-3 to work, in contrast to other synthetic dsRNA molecules that are detected by multiple cellular sensors.
Clinical trials and approval status
A randomized study of rintatolimod (AMP 516 Phase III clinical trialClinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
for treatment of CFS) in the USA was completed in 2004. The AMP 511 open-label study of rintatolimod in CFS is still recruiting participants. Open-label studies are typically used when the controlled trial has ended and treatment is continued so that the subjects and the controls may continue to receive the benefits of the investigational drug until marketing approval is obtained. Hemispherx management had missed several target deadlines for new drug application (NDA) filing in the past, including the end of 2005, the third quarter of 2006, and the first quarter of the year 2007. In October 2007, the US Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) Ampligen NDA was filed. In December 2009 the FDA issued a CRL refusing Hemisherx's new drug application for rintatolimod's treatment of CFS. The FDA concluded that the two RCTs "did not provide credible evidence of efficacy." The agency recommends a minimum of one additional six month 300 patient study, and rodent carcinogenicity studies. The company reports it is currently working with the FDA to address these concerns.
Rintatolimod is received intravenously. It is generally administered twice weekly for periods of one year or greater. Two toxicology studies were recently completed that establish the safety of intranasal and intramucosal methods of rintatolimod administration. Hemispherx states it is currently researching an oral drug that uses nucleic acid technology related to rintatolimod.
Impact
Approximately 760 patients have received rintatolimod as part of clinical trials in the US, representing about 75,000 doses. Some chronic fatigue syndrome patients have reported a complete recovery, with others reporting clear and measurable improvements, although success has not been universal. More common benefits include improved cognitive skills, an increase in energy and greater oxygen uptake. These improvements can be measured on the Karnofsky scale.Side effects and safety
Hemispherx consider that rintatolimod has been "generally well tolerated", with a "low incidence of clinical toxicity", particularly when compared to the toxicity of the diseases it is used to treat. "No serious safety issues have resulted from the administration of ~75,000 doses IV (most commonly 400 mg) twice weekly for up to one year periods or greater. Animal toxicity studies support this observation in humans with primates demonstrating the greatest margin of safety." A mild flushingFlushing (physiology)
For a person to flush is to become markedly red in the face and often other areas of the skin, from various physiological conditions. Flushing is generally distinguished, despite a close physiological relation between them, from blushing, which is milder, generally restricted to the face, cheeks or...
reaction has occurred in about 15% of patients, and other reported side effects
Adverse effect (medicine)
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...
include chills, fever
Fever
Fever is a common medical sign characterized by an elevation of temperature above the normal range of due to an increase in the body temperature regulatory set-point. This increase in set-point triggers increased muscle tone and shivering.As a person's temperature increases, there is, in...
, malaise
Malaise
Malaise is a feeling of general discomfort or uneasiness, of being "out of sorts", often the first indication of an infection or other disease. Malaise is often defined in medicinal research as a "general feeling of being unwell"...
, leukopenia
Leukopenia
Leukopenia is a decrease in the number of white blood cells found in the blood, which places individuals at increased risk of infection....
, neutropenia
Neutropenia
Neutropenia, from Latin prefix neutro- and Greek suffix -πενία , is a granulocyte disorder characterized by an abnormally low number of neutrophils, the most important type of white blood cell...
and leukocytosis
Leukocytosis
Leukocytosis is a raised white blood cell count above the normal range in the blood. It is frequently a sign of an inflammatory response, most commonly the result of infection, and is observed in certain parasitic infections...
. A full list is available on the Hemispherx website. The extent of these side-effects is unknown. According to Hemispherx, side-effects usually subside within "several months".
Controversy
Hemispherx has on two occasions received warning letters from the FDA regarding its promotion of rintatolimod as safe and effective before approval from the FDA.Manuel Asensio
Manuel P. Asensio
Manuel P. Asensio is a money manager in New York best known for his work as an activist short-seller. Since 2000, Asensio and his firm have been subject to regulatory sanctions by the Financial Industry Regulatory Authority ....
, an investment adviser who reports on companies he considers to be overvalued, has criticized Hemispherx and its rintatolimod results, alleging a variety of misdemeanors including accusations of refusing to supply rintatolimod after clinical trials have ended, and issuing misleading results to widen markets for rintatolimod.
In 1998, Hemispherx Biopharma filed a complaint against Asensio and his company, alleging defamation, conspiracy and interference with its business relations through a short selling
Short selling
In finance, short selling is the practice of selling assets, usually securities, that have been borrowed from a third party with the intention of buying identical assets back at a later date to return to that third party...
plot. After a jury rejected the defamation claims against Asensio, a mistrial was declared. Hemispherx announced in 2006 that they anticipated a new trial date to be set.
On November 2, 1999, Mary Schweitzer, a chronic fatigue syndrome patient who had been treated with rintatolimod, raised the question of why rintatolimod had never been fast-tracked by the US public health authorities at the Chronic Fatigue Syndrome Co-ordinating Committee of the U.S. Department of Health and Human Services.
In June 2009, The Street
The Street
The Street may refer to:*The Street , a drama shown on BBC One in 2006, 2007 and 2009*"The Street" , by H. P. Lovecraft*The Street , a 1946 novel by Ann Petry...
alleged Hemispherx was "seeking to divert investors' attention away from the delayed approval of rintatolimod as a treatment for chronic fatigue syndrome" by issuing three press releases in seven days about research from 2007 into possible applications for rintatolimod as a flu vaccine booster. Hemispherx stated that rintatolimod could be used against the H1N1 swine flu. The Street also alleged the Hemispherx press releases were misleading because they imply the research had been done in 2009. Hemispherx's attempts to put rintatolimod in the H1N1 market were unsuccessful. The company stated they were "shut out of the U.S. government's efforts to stockpile vaccine against the H1N1 flu."
Other uses
The manufacturer says rintatolimod can be used for Avian FluAvian flu
Avian influenza, sometimes avian flu, and commonly bird flu, refers to "influenza caused by viruses adapted to birds." Of the greatest concern is highly pathogenic avian influenza ....
and AIDS
AIDS
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome is a disease of the human immune system caused by the human immunodeficiency virus...
, although studies have been limited. Other suggested uses include Ebola
Ebola
Ebola virus disease is the name for the human disease which may be caused by any of the four known ebolaviruses. These four viruses are: Bundibugyo virus , Ebola virus , Sudan virus , and Taï Forest virus...
and Smallpox
Smallpox
Smallpox was an infectious disease unique to humans, caused by either of two virus variants, Variola major and Variola minor. The disease is also known by the Latin names Variola or Variola vera, which is a derivative of the Latin varius, meaning "spotted", or varus, meaning "pimple"...
.
External links
- Ampligen FAQ (1996)
- Hemispherx Ampligen Page
- A History of Ampligen and its Creator
- Esteve Home Page
- Bioclones Ampligen Page
- Review of rintatolimod clinical trials in CFS
- Hemispherx Biopharma SEC filings
- Peer-reviewed Ampligen for CFS phase II trial article in Clinical Infectious Diseases 1994; 18 (Suppl. 1):S 88-95