Rintatolimod: Difference between revisions

Rintatolimod
	File:Ampligen.jpg
Clinical data
Routes of; administration	IV
Identifiers
PubChem CID	38077;
CompTox Dashboard (EPA)	DTXSID50191952 ;
Chemical and physical data
Formula	C28H40N9O25P3
Molar mass	995.584 g·mol−1

Browse history interactively

← Previous edit Next edit →

Content deleted Content added

VisualWikitext

Inline

Revision as of 22:04, 9 February 2007

Ampligen, also known as polyI:polyC12U, is an experimental antiviral and immunomodulatory double stranded RNA drug developed by HEMISPHERx Biopharma, Inc. Ampligen completed a pivotal clinical trial phase III for Chronic Fatigue Syndrome (CFS), a severely debilitating diseasein 2004[1]. A new drug application, or NDA, is in preparatory stages, and Hemispherx management has targeted late 2006 for its filing with the U.S. Food and Drug Administration, although the company has missed several target deadlines for an NDA filing in the past, including the end of 2005 and the third quarter of 2006 [2]. It will we up to the FDA to approve its use.

History

Mechanism Of Action

The mechanism of action in relation to CFS is not clear.

Impact

Side Effects

Controversy

Other Uses

External links

@@ Line 26: / Line 26: @@
 }}
-'''Ampligen''', also known as '''polyI:polyC12U''', is an experimental [[antiviral drug|antiviral]] and [[immunomodulator]]y [[RNA#Double-stranded RNA|double stranded RNA]] [[drug]] developed by HEMISPHERx Biopharma, Inc. It is believed to be of use in the treatment of [[Chronic Fatigue Syndrome]] (CFS), a severely debilitating [[disease]]. Ampligen completed clinical trials phase III for CFS in 2004[http://www.hemispherx.net/content/investor/default.asp?goto=298], and an extension of the interventional uncontrolled open trial under the cost recovery programme  (Amp 511 )is currently recruiting [http://www.clinicaltrials.gov/ct/show/NCT00215813].
+'''Ampligen''', also known as '''polyI:polyC12U''', is an experimental [[antiviral drug|antiviral]] and [[immunomodulator]]y [[RNA#Double-stranded RNA|double stranded RNA]] [[drug]] developed by HEMISPHERx Biopharma, Inc. Ampligen completed a pivotal clinical trial phase III for [[Chronic Fatigue Syndrome]] (CFS), a severely debilitating [[disease]]in 2004[http://www.hemispherx.net/content/investor/default.asp?goto=298]. A [[new drug application]], or NDA, is in preparatory stages, and Hemispherx management has targeted late 2006 for its filing with the U.S. [[Food and Drug Administration]], although the company has missed several target deadlines for an NDA filing in the past, including the end of 2005 and the third quarter of 2006 [http://sec.edgar-online.com/2006/01/03/0000946644-06-000001/Section4.asp]. It will we up to the FDA to approve its use.
-A [[new drug application]], or NDA, is in preparatory stages, and Hemispherx management has targeted late 2006 for its filing with the U.S. [[Food and Drug Administration]], although the company has missed several target deadlines for an NDA filing in the past, including the end of 2005 and the third quarter of 2006 [http://sec.edgar-online.com/2006/01/03/0000946644-06-000001/Section4.asp].
 ==History==
 ==Mechanism Of Action==
 {{expert-subject|Drugs}}
+The mechanism of action in relation to CFS is not clear.
-The mechanism of action in relation to CFS is not entirely clear, but it is known to act on two important enzyme systems, one of which is the 2-5 Synthetase/[[RNase L]] anti-viral pathway. Research increasingly shows that the upregulation of this pathway is an important factor in the development of CFS [http://www.immunesupport.com/library/print.cfm?ID=4016]. The downregulation of this pathway leads to the [[immune system]] being better able to destroy viral [[RNA]] and accelerates the [[apoptosis]] of virally compromised cells{{Fact|date=February 2007}}(quotation?). Ampligen must be received [[intravenously]], but Hemispherx is researching an oral form of the drug [http://www.chronicillnet.org/online/Ampligen.html]. It is generally administered twice weekly for periods of one year or greater.
 ==Impact==
-Approximately 760 patients have received Ampligen as part of clinical trials in the US, representing about 75,000 doses. Some patients have reported a complete recovery, with others reporting clear and measurable improvements [http://www.cfids-me.org/aacfs/ampligen.html], while others have suffered relapses and serious side effects(quotation?){{Fact|date=February 2007}}.
-More common benefits include improved [[cognitive]] skills, an increase in energy, and greater oxygen uptake. These improvements can be measured on the [[Karnofsky score#Karnofsky scoring|Karnofsky]] scale.
-Some studies suggest that Ampligen is most effective against a certain subset of CFS patients (quotation?), those with severe [[debilitation]]. Other studies indicate that Ampligen has a more significant effect on those who have suffered for 5 years or less, for reasons relating to activation of the 2,5 Rnase pathway (quotation?)[http://www.co-cure.org/cheney.htm].
 ==Side Effects==
-Reported side effects include [[flushing]], [[chills]], [[fever]], [[malaise]], [[leukopenia]], [[neutropenia]] and [[leukocytosis]]. A full list is available on the Hemispherx website [http://www.hemispherx.net/content/rnd/drug_candidates.htm]. The extent of these side effects are unknown, although Hemispherx claim they usually subside within 'several months'.
 ==Controversy==
-Ampligen has been surrounded by controversy
 ==Other Uses==
-Alternative potential uses of Ampligen include fighting [[Avian Flu]], [[AIDS]] [http://www.aidsmap.com/en/docs/26E043C1-10CA-4FF7-BA24-77529D386442.asp], [[Hepatitis B]] and [[Cancer]], [http://www.hemispherx.net/content/rnd/product_candidates.htm].
 ==See also==
 *[[Chronic Fatigue Syndrome]]
@@ Line 55: / Line 46: @@
 ==External links==
-*[http://www.cfs-news.org/kitei.htm History of Ampligen Article - Mindy Kitei, Philadelphia Magazine, 1994]
 [[Category:drugs]]