ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

SURVEY: Cognitive Impairment II

Natural Bladder Control, Go Less and Live More

Vital Molecule Increases Cellular Energy and Improves Cognitive Function

Top Vitamin and Mineral Deficiencies — Are You at Risk?

How Pomegranate May Protect Against Cancer

Omega Fix for Obesity: How the Right Fats Fight Fat

Trimming the spare tire: Canola oil may cut belly fat

The Onion: Cancer Fighter and Food Preserver

Fighting Heartburn and Gerd Naturally – And Safely!

Probiotics improve cognition in Alzheimer's patients

 
Print Page
Email Article

New Ampligen Findings to Be Featured at IACFS/ME Conference; FDA Decision on Drug Delayed Until May 25

  [ 6 votes ]   [ 1 Comment ]
www.ProHealth.com • February 19, 2009


An FDA ruling was expected this month on the investigational “antiviral/immune modulatory” drug Ampligen® - potentially the first to be approved for treatment of ‘chronic fatigue syndrome’ (ME/CFS).

As of Feb 18, however, Ampligen’s maker (Hemispherx Biopharma) revealed that the FDA has delayed the decision date to May 25. At the same time, Hemispherx also announced that its Medical Director, Dr. David Strayer, will be presenting “new Ampligen clinical data” at the IACFS/ME Science Conference in Reno, NV, March 12-15.

Strayer’s presentation, scheduled in Session 1 of the Professional Meeting:

“Will include new data from the ongoing treatment IND/compassionate study (AMP 511) as well as the completed well-controlled pivotal Phase III study (AMP 516).

“Individuals suffering with CFS are known to be at greater risk than age-matched healthy populations with respect to certain catastrophic events including cancer, sudden cardio-vascular death and suicidal ideation. The new data will evaluate the potential of Ampligen… to mitigate certain of these events. Data utilized will integrate serially performed immunologic lab panels and EKGs, as well as physical performance scores and medical records (including concomitant medications used to alleviate certain symptoms of CFS).

“Ampligen®, an experimental product, may modulate nature’s primary gateway to immune response, mediated by receptors termed “toll-like receptors” (TLRs). Many other immuno-modulators may work downstream from the TLRs immune “gateways” at so-called “checkpoints.” Since “checkpoints” are not normally part of nature’s own immune-defense surveillance apparatus, these alternative “checkpoint” strategies may be associated with unintended consequences including significant toxicities.”

What Is Ampligen?

Ampligen (AMPLIfied GENetic activity) - an “orphan drug” under development & testing for 30 years and still allowed only in specific clinical trial settings conducted under U.S. governmental authorization - is termed “a nucleic acid drug,” designed to “modulate” the body’s immune system. Its mechanism of action in ME/CFS “is not entirely clear,” but it is thought to act on two enzyme systems so as to help the immune system destroy viral RNA and speed the death of virus-affected cells. In particular it may “downregulate” an anti-viral pathway which research suggests has become “upregulated” in certain ME/CFS patients (the 2-5 Synthetase/RNase L anti-viral pathway).

A "Who's-Who" of the world’s leading ME/CFS specialists have participated in Ampligen trials over the years.




Post a Comment

Featured Products From the ProHealth Store
Vitamin D3 Extreme™ Ultra EPA  - Fish Oil Ultra ATP+, Double Strength


Article Comments Post a Comment

3 month extension
Posted by: outofstep
Feb 19, 2009
According to the Hemispherx press release the FDA has extended the NDA review date to May 25th
Reply Reply
 
Natural Pain Relief Supplements

Featured Products

Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%

Natural Remedies

Coenzyme Q10 - The Energy Maker Coenzyme Q10 - The Energy Maker
Priming Your Immune System for Cold & Flu Season Priming Your Immune System for Cold & Flu Season
Relief for Dry, Itchy Skin Caused by Fibromyalgia Relief for Dry, Itchy Skin Caused by Fibromyalgia
Guarding Against the Dangers of Vitamin D Deficiency Guarding Against the Dangers of Vitamin D Deficiency
Dreaming of a Good Night's Sleep? Dreaming of a Good Night's Sleep?

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map