Well-Come to Agent for Change, a blog created by Marly Silverman, to serve as a catalyst for change that is much needed on the issues affecting millions of individuals stricken with neuroendocrineimmune disorders worldwide. Through this blog I want to share ideas, exchange, communicate and find solutions for everyday living. The goal is to pursue quality of life that will make a difference in the lives of individuals with neuroendocrineimmune disorders (NEIDs).

Thursday, December 17, 2009


P.A.N.D.O.R.A. received today a letter from HemisphereRX, the maker of Ampligen, a drug which has been shown to help individuals with CFS-ME. I thought you would like to read it too. I have cut and paste the entire letter for you. Please share with other members of our community.


To: The CFS Patients, Advocacy Community and Healthcare Practitioners

From: Dr. David Strayer
Medical Director of Hemispherx Biopharma

Re: FDA Response on Ampligen®

Hemispherx has received a “complete” response from the FDA in which the FDA requires one additional clinical study to show a convincing effect of Ampligen in the treatment of CFS and confirm the safety in the target population. The on-going open-label study (AMP 511) and the patients enrolled will continue under the current protocol.

The FDA has provided Hemispherx with a clearly articulated set of recommendations to go forward. I would like to share with you the process we plan to go through with the agency in order to identify the most expeditious path to satisfy the requirements for the approval of the Ampligen NDA.

We plan to schedule a meeting with the agency as quickly as possible in order to obtain additional guidance and clarification concerning a number of matters, including the design of this clinical trial. This will be an ongoing process with the agency.

As part of this dialogue, we plan to evaluate the utility of a special protocol assessment from the agency in order to clearly delineate the clinical trial end points, the statistical methods to be utilized, and to obtain agreement with the agency on the results necessary for approval.

Four factors will support the sufficient execution of this clinical trial. First, the CDC's awareness program has increased public knowledge of the disease. Second, the recent identification of a potential etiologic agent, namely a novel retrovirus, should help accelerate patient identification.

Third, the company plans to utilize longstanding relationships with a group of internationally renowned clinical investigators to accelerate patient enrollment.

Lastly, the company plans to expand recently entered contractual relationships with two of the largest clinical research organizations in the world to accelerate its clinical monitoring and data collection capacity.

Finally, the company has adequate finances and resources to address and respond to all of these FDA recommendations. We have been and will continue to be committed to those suffering from Chronic Fatigue Syndrome. Additional information can be found at www.hemispherx.net. (12/17/09)

1 comment:

Anonymous said...

Congratulations on your speaking and reaching out to the NEID/CLD/CFS community. We will be networking with increased focus and intent from this moment on to help Hemispherix achieve a successful second study, underscoring the urgent need for Ampligen availabilty for those for whom it is appropriate. It is my strong desire that those of like minds join forces for our common goal of wellness and back this up with constructive daily actions toward this end, regardless of scope,
to achieve freedom at lightspeed from XMRV, NEID/CFS, Peristent Lyme, stealth, cell-wall-deficient and/or manufactured pathogens, and related diseases of all types. New coping and noncombative communication skills must be learned by many of us with differing perspectives for quicker gains. As the song goes: "People have the power, BUT THE PEOPLE HAVE TO USE IT."