As you read this currently there are a number of the most well-known ME doctors, and some others, meeting with Hemispherx Pharma, (the makers of Ampligen) at a meeting in Florida. The main reason for the gathering this long weekend is so that Hemispherx can announce and explain their new "widened enrollment" plan for Ampligen trials. Hemispherx filed and was approved to expand to more doctors and clinics the testing of Ampligen in what they call CFS/ME, stating:
"In conjunction with this ongoing analysis of the Companys AMP-516 study, which is an integral part of NDA 22-151, Hemispherx is also initiating a widened enrollment of the open label AMP 511 study to increase the number of observations relating to potential interrelationships of XMRV, CFS symptoms and poly I: poly C12U (Ampligen)."
So the good news for patients is that "widened" means "more doctors in more cities!"
Hemispherx reported that they are taking this seriously. For the first time they have hired a new staff dedicated to the recruiting and approval of new clinics and physicians. So in the USA, instead of only having a choice between Dr. Lapp in Charlotte, and Dr. Peterson in the Reno area, we have confirmed that Hemispherx has recruited others including:
- Dr. Lucinda Bateman in Salt Lake City http://www.fcclinic.com/researchdept.html
- Dr. Derek Englander in New York http://www.enlander.com/
- Dr. Nancy Klimas in Miami http://www.cfsclinic.com/
The meeting this weekend in Florida will also present to these doctors some new aspects of the AMP 511 study, to now include, if not be keen on, XMRV.
So "expanded" also means that all new patients in trials will have XMRV tests and markers done at baseline and throughout the study. Because we already know from published reports that patients with XMRV have and do respond well to Ampligen we now have a definitive end-game in sight for the ultimate, long-awaited approval of this drug. In short, with more Doctors doing the study, better screening, and results that will among other things, show positive response against XMRV, the days of Ampligen being in "limbo" could be over soon.
The other bit of good news is that the new protocol allow more latitude with certain patient medications, and drug holidays. When I was on the AMP 511 trial last year, we HAD to get our infusions and average of every 3 days, come rain or shine. We also had to completely cease and desist almost every other medication that was helping us, including most antivirals, and immune modulators like Nexavir. The new protocoal they are announcing to physicians this weekend is more liberal- it allows for short "drug holidays" as well as allowing more latitude in certain meds you can stay on while doing the Ampligen trial.
I'll have a follow-up report post-Florida conference to add to this post if any other revelations come out of Hemispherx over this weekend.
Until them I am praying that the meeting is well-received, that many many more doctors jump into the mix, and that many more patients will be able to at least consider Ampligen, by way of having more locations available.