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An interview with Larry Stockl of HemispheRX, the makers of the drug Ampligen, from CFIDSMail.
Several people with Chronic Fatigue Syndrome who are scheduled to take part in the cost-recovery, open-label trials of Ampligen have told me recently that they have been waiting since September to receive the drug and that after a series of delays, their doctors are still unable to tell them exactly when they can expect to receive the treatment they were promised and which they so desperately need. These patients with CFS who are severly ill and who are willing to pay the $25,000 which HemispheRX is currently charging for a six-month supply of Ampligen, which is not currently covered by any medical insurance or other health coverage since it is still classified as an experimental drug. All anyone seems to know is that the delay may have something to do with the FDA. Ampligen, as you already know, is an interferon which is currently being tested in The United States for the treatment of CFS as well as some other diseases. It is, in fact, the only drug whcih is now being tested in The United States for treatment of CFS, although Amarillo Biosciences' Oral Interferon Alpha is scheduled to begin Phase III testing next month for Fibromyalgia and may eventually be tested for CFS as well.
That being the case, I thought it was worthwhile to try to find out what is causing the delay. I called HemispheRX, and was referred to Larry Stockl in their publicity department. Following is a partial transcript of the conversation, which took place on December 9, 1997.
CFIDSMail: Can you tell me why there's been a delay in patients who expected to receive Ampligen being able to get the drug?
STOCKL: That's between the comapny and the FDA, in terms of the number of patients that are allocated to be treated. The company reports to them monthly on the patients that are currently being tested and then there's a point in time where we will be discudding with them to increase the number of patients being treated.
CFIDSMail: Are any patients scheduled to begin the Phase II trial any time soon?
STOCKL: Currently we are past Phase II. At this juncture you have an open-label program, cost recovery, where patients are allowed to be treated.
CFIDSMail: I've talked to three people in the last few days who were told by their doctors -- Dr. Peterson, Dr. Lapp, and Dr. Wallace -- that they expected to be able to start Ampligen two and a half months ago, and that that's been delayed but no one seems to know why.
STOCKL: It has been delayed. That is between the company and the FDA. Dr. Peterson's site will be starting on Monday. He is starting with five patients. (NOTE: This was confirmed in a telephone conversation with Kathy Steininger, Dr. Peterson's research assistant.) That's (part of) the initial 20 that the FDA has authorized. We need him online for a while so that then we can go back to the FDA to request an additional increase.
CFIDSMail: Do you have any idea when you might be able to make that request?
STOCKL: I can't comment on that at this juncture.
CFIDSMail: What about the Phase III placebo trials?
STOCKL: The confirmatory study, the company is finalizing that with the FDA.
CFIDSMail: Are you still expecting to start that early next year?
STOCKL: Yes.
CFIDSMail: Any news on a possible oral form of Ampligen?
STOCKL: That is something that was misinformation, actually, that was out on the internet. Oragen drugs are a different classs of drug. They're nucleic-acid type drugs. They will be in oral form, but those are in pre-clinical stage. Someone had put out that this was an oral form of Ampligen and that's not the case.
CFIDSMail: Do you think you might have a treatment for CFS with one of those?
STOCKL: That is something that takes years of research, so that's many years out yet.
HemispheRX' web site at http://www.hemispherex.com/products.htmstates, under the heading "Ampligen."
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