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Biotech / Medical : HEB, Hemispherx Biopharma (AMEX)NEW
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To: Graham Marshman who wrote (101)12/4/1997 11:50:00 PM
From: 3Sheets   of 857
 
If HEB's Ampligen becomes FDA approved its widespread distribution may be slowed due to its nature.

Currently, Ampligen is supplied as 50 mg lyophilized (freeze dried) cakes in glass vials. These vials must be stored at 2 to 8 'C.

Reconstitution of the Ampligen appears fairly straight forward but will require a laboratory environment. A very generalized description of the reconstitution methodology is as follows: first, heat a water bath to 65 'C; inject 20 ml of sterile water into the vial; place the vial in the water bath for 30 minutes, gently swirl if needed; remove from the bath; and, allow to cool to room tempature (20-27 'C). This may require up to 2 hours. At this point the Ampligen has an useful life of 8 hours.

The Ampligen is then transferred to an IV solution and infused into the patient. Dosages for CFS folk are 400 mg twice a week, and an infusion rate of 35 to 40 minutes.

HEB has been working on a method stabilize Ampligen. But until this is achieved it is not a drug where a CFS person can run down to their local pharmacy or doctor's office to get.

The two possible senarios I see are: HEB finds a way to stabilize Ampligen; or a delivery system is set-up using hospitals and specialty clinics, similar to how the kidney dialysis system is set-up.

The specific date on this information was October 1996. Has anyone found any recent information to the contrary of this information.

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