Hemispherx Biopharma, Inc. (AMEX: HEB) (Price: $3.97) recently issued a press release titled, “Hemispherx disseminates new clinical data on experimental treatment of multi-drug resistant HIV/AIDS virus.” The press release states that two Hemispherx collaborators evaluated seven HIV infected patients enrolled in an alleged HIV clinical trial called AMP 719. The test results given in the press release claim that the mean copies per milliliter (“copies/ml”) of HIV RNA decreased 1,973 copies/ml to 3,582 and that CD4 cell count increased by 10 cells to 351. Supposedly HEB issued the results in support of their discredited claim that Ampligen possesses some potential medical value.
A measurement of average HIV RNA copies/ml is used to track the amount of HIV virus in a patient. This is also known as the viral load. Patients who are in the advanced stages of immunodeficiency can have HIV RNA levels greater than 1,000,000 copies/ml. According to the release, patients in HEB’s study began treatment with a baseline average of 5,555 copies/ml. After 15 weeks of treatment with Ampligen the patients were found to have 3,582 copies/ml.
Due to the large variations that occur between different HIV RNA measurements, meaningful changes in copies/ml are normally expressed as a function of their logarithmic value. We found that the minimal decrease in viral load normally considered to be significant is approximately three-fold (equal to 0.5 log10). According to aidsinfonyc.org, the treatment goal should be a ten-fold drop (equal to 1.0 log10) in viral load. HEB’s results are expressed in raw number form and represent a decrease of 0.19 log10, much less than half the value of a significant decrease. The alleged results are much less meaningful in comparison to the aidsinfonyc.org treatment goal. Based on the beginning baseline average of 5,555 copies/ml, a 0.5 log10 decrease is 3,798, which would equal an ending viral load of 1,757.
T-cells, also called CD4 cells, are one of the body’s defense mechanisms against viral infections. The CD4 cell per cubic millimeter (“cells/mm3”) count is a key measure of the health of the immune system. The lower the count, the weaker the immune system. In fact, according to the US Centers for Disease Control, anyone infected with HIV who has less than 200 CD4 cells/mm3 is considered to have AIDS. However, an HIV patient’s CD4 cell count varies widely depending on many factors, such as the time of day, fatigue, and stress. A patient’s T-cell count can vary by 50 cells/mm3 naturally from morning to evening. The seven patients in HEB’s study showed a mean increase of only 10 CD4 cells, from 341 to 351, over 15 weeks.
Hemispherx is being investigated for fraud by the SEC. Carter was Hemispherx’s leader when Hemispherx made payments and executed transactions that are the subject of at least 6 federal criminal indictments and other New York state indictments. Over the past 25 years, Carter has been accused of unethical and illegal behavior by Hemispherx itself, of extortion by an AIDS patient, of scientific fraud by E.I. Dupont, of improper medical work by a hospital and his own staff and was fired by that hospital after years of disputes and lawsuits. Its entire stock value is based on its public promotion of the commercial value of Ampligen that is based on questionable out-dated studies.
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