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FDA APPROVAL PROCESS
TABLE: MANNAN TOXICITY EXPERIMENTS
Effect of Mannan (M) on Toxicity of Animals
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Group (5 animals in each)
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Mortality
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Weight gain (loss)
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Signs of Toxicity
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| Control 1 |
0/5
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+5.5 g (in two weeks)
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None
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| 5-FU alone |
3/5
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2.3 g (in two weeks)
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Severe
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| 5-FU+ MI |
0/5
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+6.0 g
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None
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| 5-FU alone |
17/24 (in 8 days)
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-1.9 g (in 7 days)
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Severe
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| 5-FU + M2 |
0/24 (in 8 days)
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-0.6 g (in 7 days)
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Less severe
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| Control 3 |
0/5
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+6.2 g (in two weeks)
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None
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| Adriamycin alone |
3/5
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-1.4 g (in two weeks)
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Severe
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| Adriamycin + M3 |
1/5
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-0.9 g (in two weeks)
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Less Severe
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This Table shows the results of three animal studies. In all cases the toxic drugs were administered at dosages exceeding the lethal dose either for more than half of the animals, or for all the animals.
The chemotherapy drug, 5-fluorouracil was administered at a given amount that caused death in three out of five animals in a first study, and 17 out of 24 animals in the second, more acute study. However, the same drug (5-FU) administered at the same amount, but in the presence of either of two proprietary mannans, resulted in no death.
Furthermore, in the first study all of the mice treated with 5-FU along with the mannan gained weight equivalent to control mice (untreated), and appear normal in all aspects with no signs of toxicity. In the second, much more acute study, the mice lost some weight even in the presence of the mannan, however, the loss was more three times less than with 5-FU alone.
Experiments with Adriamycin (doxorubicin) appeared less spectacular (the last two rows in the Table), that suggests a certain drug specificity in mannan targeting.
However, in this case the mannan also decreases the toxicity, and its very presence decreases the mortality from three mice to one out of five.
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