ENERCEL^® TREATMENT

I. INTRODUCTION:

Throughout the entire study "in vivo" of experimental carcinomas treated with ENERCEL^®, a protocol of toxicological control was implemented on all the lots of animals, both treated and not treated (with ENERCEL^®) used in the experiment.

Said Protocol comprises:

a. Phvsical & Behavioral Aspect:

Daily verification of the exterior mucous, hair, scaling of the tail, stool specimen, energy, posture, movement, consumption of water and food.

b. Control of Injection Points:

Daily verification of the zones injected, presence of alterations of skin, both surface and deeper area, and areas of tissue destruction, etc.

c. Visual Observation of Organs:

In all the autopsied animals, the aspect, consistency and size, etc. of all the internal organs were verified.

d. Microscopic Study of Organs:

In all the animals autopsied, slides were prepared his histological study of the principal organs.

  II. RESULTS:

a. Physical & Behavioral Aspects:

In no case did we observe change in color and aspect of the exterior mucous membranes. Also, no change in the color, luster, consistency, and hair permanence; we observed no scaling of the tail, no signs of diarrhea. Also, no sweating or signs of dehydration.

The movement, alertness to external stimuli, and posture were normal in all the normal treated subjects in respect to those not treated. In some animals the localization and size of the tumors which they carried made it difficult to walk; but only from the mechanical aspects.

In all the animals treated and not treated, there was no significant difference in eating and drinking.

b. Control of Injection Points:

We didn't see any visual or microscopic change in the site of the daily injection of the product (ENERCEL^®) studied.

These sites showed only characteristics typical of the puncture.

c. Visual Observation of Organs:

All the dead animals were autopsied and all the organs appeared normal in respect to size, appearance, consistency, weight, blood vessels, etc.

We observed no toxic difference in the cases treated and untreated.

d. Microscopic Study of Organs:

The slide studies showed no toxic difference in either group.

III. CONCLUSION:

The sustained treatment of ENERCEL^® in the dosages and specified conditions of the study "in vivo" of the cancer experiments produced no signs or symptoms of toxicity of the treatment applied.

Dr. Carlos Botelli
Project Director
August 14, 1992