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Chronic Toxicity Study Confirms Safety of Phase 2® Ingredient
KEARNY, NJ, NOV. 5, 2002--Pharmachem Laboratories, Inc., today announced that a Chronic Toxicity Study (L.D.50) demonstrated that Phase 2 Starch Neutralizer™, the first standardized white bean extract used in a variety of weight loss supplements, is safe and non-toxic.
“Phase 2® showed no signs of chronic toxicity at doses up to 1.0 gm/kg body weight for up to 90 days,” said Ramadasan Kuttan, Ph.D., director, Amala Cancer Research Center, Thrissur, India, who conducted the study along with R. C. Srimal, M.D. “The data indicates that administration of Phase 2® for 90 days did not produce any adverse reaction as seen from the organ weight, necropsy, haematological values and biochemical values.”

Additional findings of the study were as follows:

• There was no significant weight changes in any of the animals.
• Food consumption in the Phase 2® groups (1 gm and 5 gm) was found to be decreased significantly, especially after two months of treatment, compared to controls.
• Liver function tests indicated that chronic administration of Phase 2® at the doses given did not produce any change in the liver function tests such as GOT, GPT, ALP, Bilirubin, total protein and Albumin/Globulin ratio.
• Chronic administration of the Phase 2® did not produce any change in the renal function as indicated from serum urea, creatinine and electrolyte levels.
• Chronic administration of Phase 2® did not produce any change in the haematological parameters such as total WBC, differential count and platelets.
• There was no change in necroscopy of the animals and organ weight of the animals such as liver, kidney, spleen were unchanged.
• There was no significant change in the lipid profile of animals treated with Phase 2®
• Histopathology of liver and kidney of the Phase 2® -treated groups was normal and similar to controls.

An LD 50 study for acute toxicity, conducted earlier this year, also confirmed that Phase 2® is “safe and non-toxic.”


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