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A Natural Healthcare Company Pharmanex, Inc. Selected by Nature... Proven by Science.

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Presentation on theme: "A Natural Healthcare Company Pharmanex, Inc. Selected by Nature... Proven by Science."— Presentation transcript:

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2 A Natural Healthcare Company Pharmanex, Inc. Selected by Nature... Proven by Science

3 Cholestin n History as a food n Manufacture n Science behind Cholestin u China u U.S.

4 Red Yeast Rice (Monascus purpureus Went) n Food supplement in China n Spice for the preparation of fish, meat, and bean curd n Rice wine n Traditional Chinese Medicine for blood circulation and digestion n Cholestin = Rice fermented with red yeast

5 Red Yeast Rice Preparation (circa 17th century)

6 History of Cholestin n 20th Century u Introduced in the US n 1970s u Link between cholesterol and heart disease u Discovery of cholesterol lowering properties by Japanese professor n 1990s u Development by Chinese company as an alternative to costly drugs u Licensed by Pharmanex to market as dietary supplement

7 China: 17 clinical studies Cholestin: Clinical Proof for Lowering Cholesterol n UCLA study u Placebo, double- blind design u 83 patients n Average cholesterol decrease of 16% n U.S. multi-center study u Open-label, wash-out design u 187 patients n Average cholesterol decrease of 15.5% Exclusive Red yeast rice -over 10 year research All natural fermentation Standardized U.S.

8 0 (weeks) 8 Age: 50 - 80 years Total cholesterol: > 200 mg/dL Triglycerides: 180 - 500 mg/dL Inclusion Criteria: Placebo (n=35) Red yeast rice extract (n=35,1.2 g/day) Randomized Study presented at AHA

9 Patients’ Profile Treatment groupPlacebo group Number of patients 35 Sex 22 M, 13 F Age (years) 62.7 ± 4.263.5 ± 5.0 Age range (years) 55 - 7950 - 74 Disease history (years) 1 - 231 - 20 Associated with coronary heart disease 57 Associated with hypertension 13 Associated with vascular diseases 33 American Heart Association, Orlando Florida, March 26, 1999

10 Red yeast rice extract 150 175 200 225 250 048 (weeks) placebo (mg/dL) -17.4% p=0.002 -25.9% p=0.001 Changes in Total Cholesterol

11 (mg/dL) 100 120 140 160 180 Red yeast rice extract placebo 048 (weeks) -17.6% p<0.001 -32.8% p<0.001 Changes in LDL Cholesterol

12 (mg/dL) 160 180 200 220 240 260 280 300 Red yeast rice extract placebo 048 (weeks) -23.0% p=0.05 -19.9% p=0.037 Changes in Triglycerides

13 Placebo/diet 12 week treatment phase Week 8Week 9 Week 11 Week 12 Randomization 1 week Treatment arm Placebo arm Combined analysis UCLA Cholestin study in patients with Elevated cholesterol

14 Treatment groupPlacebo group PrePostPrePost Total cholesterol 250±30210±31*255±29250±36 Triglycerides 133±48124±44*143±46146±47 LDL cholesterol 173±27134±27*180±30175±33 HDL cholesterol 50±1350±1446±1046±11 *, p<0.05, compared to baseline. Values are means ± S.D., mg/dL UCLA Study: Data Summary

15 nPre-treatmentpost 12-week treatment ALT(IU/L)42 22 ± 920 ± 8 AST(IU/L)42 24 ± 523 ± 6 BUN(mg/dL)42 16 ± 415 ± 4  -GTP (IU/L)42 27 ± 1823 ± 19 LDH(IU/L)42 155 ± 25152 ± 23 UCLA Study: Liver and Kidney functions

16 0 4 12 14 * American Heart Association Step 1 diet alone Total cholesterol: 200 - 240 mg/dL LDL-cholesterol:135 - 190 mg/dL Subjects: weeks Cholestin (2.4 g/day) Diet* Multi-center Study Presented at AHA

17 100 120 140 160 180 200 220 240 (mg/dL) Total Cholesterol LDL Cholesterol -21.7% -19.5% -15.5% -13.6% Diet + CholestinDiet 0 4 812 14 (weeks) Cholesterol data

18 140 160 180 200 220 240 260 280 0 4 812 14 (weeks) Diet + Cholestin  Diet (mg/dL) All patients Patients with baseline TG >200 mg/dL -21.9% -15.7% -4.1% -3.8% Diet Triglyceride data

19 Patients with baseline HDL Male <40 mg/dL Female <45 mg/dL All patients 30 35 40 45 50 55 0 4 812 14 (weeks) Diet + Cholestin Diet (mg/dL) +13.6% p<0.01 +8.3% p<0.01 HDL data

20 Multi-center study: Summary n Total cholesterol decreased by 15.5% n LDL-cholesterol decreased by 21.7% n HDL-cholesterol increased by 13.6% * n Triglycerides decreased by 21.9% ** * Males with baseline HDL-c  40 mg/dL or females with  45 mg/dL ** Patients with baseline triglycerides >200 mg/dL

21 How does Cholestin work? Fatty foods Acetyl-CoA HMG-CoA Cholesterol Other body fats HMG-CoA reductase enzyme Cholestin

22 Conclusion n Cholestin is a natural dietary supplement n Safe and highly effective in maintaining normal blood lipids n Effective if taken regularly


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