BioGinkgo 27/7 A 100 Yr. Old Bonsai Ginkgo Tree Proprietary extract of ginkgo leaves Addresses #2 concern among aging baby boomers Loss of memory 1 Ginkgo biloba L. plant: History Oldest living plant species, nick named “living fossil”. In China, it is called “thousand-year-old tree” Described in the ancient Chinese pharmacopoeiaShen nown Ben Cao Since 1960s, Ginkgo biloba extract is the most widely used herb in Europe 2 Ginkgo biloba L. leaf: History, cont’d Pharmanex scientific advisor, Prof. Koji Nakanishi, Columbia University: Discovered a class of unique ginkgolides in ginkgo plant Ginkgolides can increase blood flow by blocking PAF, a substance that causes platelet clumping 3 BioGinkgo 27/7: Uniqueness Pharmanex extraction process enriches for ginkgolides Only Ginkgo extract that provides for adequate and persistent amounts of ginkgolides in the blood 4 Blood concentration of ginkolides after oral intake of BioGinkgo 27/7 or Ginkoba Ginkgolide levels (µg/ml) 12 BioGinkgo 27/7 Ginkoba 10 8 6 4 2 0 30 minutes Published in Planta Medica 12 hours 5 BioGinkgo 27/7 - Attributes Unique formulation of enriched for levels of ginkgolides Improved bioavailability compared to competitors Undesirable Ginkgolic acids removed One of the few companies to manufacture its own ginkgo product 6 Bioginkgo 27/7 process scheme Selected leaves 1. crushed 2. aq. Alcohol extract 3. precipitation QA/QC 4. chromatography 5. remove Ginkgolic acids 6. drying Flavone-lactone mixture Finished bulk preparation 7 Chemical fingerprint of ginkgolide terpene lactones 8 Ginkgo biloba Extract: Cerebral Insufficiency Taillander et al. Presse Med. 1986 15 1583-1587 12-month placebo controlled trial of 210 elderly patients Ave. age 82 years End points: Symptoms scale including dizziness, tinnitus, headaches, lack of energy, and difficulties in memory and concentration at 3, 6, 9, and 12 months Treatment Placebo Ginkgo Time of assessment 3 6 9 12 months 4% 4% 8% 8% 10% 15% 15% 17% 9 JAMA clinical study A Placebo-Controlled, Double-blind, Randomized Trial A 52-week multi-center study Patients: Outpatients with Alzheimer disease or multi-infarct dementia, without other significant medical conditions. 10 JAMA clinical study: Study Design Complete outcome evaluation at 12, 26, and 52 weeks. Primary Outcome Measures. Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), Geriatric Evaluation by Relative's Rating Instrument (GERRI), and Clinical Global Impression of Change (CGIC). 11 JAMA clinical study: Conclusions Ginkgo group score better than placebo in ADAS-Cog and GERRI score No difference in the Clinical Global Assessment Index Ginkgo was safe Appears capable of stabilizing and improving the cognitive performance and the social functioning of patients for 6 months to 1 year. 12 BioGinkgo 27/7: summary BioGinkgo enhances blood circulation to brain, arms, legs Mechanism of action believed to be related to flavonoids and ginkgolides BioGinkgo is recommended to be taken one tablet twice a day 13 Introducing…Bio St. John’s Standardized St. John’s wort to 0.3% hypericin (Hypericum perforatum) PLUS CordyMax Cs-4 [Patent Pending] (Cordyceps sinensis) Each capsule of Bio St John’s contains 375 mg of CordyMax and 225 mg St John’s wort extract. The daily recommended dosage is two capsules twice a day. 14 Bio St. John’s : Claims Stabilizes mood and promotes a positive outlook Provides vitality and stamina Reduces fatigue without stimulants 15 Bio St. John’s: Benefits Bio St. John’s is not a substitute for prescription anti-depressant drugs 16 St. John’s Wort: Brit. Medical Journal Study Meta-Analysis (BMJ, 1996) 23 randomized trials with 1,757 patients % patients respond to treatment SJW (55.1%) vs Placebo (22.3%) SJW (63.9%) vs Antidepressant (58.5%) Test on mild/moderate depression major depression or manic depressive disorder not tested 17 Putative mechanisms of action Monoamine oxidase inhibition Selective serotonin-reuptake inhibition Inhibition of catechol Omethyltransferase GABA and neurokinin receptors Overall outcome: Effect on neurotransmitters function 18 St. John’s wort : Safety/Possible side effects Most common adverse effects are: GI symptoms Tiredness/sedation Dizziness/confusion Photosensitivity, but this appears to occur rarely 19 Efficacy with age Age Before St.John’s wort After St.John’s wort 20 Bio St. John’s A combination of St. John’s wort and CordyMax The recommended dose for Bio St John’s is 4 capsules daily It is not a replacement for prescription anti-depressants 21