27th International Congress of Applied Psychology
Issues and challenges in the ‘Seed to Patient’ concept:
Remotiv and Ginc...
27th International Congress of Applied Psychology
Natural products vary enormously
 Wine – grapes can become a bottle of ...
27th International Congress of Applied Psychology
Product quality - variability of products
PLANT
(Species, sub-species, g...
27th International Congress of Applied Psychology
Variation due to harvesting time
Source: Prof Rudi Bauer
University of G...
27th International Congress of Applied Psychology
Seasonal variation
Source: Prof Rudi Bauer
University of Graz, Austria
27th International Congress of Applied Psychology
Multi-target therapy
PLANT IS A LIVE FACTORY PRODUCING A VARIETY
OF CHEM...
27th International Congress of Applied Psychology
Because phytochemical profiles are so complex,
pharmacoequivalence (comm...
27th International Congress of Applied Psychology
Phytoequivalence
27th International Congress of Applied Psychology
The Swiss Zeller AG is today one of
the leading companies in the
develop...
27th International Congress of Applied Psychology
Facts about St John’s wort drug interactions
Fact 1. Hyperforin is the m...
27th International Congress of Applied Psychology
Hyperforin content of Australian SJW Products
0
2
4
6
8
10
12
14
P1 P2 P...
27th International Congress of Applied Psychology
0
2
4
6
8
10
12
14
16
18
Remotiv Brand 2 Brand 3 Brand 4 Brand 5 Brand 6...
27th International Congress of Applied Psychology
Probable Mode of Action
• Centrally acting in synaptic cleft
– inhibits ...
27th International Congress of Applied Psychology
Clinical trials
HamiltonDepressionRatingScale
1. Schrader E Human Psycho...
27th International Congress of Applied Psychology
Clinical trials cont.
1. Schrader E Human Psychopharmacol 1998;13:163-16...
27th International Congress of Applied Psychology
Features and Benefits
Feature Benefit
Specifically clinically proven to ...
27th International Congress of Applied Psychology
Gincosan GK501+G115
Ginsana‟s products are the result
of the most rigoro...
27th International Congress of Applied Psychology
• Ginkgo extract GK501
– Improved supply of oxygen to the brain: vasodil...
27th International Congress of Applied Psychology
Seed to Patient: quality of ginseng roots
Ginseng roots : batches accept...
27th International Congress of Applied Psychology
The Gincosan synergy
27th International Congress of Applied Psychology
COGNITION DOMAINS
ATTENTION, CONCENTRATION, VIGILANCE
WORKING(SHORT-TERM...
27th International Congress of Applied Psychology
Im pairm ents in various disease conditions com pared to age-m atched co...
27th International Congress of Applied Psychology
P o w e r o f A tte n tio n
A g e B a n d
1
8
-2
5
2
6
-3
0
3
1
-3
5
3
6...
27th International Congress of Applied Psychology
27th International Congress of Applied Psychology
Gincosan and Serial Sevens
Changefrombaseline
Scholey AB & Kennedy DO (2...
27th International Congress of Applied Psychology
Gincosan and Serial Sevens
Changefrombaseline
Scholey AB & Kennedy DO (2...
27th International Congress of Applied Psychology
Background
• Six randomized placebo controlled trials on Gincosan
• Cogn...
27th International Congress of Applied Psychology
Gincosan-main clinical trial
Randomised
Double-blind
Placebo-controlled
...
27th International Congress of Applied Psychology
• Screening period: Training
• Week 0 Pre-dose 1h 3h 6h post
• Week 4 Pr...
27th International Congress of Applied Psychology
Gincosan: main clinical trial
27th International Congress of Applied Psychology
Hypothesis on ‘Quality of Memory’ factor and Aging
27th International Congress of Applied Psychology
Features and Benefits
Feature Benefit
Natural cognitive enhancer contain...
27th International Congress of Applied Psychology
Gincosan: Safety Profile
No serious adverse events reported
2000 – 2004 ...
27th International Congress of Applied Psychology
Gincosan and Remotiv: the value of evidence
• Reliability and confidence...
27th International Congress of Applied Psychology
“The Seed to Patient” Journey…
35
The result of a fully controlled Seed ...
27th International Congress of Applied Psychology
The health professionals and Flordis
• Flordis relies on the clinical fe...
27th International Congress of Applied Psychology
Conclusions
• The variability that can occur at any stages in herbal med...
27th International Congress of Applied Psychology
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  • All this complexity comes with a cost as well, that is is nearly impossible to have generics with herbal extracts, as the phytochemical profiles are so complex and dependent on the many variables from the seed to the finished product
  • 1
  • Zangara presentation Cape Town

    1. 1. 27th International Congress of Applied Psychology Issues and challenges in the ‘Seed to Patient’ concept: Remotiv and Gincosan case studies Andrea Zangara andre.zangara@sfihealth.com Research and Development Director, SOHO-Flordis International Adjoined with: Swinburne University, Au (Brain Sciences Institute) Newcastle University, UK (Medicinal Plants Research Centre)
    2. 2. 27th International Congress of Applied Psychology Natural products vary enormously  Wine – grapes can become a bottle of premium wine or a cheap cask wine  The quality of the finished wine is a result of how the grapes have been handled - from the growing on the vine to processing by the wine maker, to its ultimate arrival into the hands of the person drinking the glass of wine Natural medicines are no different – therefore What is the journey that a medicinal plant has to take to become a tablet taken by the patient?
    3. 3. 27th International Congress of Applied Psychology Product quality - variability of products PLANT (Species, sub-species, growth conditions, methods of cultivation) Harvesting/storage (Time of year/month & stage of growth cycle, storage conditions 0C, packaging) Extraction (Method, conditions & equipment used, solvent/s used, concentrations) FINISHED PRODUCT (Formulation, manufacturing, packaging, storage conditions) Enormous variability can occur at all these stages Clinical Trials On Finished Products
    4. 4. 27th International Congress of Applied Psychology Variation due to harvesting time Source: Prof Rudi Bauer University of Graz, Austria
    5. 5. 27th International Congress of Applied Psychology Seasonal variation Source: Prof Rudi Bauer University of Graz, Austria
    6. 6. 27th International Congress of Applied Psychology Multi-target therapy PLANT IS A LIVE FACTORY PRODUCING A VARIETY OF CHEMICAL COMPOUNDS
    7. 7. 27th International Congress of Applied Psychology Because phytochemical profiles are so complex, pharmacoequivalence (common with synthetic medicines based on single chemicals) is very hard to obtain Pharmacoequivalence vs. Phytoequivalence HPLC Chromatograms: (A) Bacopa monnieri Extract, (B)Acetaminophen, Caffeine, Aspirin A B
    8. 8. 27th International Congress of Applied Psychology Phytoequivalence
    9. 9. 27th International Congress of Applied Psychology The Swiss Zeller AG is today one of the leading companies in the development and production of phytopharmaceuticals on a scientific basis worldwide Remotiv (Ze 117) • Formal indication: Relief of mild to moderate depression, anxiety & restlessness • Ingredient: Special extract of Hypericum (St John’s wort) Ze 117 Ethanolic extract -manufactured using Seed to patient standardisation Equivalent to dry hypercum perforatum herb 1.375g . Remotiv Ze 117 (Zeller AG, Switzerland)
    10. 10. 27th International Congress of Applied Psychology Facts about St John’s wort drug interactions Fact 1. Hyperforin is the main constituent in St John’s wort responsible for drug interactions Hyperforin has been identified as a very potent and selective inducer of CYP enzymes Fact 2. Clinical drug Interactions with St John’s wort depend on the hyperforin content in the extract1 The higher the levels of hyperforin the higher the risk of interactions with concomitant drugs Fact 3. Remotiv® (Ze 117) has negligible levels of hyperforin2 Remotiv has the lowest level of hyperforin compared to other Australian St John’s wort products3 1. Madabushi R et al Eur Clin Pharmacol 2006: 62 (3):225-233 2. Wurglics M et al Am Pharm Assoc 2001; 41(4):560-566 3. Kimble B et al Variations in active components of Hypericum perforatum products in Australia ICCMR Mar 2008 Poster 197
    11. 11. 27th International Congress of Applied Psychology Hyperforin content of Australian SJW Products 0 2 4 6 8 10 12 14 P1 P2 P3 P4 P5 P6 P7 Products mg Source: ICCMR P1197 Kimble B. et al (University of Sydney, Department of Pharmacy April 1st 2008) 1) Blackmores 2) Mediherb 3) Herron 4) Remotiv/Flordis 5) Nature’s Own 6) Blooms 7) Herbs of Gold Hyperforin is a big issue as it is responsible for interactions
    12. 12. 27th International Congress of Applied Psychology 0 2 4 6 8 10 12 14 16 18 Remotiv Brand 2 Brand 3 Brand 4 Brand 5 Brand 6 Brand 7 Brand 8 Hyperforin/Dosage Unit (mg) Hyperforin content of 8 different St John's Wort products1* Batch 1 Batch 2 Batch 3 Batch 4 Batch 5 1. Wurglics M et al Am Pharm Assoc 2001; 41(4):560-566 * Study was conducted on products purchased in Germany. Variablity of Hyperforin within same products
    13. 13. 27th International Congress of Applied Psychology Probable Mode of Action • Centrally acting in synaptic cleft – inhibits reuptake of serotonin & noradrenaline and dopamine – most similar to Tricyclics and SNRIs Class Noradrenaline Serotonin Dopamine Histamine Remotiv ++ ++ ++ --- Tricyclics ++ (strong) ++ ++ (increase) ++ (block) SNRI ++ ++ + --- SSRI --- ++ --- +
    14. 14. 27th International Congress of Applied Psychology Clinical trials HamiltonDepressionRatingScale 1. Schrader E Human Psychopharmacol 1998;13:163-169 2. Woelk H et al BMJ 2000; 321:536-539 3. Schrader E et al Int Clin Psycopharma 2000; 15:61-68
    15. 15. 27th International Congress of Applied Psychology Clinical trials cont. 1. Schrader E Human Psychopharmacol 1998;13:163-169 2. Woelk H et al BMJ 2000; 321:536-539 3. Schrader E et al Int Clin Psycopharma 2000; 15:61-68 4. Brattström A Phytomedicine 2009; 16:277-283 5. Dr. D Mazza, Aust Doctor 6 July (2001) 55:57 6. Will-Shahab L et al Eur J Clin Pharmacol 2009;65(3):287-94
    16. 16. 27th International Congress of Applied Psychology Features and Benefits Feature Benefit Specifically clinically proven to be equally effective as synthetic anti-depressants yet better tolerated Can be confident patients will get proven relief of mild to moderate depression and anxiety without experiencing the adverse events commonly associated with other anti- depressants Fully controlled „Seed-to-Patient' manufacturing process Reliable and consistent results with every tablet Negligible levels of hyperforin Can be used with a wider audience because of the reduced risk of interactions with other medications Clinically proven to not interact with the pharmacokinetics of the oral contraceptive pill Unlike some other anti-depressants, Remotiv can be recommended to women who are currently taking the OCP
    17. 17. 27th International Congress of Applied Psychology Gincosan GK501+G115 Ginsana‟s products are the result of the most rigorous scientific research from the Pharmaton legacy and the experience acquired over many years activity within the Boehringer Ingelheim Group • Formal indication: – To improve memory, concentration, reduce mental fatigue • Ingredient: – Ginkgo biloba leaf 2.16 standardised to ginkgo flavonglycosides 14.7 mg, ginkgolides and bilobalide 3.6 mg(GK501) – Panax ginseng root 212.5 mg standardised to ginsenosides 4 mg(G115)
    18. 18. 27th International Congress of Applied Psychology • Ginkgo extract GK501 – Improved supply of oxygen to the brain: vasodilatory effect – Neuroprotective properties – Terpene lactones inhibit platelet activating factor- receptors of the target cells • Ginseng extract G115 – Improved oxygen/ glucose utilisation in the brain – Neuroprotective properties – Anti-fatigue Mode of action
    19. 19. 27th International Congress of Applied Psychology Seed to Patient: quality of ginseng roots Ginseng roots : batches accepted vs. batches rejected 0 10 20 30 40 50 60 70 80 90 100 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 years %ofthetotalbatchesanalyzed %accepted %rejected
    20. 20. 27th International Congress of Applied Psychology The Gincosan synergy
    21. 21. 27th International Congress of Applied Psychology COGNITION DOMAINS ATTENTION, CONCENTRATION, VIGILANCE WORKING(SHORT-TERM ) MEMORY EPISODIC (LONG-TERM) MEMORY
    22. 22. 27th International Congress of Applied Psychology Im pairm ents in various disease conditions com pared to age-m atched controls Pow er of A ttention E lderly B orderline H ypertensives M C I C hronic F atigue C linicalT rial A dultA D H D C arotid A rtery B ypass G raftP atients P re-O p F ibrom yalgia Y oung H ypertensivesE pilepsy M S P arkinson's unm edicated C arotid A rtery B ypass G raftP atients P ost-O p C arotid S inus H ypersem sitivity O rthostatic H ypotension C hronic F atigue S elf-H elp group S trokeA D - M ild A D - M oderate A D - S evere V ascular D em entia P arkinson's disease dem entia StandarddeviationsfromNorm 0 1 2 3 4 5 6 7 8 9
    23. 23. 27th International Congress of Applied Psychology P o w e r o f A tte n tio n A g e B a n d 1 8 -2 5 2 6 -3 0 3 1 -3 5 3 6 -4 0 4 1 -4 5 4 6 -5 0 5 1 -5 5 5 6 -6 0 6 1 -6 5 6 6 -7 0 7 1 -7 5 7 6 -8 0 8 1 -9 0 msec 1000 1100 1200 1300 Attention and aging
    24. 24. 27th International Congress of Applied Psychology
    25. 25. 27th International Congress of Applied Psychology Gincosan and Serial Sevens Changefrombaseline Scholey AB & Kennedy DO (2002) Human Psychopharmacology 17, 35-44 Number of responses 0 1 h r 2 .5 h r 4 h r 6 h r 1 0 . 0 0 . 0 2 . 5 5 . 0 7 . 5 1 2 . 5 placebo **** **** **** ** 320mg ** 640mg 960mg
    26. 26. 27th International Congress of Applied Psychology Gincosan and Serial Sevens Changefrombaseline Scholey AB & Kennedy DO (2002) Human Psychopharmacology 17, 35-44 Number of responses 0 1 h r 2 .5 h r 4 h r 6 h r 1 0 . 0 0 . 0 2 . 5 5 . 0 7 . 5 1 2 . 5 placebo **** **** **** ** 320mg ** 640mg 960mg blood flow? blood glucose?
    27. 27. 27th International Congress of Applied Psychology Background • Six randomized placebo controlled trials on Gincosan • Cognitive Drug Research (CDR) computerised assessment system as the primary cognitive outcome tool • All have identified beneficial effects on cognitive function • Over 600 volunteers, comprising student populations, healthy middle aged adults, healthy elderly people, and volunteers with neurasthenia
    28. 28. 27th International Congress of Applied Psychology Gincosan-main clinical trial Randomised Double-blind Placebo-controlled Parallel group 14 week repeated assessment trial in 256 normal middle aged (40-65)-volunteers
    29. 29. 27th International Congress of Applied Psychology • Screening period: Training • Week 0 Pre-dose 1h 3h 6h post • Week 4 Pre-dose 1h 3h 6h post • Week 8 Pre-dose 1h 3h 6h post • Week 12 Pre-dose 1h 3h 6h post • Week 14 Pre-dose 1h 3h 6h post Gincosan: main clinical trial
    30. 30. 27th International Congress of Applied Psychology Gincosan: main clinical trial
    31. 31. 27th International Congress of Applied Psychology Hypothesis on ‘Quality of Memory’ factor and Aging
    32. 32. 27th International Congress of Applied Psychology Features and Benefits Feature Benefit Natural cognitive enhancer containing extracts of Ginkgo biloba (GK501) and Panax ginseng (G115) Unique synergistic effect which improves cognitive function Specifically clinically proven to be effective in improving memory and cognition in 6 „gold standard‟ double- blind, placebo-controlled trials You can be confident that you will be using the EXACT product proven to be effective in clinical trials Ginkgo biloba (GK501) improves the supply of oxygen and nutrients to the brain whilst Panax ginseng complements this by improving oxygen and nutrient use in the brain Improves cognitive results in memory and concentration, including all 5 measures of cognitive function: long term memory for words and pictures, working memory for numbers and locations, speed of memory processes, power of concentration and consistency of concentration
    33. 33. 27th International Congress of Applied Psychology Gincosan: Safety Profile No serious adverse events reported 2000 – 2004 Worldwide • Total patient exposure: 33,632 patient-years (including clinical trials) • Total cases: 18 (all were non-serious) – Nervous system disorders (37.0%) – Gastrointestinal disorders (33.3%) – Psychiatric disorders (11.1%)
    34. 34. 27th International Congress of Applied Psychology Gincosan and Remotiv: the value of evidence • Reliability and confidence – Reproducible effective results – High level of safety • Natural products with specific evidence are credible mainstream medicines • Seed to Patient control and Specific Clinical Trials add extra value and insure long life to product
    35. 35. 27th International Congress of Applied Psychology “The Seed to Patient” Journey… 35 The result of a fully controlled Seed to Patient Journey is a properly standardised herbal medicine which can be used in clinical trials. Unknown origin of seed/plant Unknown growing, harvesting and storage methods Raw materials bought on world market – processing unknown Only the finished product is standardised Clinical trials Known origin of seed/plant Consistent growth, harvesting and storage Consistent processing methods Entire seed to patient journey is standardised Clinical trials using the specific product Commodity Herbal Product Specifically Clinically Proven Herbal Medicine
    36. 36. 27th International Congress of Applied Psychology The health professionals and Flordis • Flordis relies on the clinical feedback and advices from health professional • Health professionals have the ability to understand the value of our philosophy and to propose our products to patients as solutions • Our products are very effective, a trained health professional provides guidance to patients in their use • Prescribing SCP products is a professional and ethical choice and provides the patient with a safe, effective, and informed solution
    37. 37. 27th International Congress of Applied Psychology Conclusions • The variability that can occur at any stages in herbal medicines development, is due to many controllable factors • By controlling them, unique products are developed • Evidence based herbal medicine requires proof of safety, quality and efficacy • If products are not equivalent, individual clinical evaluation is needed • Specifically clinically proven refers to the use of the EXACT product that has been studied in clinical trials • “Generic” (untested) products and borrowed science represent a threat to consumers and the whole reputation of the market • Consumers should be increasingly aware of the need to ask for specific evidence
    38. 38. 27th International Congress of Applied Psychology

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