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A Standardized Supplement For The Treatment of Psoriasis
Inflammation ,[object Object],[object Object],[object Object],Cytokine  Targets IFN-  IL-17 IL-16 IL-15 IL-12 IL-10 IL-8 IL-6 IL-1  TNF- 
TNF -   ,[object Object],[object Object],[object Object],[object Object],[object Object],Crystal structure of TNF-alpha Cytokine involvement in Inflammation
TNF -   Atherosclerosis COPD Rheumatoid  Arthritis Psoriasis IBD Ankylosing Spondylitis Diseases related to TNF -  
[object Object],[object Object],[object Object],[object Object],[object Object],Treatment Market There is scope  for holistic medicine  with proven TNF-    inhibition activity Global Arthritis Market Review 2008  (World Top Ten RA Drugs)
Medicinal Plants in Inflammation ,[object Object],[object Object],[object Object]
Botanical name:  Sphaeranthus indicus English Name: East Indian Globe-Thistle  Indian Name: Gorakhmundi A much branched, strongly-scented annual with winged stem and the wings toothed. Flowers compound heads, globose avoid, glandular hairy Traditional uses:  Time tested herb and widely used in Ayurveda Used in Indigestion, Bronchitis, Spleen diseases, Elephantiasis, Inflammatory conditions of pelvis in women, Piles, Asthma, Treatment of glandular swelling in the neck Sphaeranthus indicus Fruiting & flowering  Inflorescence head Herb in nature Pharmacognostically standardized  & Extraction process developed to  obtain  holistic extract
HPTLC comparison – Tinefcon ,[object Object],[object Object],Marker Extract Marker Overlay chromatograph of  three different batches of extract
Safety   Check Efficacy Check Quality Check Certificate of Analysis with Specification
[object Object],In vitro  activity ,[object Object],[object Object],[object Object],S uppresses the production of pro-inflammatory cytokines  (TNF-  , IL-1  , IL-6 and IL-8) by    synovial cells  obtained from  R heumatoid Arthritis patients ,[object Object],Tinefcon
Tinefcon  inhibits  LPS-induced TNF-   release in mice ** Bar graph: Mean  +  SEM;  * p<0.0005  Student’s T-test Tinefcon  inhibits  LPS-induced IL-1   release in mice In vivo  activity
In vivo  activity – Histopathology  Protects cartilage degradation in joints
Tinefcon  reduces the severity of  experimental colitis in mice In vivo  studies – Ulcerative Colitis model Rectal Bleeding 0.00 0.25 0.50 0.75 1.00 N D Sp Rectal Bleeding Index % Weight Loss -10 -5 0 5 10 15 20 25 30 N D Sp % Weight Loss During Study Disease Activity Index 0 2 4 6 8 10 N D Sp DAI Score Colon Length 0 4 8 12 N D Sp Colon Length (cm) Stool Consistency 0 1 2 3 N D Sp Stool Consistency Index N:  Naïve mice D: DSS-fed mice Sp: DSS-fed mice + Tinefcon    (400 mg/kg p.o.) * * * *
Naïve Well preserved architecture Tinefcon  (400 mg/kg p.o.) DSS Complete loss of architecture Protection from mucosal erosions Tinefcon  treated mice reduces DSS-induced alterations in mucosal architecture and colonic damage In vivo  studies – Ulcerative Colitis model (Histopathology analysis)
Tinefcon  extract reduces development and progression of atherosclerosis in LDLr-deficient mice Bar graph: Mean  +  SEM;  * p<0.05 vs vehicle, ANOVA Atherosclerotic lesion quantitation In vivo  studies – Atherosclerosis model Veh   Feno   Tinefcon  Tinefcon   100 mg/kg  100 mg/kg  300mg/kg -26% -22% -21% * * *
**p<0.01 by ANOVA (Dunnett’s Test) Tinefcon  Inhibits Atherosclerosis Progression in  Hyperlipidemic Hamsters In vivo  studies – Atherosclerosis model Vehicle  Fenofibrate  Tinefcon    (100 mpk)  (200 mpk) Vehicle  Fenofibrate  Tinefcon    (100 mpk)  (200 mpk)   Vehicle Fenofibrate Tinefcon Mean 0.5025 0.0834 0.2736 STD 0.2151 0.1131 0.1482 SEM 0.06487 0.03577 0.04686 % Change   -84 -45
Psoriasis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Psoriasis patients diagnosed by type Psoriasis skin
Psoriasis - Prevalence Worldwide estimated 125m people suffer from psoriasis Sources; International Federation Psoriasis Association (IFPA) 2007 ~  5% ~ 3 % ~ 2.6  % ~ 2.0  % ~ 2.5 % ~ 1  % ~ 1 % ~ 1.5  % ~ 2  %
Treatment Options for Psoriasis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Trials - Objectives ,[object Object],[object Object],[object Object],[object Object],[object Object],Randomized, double-blind, placebo controlled, pilot study to evaluate the safety and efficacy of 2 doses of Tinefcon   tablets in subjects with  moderate to severe psoriasis
Study Design ENROLMENT (N = 74) WASH OUT 2 wks- TOPICAL Rx WASH OUT 4 wks- PUVA Rx RANDOMIZATION 1:1:1 Tinefcon  2.8 g/day Placebo Tinefcon 1.4 g/day STUDY COMPLETED (N = 48) E M O L L I E N T S
Efficacy parameters ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Safety parameters ,[object Object],[object Object],[object Object]
0 10 20 30 40 50 60 70 Placebo 1.4g 2.8g Treatment % Patients 75% improvement in PASI score Effect of Tinefcon   in Psoriasis Patients
BASELINE AFTER 12 WEEKS OF  TREATMENT Photographic evidence Case 1 Case 2
Gene Expression Profile for Patients Significant drug response observed in patients as shown by gene expression pattern Biomarker for  Psoriasis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],No response Response
Epidermal Thickness and Drug Response Statistically significant reduction in epidermal thickness observed after drug therapy ,[object Object],[object Object]
Conclusion – clinical study ,[object Object],[object Object],Hence, a study with large sample size to further  confirm its efficacy is underway
Patent Status ,[object Object],Tinefcon is an innovative product for the treatment of inflammatory disorders PCT National Phase entry  effected in  16 countries   (Algeria, Australia, Brazil, Canada, China, Europe, Hong Kong, Eurasia, Georgia, India, Japan, Mexico, Morocco, South Africa, Ukraine & USA) ,[object Object]
Unique Selling Property - I ,[object Object],Convenient ,  Effective ,  Safe  and  Inexpensive   Option Obtained from time tested and widely used herb of Ayurveda  A contaminant free, completely standardized product Manufactured under GMP standards Inhibits the release of pro-inflammatory cytokines
Unique Selling Property – II ,[object Object],Orally active Does not interact with enzymes involved in drug - drug  interaction Safe & non-toxic A new choice for psoriasis patients Well tolerated in patients with moderate to severe psoriasis Convenient ,  Effective ,  Safe  and  Inexpensive   Option
Histo- pathology Analysis Gene  expression PASI 75%  Score Epidermal  thickness Tinefcon Tinefcon  (An  Efficacious  Phytopharmaceutical)

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Information for doctors

  • 1. A Standardized Supplement For The Treatment of Psoriasis
  • 2.
  • 3.
  • 4. TNF -  Atherosclerosis COPD Rheumatoid Arthritis Psoriasis IBD Ankylosing Spondylitis Diseases related to TNF - 
  • 5.
  • 6.
  • 7. Botanical name: Sphaeranthus indicus English Name: East Indian Globe-Thistle Indian Name: Gorakhmundi A much branched, strongly-scented annual with winged stem and the wings toothed. Flowers compound heads, globose avoid, glandular hairy Traditional uses: Time tested herb and widely used in Ayurveda Used in Indigestion, Bronchitis, Spleen diseases, Elephantiasis, Inflammatory conditions of pelvis in women, Piles, Asthma, Treatment of glandular swelling in the neck Sphaeranthus indicus Fruiting & flowering Inflorescence head Herb in nature Pharmacognostically standardized & Extraction process developed to obtain holistic extract
  • 8.
  • 9. Safety Check Efficacy Check Quality Check Certificate of Analysis with Specification
  • 10.
  • 11. Tinefcon inhibits LPS-induced TNF-  release in mice ** Bar graph: Mean + SEM; * p<0.0005 Student’s T-test Tinefcon inhibits LPS-induced IL-1  release in mice In vivo activity
  • 12. In vivo activity – Histopathology Protects cartilage degradation in joints
  • 13. Tinefcon reduces the severity of experimental colitis in mice In vivo studies – Ulcerative Colitis model Rectal Bleeding 0.00 0.25 0.50 0.75 1.00 N D Sp Rectal Bleeding Index % Weight Loss -10 -5 0 5 10 15 20 25 30 N D Sp % Weight Loss During Study Disease Activity Index 0 2 4 6 8 10 N D Sp DAI Score Colon Length 0 4 8 12 N D Sp Colon Length (cm) Stool Consistency 0 1 2 3 N D Sp Stool Consistency Index N: Naïve mice D: DSS-fed mice Sp: DSS-fed mice + Tinefcon (400 mg/kg p.o.) * * * *
  • 14. Naïve Well preserved architecture Tinefcon (400 mg/kg p.o.) DSS Complete loss of architecture Protection from mucosal erosions Tinefcon treated mice reduces DSS-induced alterations in mucosal architecture and colonic damage In vivo studies – Ulcerative Colitis model (Histopathology analysis)
  • 15. Tinefcon extract reduces development and progression of atherosclerosis in LDLr-deficient mice Bar graph: Mean + SEM; * p<0.05 vs vehicle, ANOVA Atherosclerotic lesion quantitation In vivo studies – Atherosclerosis model Veh Feno Tinefcon Tinefcon 100 mg/kg 100 mg/kg 300mg/kg -26% -22% -21% * * *
  • 16. **p<0.01 by ANOVA (Dunnett’s Test) Tinefcon Inhibits Atherosclerosis Progression in Hyperlipidemic Hamsters In vivo studies – Atherosclerosis model Vehicle Fenofibrate Tinefcon (100 mpk) (200 mpk) Vehicle Fenofibrate Tinefcon (100 mpk) (200 mpk)   Vehicle Fenofibrate Tinefcon Mean 0.5025 0.0834 0.2736 STD 0.2151 0.1131 0.1482 SEM 0.06487 0.03577 0.04686 % Change   -84 -45
  • 17.
  • 18. Psoriasis - Prevalence Worldwide estimated 125m people suffer from psoriasis Sources; International Federation Psoriasis Association (IFPA) 2007 ~ 5% ~ 3 % ~ 2.6 % ~ 2.0 % ~ 2.5 % ~ 1 % ~ 1 % ~ 1.5 % ~ 2 %
  • 19.
  • 20.
  • 21. Study Design ENROLMENT (N = 74) WASH OUT 2 wks- TOPICAL Rx WASH OUT 4 wks- PUVA Rx RANDOMIZATION 1:1:1 Tinefcon 2.8 g/day Placebo Tinefcon 1.4 g/day STUDY COMPLETED (N = 48) E M O L L I E N T S
  • 22.
  • 23. 0 10 20 30 40 50 60 70 Placebo 1.4g 2.8g Treatment % Patients 75% improvement in PASI score Effect of Tinefcon in Psoriasis Patients
  • 24. BASELINE AFTER 12 WEEKS OF TREATMENT Photographic evidence Case 1 Case 2
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31. Histo- pathology Analysis Gene expression PASI 75% Score Epidermal thickness Tinefcon Tinefcon (An Efficacious Phytopharmaceutical)