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Flex Now Knee Joint Care
 

Flex Now Knee Joint Care

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Over 30 pharmaceutical-standard clinical trials and studies prove FlexNow® with 100% SheaFlex70™ has a statistically significant and clinically meaningful impact on joint care and management. Our ...

Over 30 pharmaceutical-standard clinical trials and studies prove FlexNow® with 100% SheaFlex70™ has a statistically significant and clinically meaningful impact on joint care and management. Our experience includes human, double-blind, placebo-controlled university hospital clinical trials. Studies you can trust, by professionals you can trust.

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    Flex Now Knee Joint Care Flex Now Knee Joint Care Presentation Transcript

    • FlexNow ® with 100% SheaFlex70 TM FlexNowppt081509b brought to you by BSP Pharma Inc.
    • Table of Contents FlexNowppt081509b
      • Value Proposition
      • Testimonials
      • Clinical Review
        • Destructive Inflammation Cascade
        • Alternative Interventions
        • Selected Clinical Trial Review
      • Safe / All Natural / Sustainable
      • Summary
    • The Next Generation of Joint Care : Quadruple Action Joint Solution
      • Proven : Over 30 clinical trials and studies prove FlexNow with 100% SheaFlex70 :
              • Reduces   inflammation by 9 times
              • Improves cartilage retention by 44%
              • Increases bone retention by 10%
              • Alleviates pain by 45%
      FlexNowppt081509b
    • The Next Generation of Joint Care: FlexNow with 100% SheaFlex70
      • New, Unique and Incremental :
        • Not a building block (like GS), Not a lubricant (like HA), Not a COX-inhibitor
        • Single ingredient product, Not a compound formula
        • Exclusive, Patented and available only through BSP Pharma
      • Safe and All Natural :
        • No contraindications, No side effects, No allergies
        • Active material: High Triterpene Shea Nut Extract [HTSNE]
        • Source material: Shea Nuts
          • not a nut, but the pit of the shea fruit
          • used to make shea butter, common in cosmetics
          • Shea butter contains less than 6% shea triterpenes; FlexNow with 100% SheaFlex70 contains 70% shea triterpenes
      • Sustainable :
        • Wild-crafted/harvested
        • Processed in concert with the UN Development Programme
      FlexNowppt081509b
    • Target Consumers
      • Target Market : Joint Health
        • 60+mm joint care consumers;
        • 45+mm Osteo-Arthritis sufferers;
        • 30+mm GS users
      • FlexNow® with 100% SheaFlex70™ is effective for individuals who experience or are experiencing joint discomfort or pain , stiffness , loss of flexibility or mobility – anyone who may not be as active as they would like, due to joint issues:
        • Arthritis sufferers
        • Athletes : Professional, amateur and occasional
        • Menopause
        • Accident prone consumers
        • Genetic predisposition to joint issues
        • GS/CS and other joint care product users who have not realized complete relief – Add FlexNow to existing regimen (not a replacement solution)
      FlexNowppt081509b
    • Dose Regimen: FlexNow with 100% SheaFlex70
      • Take one dose of 3 softgels per day, with or without food;
      • Effective with or without other joint care products. Recommended with building block products (eg, GS/CS)
      • 4-6 week dosing cycle required for clinical benefits
      FlexNowppt081509b
    • Table of Contents FlexNowppt081509b
      • Value Proposition
      • Testimonials
      • Clinical Review
        • Destructive Inflammation Cascade
        • Alternative Interventions
        • Selected Clinical Trial Review
      • Safe / All Natural / Sustainable
      • Summary
    • Testimonials: FlexNow with 100% SheaFlex70
      • Hundreds of consumers have contacted us and shared stories of how FlexNow has changed their lives:
        • Arthritis: Hands, Knees, Shoulders, Feet, Neck, Elbows, Spine
        • Chronic and Acute Pain
        • Bone repair
        • Endurance
      • Representative testimonials may be found at www.PowerOfShea.com/testimonials
      FlexNowppt081509b
    • Testimonials: FlexNow with 100% SheaFlex70
      • The Skeptic
      • Being an RN with over 30 years experience...
      • I decided to try it for the horrible inflammatory arthritic condition I was experiencing in my hands.
      • I had tried all the over the counter and prescription NSAIDs and nothing worked to relieve the pain and swelling. I was desperate for help, and I could no longer turn the key to start my car, open a jar, turn a door knob, or hold a hair dryer.
      • After 7 days the swelling had improved, and I was close to making a fist again. Now, after taking FlexNow® with 100% SheaFlex70™ for 3 months, my hands are pain free and I can wear my rings again. I am so glad I tried FlexNow® with 100% SheaFlex70™…
      • Maridel - AL
      • Joint Replacement/Replacement
      • My left knee was rebuilt twice. My last surgery was in 1999.
      • When I blew out my “good” knee in 2007, I realized it was time to put away my bike for good. Very depressing – but I figured it’s just part of getting old.
      • My health food store talked me into trying FlexNow® with 100% SheaFlex70™.
      • In two weeks I felt good enough to try my stationary bike. By the end of March, I could ride my bike outdoors again. Without PAIN.
      • Both of my knees are pain-free. I have built up muscle tone, finally. My limp is gone, finally. I’ve lost almost 20 pounds due to the exercise. I FEEL GOOD. Your product is fantastic. At age 50, I feel like I have a new lease on life. I feel healthy…
      • Sharon - PA
      • Relapse :
      • I once ran out of your product, and had trouble finding it. By the time I got re-supplied, I had slipped back into agony….
      • Kathy - FL
      FlexNowppt081509b
    • Table of Contents FlexNowppt081509b
      • Value Proposition
      • Testimonials
      • Clinical Review
        • Destructive Inflammation Cascade
        • Alternative Interventions
        • Selected Clinical Trial Review
      • Safe / All Natural / Sustainable
      • Summary
    • Inflammation: the root of disease
        • Diseases of the heart —blood vessel inflammation
        • Malignant neoplasms— inflammation proven to contribute to oncogenesis
        • Cerebrovascular disease— blood vessel inflammation
        • Chronic lower respiratory disease— bronchi chronic inflammation
        • Diabetes —especially Type II, excessive inflammation impacts blood sugar metabolism
        • Influenza and pneumonia— over-expression of inflammation at immune system trigger
        • Alzheimer’s Disease —inflammation predisposes neurofibrilary plaques and tangles
        • Nephritis and nephroses —chronic kidney inflammation
        • Chronic liver disease/cirrhosis —chronic liver inflammation
      • Source: National Vital Statistics Report, Volume 53, Number 5 (October 2004)
      FlexNowppt081509b
    • Joint Structure FlexNowppt081509b cartilage Joint capsule (ligaments) bone bone muscle synovial fluid tendon synovial tissue
    • Stages of Osteoarthritis FlexNowppt081509b
    • Destructive Inflammation Cascade
      • When the body is injured or infected with a pathogen, the immune system releases cytokines
      • Cytokines target the area of concern, increase vascularity (allowing the body access to fight and repair) and drive inflammation
      • Joint stress (eg, wear and tear: micro cartilage tear or bone fissure) often results in a destructive inflammation cascade
        • Cytokines released; vascularity increases
        • Inflammation builds in the affected area
        • Pain, tenderness and discomfort are evident
        • Cytokines strip cartilage and erode bone tissue
          • Body sends bone tissue and cartilage repair elements to affected area
          • Inflammation impedes proper repair:
              • bone spurs and/or hard/dense bone build up, further damaging already weakened and inflamed cartilage
              • Inflamed cartilage is challenging to repair properly; raw material may be challenging to deliver to the inflamed areas, increasing likelihood of additional bone damage
          • incremental damage occurs through use of poorly repaired site
        • More cytokines are released -- cytokine production can multiply 1000 fold when activated
        • Inflammation builds further, and the destructive inflammation cascade continues…
      FlexNowppt081509b
    • FlexNowppt081509b Cytokines drive inflammation in the body, can ramp up 1,000 fold when activated, often resulting in a destructive inflammation cascade
    • How it works: FlexNow ® with 100% SheaFlex70 TM
      • Managing cytokines and the destructive inflammation cascade is key to reducing pain and effectively repairing the affected areas.
      • FlexNow with 100% SheaFlex70 modulates the production of cytokines and controls the destructive inflammation cascade:
      • Cytokine management : FlexNow with 100% SheaFlex70 reduces cytokine production : IL-6 by 31% and TNF-a by 24%, resulting in:
          • Inflammation reduction : Reduces inflammation by 9X
          • Cartilage retention : Decreases breakdown in collagen / cartilage by 44%
          • Bone regulation : Reduces Osteocalcin (a measure of bone destruction) by 10%
          • Pain management : Alleviates pain by 45%
      FlexNowppt081509b
    • Joint Structure FlexNowppt081509b cartilage Joint capsule (ligaments) bone bone muscle synovial fluid tendon synovial tissue
    • Composition of Joint Cartilage FlexNowppt081509b
      • The least abundant part of cartilage is proteoglycans , representing 30%
        • The shock absorbing part of the cartilage matrix
        • Glucosamine/chondroitin impacts proteoglycans
      • The most abundant part of cartilage
        • is collagen , representing 70%
        • The meshwork that holds proteoglycans in place in cartilage
        • FlexNow with 100% SheaFlex70 [High Triterepene Shea Nut Extract] impacts the collagen portion of the cartilage matrix
      • Healthy Cartilage structure:
      • Collagen: Golden bands
        • 70% of cartilage
        • Impacted by FlexNow with 100% SheaFlex70 [High Triterepene Shea Nut Extract]
      • Proteoglycans: Turquoise
        • 30% of cartilage
        • Impacted by GS/CS
      Healthy Joint Cartilage FlexNowppt081509b
    • FlexNowppt081509b Damaged Joint Cartilage
      • When joint injury occurs:
      • Collagen meshwork (golden bands) breaks and shreds
      • Proteoglycans (turquoise) leak out, reducing joint lubrication / shock absorbing qualities
      • Destructive inflammation cascade:
        • Cytokines are released
        • Inflammation increases
        • Proper repair of the joint is challenged…
        • Additional damage occurs, and the cycle continues
      • FlexNow with 100% SheaFlex70 [High Triterepene Shea Nut Extract] has been proven to reduce cytokine production , resulting in:
        • Inflammation reduction : Reduces inflammation by 9X
        • Cartilage retention : Decreases breakdown in collagen / cartilage by 44%
        • Bone regulation : Reduces Osteocalcin (a measure of bone destruction) by 10%
        • Pain management : Alleviates pain by 45%
    • Inflammation: Categories of Allopathic Intervention
      • Non-steroidal anti-inflammatory drugs (NSAIDS)--COX 1 and 2 blockade: ibuprofen (Motrin), naproxen (Aleve), ketoprofen (Orudis)
      • Steroids —broad spectrum suppression of immune and inflammation response: prednisone, dexamethasone (Decadron), hydrocortisone
      • COX 2 Inhibitors : celecoxib (Celebrex )
      FlexNowppt081509b
    • FlexNow vs Alternatives
      • Relative to other remedies, FlexNow with 100% SheaFlex70 offers more relief and is better for the body than :
      • Steroids : Clinical benefits are similar, without the side effects
      • Analgesics : Taken every day, FlexNow joint-specific pain management exceeds the benefits of analgesics, without the side effects
      • Glucosamine :
        • 48% better than GS; even better with GS.
        • GS targets 30% of the cartilage matrix (proteoglycan); FlexNow impacts the other 70% (collagen)
      FlexNowppt081509b
    • FlexNowppt081509b
    • FlexNowppt081509b Over 30 Clinical Trials and studies prove: FlexNow with 100% SheaFlex70
      • Reduces   inflammation by 9 times
      • Improves cartilage retention by 44%
      • Increases bone retention by 10%
      • Alleviates pain by 45%
    • ACCMER Trial Parameters
      • Randomized Placebo Controlled Trial on the Safety and Efficacy of BSP-201 in Osteoarthritis. ACCMER.* Cheras PA, Myers SP, Outerbridge K, Nielsen G. Sept. 4 2007.
      • A randomized, double-blind, placebo-controlled single center study.
      • Active: FlexNow with 100% SheaFlex70
      • Subjects:
        • 117 participants, 58 active, 59 placebo
        • Radiologic and clinical evidence of osteoarthritis of the knee and/or hip
      • Measures:
        • WOMAC (Western Ontario and McMaster Universities OA index)
        • COAT Scores (Comprehensive Osteoarthritis Test)
      • Duration: 15 weeks
      • Note: At the end of the study, scores were not at plateau, trending downward. Longer studies in the future may yield even more optimal results.
      • *Australian Centre for Complementary Medicine Education & Research
      FlexNowppt081509b
    • ACCMER Overall Trial Results
      • Cytokine Reduction :
        • 17.9% TNF-a overall reduction; 23.9% reduction in group with elevated TNF-a
        • IL-6 fell by 30.9%
        • CRP was reduced by 20.6%
      • Cartilage retention : CTX-II cartilage marker:
        • Reduction of 28.7% in subjects with elevated levels,
        • Placebo group increased 17.6%
        • 46.3% reduction in cartilage destruction
      • Bone retention : Osteocalcin (marker of bone destruction) 9.2% reduction in elevated group
      • Pain management : statistically significant pain reduction for both men and women
      FlexNowppt081509b
    • HTSNE and Dexamethasone ( steroid ) produce similar Arthritis Clinical Scores : Controls Arthritis FlexNowppt081509b High Triterpene Shea Nut Extract: Screening for Effect on Rat; Type II Collagen Arthritis. Jorgensen JD, Weidner MS. Unpublished pharmacological report. April 10, 2003 Level of statistical significance: * p<0.0001, Mann-Whitney U test
    • FlexNowppt081509b Level of statistical significance: * p<0.0001, Mann-Whitney U test *HTSNE = High Triterpene Shea Nut Extract HTSNE and Dexamethasone ( steroid ) exhibit similar infammation reduction properties: Reduces inflammation
    • HTSNE and Dexamethasone ( steroid ) exhibit similar infammation reduction properties: Reduces inflammation by 9-times FlexNowppt081509b Level of statistical significance: **** p<0.0001, Mann-Whitney U test BSP 201 Screening for Antiinflammatory effect in the Rat-carrageenin induced paw edema assay. Jorgensen JD, Weidner MS. Unpublished pharmacological report. Dec. 20, 2002
    • HTSNE and Ibuprofen produce similar inflammation control: Reduces inflammation
      • BSP 201 Screening for Antiinflammatory effect in the Rat-carrageenin induced paw edema assay. Jorgensen JD, Weidner MS. Unpublished pharmacological report. Dec. 20, 2002
      • Levels of statistical significance: * p<0.001, Mann-Whitney U test
      • ** p<0.0001, Mann-Whitney U test
      FlexNowppt081509b
    • HTSNE and Ibuprofen produce differentiated Stomach and Intestinal Ulcers/Damage profiles: No gastrointestinal damage FlexNowppt081509b Level of statistical significance: * p<0.0001, Mann-Whitney U test *HTSNE = High Triterpene Shea Nut Extract
    • HTSNE : Exercise Induced Pain and Inflammation Trial with Visual Analog Scale (VAS): Significantly reduces pain and inflammation FlexNowppt081509b A Double-Blind Randomized Placebo Controlled Parallel Group Study Demonstrates Analgesic Effects of Sheanut Oil Extract [BSP-201] in Exercise Induced Muscle Tenderness. Srendt-Nielsen L, Rosetzsky A, Weidner MS. Sept 15, 2003 *HTSNE = High Triterpene Shea Nut Extract
    • HTSNE : Better than Analgesics and GS – Significantly reduces pain and inflammation FlexNowppt081509b A Double-Blind Randomized Placebo Controlled Parallel Group Study Demonstrates Analgesic Effects of Sheanut Oil Extract [BSP-201] in Exercise Induced Muscle Tenderness. Srendt-Nielsen L, Rosetzsky A, Weidner MS. Sept 15, 2003 *HTSNE = High Triterpene Shea Nut Extract
    • FlexNow ® with 100% SheaFlex70 TM The Next Generation of Joint Care
      • Over 30 clinical trials and studies
      • Reduces cytokine production 24-31%, producing breakthrough results:
              • 1)  Reduce   inflammation by 9 times
              • 2) Improve cartilage retention by 44%
              • 3)  Increase bone retention by 10%
              • 4)  Alleviate pain by 45%
      • Safe and Natural substitute for Steroids and Analgesics
      • Better than GS; even better with GS
      FlexNowppt081509b
    • Table of Contents FlexNowppt081509b
      • Value Proposition
      • Testimonials
      • Clinical Review
        • Destructive Inflammation Cascade
        • Alternative Interventions
        • Selected Clinical Trial Review
      • Safe / All Natural / Sustainable
      • Summary
    • Safe & All Natural
      • Clinically proven : FlexNow® with 100% SheaFlex70™ has been the subject of over 30 clinical trials and studies, and has been commercially available for a few years. Over the course of hundreds of clinical trial subjects and tens of thousands of consumers, just like you, there have been:
        • no adverse effects (no side effects)
        • no allergies (the shea nut is not a nut, but the pit of the shea fruit)
        • no contraindications (no interactions with pharmaceutical or OTC products)
      • FDA-approved : FlexNow® with 100% SheaFlex70™ is accepted by the FDA as having met every safety and toxicological requirement for a dietary supplement. FlexNow® with 100% SheaFlex70™ was one of only seven dietary supplements accepted by the FDA in 2004, given the overwhelming evidence supporting the product’s efficacy and safety.
      • Centuries of use : All natural shea oil and shea butter, the raw materials used to produce FlexNow® with 100% SheaFlex70™ have been used as a food and food ingredient in Africa and Europe, for hundreds of years – shea oil and shea butter are common ingredients in both baked goods and chocolate production.
      • Et al : FlexNow® with 100% SheaFlex70™ contains no added sugars (sucrose, fructose, or lactose), no salt (sodium chloride), no nuts, yeast, wheat (gluten-free), corn, fish, or milk, and no artificial colors or preservatives.
      FlexNowppt081509b
    • Sustainable/Green
      • Good for the plant/Green farming:
      • Shea trees grow wild in West Africa, where all of our shea nuts are grown. The shea nuts (actually the pit of the shea fruit) used in the manufacture of FlexNow® with 100% SheaFlex70™ are wild-crafted/harvested and processed in concert with the UN Development Programme. 
      • Wild-crafted plants are carefully gathered from their natural, wild habitat, where they have not been sprayed with pesticides or fertilized with synthetic fertilizers.
      • Wild-crafting is a sustainable agricultural process that respects the living plant. Only the shea fruit is taken during harvest; the tree is left unharmed.  
      • Good for the community :
      • Local villagers collect ripe shea fruit which has fallen to the ground, process a portion for local use and sell the bulk of the shea nuts to our company, food companies and skin care companies.
      • The UN Development Programme has established education and training programs to support the commercialization and management of the wild-craft farming, harvesting, processing and sale of shea fruit and shea nuts. 
      • The UN Development Programme has helped tens of thousands of villagers, particularly West African women, to become independent and improve their economic position.
      FlexNowppt081509b
    • FlexNowppt081509b Shea nut harvesting in Burkina Faso, Ghana, and the Ivory Coast
    • FlexNowppt081509b
    • Table of Contents FlexNowppt081509b
      • Value Proposition
      • Testimonials
      • Clinical Review
        • Destructive Inflammation Cascade
        • Alternative Interventions
        • Selected Clinical Trial Review
      • Safe / All Natural / Sustainable
      • Summary
    • FlexNow with 100% SheaFlex70 : Quadruple Action Joint Solution
      • Proven : Over 30 clinical trials and studies prove FlexNow:
              • Reduces   inflammation by 9 times
              • Improves cartilage retention by 44%
              • Increases bone retention by 10%
              • Alleviates pain by 45%
      • Safe and Natural substitute for Steroids and Analgesics
      • Better than GS; even better with GS
      • New, Unique and Incremental:
        • Single ingredient product, Not a compound formula
        • Exclusive, Patented and available only through BSP Pharma
        • Acts uniquely, and synergistically , with other joint care
      • Safe and All Natural:
        • No contraindications, No side effects, No allergies
        • Source material: Shea Nuts (not a nut, but the pit of the shea fruit)
      • Sustainable :
        • Wild-crafted/harvested
        • Processed in concert with the UN Development Programme
      FlexNowppt081509b
    • Table of Contents FlexNowppt081509b
      • Back-Up
    • BSP Pharma Inc.
      • BSP Pharma Inc. is a North American pharmaceutical, OTC and dietary supplement developer/marketer, focused on identifying and commercializing novel, natural substances with the following characteristics:
        • Clinically proven to have substantial and meaningful clinical benefits
        • Safe and approved by the FDA
        • Derived from nature and naturally occurring materials
      • BSP Pharma Inc. is:
        • incorporated in Delaware,
        • a subsidiary of BSP Pharma A/S:
          • conducts business in Europe, Asia and North America
          • owned by Innoventure, a private equity firm, based in Denmark.
      • BSP is an acronym for ButyrSpermum Parkii , the latin name for shea butter, the source material for our first commercial product, FlexNow® with 100% SheaFlex70™ , the subject of over 30 clinical trials and studies.
      FlexNowppt081509b
    • Contact FlexNowppt081509b
      • If you have any questions/issues or would like to order, please contact:
      • BSP Pharma Inc.
      • 500 Scarborough Drive
      • Suite 301
      • Egg Harbor Twp., NJ 08234
      • Office: 1-877-778-1212
      • [email_address]
    • Clinical Dossier
      • The efficacy of FlexNow on Rheumatoid Arthritis – Full Trial;” Dr. K, University Hospital, Japan; 2010: Study in development.
      • “ The efficacy of FlexNow on Rheumatoid Arthritis – Pilot Study;” Dr. K, University Hospital, Japan; 2009: Pilot trial/in progress, 3 month duration, positive trend required and confirmed.
      • “ FlexNow and Glucosamine Synergism in Osteo-Arthritis;” Duke University, Durham, NC, USA; 2009: Study in development. 10-month, guinea pig OA animal model. 4 study arms: placebo, FlexNow, Glucosamine and FlexNow + Glucosamine. Outcome measures: inflammatory, bone and cartilage biomarkers together with histological examination.
      • “ Safety and Efficacy on Japanese Osteo-Arthritis Patients;” Dr. K, University Hospital, Japan; 2009: Safety parameters, plus pain and stiffness measures. Results pending.
      • “ Meta Analysis of BSPPEMS + GIBPEMS;” Tonny Jorgensen, CSO; BSP Pharma A/S; 2009: Preliminary results show the pain level in the glucosamine group is 73% higher than in the FlexNow group.
      • “ Randomised placebo controlled trial on the safety and efficacy of BSP-201 in Osteo-Arthritis,” Dr. Phillip Cheras; ACCMER, University of Queensland, Brisbane, Australia; 2007: Substantial and statistically significant anti-inflammatory effect in humans, plus chondroprotective and bone remodelling effects.
      • 7) “GIB: Evaluation of Glucosamine Sulphate and Ibuprofen versus Placebo;” Dr. Allan Rosetzsky; Klifo, A/S, Copenhagen, Denmark; 2005: Treatments revealed no significant effect except from Glucosamine Sulphate which had a higher VAS pain score compared to placebo, which is the opposite of what was expected.
      FlexNowppt081509b
    • Clinical Dossier
      • “ Evaluation of The Efficacy and Safety of a Sheabutter Extract on Cold Sores (Acute and Prophylactic);” Dr. Phillip A. Cheras; ACCMER, Brisbane, Australia; 2005: The product was able to significantly reduce the reoccurrence of cold sores.
      • “ A Randomized Double-Blinded Placebo Controlled Study of BSP-103 for the Treatment of Patients With Moderate To Severe Plaque Psoriasis;” Dr. Frederic Boudjema; Pharmascan, Villeurbanne, France; 2004: Post hoc data analysis revealed that the subgroup with initial PASI>20 achieved a statistical reduction of >30% after 3 months.
      • “ A Double-Blind Randomized Placebo Controlled Parallel Group Study Demonstrates Analgesic Effects of Sheanut Oil Extract [BSP-201] in Exercise Induced Muscle Tenderness (BSPPEMS);” Lars Arendt-Nielsen, DmedSci, Ph.D.; Aalborg University, Denmark; Journal of Musculoskeletal Pain, Vol. 17, Issue 1, February 2009, pages 8-14; 2003: Study found a significant 49% pain reduction in the active group compared to placebo. Product was found to be safe.
      • “ Mouse Micronucleus;” Karin Kaaber, DVM; ScanTox; 2003: No genotoxicity observed.
      • “ Ames Test;” Karin Kaaber, DVM; ScanTox, Denmark; 2003: No genotoxicity observed.
      • 13) &quot;Acute Oral Toxicity;&quot; Karin Kaaber, DVM; ScanTox, Denmark, 2003: LD50 >2000mg/kg
      FlexNowppt081509b
    • Clinical Dossier
      • &quot;Ulcerogenic Effect;“ Karin Damm Jorgensen, DVM, Study Director; BioAdvice, Vedbaek, Denmark; 2003: This ulcerogenic safety study confirmed that BSP201 caused no gastrointestinal lesions in contrast to Ibuprofen, which was used as the control.
      • “ Determination of Anti-Inflammatory Properties of Topical Formulations Containing Shea Butter Extract on Lesional Skin of Patients With Atopic Dermatitis;” J. Gassmüller, MD; BioSkin Institute for Dermatological Research, Hamburg, Germany; 2003.
      • “ Evaluation of the irritating and sensitizing potential by repeated 48-hours epicutaneous applications under patch-tests (Marzulli & Maibach method);” Dr. Yvette Weltert, dermatologist; Pharmascan, Villeurbanne, France; 2003: The product can be considered hypoallergenic. The product was not associated with any clinically significant photo allergenic response.
      • “ Cutaneous Irritancy by MTT Assay on Human Skin Biopsies;” Alain Deguercy; Laboratoire Dermscan, Villeurbanne, France; 2003: The product is non-irritant in this model.
      • “ Evaluation of Ocular Irritancy. (HET-CAM Assay);” Alain Deguercy; Laboratoire Dermscan, Villeurbanne, France; 2003: The product is non-irritant in this model.
      • 19) “Topical Safety Study; Photosensibility;” Dr. Marlena Nowakowska, MD; Group Dermscan, France; 2003: The product is non-photosensitising.
      FlexNowppt081509b
    • Clinical Dossier
      • “ Evaluation of The Acute Cutaneous Tolerance. 48h Occlusive Patch Test Under Dermatological Control;” Dr. Yvette Weltert; Palmer Research-Dermscan Group; St. Etienne, France; 2003: Product is non-irritant.
      • “ Screening of Anti-Inflammatory Effect in The Repeated Oxazolone Mouse Ear Oedema Assay;” Morten Sloth Weidner, Ph.D.; Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark; 2003: This model simulates chronic inflammatory conditions. When administered systemically, the product demonstrated a dose dependent anti-inflammatory response. The highest concentration was approximately twice the response as the positive control 10/mg methyl prednisolone.
      • “ Screening For Anti-Iinflammatory Effect in The TPA Subchronic Mouse Ear Oedema Assay;” Hans Christian Wulf, Dr. Med.; Morten Sloth Weidner, Ph.D.; Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark; 2003: This model simulates chronic inflammatory conditions. The product had a statistical significant inhibitory effect on repeated TPA induced oedema (very strong inflammation) (x4) formulation optimisation tests.
      • 23) “Screening of Anti-Iinflammatory Effect in The Oxazolone Mouse Ear Oedema Assay;” Hans Christian Wulf, Dr. Med.; Morten Sloth Weidner, Ph.D.; Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark; 2003: Confirmed topical anti-inflammatory effect as well as a significant dose dependent systemic anti-inflammatory effect equal in the highest dose to 30mg/kg methyl prednisolone.
      FlexNowppt081509b
    • Clinical Dossier
      • “ Screening For Anti-inflammatory Effect in The Arachidonic Acid Mouse Ear Edema Assay;” Hans Christian Wolf, Dr. Med.; Morten Sloth Weidner, Ph.D.; Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark; 2003: Product provided anti-inflammatory effect.
      • “ Collagen II Rat Arthritis Assay;” Karin Damm Jorgensen, DVM, Study Director; BioAdvice, Vedbaek, Denmark; 2003: This chronic joint inflammation model confirmed the alleviation of joint specific chronic inflammation to a level equal to dexamethasone.
      • “ Carrageenin Induced Rat Paw Oedema assay;” Karin Damm Jorgensen, DVM, Study Director; BioAdvice, Vedbaek, Denmark; 2002: This acute inflammatory model confirmed the dose dependent anti-inflammatory effect of BSP201. The effect of a daily dose was comparable to a moderate dose of Ibuprofen. (x3)
      • “ The Effect of Sheanut Oil on Serum Lipids and Lipoproteins in Normocholesterolemic and Mildly Hypercholesterolemic Humans;” Eric Berg Schmidt; Department of Medicine, Hjorring/Bronderslev Hospital; Journal of the American College of Cardiology, Abstract 2894, May 1, 2002, Vol. 39, Issue 9, Suppl. B; 2001: LDL cholesterol decreased 8% in active group. Product was found to be safe.
      • 28) “Screening For Anti-Inflammatory Effect in The Mouse Ear Oedema Assay (TPA);” Karin Damm Jorgensen, DVM; Panum Institute, Copenhagen, Denmark; 2001: All versions of the product demonstrated a statistically significant dose dependent anti-inflammatory effect. A dosage of 1mg demonstrated the same inhibition as 0.2mg hydrocortisone-17-butyrate. (x2)
      FlexNowppt081509b
    • Clinical Dossier
      • “ TNF-α/IL-6 Study;” Morten Weidner; Astion A/S, Copenhagen, Denmark; 2001: This test showed a strong reduction of pro-inflammatory cytokines TNF-α and IL-6 equal to the effect obtain with a comparable dosage of methyl prednisolone. (x2)
      • “ NF-κB Mechanistic Study;” PanLabs Taiwan Ltd., Taipei, Taiwan; 2000: FlexNow was shown to inhibit NF-κB dependent transcription response.
      • “ Receptor Binding;” PanLabs Taiwan Ltd., Taipei, Taiwan; 2000: Confirmed safety. FlexNow did not bind to the glucocorticoid receptors suggesting a different mode of action and side effect profile than steroids.
      • 32) “Evaluation of Anti-Viral Effect;” James H. Gilbert, Ph.D., MDS; PanLabs Biosafety, Bothell, WA, USA; 1999: Product demonstrated antiviral activity against herpes simplex and to a lesser extent Influenza A. It did not show an effect against rhinovirus.
      FlexNowppt081509b
    • ACCMER: Highest Risk Group Results
      • Cytokine Reduction :
        • 24%% reduction in TNF-a
        • IL-6 fell by 22%
        • CRP was reduced by 22%
      • Cartilage retention : CTX-II cartilage marker:
        • Reduction of 39%
        • Placebo group increased 31%
        • 70% reduction in cartilage destruction
      • Bone retention : Osteocalcin (marker of bone destruction) 7.8% reduction in elevated group
      • Pain management : statistically significant pain reduction for both men and women
      FlexNowppt081509b