Your Federal Quarterly Tax Payments are due April 15th Get Help Now >>

intercytex by suchenfz

VIEWS: 53 PAGES: 40

									                 Wound Care

                 Guest Speakers
           Patricia Grocott, KCL London
Sylvie Hampton, Tissue Viability Consultancy Services
            Penny Johnson, Intercytex
Intercytex Group plc

Developing Commercial Cell Therapies

02 October 2008


Penny Johnson
Director of Research, UK




                                       2
Regenerative Medicine


                                        Aging




                                        Trauma




                                        Disease


                10-100 Trillion Cells
                                                  3
Defining the terminology...

               Regenerative Medicine




     Cells                                Matrix   Factors




Cell Therapy   Tissue Engineering


                               Products

                                                             4
 Regenerative Medicine poised for commercial
 success

• Market demographics,
  health economics
   • 6,000 Americans a day turn 65

   • By 2011 this will be 10,000 a day

   • Average 65 year old has 3 chronic
   diseases


     “The Silver Tsunami”




                                               5
Regenerative Medicine poised for commercial
success

 •   Scientific discovery is moving very fast (eg. iPS cells)
 •   Global Proliferation of “Centers of Excellence” in Tissue Engineering
 •   Public sector spending has escalated
 •   Private sector is rebounding…. most startups remain small but a few are
     pulling out from the pack.
 •   Established healthcare companies with deep pockets are entering into the
     field
 •   Regulations are becoming harmonised in EU – opening a 500 million market;
     300 million in the US




                                                                                 6
Intercytex Group plc
The Regulations …..getting clearer

Regulations to cover how we obtain the tissue, culture the cells, make the product
                               and test it. (US/UK)
What is cell therapy?
   Device         Biologic                                                 ATMP
    Regs           Regs                                                    Regs
    (US)           (U.S.)                                                (Europe)


  Apligraf                                                               ICX-PRO
Dermagraft       ICX-PRO
                                                                          Vavelta
 ICX-SKN?        ICX-TRC
                                                                         ICX-TRC
                  Vavelta
                                                                         ICX-SKN
        Population:                                                     Population:

        300 Million                                                     500 Million

                                                                                      7
Whole Cell Bioprocessing –
turning cells into cell therapies

                 Procure                       Deliver & Implant



       •Small sample of tissue taken
       •Sample transported to ICX in
                                            •Transport to the clinical site
       special medium to keep the cells
       alive                                •Deliver to the patient

                                                                              … whilst
                                                                              preserving the
                  Isolate                     Expand & Formulate              key functional
                                                                              properties of
                                                                              the cells



       •The specialised cells are removed
       from the tissue and the culturing      •Expand the cells in culture
       process begun in small flasks          •Assemble them in construct
                                                                                               8
Whole Cell Bioprocessing –
turning cells into cell therapies




                                    9
Intercytex Group plc
The Regulations …..getting clearer

Regulations to cover how we obtain the tissue, culture the cells, make the product
                               and test it. (US/UK)
The leading developer of regenerative
medicine products to restore skin and hair
  Device   Biologic                                                        ATMP
    Regs           Regs                                                    Regs
    (US)           (U.S.)                                                (Europe)


  Apligraf                                                               ICX-PRO
Dermagraft       ICX-PRO
                                                                          Vavelta
 ICX-SKN?        ICX-TRC
                                                                         ICX-TRC
                  Vavelta
                                                                         ICX-SKN
        Population:                                                     Population:

        300 Million                                                     500 Million

                                                                                      10
Skin Diseases -US ALONE


        Indication           Prevalence/Incidence in US      Market Potential
  Male Pattern Baldness   40 million males                 > $1 billion


  Skin Regeneration        2 million chronic wounds        > $1 billion
                          33 million surgical wounds
                           9 million major trauma wounds




                                                                                11
Intercytex – key facts


• Founded in 1999
• Raised > £40 million in public/private equity
  financing
• Offices in Cambridge (UK), Manchester (UK) and
  Woburn, MA
• All products produced from in-house licensed GMP
  manufacturing facility
• 75 employees
• Listed on London Stock Exchange (AIM) in Feb 06
• Additional funding in May 2007

                                                     12
Intercytex Business Model


    • Focussed biological area: skin (sp. Human Dermal Fibroblasts)
    • Two business areas: Woundcare and Aesthetic Medicine
    • One well established but slow growth, one rapidly changing and
      growing…spreads risk
    • Mix of reimbursed and not reimbursed
    • Mix of autologous and allogeneic
    • Mix of technologically easy and challenging projects matched by
      potential returns
    • Aim to retain as much value from the projects by becoming
      increasingly fully integrated



                                                                        13
       Regenerative medicine
       A major commercial opportunity
           The projected US market for regenerative medicine products is estimated to be $100 billion*


           Technology Drivers                                                               Major Product        Market Drivers
                                                                                           Opportunities in
                                                                                            Skin and Hair
         Scientific understanding                                                                              Ageing population
                                                                                          Chronic wounds
                    Cell biology                                                                                Health economics
                                                                                            Acute wounds
                       Genetics                                                                                 Growing wealth
                                                                                         Skin function and
          Developmental biology                                                              appearance       Individual appearance

                                                                                          Hair restoration



                                              Intercytex has late stage regenerative medicine
                                                      products to restore skin and hair
* Source: US Dept. of Health & Human Services “2020: A New Vision –A Future for Regenerative Medcine”
                                                                                                                                      14
Product pipeline based on living human cells

                                 ICX-PRO
                                 Healing chronic wounds
                                  Allogeneic fibroblasts


                                 ICX-SKN
                                 Skin graft for acute wounds
                                  Allogeneic fibroblasts


                                 Vavelta
                                 Facial rejuvenation
                                  Allogeneic fibroblasts

      Skin                       ICX-TRC
                                 Hair regeneration
                                  Autologous cells


                                                               15
Product pipeline based on living human cells

                                 ICX-PRO
                                 Healing chronic wounds
                                  Allogeneic fibroblasts




      Skin


                                                           16
Woundcare - a diverse area
Nature

 Close         Remove        Remove          Optimise          Cell
                                                                           New skin
  gap         infection       debris       environment     stimulation

Medicine

 BASIC                    ADVANCED                                ACTIVE

  Sutures       Iodine       Enzymes         Alginates       Regranex
   Gauze         Silver                    Hydrocolloids      Apligraf
 Bandages                                                  (Dermagraft)
                                                               Orcel

                                                             ICX-PRO        ICX-SKN




            None of these actively heal wounds
                                                                                      17
Cyzact™




  • Human fibroblasts in a human fibrin matrix (technologically simple)
  • Young, active fibroblasts promote healing
  • New standard in ease of use
  • First indication venous leg ulcers, follow on with diabetic foot ulcers
  • Expected launch in 2010 in the US

                                                                              18
ICX-PRO


  Cyzact™ - design based on physician feed-back

                       Ease of       Manufacturing     Storage      Preparation   Ease of         Indication
                     manufacturing       time                                     handling

   Cyzact™                             1 day         Fridge          none                        (VLU)
                                                       (21                                         (DFU)
                                                      days)
   Apligraf®                           20 days        10 days         none                          VLU
   (Organogenesis)                                                                                    DFU

   Dermagraft®                        ~2 weeks      -80C freezer   complicated                      DFU
   (Applied                                                                                          (VLU)
   Biohealing)
   Orcel®                            10 – 14 days   -80C freezer   complicated                     (VLU)
   (Ortec)                                                                                           (DFU)


                                                                                   Product not yet approved for
                                                                                      bracketed indications
                                                                                                                  19
ICX-PRO


   Cyzact™: Mode of action

                              Ease of manufacture, storage, handling, low COG


             Differentiated
                  cells

               Transplant




             Differentiated            Mesenchymal                 Organ        Tissues &
                  cells                condensates               rudiments       organs


            Cost effective
            Wound Healing
            Accelerator
                                                                                            20
Venous Stasis Ulcer




                      21
Product pipeline based on living human cells




                                 ICX-SKN
                                 Skin graft for acute wounds
                                  Allogeneic fibroblasts




      Skin


                                                               22
ICX-SKN


    2nd Generation Tissue Engineering


  Undifferentiated        Differentiated          Mesenchymal          Organ     Tissues &
        cells                  cells              condensates        rudiments    organs

                            Transplant




                                       Healing by secondary intent


  Undifferentiated        Differentiated          Mesenchymal          Organ     Tissues &
        cells                  cells              condensates        rudiments    organs


                     Cost effective              ICX-PRO
                     Wound Healing
                     Accelerator
                                                                                             23
ICX-SKN


    2nd Generation Tissue Engineering
                                                 Grow matrix



  Undifferentiated       Differentiated             Mesenchymal              Organ                 Tissues &
        cells                 cells                 condensates            rudiments                organs

                           Transplant                                      Transplant




                                          Healing by secondary intent                  Graft remodeling


  Undifferentiated       Differentiated             Mesenchymal              Organ                 Tissues &
        cells                 cells                 condensates            rudiments                organs


                     Cost effective               ICX-PRO                Functional skin     ICX-SKN
                     Wound Healing                                      graft replacement
                     Accelerator
                                                                                                               24
ICX-SKN
  ICX-SKN

  ICX-SKN – The Product




                          • Cell-produced human
                            collagenous matrix
                          • Human fibroblasts
                          • To repair “holes” formed by
                            surgery or trauma
                          • Phase I size 2cm x 2cm
                                                          25
    ICX-SKN – Phase I Results


Subject 4

A                                   B           C




          day 0                                     day 28

               1                2       5   3


                                            6


                                                             26
ICX-SKN – Phase I Histology




A                             B




                                         SKN



                       Epi
                                  skin




                       Derm
                                               27
Product pipeline based on living human cells




                                 Vavelta
                                 Facial rejuvenation
                                  Allogeneic fibroblasts

      Skin


                                                           28
VAVELTA


  Mode of Action


          24 years old                         48 years old




    Cellular replacement: Matrix Remodelling
                                                              29
VAVELTA

  Additional possible applications of the
  technology

  Contractures




                                            30
Product pipeline based on living human cells




      Skin                       ICX-TRC
                                 Hair regeneration
                                  Autologous cells


                                                     31
                                   ICX-TRC


Same age, same numbers of hair

                                 Person feels:

                                 •A loss of self-esteem
                                 •Depressed
                                 •Introverted
                                 •Unattractive




                                                          32
                                    ICX-TRC


Same age, same numbers of hair

                                 Others feel he is:

                                 • 5-10 years older
                                 •Less attractive
                                 •Less masculine
                                 •Less virile




                                                      33
                                    ICX-TRC


Same age, same numbers of hair

                                 He is:

                                 •Less likely to get a job
                                 interview
                                 •Less likely to be
                                 elected




                                                         34
Hair restoration – currently a $1.7 bn market in the
US


 • Hair transplant surgery up to $10,000            Pharmaceuticals                     Hair pieces
                                                        $200m                            $600m
   per procedure
                                                        Topicals
 • More than one procedure often                        $100m
   required to give desired effect



                                                                           Hair
                                                                      Transplantation
                                                                          $800m


Only 1 in 50 balding males currently seeks any kind of treatment


                                                                                                      35
                                                             ICX-TRC


Hair transplant – a long, painful and costly process




• Limited by donor tissue availability
• Extensive tissue removal (2,000-5,000 follicles)
• Donor site is large – causes scarring
• Pain, bleeding and swelling during and immediately after implantation
• Currently unregulated
• $800m market opportunity in the US alone

                                                                          36
ICX-TRC


 Scientific Basis

                    40 Years of Supporting Research and
                             Proof of Principal

     1964- Cohen shows hair induction from transplanted dermal papilla.
     1967- Oliver demonstrates whisker induction using dermal papilla.
     1984- Dermal Papilla cells first cultured (human and rat).
     1984- Jahoda et al show induction of hair growth by (minimally) cultured
           dermal papilla cells.
     1992- Jahoda and Reynolds demonstrate cultured dermal papilla cell
           induction of hair in glabrous skin (rat foot pad).
     1996- Yoshizato et al demonstrate long-term culture of hair inductive
           dermal papilla cells. Intercytex has exclusive license.

                                                                                37
                                                         ICX-TRC


Follicular cell implantation


                         Critical proprietary step




           • Not limited by donor tissue
           • Minimal tissue removal (approx. 120 follicles)
           • Minimal scarring
           • Minimal pain, bleeding and swelling
           • Repeat procedures possible from a single biopsy
                                                                   38
ICX-TRC


  Hair Induction Assay: Long term growth


      A                    B




            5 Months               11 Months




                                               39
Final Words

“Incredible things will happen a half century from now. We’ll
have cellular therapies .. to treat disease. We will be building
organs in cell culture and replacing worn out or diseased organs.
We’ll be putting into our bodies adult stem cells .. to make new
kinds of therapeutic agents never made before”



                                                                    David Baltimore
                                                                    Nobel Laureate




Michael Lysaght
                                                                                      40

								
To top