Intercytex

From Cells to Cell Therapy

Paul Kemp
Chief Scientific Officer

1
 Intercytex

• Approx. 90 FTEs

• IPO on AIM in 2006

• £10m per annum on R&D

• Laboratories in Manchester and Boston

• Licensed GMP manufacturing facility in

Manchester UK

• Clinical/regulatory groups in
Manchester/Cambridge/Boston

• Commercial/Marketing in
Manchester and Cambridge 2
Cell therapy products to restore and
regenerate skin and hair

ICX-PRO
Disease Treatment of chronic
wounds

VAVELTATM
Facial rejuvenation
Ageing
(Aesthetics)
ICX-TRC
Hair regeneration

Skin
ICX-SKN
Trauma Skin graft replacement

3
The allogeneic fibroblast
An immunological perspective

4
Intercytex: cells to cell therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Isolating Fibroblasts

5
Intercytex: cells to cell therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Expanding Fibroblasts

6
Intercytex: cells to cell therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Storage

7
Intercytex: cells to cell therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Creating working cell bank

8
Intercytex: cells to cell therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Storage

9
Testing for safety
Required Test
Assay
MCB WCB EOP
Sterility (Ph. Eur / USP) + + +
Mycoplasma (by cell culture and inoculation) + + +
Species identification (by Isoenzyme analysis) + + -
Karyology + - +
Tumourgenicity (by in vivo assay) + - +
Detection of adventitious viruses
+ - -
28 day (by in vitro assay)
Detection of adventitious viruses
- + +
14 day (by in vitro assay)
Detection of adventitious viruses
+ - +
(by in vivo assay)
Human virus detection (by PCR)
+ - -
(HIV-1 and 2, HTLV-1 and 2, EBV, HBV, B19, HCMV, HPV, HHV-6, 7 and 8, HCV)

Bovine polyoma virus screen (by PCR) + - -

SV-40 screen (by PCR) + - -
Detection and quantification of Retrovirus associated reverse transcriptase activity
+ - +
(by RT – PCR)
General virus detection (by TEM) + - +
Bovine screen (by in vitro assay)
+ - -
(BVDV, REO-3, BAV, BRSV, BP)

In vitro porcine virus screen (by in vitro assay)

+ - -
(PPV, PAV, TGE and HEV)

Bacteriostasis and fungistasis + + + 10

Products

ICX-PRO
Disease Treatment of chronic
wounds

VAVELTATM
Facial rejuvenation
Ageing
(Aesthetics)
ICX-TRC
Hair regeneration

ICX-SKN
Trauma Skin graft replacement

11
ICX-PRO - The product

• Human fibroblasts in a human fibrin matrix

• Young, active fibroblasts promote healing
• Ease-of-use and storage
• Indications
– venous leg ulcers
diabetic foot ulcers 12
ICX-PRO – Clinical status
Phase II trial (n=90) open label - complete
– Good safety and efficacy data at 24 weeks
– 80% of patients with hard-to-heal ulcers showed clinical
benefit
– 41% of patients with wounds <20cm2 had complete
closure

Phase III trial (n=396) double blind, controlled -

ongoing
– Pivotal trial
– Multicentre – US, Canada and the UK
– Three arms – Control, Vehicle (Fibrin) and ICX-PRO
– Interim data positive
– Final data available mid 2008 13
ICX-SKN – The Product

• Cell produced human

collagenous matrix
• Human fibroblasts
• To repair “holes” formed by
surgery or trauma

14
ICX-SKN – Clinical status

• Phase I trial - complete

– Replacement of excision biopsy of the
arm with ICX-SKN
– Safety and persistence at one month
– Preliminary results very encouraging
– Full results available Q2 2007

15
ICX-SKN – Clinical results

SKN

SKIN

16
ICX-TRC – The product
Autologous hair regeneration
Reimplantation
Critical proprietary step
Biopsy

DP cells
Cell culture

Growth

• Dermal papilla (DP) cells at the base of the follicle have hair inductive
properties

• ICX proprietary method multiplies a small sample, maintaining inductive

properties

• When re-implanted cultured DP cells promote new hair growth

17
How ICX-TRC is expected to work

a) Rejuvenation b) Follicle neogenesis

Stenn et al
18
ICX-TRC – Clinical status

• Phase I trial (n=7) – complete

– No safety issues

– 5 of 7 had increased hair numbers after treatment

• Phase II trials (n = ~10 per cohort) – ongoing

– Efficacy trials designed to look for new hair growth
– Rolling programme to optimise formulation/delivery
– First cohort enrolled, 6 patients treated
– Preliminary data available H2 2007

19
ICX-TRC – Automation

Processing Chamber

Incubator

Liquid Handler

Cell Counter 20
Repopulation
 VAVELTATM - Facial rejuvenation

• Allogeneic (donor) human fibroblasts

• Repopulates skin with young, active cells
• Stimulates soft tissue augmentation
generating collagen and hyaluronic acid
• Superficial injection into the upper dermis
• Not another filler
Intercytex: Cells to Cell Therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Expanding cells
Intercytex: Cells to Cell Therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Harvesting cells
Intercytex: Cells to Cell Therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Filling vials
Intercytex: Cells to Cell Therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Packaging
Intercytex: Cells to Cell Therapy
MCB (100 vials) WCB (300 vials) Product

1 vial 1 vial 1 vial

Shipping
 From cells to cell therapy
Summary

• Cell therapy has been shown to be safe and effective

• Clinical efficacy data on all four products during 2007
• Tissue repair market largely untapped
• Aesthetic medicine and other ‘patient pays’ markets are expanding

Proven science – novel product development

Intercytex is proud to be at the forefront of this
technology