ASX ANNOUNCEMENT
VALIDATED CANCER MARKER PRESENTATION
Sydney, 19 March 2010: Darren Jones head of product development of Cellmid Limited presented at the Pharma R&D Partnering World Asia conference. A full copy of his presentation is attached. For further information visit www.cellmid.com.au or contact: Maria Halasz, CEO M +61 416 008 413 About Cellmid Limited (ASX: CDY) Cellmid Limited is a biotechnology company listed on the Australian Stock Exchange. The Company is the owner of the most comprehensive intellectual property portfolio around midkine globally. Midkine is a significant novel therapeutic and diagnostic target. It is a native protein expressed during early cancer formation as well as at the onset of a number of inflammatory processes. Cellmid is committed to the commercialisation of its portfolio of therapeutic and diagnostic products. In addition to its product development programs Cellmid is actively seeking partners for some of its non-core assets. Investment in biotechnology companies There are a number of inherent risks associated with the research, development and commercialisation of pharmaceutical products. Investment in companies specialising in these activities carry specific risks which are different to those associated with trading and manufacturing businesses. As such, these companies should be regarded as highly speculative. Medical Therapies recommends that investors seek professional advice before making an investment in its shares.
CELLMID LIMITED ACN 111 304 119 ASX I CDY Level 6, 40 King Street, Sydney NSW 2000 AUSTRALIA TELEPHONE +61 2 9299 0311 FACSIMILE +61 2 9299 2198 WEB www.cellmid.com.au
1
Midkine
A validated marker for the early diagnosis and disease management of cancer
March 2010
2
Cellmid (ASX:CDY)
Cellmid business strategy: “own the target” (midkine)
Cellmid owns the most comprehensive global patent portfolio around midkine (MK)•19 patent families, ~70 patents • MK to detecting early cancers, use of anti-MK agents to treat autoimmune & inflammatory diseases and cancers, use of MK to treat heart & brain ischemias
• Production of MK and anti-MK antibodies
Cellmid holds a vast knowledge base and inventory around MK• Over 250 papers on MK published by Cellmid inventors• Scientific discoverers of MK retained as advisors to Cellmid• >130 monoclonal antibodies, 7g of purified MK protein, MK knock-out mouse model
Targeting multiple partnerships with global leaders to advance diagnostic and therapeutic portfolio
Additional opportunities actively pursued through partnering significant non-core diagnostic, antibody and nucleotide assets
Midkine
Small protein (13kD, 121 aas) with two domains
Growth factor prominent in embryogenesis but largely undetectable in adults
Actions: inhibits apoptosis, modulates angiogenesis, promotes cell growth and drives inflammatory cell migration
Has an important role in cancer progression, onset of inflammatory diseases and preservation and repair of injured tissue
4
Midkine Product Development
Midkine for cancer diagnosis
Ikematsu et al Br J Cancer 2000
Serum midkine is elevated in many different types of carcinoma
1 2 3 4 5
MK ng/mL
Esophageal **n = 18, 0.71 (0.47-1.28)
Gastric **n = 30, 0.77 (0.58-1.24)
Duodenal *n = 2, 0.71 (0.46-0.96)
Colon **n = 25, 0.97 (0.72-1.70)
Hepatocellular **n = 25, 1.22 (0.83-5.48)
Bile duct **n = 12, 1.33 (1.02-2.28)
Pancreatic **n = 9, 0.66 (0.55-0.77)
Thyroid **n = 5, 0.74 (0.65-1.14)
Lung **n = 19, 1.19 (0.60-2.44)
Breast **n = 5, 0.72 (0.58-2.06)
Normal: n = 135, mean = 0.15 (100% range 0.00-0.50). Assay cut-off, 0.50ng/mL
Midkine for breast cancerdetection
Midkine plasma concentration in combination with conventional markers greatly enhances disease detection over conventional markers alone
Ibusuki et al Cancer Sci 2009
Combination of tumor markers No. of cases (%)
1. CA15-3/CEA/NCCST-439 positive 44 (29.9%)2. Midkine/CA15-3/CEA positive 66 (44.9%)3. Midkine/CA15-3/NCCST-439 positive 61 (41.5%)4. Midkine/CEA/NCCST-439 positive 66 (44.9%)
1 vs 2, P<0.0001; 1 vs 3, P=0.0031; 1 vs 4, P<0.0001 (McNeman test)
n =147 breast cancer patients
Shimada et al Oncol Rep 2003
Midkine for early detection of esophageal cancer
Midkine serum concentration in 60 Stage I superficial esophageal squamous cell carcinoma patients greatly enhances disease detection over conventional markers
0
10
20
30
40
50
60
Midkine p53 Ab CEA SCC CYFRAMidkine
5050
2013
8 8
%
Using serum MK cut-off of >300pg/mL (mean normal serum MK conc + 2 std.devs)
Ikematsu et al Brit J Cancer 2003
Midkine for disease staging
Midkine serum concentration in 220 patients with staged neuroblastoma
0
2
4
6
10
100
1000
1000
0
1000
00
1000
00010 102 103 104 105 106
Midkine (pg/ml)
Normal
Stage 1
Stage 2
Stage 3
Stage 4
Stage 4S(91.7%; n=12)
(83.9%; n=56)
(70.0%; n=40)
(59.0%; n=39)
(38.4%; n=73)
(0.0%; n=17)
P<0.0001
Five year survival curves of 93 patients with esophageal squamous cell carcinoma
Midkine as prognostic
Shimada et al Cancer Sci 2003
S-MK>300pg/ml (n=57)
P<0.001
100
80
60
40
20
0
0 10 20 30 40 50 60
Months
S-MK<300pg/ml (n=36)
Survival Rate (%)
Current and future work
Fully validated ELISA for detecting MK nearing completion
Large comparative studies of blood MK with conventional markers
Strategy: license diagnostic use of MK for cancer by indication•Exclusive and non-exclusive license opportunities are available in several cancer indications
•Actively looking for licensees
Lung cancer: licensed to Celera Corporation October 2009•Risk assessment, early detection, prognosis, disease progression & reoccurrence
11
Thank you
CELLMID LIMITED40 King StreetSydney NSW 2000AUSTRALIAT: +61 2 9299 0311F: +61 2 9299 2128www.cellmid.com.au
Darren JonesHead of Product [email protected]