Radiohalogen Molecular Imaging And Therapy Agents At MDS

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Radiohalogen Molecular Imaging And Therapy Agents At MDS

Radiohalogen

Molecular

Imaging and

Therapy Agents

at MDS Nordion

6 th International Symposium on Radiohalogens

Dennis W. Wester,

Director, Applied Research

Vancouver Operations

Sep 6-11, 2008


Our Global R&D and Manufacturing Sites

Vancouver, BC

Kanata, ON

Fleurus, Belgium


Fleurus, Belgium

Main radiohalogen products:

• [ 18 F]-FDG

• I-123


Current [ 18 F]-FDG Production

• Collaboration with University of Liege

• IBA 18-MEV Cyclotron

• Product for Belgian and French markets


Future [ 18 F]-FDG Production

MDS Nordion facility

• IBA 30 MeV Cyclotron


Future [ 18 F]-FDG Production

• Coming soon!


Fleurus, Belgium

Main radiohalogen products:

• [ 18 F]-FDG

• I-123


I-123 Production in Fleurus

• Several productions per week

• 3-4 Ci at EOB

• Target and purification system from MDSN VanOps

• Customers in Nordic countries, UK, Poland

• MIBG production halted in 2004


Vancouver, BC

• Xe-124 targetry

• I-123 radiochemical

• Oral I-123

• Zemiva

• Altropane


Xe-124 Targetry

• Three cyclotrons: CP-42, TR-30-1, TR-30-2


Vancouver, BC

• Xe-124 targetry

• I-123 radiochemical

• Oral I-123

• Zemiva

• Altropane


I-123 Radiochemical

• Supplied in 0.1 N NaOH

• No carrier added

• ≥99.8% 123 I

• ≤0.2% other radionuclides

• Available Monday—Thursday


Vancouver, BC

• Xe-124 targetry

• I-123 radiochemical

• Oral I-123

• Zemiva

• Altropane


Oral I-123

• Sodium Iodide I-123 Oral Solution

• Supplied as a solution (0.1 N NaOH) for oral administration

• Available in MBq quantities requested by the customer at time of calibration

• >99.8% I-123 (


Vancouver, BC

• Xe-124 targetry

• I-123 radiochemical

• Oral I-123

• Zemiva

• Altropane


Zemiva

• Iodinated phenyl fatty acid

• Contract manufacturing for Molecular Insight Pharmaceuticals

• Clinical-stage molecular imaging pharmaceutical product candidate

• Several other indications relating to the future development for Zemiva have been

identified, such as diabetes, chronic kidney disease and heart failure

CH 3

I (CH 2 ) 12 CH CH 2

COOH

15-(p-Iodo-phenyl)-3-R,S-methylpentadecanoic acid (BMIPP)


Vancouver, BC

• Xe-124 targetry

• I-123 radiochemical

• Oral I-123

• Zemiva

• Altropane


Altropane ®

• 123 I-labeled small molecule with high selectivity for the Dopamine Transporter

(DAT), as an aid in the diagnosis of Parkinson’s Disease

• Contract manufacturing for Alseres Pharmaceuticals


Altropane ®

• Five clinical studies testing nearly 500 individuals using Altropane as a

molecular imaging agent

Normal human SPECT brain scan

using Altropane

Image Source: Boston University

Medical Center

Human Parkinson's Disease

SPECT brain scan using Altropane

Image Source: Hospital of the

University of Pennsylvania


Kanata, ON

• I-131 radiochemical

• Neuradiab

• Bexxar

• Azedra

• Iotrex


I-131 Radiochemical

• Fission product from IRE (Belgium) and NTP (South Africa)

o (50-60 Ci/mg)

• Neutron-capture from Te-130

o (~20 Ci/mg, no carrier added)

• Used mainly for I-131 capsules

o e.g., Curicap® is a soluble gel capsule filled with [I-131]-NaI


Kanata, ON

• I-131 radiochemical

• Neuradiab

• Bexxar

• Azedra

• Iotrex


Neuradiab

• Contract manufacturing for Bradmer Pharmaceuticals

• Anti-tenascin monoclonal antibody (81C6) radiolabeled with I-131

• Used for glioblastoma multiforme (GBM) intracavity treatment after resection


Kanata, ON

• I-131 radiochemical

• Neuradiab

• Bexxar

• Azedra

• Iotrex


Bexxar ®

• Contract manufacturing for

GlaxoSmithKline

• IgG – Anti CD 20, MW: 160,000 Da

• Treatment of refractory B-cell

Non-Hogkins Lymphoma

• Activity: 112-166 mCi

• Antibody concentration: 1.1

mg/mL (Tx)

• Shelf life: 5 days @ -80°C

• (U.S. Patent 5,961,955)


Kanata, ON

• I-131 radiochemical

• Neuradiab

• Bexxar

• Azedra

• Iotrex


131

I-MIBG (meta-iodobenzylguanine)

Neuroblastoma: Bone scan and

MIBG exam. Diffuse skeletal

metastases are evident on bone

scan, but are more clearly revealed

on the MIBG exam. Uptake within

the patients primary lesion can also

be seen on the MIBG exam. A plain

film skeletal survey demonstrated a

very subtle periosteal reaction

within the distal left femoral

metaphysis, but was otherwise

normal


Azedra

• Iodine-labeled MIBG either diagnostically for imaging disease or

therapeutically to deliver targeted radiation to the tumor site

• Contract manufacturing for Molecular Insight Pharmaceuticals

• Cold contaminants are avoided using proprietary Ultratrace technology

• Received Orphan Drug status and a Fast Track designation by the US FDA


Kanata, ON

• I-131 radiochemical

• Neuradiab

• Bexxar

• Azedra

• Iotrex


Iotrex TM

• Contract manufacturing for

Hologic (was Cytyc and

Proxima)

• Component of GliaSite Radiation

Therapy System

• Treatment of Glioblastoma

multiforme (GBM)

• Activity: 195 mCi ( 125 I)

• Shelf life : 27 days @ 15-25 °C


Summary

• All three MDS Nordion sites (Fleurus, Vancouver, Kanata) are involved with

radiohalogens

• Both diagnostic and therapeutic isotopes are used

• Products range from radiochemicals to radiopharmaceuticals

• Thanks for your attention (and business)

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