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Epistem Presents GenetRx™ Clinical Data from Two Recently Completed Studies

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Epistem plc will present clinical results from two recently completed studies. The first study demonstrates androgen receptor pathway activity in hair from elderly volunteers.

In a second, phase I, study novel pharmacodynamic markers for Enzon Pharmaceuticals Inc’s survivin messenger ribonucleic acid (mRNA) antagonist were identified from hair follicle analysis.

Data will be presented in poster sessions at the AACR-NCI-EORTC “Molecular Targets and Cancer Therapeutics” Conference, Boston on Monday 16th November and Wednesday 18th November 2009.

The first study was completed successfully in 12 healthy normal volunteer elderly men and involved collection of plucked eyebrow and scalp hair. Dr Ged Brady will present data which demonstrates plucked human scalp hairs as a preferred method for assessing androgen receptor directed therapies.

Quantitative PCR analysis identified a panel of 7 genes which were reliably expressed in most scalp hairs. This gene panel could be used to monitor drug induced gene expression change for compounds targeting the androgen receptor pathway, whilst using single plucked hair as a non invasive surrogate tissue.

Data will be presented in: Poster Session C, Abstract C130: Plucked human scalp hairs are a suitable tissue for assessing androgen receptor directed therapies. Wednesday 18th November 12:30 pm - 2.30 pm.

In the second, Phase I dose escalation, study in cancer patients for Enzon Pharmaceutical Inc’s compound EZN-3042 (a novel survivin messenger ribonucleic acid (mRNA) antagonist) hair follicle analysis was used to identify novel pharmacodynamic markers to support dose scheduling decisions. These results will be presented in:

Poster Session A, Abstract A99: EZN-3042 (E), a novel survivin messenger ribonucleic acid (mRNA) antagonist, administered as a single agent (SA) or with docetaxel (D): results of a Phase 1, first-in-human, pharmacokinetic (PK), combination after single agent (CASA) dose-escalation study. Monday 16th November 12.30 pm - 2.30 pm.

Epistem has previously presented data on the use of GenetRx™ technology to monitor the effects of a range of different classes of drugs including: erlotinib, an epidermal growth factor receptor inhibitor; gemcitabine, commonly known as Gemzar and a c-Met inhibitor. These positive new data confirm the clinical utility of GenetRx™ to monitor drug induced changes in epithelial tissue. Epistem is active in collaborations with partners developing compounds which modulate the Notch, c-Met and Hedgehog signalling pathways.