coramsine phase ii cancer trials

PROGRESS UPDATE – CORAMSINE® PHASE II CANCER TRIALS

Summary

• Phase II Australian trials commissioned and are on track to commence
recruitment in Q2 2006

• Positive written response received from U.S. Food and Drug Administration to
Solbec’s pre-IND submission for Coramsine® - U.S. based Phase I trials not
required

Perth, Australia. 3 February 2006: Solbec

Pharmaceuticals (ASX: SBP) advises that
following the successful completion of Coramsine’s® Phase I cancer clinical trials, the
Company has proceeded with the commissioning of the Australian Phase II trials as
outlined below:

The Company has selected the Principal Investigator for its Australian Phase II
metastatic renal cell carcinoma trial and begun identifying suitable trial sites. The first
ethics submissions will be made in February.

The manufacturing and quality agreements for the GMP production of the clinical trial
material are now in place with Patheon UK Limited. It is expected that the Australian
trials will commence recruitment during Q2 2006.

Solbec is also pleased to announce the receipt of a positive written response from the
U.S. Food and Drug Administration (FDA) in respect of the pre-IND (Investigational
New Drug) submission for Coramsine® in the treatment of advanced solid tumours.

The FDA have reviewed Coramsine’s® pre-clinical and clinical dossier and have confirmed
that Coramsine® is suitable to move into Phase II cancer clinical trials subject to the
FDA’s acceptance of Coramsine’s® full IND application.
“We are delighted that the FDA have provided such a timely response to our pre-IND
submission and their advice is such that U.S. based Phase I trials will not be necessary.”
said the Company.

“This response allows Solbec to proceed with Coramsine’s® full
IND application prior to the commencement of U.S. clinical trials.”

The Australian Phase II trials will be partly funded by a $2.26M Australian Government
Commercial Ready grant awarded to Solbec in December 2005.
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