ann, page-5

25th August 2004
ENGAGEMENT OF RATIONAL THERAPEUTICS TO EXTEND PHASE II
TRIALS
Summary:
• Solbec Pharmaceuticals Ltd commissions US company Rational Therapeutics to carry out
Phase II targeting studies for its anticancer drug SBP002
• The study follows the success of Solbec’s Phase I/II clinical trials
• The aims are to identify cancers with the highest sensitivity to SBP002 and determine
whether the drug can be combined with existing drugs to increase their anti-cancer
activity
• Preliminary results show that four types of tumour are potential targets for Solbec's lead,
SBP002
Solbec Pharmaceuticals Ltd (ASX: SBP) has commissioned US group, Rational Therapeutics in
California, to determine the most promising tumour targets for Solbec's anti-cancer lead, SBP002,
and which therapeutic drugs currently in use show enhanced activity in combination SBP002.
This extension of Solbec's phase IIB clinical trial program involving SBP002 follows successful
Phase I trials of the lead in patients with advanced cancer.
The studies by Rational Therapeutics will employ EVA® technology in which a sample of a
patient's own cancer is tested for survival upon exposure to a potential chemotherapeutic agent.
The assay is purported to provide positive prediction of tumour activity of up to 90%.
Studies of the effect of SBP002 on Mesothelioma are already in progress. The aim of the current
study is to determine what other cancer types are most sensitive to SBP002, and whether the
combination of SBP002 with currently available cancer drugs provides a more effective anticancer
activity.
Preliminary work by Rational Therapeutics has shown that melanoma, non small cell lung cancer
(NSCLC), renal cancer and colon cancers are susceptible to SBP002 and that SBP002 improved
the activity of standard cancer treatments, providing a positive response in 57% of the tumours
treated. A response rate of only 15% is needed to obtain marketing approval for a cancer drug.
These preliminary results have been presented at two of the world’s largest cancer conferences,
The American Society of Clinical Oncologists and American Association of Cancer Researchers.
Solbec commissioned the new studies so as to provide targeted information on the choice of
tumour types and treatment protocols for new phase IIB clinical trials that will give SBP002 the
greatest chance of success.
The head of Rational Therapeutics is Dr Robert Nagourney who is the Medical Director of the
Malcolm C Todd Cancer Institute in Long Beach, California and Adjunct Associate Professor in
Pharmacology at the University of California, Irvine.