solbec ann phase 2 targets

SOLBEC CONFIRMS MALIGNANT MELANOMA AND METASTATIC
RENAL CELL CARCINOMA AS INITIAL TUMOUR TARGETS FOR
MULTIPLE TARGET PHASE II ACTIVITY TRIALS
Summary
Malignant (stage III/IV) Melanoma and Metastatic (stage III/IV) Renal Cell
Carcinoma will be the first two tumour targets for Solbec’s Multiple Target Activity
Trials of Coramsine® in the treatment of advanced solid tumours
Perth, Australia. 24 October 2005: Solbec Pharmaceuticals Limited (ASX: SBP)
announced today that after a review of all pre-clinical and clinical data, malignant
melanoma and metastatic renal cell carcinoma (mRCC) will be the first two tumour
types selected for multiple target activity (Phase II) trials of Coramsine® in the
treatment of advanced solid tumours.
Selection Process
Coramsine® has shown activity against a range of tumours in in vitro, ex vivo and in
vivo studies. Phase I trial results highlighted mRCC and non small cell lung cancer as
potential targets. The ex-vivo studies highlighted melanoma, endometrial cancer, breast
cancer, colo-rectal cancer and mRCC as potential targets. Coramsine® made available
to late stage cancer patients through the Therapeutic Goods Administration’s Special
Access Scheme highlighted a range of cancers including: melanoma, mesothelioma,
lung (met) cancer and colorectal cancer as potential targets.
Additional ex vivo studies commissioned by Solbec showed that Coramsine®, in
conjunction with several widely used chemotherapeutic agents, displayed a synergistic
action against both melanoma and mRCC.
In light of all of the above, Solbec’s Scientific Advisory Board selected malignant
melanoma and metastatic renal cell carcinoma as the first two tumour types for multiple
target activity (Phase II) trials. Mesothelioma, non small cell lung cancer and colorectal
cancer are strong alternative activity trial targets; and each may be the subject of
supplementary activity trials at a later date.
Timeframe
The proposed activity trials against mRCC and malignant melanoma will provide
necessary regulatory data to satisfy global regulatory requirements for the next stage of
Coramsine’s® clinical development program in oncology. The Company anticipates the
first patients will be enrolled late Q2 2006. Other exploratory activity trials in different
tumour types (see above) will follow. These proposed trials will generate additional
clinical activity data on Coramsine® to enable selection of priority tumour target(s) for
subsequent Phase III drug registration trials.