Solbec chooses initial tumour targets

Solbec Pharmaceuticals (ASX:SBP) has selected malignant melanoma and metastatic renal cell carcinoma (mRCC) as the first two tumour types for multiple target activity phase II trials of its lead compound Coramsine in the treatment of advanced tumours.

"It has been a long arduous task," said Solbec's CEO and managing director Stephen Carter. "We got down to a number of candidates and the decision was based on some significant studies, phase I trials and special access studies. Both melanoma and metastatic renal cell carcinoma are open to orphan drug status and have the potential for fast track programs.

"The company has not removed its focus on mesothelioma, but due to the low number of patients, and difficulty in treating the later stage patients, melanoma and metastiatic renal cell carcinoma were chosen," he said.

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, which is currently available to late stage cancer patients through the TGA special access scheme, highlighted a range of cancers as potential targets including melanoma, mesothelioma, lung (met) cancer and colorectal cancer.

Additional studies commissioned by Solbec showed that Coramsine, in conjunction with several widely used chemotherapeutic agents, displayed a synergistic action against both melanoma and mRCC.

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. Solbec anticipates the first patients will be enrolled late Q2 2006. These proposed trials will generate additional clinical activity data on Coramsine to enable selection of priority tumour targets for subsequent phase III drug registration trials.

"Solbec has a $5 million equity line to fund the trials and plans to raise further capital on the ASX following shareholder approval at the AGM in November," said Carter.