Solbec's Coramsine granted orphan drug status for malignant melanoma

Solbec Pharmaceuticals (ASX:SBP) has received orphan drug designation from the US Food and Drug Administration for its lead anti-cancer compound Coramsine for the treatment of high risk stage II, stage III and stage IV melanoma.

The orphan drug designation for melanoma follows the announcement in November 2005 of the FDA's grant of orphan drug status for Coramsine in the treatment of metastatic renal cell carcinoma (mRCC).

Solbec has selected malignant melanoma and mRCC as the first two tumour types for multiple target activity phase II trials of Coramsine in the treatment of advanced tumours.

"It is inline with our strategy to pursue orphan drug applications for both cancer targets in the phase II activity trials," said Solbec business development manager David Sparling. "As we move down the track we can potentially rely on either indication to afford us the benefit of orphan drug designation moving into US clinical trials."

Solbec anticipates the first patients for the Australian arm of the phase II activity trials will be enrolled in the second quarter 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.

"We have commissioned the Australian arm of the phase II activity trials and the first ethics submissions in selected trial sites will be made before the end of February 2006. In addition we have received positive written response for the US FDA confirming that US based phase I trials will not be necessary and Coramsine can move directly into US phase II clinical trials subject to the FDA's acceptance of Coramsine's full IND application," said Sparling.