interesting read

From their web site:

Developing an injectable formulation of SBP002

Injectable SBP002 therapy is being developed for the treatment of malignant pleural Mesothelioma and metastatic Melanoma. These two cancers have been chosen for several reasons:

• Strong activity has already been demonstrated in Special Access patients for respiratory cancers including Mesothelioma and Melanoma (metastatic);
• No effective treatment is currently available
• Incidence in the population allows SBP002 to be considered for Orphan Drug status

A full explanation of the action of SBP002 can be found on this website at The Science of SBP002.

Orphan Drug Status

Having met with the Food and Drug Administration in the USA and the European Medicines Evaluation Authority (European Union Regulators), these groups noted that SBP002 would be a strong candidate for the Orphan Drug Program. The benefits of this program are substantial and include

• Reduction in clinical data required
• Fast track review of dossier
• Market protection upon Registration
• Tax breaks
• Acceptance into the orphan drug program can reduce the development timeframe from 5-9 years down to 2-3 years (e.g. ST1--571 [Gleevac – Novartis] 2.5 years from concept to market in the USA.)

Both the indications being sought will satisfy the Orphan Drug requirements. While SBP002 targets indications that have low incidence in the population this is not seen as a negative on future profitability because the reality is that over 90% of all cancer prescribing is “off label” - that is for treatment of cancers not on the approved indications. Solbec considers that this will also be the case with SBP002 Therapy.

For further information on Orphan Drug status, please see: www.fda.gov/orphan/designat/apply.htm

For further information on the drug development process, please see: www.fda.gov/fdac/special/newdrug/ndd_toc.html

Extensive applications for SBP002

SBP002 Therapy has shown very exciting results in the Special Access patients treated to date on diverse cancers of the brain, colon, liver, lungs, blood, skin, bladder and reproductive organs. We are working with medical researchers to have these and future results released to the public domain via peer-reviewed journals.

Solbec is further developing SBP002 for Veterinary use in the treatment of external cancers such as Basal Cell, Squamous Cell Carcinomas and Melanomas in dogs, cats and horses. These are a major problem and with changing demographics more people are having their animals treated. Preliminary estimates show the potential size of this market in Australia, USA and Europe to be approximately 1 billion dollars annually.

Development of the Veterinary product will be carried out in parallel to the human work and there are considerable overlays of the two programs, resulting in reduced trial requirements and therefore costs.