Meditech boosted by Phase II results

With all patients in the first stage of its Phase II HyCamp clinical trial escaping the gastrointestinal side-effects normally associated with standard colon cancer treatment irinotecan, Meditech (ASX:MTR) has announced it will forge ahead with second stage of its trial.

In the first stage of the trial, 12 patients were treated with HyCAMP – a combination of Meditech’s hyaluronic acid and irinotecan.

Normally, about a third of patients undergoing irinotecan chemotherapy require treatment modification or are withdrawn prior to completion of their treatment regimes due to toxic side-effects.

Meditech also reported ‘encouraging signs of efficacy’ in terms of both tumour response and stablilisation of the disease. ‘You can’t say whether [the results are] better or worse [than treatment with irinotecan alone] because it is a very small sample,” said Meditech chairman Prof Richard Fox.

It appears that hyaluronic acid transports the drug to cancer cells, which express high affinity receptors for hyaluronic acid. When the drug complex binds to the cell, the drug is internalised along with the hyaluronic acid. Earlier studies have suggested that because of this targeting action, HyCamp uses much less drug than irinotecan alone, reducing its toxicicity.

Prof Fox described the data to date as ‘super-encouraging’. “The other thing is all these patients had failed other treatments,” he said.

The next tranche of the Phase II trial – a randomised study comparing safety and efficacy of HyCAMP with irinotecan -- will start in the next month and run for 12 to 18 months. There will be 43 patients in each arm of the trial.

“Although we don’t expect to have statistically validated results until the Phase IIb trial is complete, results to date are certainly very encouraging and must be regarded as a best case scenario at this stage,” said principal investigator, Dr Peter Gibbs.

The HyCamp derivative also has the potential to extend irinotecan’s patent life. Currently the patents are held in both Europe and the US by international pharmaceutical company Pfizer, and are due to expire between 2006 and 2009. Meditech’s patents covering HyCAMP have patent expiration dates occurring between 2020 and 2023.

Meditech shares, which have slumped recently amidst a shareholder stoush that ousted CEO Chris Carter -- were up 11 per cent to $0.19 at time of writing.