Brain tumour studies approved in Asia

The South Korean health agency KFDA and the Taiwanese health agency TFDA have approved the implementation of phase III clinical studies using Antisense Pharma's anti-cancer drug trabedersen for patients with high-grade brain tumours.

Trabedersen is a gene-silencing substance inhibiting the tumour factor Transforming Growth Factor beta 2 (TGFβ2) at its translational level. The efficacy and tolerability of trabedersen for high-grade glioma has already been demonstrated during a randomised and actively controlled phase IIb study. It is also in clinical development for indications such as advanced pancreas carcinoma, malignant melanoma and colorectal carcinoma.

The involvement of Southeast Asian countries for clinical testing of trabedersen is part of Antisense Pharma's strategic development programme for its global marketing. Including South Korea and Taiwan, 13 countries are now participating in the international pivotal study.

The randomised and actively controlled phase III study SAPPHIRE is scheduled to begin at medical centres in South Korea and Taiwan during the first quarter of 2011.

"Our pivotal phase III study not only meets the enormous interest in trabedersen from South Korean and Taiwanese physicians who, like their colleagues from all over the world, have so far no satisfactory medical treatment to provide to their critically ill patients suffering from malignant brain tumours," explained Dr Karl-Hermann Schlingensiepen, Antisense Pharma's CEO.

"The global involvement of neurosurgeons and neurooncologists for the clinical development of trabedersen also allows us to introduce them to our completely new therapy concept at an early stage. This means that by the time trabedersen launches, these doctors will be familiar with the concept and can leverage their clinical practice experience."