Antisense Pharma has announced that the South Korean health agency KFDA as well as the Taiwanese health agency TFDA have granted their approvals for the implementation of clinical studies using the anti-cancer drug trabedersen for patients with high-grade brain tumors. Trabedersen is a gene-silencing substance inhibiting the tumor factor Transforming Growth Factor beta 2 (TGF-β2) at its translational level.
The efficacy and tolerability of trabedersen for high-grade glioma has already been demonstrated during a randomized and actively controlled Phase IIb study.1 The substance is currently 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 program for the global marketing of this compound. Including South Korea and Taiwan, a total of 13 countries are now participating in the international pivotal study.
High unmet need for medical innovations for patients with highly malignant glioma
The randomized and actively controlled Phase III study SAPPHIRE is scheduled to begin at selected medical centers in South Korea and Taiwan during the first quarter of 2011. The medical demand for therapies against high-grade brain tumors remains to be high: according to the World Health Organization (WHO), Southeast Asia annually has more than 13,000 incident cases of central nervous system tumors, with a mortality rate of more than 77%.
“Our pivotal Phase III study not only meets the enormous interest in trabedersen of South Korean and Taiwanese physicians, who - just as 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 tumors“, explains Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer of Antisense Pharma. “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 will be launched, these doctors will be familiar with the concept and can leverage their clinical practice experience.”
Smooth approvals by KFDA and TFDA
“The excellent exchange with the regulatory authorities in South Korea and Taiwan has led to a prompt granting of approvals, thus confirming the professional work of our team and Antisense Pharma’s expertise in clinical drug development“, comments Dr. Hubert Heinrichs, Chief Medical Officer of Antisense Pharma. “Key factors for the decision taken by KFDA and TFDA have surely been the very encouraging results of previous clinical studies which confirm the safety, tolerability and efficacy of trabedersen.”