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Antisense Pharma: Promising Phase IIb Results of Targeted Therapy,with AP 12009 in Recurrent Anaplastic Astrocytoma

delayed time to response combined with the long duration of the response is in accordance with the postulated immunostimulatory effect of the AP 12009 treatment. Adressing this fact Prof. Wong pointed out that in this study progression free survival would have not been a good endpoint, indicating that “perhaps the endpoints for a study need to be re-evaluated for each individual agent.”

The efficacy of the treatment is reflected by the prolonged median survival times for both AP 12009 treatment groups, as compared to the control group in the AA patient population. Median overall survival (mOS) in the AP 12009 10 ?M group has not yet been reached, whereas mOS for the control group is 21.1 months. 67% of the patients in the AP 12009 10 ?M group versus 42% in the control group are currently still alive. While central blinded reading of the GBM patient data is still ongoing, survival data were presented as well as case reports, revealing sustained long-term responses in this patient group.

As a monotherapy AP 12009 was comparable to temozolomide in glioblastoma patients. “That by itself is quite interesting,” commented Prof. Wong.

Dose-finding as a primary objective of the study has been achieved, as both efficacy and safety parameters are in favor of the 10 ?M dose of AP 12009. “I am very optimistic about this drug,” Prof. Wong concluded.

An international Phase III study with AP 12009 (10 ?M) for patients with recurrent or refractory anaplastic astrocytoma in study centers at North America, Europe and Asia is currently being prepared.

Karl-Hermann Schlingensiepen, M.D., Ph.D., Chief Executive Officer of Antisense Pharma commented, “AP 12009 is an example of Antisense Pharma´s commitment to meet unmet medical needs for patients and their families. The data on AP 12009 in the lead indication high-grade glioma as presented at this years ASCO Annual Meeting represent a major achievement and
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