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news.TransMolecular has reported positive Phase II interim results for the intracavitary delivery of its anti-cancer compound 131I-TM-601 in recurrent malignant glioma. An interim efficacy analysis from the study demonstrated that the overall survival from the time of recurrence for the highest dosing regimen was estimated at 12.1 months, versus 9 months for the lowest dose group.
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In the initial dose escalation Phase of the trial, 15 patients were treated sequentially in four dose cohorts with escalating doses of radiolabeled TM-601. Because no dose-limiting toxicities were observed in this part of the study, it has been advanced into a randomized phase in which patients receive either three or six doses of radiolabeled TM-601 administered at 40 mCi-0.8 mg on a weekly basis. A total of 56 evaluable patients were included in the interim efficacy analysis, from both the dose-escalation phase and the randomized phase of the study.
The pooled survival analysis of all 59 patients yielded a median overall survival of 9.4 months. Patients treated at the two highest dosing regimens (40 mCi-0.8 mg for 3 or 6 doses) also had median overall survival rates of 9.4 months. However, a comparison of overall survival between the third dose and sixth dose groups demonstrated the superiority of the sixth dose regimen, with the sixth dose regimen resulting in an estimated survival of 12.1 months, versus an estimated 9 months for the third dose group.
Michael Egan, president and CEO of TransMolecular, said: “The platform we are building for this compound has produced additional therapeutic opportunities, and we have filed protocols with FDA for a Phase II intravenous trial in glioma as well as a Phase I trial in malignant glioma with non-radiolabeled TM-601, both of which we expect to initiate in the near-term.”