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Clinical Trials

Date: 2013-05-13

Type of information: Completion of the trial

phase: 1b

Announcement: completion of the trial

Company: PharmaMar (Spain)

Product: PM01183 (lurbinectidin) in combination with doxorubicin

Action mechanism:

transcriptional inhibitor. PM01183 is a novel synthetic marine-derived compound that covalently binds to the minor groove of the DNA. These PM01183-DNA adducts give rise to double strand breaks and perturbations of the cell cycle inducing cell death. PM01183 induces a specific degradation in tumour cells of RNA polymerase II, without interfering other RNA polymerases (I and III)-the degradation depends on whether the transcription process is active (transactivated transcription) and does not affect basal transcription. In preclinical trials, the compound evidenced strong activity against tumour cell lines of different origins.

Disease:

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Trial details:

Latest news:

* On May 13, 2013, Zeltia has announced that its subsidiary PharmaMar has completed a Phase Ib trial with PM01183 in combination with Doxorubicin. The results of the trial will be presented at an upcoming oncology conference. The combination displayed antitumour activity in all types of cancer included in the trial.
Complete and partial radiological remissions were observed in patients with small-cell lung, bladder, breast, endometrial and ovarian cancers, neuroendocrine tumours, and synovial sarcoma. The combination evidenced noteworthy activity as second-line treatment in small cell lung cancer, where a high percentage of patients responded to the treatment, and in endometrial cancer, where all of the patients displayed clinical benefit. Backed by these results, the Company is already planning a potential pivotal trial in small-cell lung cancer and a confirmatory activity trial in endometrial cancer.

Is general: Yes