Date: 2015-01-13
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: PharmaMar (Spain)
Product: PM1183 (lurbinectidin) in combination with doxorubicin
Action
mechanism: 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: small cell lung cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: * On January 13, 2015, PharmaMar will start a Phase III study of PM1183 in combination with doxorubicin against topotecan in small cell lung cancer (SCLC), given the activity observed in an interim analysis of an ongoing Phase Ib trial. The results of this study will be presented at a prominent international cancer meeting this year, which will be soon announced. Patients with small cell lung cancer (SCLC) after failure of standard chemotherapy, as well as bladder, gastric, breast, endometrial or ovarian cancer, neuroendocrine tumors and softtissue sarcomas were treated with the combination in a Phase I. The treatment showed efficacy across all cancer types, including several complete responses. This clinical response was remarkable in certain tumor types, particularly in SCLC, and consequently more patients with this type of tumor were enrolled. The treatment was generally well tolerated, and these patients had marked objective tumor responses and were able to receive several cycles of treatment. Preliminary results presented last year at the 15th 2 World Conference on Lung Cancer showed that 71% of SCLC patients responded to PM1183 plus doxorubicin as second-line therapy. PharmaMar will start a head-to-head study to compare the combination against topotecan for this indication.
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