The Phase III Clinical Trial Using PM1183 In Treating Ovarian Cancer (CORAIL) Continues Following The IDMC's Positive Recommendation .
Termina la primera etapa de la Fase III del PM01183 en el tratamiento de Cáncer de Ovario Resistente a Platinos .
El Comité Independiente de Monitorización de Datos ( IDMC ) por sus siglas en inglés) ha notificado a PharmaMar que recomienda que se continue sin ningún cambio el ensayo de la Fase 3 ( CORAIL ) actualmente en curso con PM01183 en pacientes con Cáncer de Ovario Resistente a Platinos .
La recomendación del IDMC viene tras un análisis exhaustivo de los datos de eficacia y seguridad obtenidos de los 90 primeros pacientes tratados en la
primera etapa del ensayo de la Fase 3 .
Por ello se puede decir que estamos ante un avance importantisimo del PM01183 que le otorga una nueva espectaiva más consistente de la que ya de por si tenía antes de esta recomendación del IDMC .
A tener en cuenta que PharmaMar esta llevando a cabo dicha Fase III en solitario en 28 Hospitales ... todos ellos de Estados Unidos ... o sea que puertas abiertas en US para este Farmaco ... algo que no todos los Farmacos no Patrios pueden presumir de ello .
Health Authority : United States: Food and Drug Administration .
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PharmaMar gets IDMC recommendation to continue phase III study with PM1183 in ovarian cancer
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| Madrid, Spain, Tuesday, February 09, 2016, 13:00 Hrs [IST] |
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PharmaMar, a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs, announced that the Independent Data Monitoring Committee (IDMC) has notified the company of its recommendation that the phase III (CORAIL) trial currently under way with PM1183 in platinum-resistant ovarian cancer patients should continue without any changes.
The IDMC's recommendation came after an analysis of the safety data obtained with the first 80 patients treated in the trial. This pivotal randomised phase III trial assesses the efficacy of PM1183 compared with the standard treatment for this indication—topotecan or pegylated liposomal doxorubicin—in a total of 420 patients.
PM1183 is an investigational drug from the class of inhibitors of the enzyme RNA polymerase II, which is crucially involved in transcription. By targeting transcription, the drug inhibits the expression of factors important for tumour progression, and impairs the DNA repair system called NER, thereby enhancing tumour cell killing. PM1183 (lurbinectedin) is currently being investigated in different tumour types, including a phase 3 study for platinum-resistant ovarian cancer, a phase 2 study for BRCA1/2-associated metastatic breast cancer and a phase 1b study for small cell lung cancer.
It is estimated that about 240,000 cases will be diagnosed worldwide and about 150,000 women will die of ovarian cancer. Among gynaecological malignancies, it is the second most common cancer and the one causing more deaths. Most patients with ovarian cancer have late-stage disease, in which the cancer has spread, at the moment of diagnosis. Debulking surgery to remove most of the tumour is usually followed by chemotherapy; however, about 80 per cent of women will relapse after treatment with platinum or a taxane and they may benefit from other therapeutic alternatives.
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