BioPharma DIVE // By Suzanne Elvidge .
March 27, 2017.
The sea covers around 70% of the earth, and contains around 97% of the world's water. It's also home to almost 240,000 species (that have been identified so far), from mammals and fish, down to bacteria and viruses. However, as a resource, it is still untapped.
Bioprospecting is the discovery and development of new products based on resources from the natural world. Hundreds of plant-based gargles, pills, infusions and ointments date back to Ancient Egypt. Between 1981 and 2014, around two-thirds of the small molecule drugs approved by the Food and Drug Administration were derived from or inspired by natural sources, according to the Journal of Natural Products.
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The most recent marine-sourced drug to reach the market is Spanish company PharmaMar's Yondelis (trabectedin), launched in 2015. This cancer drug comes from an extract from a sea squirt, first found to have anticancer activity in the late 1960s.
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A Ssnapshot of Late Stage Development:
PharmaMar
PharmaMar is a Madrid, Spain-based company with a focus on anticancer drugs from marine sources. Its first drug onto the market was Yondelis. Plitidepsin and lurbinectedin, both derived from sea squirts, are partnered with Chugai.
The plitidepsin Phase 3 trial in combination with dexamethasone in multiple myeloma will read out in the second half of 2017, and Phase 2 trials are under way in T-cell lymphoma as a monotherapy and in multiple myeloma as part of a triple therapy. Lurbinectedin is being assessed as a single agent in platinum-resistant ovarian cancer, with a readout in the second half of 2017, and other clinical trials are under way in small cell lung cancer, breast cancer and solid tumors.
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Journal Oncology // Cancer Network .
March 27, 2017 // By Dave Levitan .
A novel compound known as PM01183 (lurbinectedin) showed promising activity in a two-stage phase II trial of women with platinum-resistant/refractory ovarian cancer.
PM01183 is a synthetic tetrahydroisoquinoline that selectively inhibits active transcription, inducing DNA breaks and apoptosis and affecting the inflammatory microenvironment. “Strong preclinical antitumor activity was observed in cisplatin-resistant epithelial ovarian cancer models,” wrote study authors led by Andrés Poveda, MD, of the Instituto Valenciano de Oncología in Valencia, Spain.
This study included two phases: in the first exploratory stage, 22 patients with platinum-resistant/refractory ovarian cancer were treated with single-agent PM01183 at 7.0 mg every 3 weeks. The second stage was randomized, with 30 patients receiving PM01183 and 29 control patients receiving topotecan (15 crossed over to receive PM01183). The results were published in Annals of Oncology.
Among the 52 total patients treated with PM01183, there were 12 confirmed responses, including 1 complete response and 11 partial responses, for an objective response rate of 23%. The median duration of response was 4.6 months, and 23% of the responses lasted at least 6 months. The median progression-free survival (PFS) in these patients was 4.0 months, and the median overall survival (OS) was 10.6 months.
Most of the responders (75%) had an ECOG score of 0 at baseline, and most were younger than 65 years of age. Ten of the 12 (83%) had platinum-resistant disease, and two had a BRCA mutation. The objective response rate was 30% among the 33 patients with platinum-resistant disease, and the median PFS was 5.0 months.
There were no responses seen among the 29 topotecan patients. Just among the randomized patients, the median PFS was 3.9 months with PM01183 and 2.0 months with topotecan (P = .0067); OS was no different, at 9.7 months with the study drug and 8.5 months with topotecan (P = .2871).
Myelosuppression was the most common adverse event seen with PM01183. Grade 3/4 neutropenia occurred in 85% of PM01183 patients (64% with grade 4), and grade 3/4 thrombocytopenia occurred in 33%. Fatigue of any grade occurred in 77% of PM01183-treated patients, and was the most common nonhematologic toxicity. There was 1 patient with grade 3 rhabdomyolysis that was related to treatment. No treatment-related deaths occurred in the study.
“PM01183 is an active drug in platinum-resistant/refractory ovarian cancer and warrants further clinical development, particularly in platinum-resistant disease, where its activity was remarkable,” the authors concluded. The drug is now being tested in the phase III CORAIL trial, which includes patients with platinum-resistant ovarian cancer.
Barcelona, 27 mar (EFE).
El Instituto Oncológico Baselga (IOB) ha informado hoy de la puesta en marcha de su actividad como nuevo centro de oncología perteneciente al Hospital El Pilar de Barcelona, del grupo Quirónsalud.
Según un comunicado emitido por el Instituto, el IOB, formado por un grupo de oncólogos reconocidos a nivel mundial, trabajará de forma coordinada con los equipos médicos del Hospital El Pilar, liderados por su director médico, el doctor José Antonio Neguillo.
A través de este acuerdo, el Instituto introducirá en el Hospital El Pilar su visión integral del cáncer y un completo equipo médico encabezado por el director médico del Instituto Oncológico Baselga del Hospital Quirón de Barcelona, el doctor Josep Tabernero, y el director del IOB en Madrid, el doctor Javier Cortés.
La unidad de oncología del IOB en el Hospital El Pilar estará liderada por los doctores José Manuel Pérez, Jesús Soberino y Cristina Urbano.
Esta operación se enmarca en el proceso de renovación y modernización general del Hospital El Pilar emprendido en los últimos años y que contempla la introducción continua de mejoras con el fin de consolidar este centro como un referente de la sanidad privada.
