Enrollment: 306
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure) .
Status Completed .
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Administrative Data
Organization name Noscira SA
Organization study ID NP031112-10B04
Sponsor Noscira SA
Collaborator ICON Clinical Research
Health Authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Health Authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Health Authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Health Authority Germany: Federal Institute for Drugs and Medical Devices
Health Authority Belgium: Federal Agency for Medicinal Products and Health Products
Health Authority Finland: Finnish Medicines Agency
04 octubre 2012
Pharmamar’s New Candidate Avails .
European BioTechnology News .
Clinical data presented at a Congress in Vienna shows that a new Pharmamar drug could step up to the success of its paragon Yondelis.
Pharmamar S.A. from Colmenar Viejo is part of Spain’s largest biotech Zeltia S.A. It is known for its marine tunicate-derived anti-cancer drug Yondelis. But there is another potentially marketable drug named PM01183 (lurbinectedin) in the pipeline. On 30 September, new clinical data was presented at the 37th Congress of the European Society of Molecular Oncology (ESMO) in Vienna. Results from the first part of a two-stage Phase II study in patients with platinum-resistant or refractory ovarian cancers were well-perceived, where a confirmed response to the treatment was observed in 6 out of 22 patients. Moreover, the disease had only progressed in 6 patients at the first evaluation, which means that the tumour remained stable in the remaining 10 patients (disease control rate: 73%). The drug showed no toxicity-related problems. The second stage was launched in April with the enrolment of 60 additional patients, who will be randomised to either the PM01183 arm or the active comparator arm where GSK’s topotecan is given.
Other indications where PM01183’s potential is scrutinised include non-small-cell lung carcinoma and breast cancer. Data of a Phase Ib study also presented at the meeting suggest that a combination of PM01183 with the nucleoside analogue gemcitabine improves the anti-tumour activities in the first mentioned indication when compared to treatments with each drug alone. The latter indication is dealt with in a Phase II study with metastatic breast cancer (MBC) patients which started in June this year. Here, patients are stratified into one group where the women have certain deleterious germline mutations in BRCA1/2 and another with woman without such mutations. Pharmamar wants to show that PM01183 works for BRCA 1/2-associated MBCs.
Pharmamar also tries to widen the scope of Yondelis, the first cancer medication ever to be developed in Spain. Moving from 2nd line to 1st line indications Yondelis (trabectedin) is currently under investigation for its strength to fight non-operable and/or metastatic soft tissue sarcomas. In the trial named GEIS-20 standard doxorubicin treatment is compared against a doxorubicin-trabectedin-combination. Results of the Phase II, open label, randomised study with 182 patients are expected in Q4/12.
Clinical data presented at a Congress in Vienna shows that a new Pharmamar drug could step up to the success of its paragon Yondelis.
Pharmamar S.A. from Colmenar Viejo is part of Spain’s largest biotech Zeltia S.A. It is known for its marine tunicate-derived anti-cancer drug Yondelis. But there is another potentially marketable drug named PM01183 (lurbinectedin) in the pipeline. On 30 September, new clinical data was presented at the 37th Congress of the European Society of Molecular Oncology (ESMO) in Vienna. Results from the first part of a two-stage Phase II study in patients with platinum-resistant or refractory ovarian cancers were well-perceived, where a confirmed response to the treatment was observed in 6 out of 22 patients. Moreover, the disease had only progressed in 6 patients at the first evaluation, which means that the tumour remained stable in the remaining 10 patients (disease control rate: 73%). The drug showed no toxicity-related problems. The second stage was launched in April with the enrolment of 60 additional patients, who will be randomised to either the PM01183 arm or the active comparator arm where GSK’s topotecan is given.
Other indications where PM01183’s potential is scrutinised include non-small-cell lung carcinoma and breast cancer. Data of a Phase Ib study also presented at the meeting suggest that a combination of PM01183 with the nucleoside analogue gemcitabine improves the anti-tumour activities in the first mentioned indication when compared to treatments with each drug alone. The latter indication is dealt with in a Phase II study with metastatic breast cancer (MBC) patients which started in June this year. Here, patients are stratified into one group where the women have certain deleterious germline mutations in BRCA1/2 and another with woman without such mutations. Pharmamar wants to show that PM01183 works for BRCA 1/2-associated MBCs.
Pharmamar also tries to widen the scope of Yondelis, the first cancer medication ever to be developed in Spain. Moving from 2nd line to 1st line indications Yondelis (trabectedin) is currently under investigation for its strength to fight non-operable and/or metastatic soft tissue sarcomas. In the trial named GEIS-20 standard doxorubicin treatment is compared against a doxorubicin-trabectedin-combination. Results of the Phase II, open label, randomised study with 182 patients are expected in Q4/12.
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