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Successful Planned Independent Analysis of Pivotal Phase III Trial of YONDELIS(R) in Ovarian Cancer
Madrid (ots/PRNewswire) - PharmaMar today announced the successful planned review by the Independent Data Monitoring Committee (IDMC) of the YONDELIS(R) (trabectedin) Phase III pivotal clinical trial in ovarian cancer, known as OVA-301. The IDMC recommended that the present study should continue without modification.
The IDMC can recommend that the study protocol be stopped, temporarily suspended or amended if it determines that a trial is not meeting the necessary safety and efficacy requirements. In the case of OVA-301, this recommendation means that the trial is progressing positively as expected.
The OVA-301 pivotal Phase III multi-national study will enrol a total of 650 patients. The accrual halfway point in the study (325 patients) has occurred and recruitment is on target for completion in the first half of 2007. Currently there are 130 active clinical trial sites in 21 countries in the US, Europe, Asia and South America.
The pivotal trial OVA-301 compares monotherapy CAEYLX(R) (doxorubicin HCl liposome injection), marketed as DOXIL(R) in the United States, to a combination of YONDELIS(R) and CAELYX(R) (DOXIL(R)) in ovarian cancer patients who have relapsed after receiving standard first-line chemotherapy. The primary objective is to test the hypothesis that this combination therapy improves progression-free and overall survival in women with relapsed ovarian cancer.
Dr Miguel A. Izquierdo, PharmaMar's Director of Clinical Development, said:
"The data presented in various congresses over the last two years indicate that YONDELIS(R) is amongst the most active agents in the treatment of patients with relapsed ovarian cancer. We are pleased that the recommendation from the IDMC has now confirmed the positive progress of this pivotal trial. Recruitment for the study is on track and we look forward to generating the data that will enable us to present an application for marketing approval for YONDELIS(R) in ovarian cancer."
About the IDMC
The IDMC is an independent advisory group of experts with a mandate to periodically review and evaluate safety and / or efficacy data during a clinical trial or product development program. Membership includes individuals with clinical, scientific, and statistical expertise in the relevant therapeutic area.
About Ovarian Cancer
Ovarian cancer is the most common gynaecological cancer in women, representing the seventh most common cancer and the fourth most deadly. Incidence of ovarian cancer in the European Union is about 43,000 new cases each year and approximately 31,000 deaths occur per year. According to the World Health Organisation, the highest incidence rates occur in the United States, Canada, Scandinavia and Eastern Europe and the lowest rates in Africa and Asia.
The death rate for this disease has not changed significantly in the last 50 years. Ovarian cancer is predominantly a disease of older, post-menopausal women with the majority of cases being diagnosed in women over 50 years (the median age of women with ovarian cancer is 60) although it may occur in younger women with a family history of the disease. The vast majority of patients are diagnosed once the cancer has already spread from the ovary and the disease is advanced. Long term survival remains unfavourable: the 5-year survival rate for these women is only 15%-20%, whereas the 5-year survival rate for Stage I disease patients is nearly 90% and for Stage II disease patients is 70%.
YONDELIS(R) was originally isolated from the marine tunicate Ecteinascidia turbinata. YONDELIS(R) has a distinct mechanism of action. It is a unique anti-cancer agent that binds into the minor groove of the DNA and interacts with DNA repair enzymes and transcription factors, interfering with different cell cycle processes.
In addition to ovarian cancer, YONDELIS(R) is being studied in soft tissue sarcomas (STS) and in Phase II in prostate and breast cancers. It was designated Orphan Drug status for STS and ovarian cancer by the European Commission (EC) and the United States Food and Drug Administration (US FDA).
YONDELIS(R) is being developed by PharmaMar together with Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD). If key studies are successful and support marketing approval, the agreement between the parties provides that PharmaMar will market YONDELIS(R) in Europe while Ortho Biotech Products, L.P. and Janssen-Cilag will market the product in the US and the rest of the world respectively.
PharmaMar is the world's leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative, marine-derived medicines. PharmaMar's clinical portfolio currently includes 6 compounds: YONDELIS(R) (co-developed with J&JPRD), in Phase III clinical trials, was designated Orphan Drug status for soft tissue sarcomas and ovarian cancer by the European Commission (E.C.) and by the United States Food and Drug Administration (US FDA); Aplidin(R), in Phase II, was designated Orphan Drug status for acute lymphoblastic leukaemia and multiple myeloma by the E.C. and the US FDA; Kahalalide F, in Phase II; and ES-285, Zalypsis(R) and PM02734, in Phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange, ZEL).
For more information, contact:
PharmaMar Communications Tel: +34-91-846-6000
David Yates / Sarah MacLeod
Financial Dynamics Tel: +44-20-7831-3113
Catherine Moukheibir / Carlos Ruiz-Garma
Zeltia Capital Markets Operations Tel: +34-91-444-4500
This press release is also available in the News section on PharmaMar's web site: http://www.pharmamar.com/en/press/
ots Originaltext: PharmaMar
Im Internet recherchierbar: http://www.presseportal.ch
For more information, contact: Media: Lola Casals, PharmaMar
Communications, Tel: +34-91-846-6000; David Yates / Sarah MacLeod,
Financial Dynamics, Tel: +44-20-7831-3113; Investors: Catherine
Moukheibir / Carlos Ruiz-Garma, Zeltia Capital Markets Operations,