Pharmamar Initiates A Phase II Study Of Yondelis® In Children With Recurrent Soft Tissue Sarcomas

Main Category: Dermatology
Also Included In: Cancer / Oncology;  Pediatrics / Children's Health
Article Date: 24 Mar 2008 - 1:00 PDT

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PharmaMar announces the initiation of a Phase II multicenter study of Yondelis® (trabectedin) in children with recurrent rhabdomyosarcoma, Ewing´s sarcoma, or non-rhabdomyosarcomatous soft tissue sarcomas.

The study will determine a safe and tolerable dose of Yondelis in pediatric patients and assess the efficacy at that dose based on response rates. Additionally, toxicity and pharmacokinetics in these patients will be determined. A total of 60 patients aged 12 months to 21 years old will be accrued within approximately 2 years. Yondelis® will be administered as an intravenous infusion for 24 hours every 3 weeks.

The study is being carried out by the Children's Oncology Group (COG) in centers of the USA and Canada. COG is an international research group with more than 200 hospitals that treat children with cancer in the United States, Canada, Australia, and Switzerland. The study is being managed by our co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The COG carried out a Phase I clinical trial to determine Yondelis® dose-limiting toxicities and maximum tolerated dose in children with refractory solid tumors, establishing the recommended dose for pediatric phase II trials, and characterizing the pharmacokinetics of Yondelis® in children. The study, published in Clinical Cancer Research in 2005 determined that Yondelis® is safe in children (Clinical Cancer Research Vol. 11, 672-677, Jan 2005).

Sylvain Baruchel, MD., Director of the New Agent and Innovative Therapy Program of the Hospital for Sick Children in Toronto, Canada, is the principal investigator of the current study and the already completed Phase I.

PharmaMar is committed to increasing the availability of medicines for children through promoting the pediatric development of its pipeline when appropriate. In line with this approach PharmaMar is planning to start new pediatric studies in the future.

Yondelis® is currently being developed by PharmaMar in partnership with Johnson & Johnson Pharmaceutical Research & Development L.L.C.. According to the licensing agreement,

PharmaMar will market Yondelis® in Europe (including Eastern Europe) while Ortho Biotech Products, L.P., will market it in the U.S., and Janssen-Cilag will market it in the rest of the world.

About soft tissue sarcomas in children*

Soft tissue sarcomas are a heterogeneous group of malignancies of mesenchymal origin that develop at a variety of primary sites throughout the body. In children, soft tissue sarcomas generally are classified as either rhabdomyosarcomas (RMS) or non-rhabdomyosarcomas (non-RMS), with the non-RMS being further divided into multiple histologic subtypes which also include Ewing´s sarcoma. Rhabdomyosarcoma is the most common soft tissue sarcoma among children 0-14 years, representing nearly 50% of soft tissue sarcomas for this age range with an incidence rate of 4.6 per million.

According to the United States National Cancer Institute the incidence of soft tissue sarcomas in children and adolescents younger than 20 years of age was 11.0 per million, representing 7.4% of cancer cases for this age group.

*Source: National Cancer Institute, Surveillance Epidemiology and End Results (SEER) Cancer Incidence and Survival Among Children and Adolescents: United States SEER Program 1975-1995. ICCC IX, Soft Tissue Sarcomas. National Cancer Institute
SEER Pediatric Monograph.

PharmaMar, based in Madrid, Spain, is a subsidiary of Grupo Zeltia (Spanish Stock Exchange, ZEL) that is quoted in the Spanish Stock Exchange since 1963 and the Spanish continuous market since 1998. Grupo Zeltia is currently part of the Ibex Nuevo Mercado (New Market). http://www.pharmamar.com

This document is a press release, not a brochure. This document does not constitute nor is part of any offer or invitation to sell or issue any application of purchase, offer or shares subscription of the Society. Likewise, this document nor its distribution is part or can be of base for any contract or investment decision and does not constitute any kind of recommendation in relation with the shares of the Company.