NEWS RELEASE
PHARMAMAR INITIATES A PHASE II STUDY OF YONDELIS®
IN CHILDREN WITH RECURRENT SOFT TISSUE SARCOMAS
http://www.pharmamar.com/en/press/news_release.cfm?newsReleaseID=178&year=2008
17 March 2008
Yondelis is being commercialized in the European Union for the treatment of advanced soft tissue sarcoma in adults.
Madrid,
March 17th, 2008: 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 Childrens 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.
Important note
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).
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.
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For more information: www.pharmamar.com