- IDMC Recommends Adoption of 24hr Dosing in Pivotal Trial
PharmaMar today announces that the independent data monitoring
committee (IDMC) for the pivotal trial of YONDELIS(R) in Soft Tissue
Sarcoma (STS) has reviewed data from a pre-planned interim analysis
of the primary end-point, Time to Progression (TTP), which indicate
that there is a positive trend in TTP in favour of patients receiving
the 24hr dosing regime.
The trial, known as STS-201, compares the efficacy of two dosing
schedules of YONDELIS (24hr and weekly) in STS patients who have
failed to respond to prior available therapies. Enrolment of 270
patients was completed during the second quarter of 2005, making this
the largest randomised trial ever conducted in this patient setting.
Following the review, the IDMC has concluded that the 24hr regime
provides an added advantage to patients. In addition, no unexpected
toxicities were identified in this trial. In light of the IDMC's
findings, PharmaMar and its partner for the development of Yondelis,
Johnson & Johnson Pharmaceutical Research & Development (J&JPRD),
have offered all patients who are still in treatment the option of
switching to the 24hr regime. Analysis of the resulting data is
likely to take some additional time to compile and review.
Both PharmaMar and J&JPRD are continuing to work with the
regulatory authorities towards submission of Yondelis in STS for
marketing authorisation in the shortest possible timeframe. In this
context, PharmaMar also announces that it has held a pre-submission
meeting with the EMEA to confirm plans for submission of the MAA
(Market Authorisation Application) and that it has presented a formal
letter of intent to file. The decision to submit was taken after
discussions with the European regulatory authorities on the STS-201
trial, which we confirm will form the basis for filing. No further
studies will be conducted prior to the submission.
Isabel Lozano, PharmaMar's CEO, commented: "We are pleased to
report today that the IDMC's analysis of the data supports the 24
hour dosing regime as the most beneficial for patients. PharmaMar and
J&J PRD continue to work diligently with the regulatory authorities
towards submission for potential approval of Yondelis in STS as well
as to develop the compound in other indications."
Notes to Editors:
Pivotal STS trial summary
The study is a randomised, multicenter, open-label, pivotal study
of YONDELIS comparing two different treatment schedules (weekly
versus 24hr) in patients with previously treated, advanced or
metastatic STS, who have failed to respond to standard STS
chemotherapy, doxorubicine and ifosfamide. The primary objective is
to compare the efficacy of the two treatment dosing schedules of
YONDELIS based on Time To Progression (TTP). Other secondary
end-points are response rate and overall survival).
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.
YONDELIS(R) (trabectedin), is PharmaMar's most advanced compound
in development. It was originally isolated from the marine tunicate
Ecteinascidia turbinata, but now is manufactured by chemical
synthesis. YONDELIS is being developed by PharmaMar in partnership
with Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
If key studies are successful and support marketing approval,
PharmaMar will market YONDELIS in Europe (including Eastern Europe)
while Tibotec Therapeutics, a division of Ortho Biotech Products,
L.P. and Janssen-Cilag, will market it in the rest of the world.
YONDELIS is also being studied in a Phase III pivotal trial in
ovarian cancer, as well as evaluated in breast and prostate cancers.
In clinical studies to date, YONDELIS has shown a good safety and
tolerability profile. The most frequent side effect is neutropenia,
which is reversible and manageable. A transient increase in
transaminases has been observed.
YONDELIS is a new chemical entity with a unique multicomponent
mechanism of action. It is the only chemotherapy agent that binds to
the DNA's minor groove and bends toward the major groove, producing
its therapeutic effect by interfering with various cell division
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: YONDELIS (co-developed with Johnson & Johnson
Pharmaceutical Research & Development) in Phase III clinical trials;
it is designated Orphan Drug for soft tissue sarcomas and ovarian
cancer by the European Commission (E.C.) and by the United States
Food & Drug Administration (US FDA). Aplidin(R), in Phase II,
designated Orphan Drug for acute lymphoblastic leukaemia and for
multiple myeloma by the E.C. and by the 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:
Media: Lola Casals, PharmaMar Communication
Investors: Catherine Moukheibir, Zeltia Capital Markets Operations
This press release is also available in the News section on
PharmaMar's web site: http://www.pharmamar.com/en/press/
ots Originaltext: Zeltia Group
Im Internet recherchierbar: http://www.presseportal.ch
For more information, contact: Media: Lola Casals, PharmaMar
Communication, tel.: +34-91-846-6000. Investors: Catherine
Moukheibir, Zeltia Capital Markets Operations, tel.: +34-91-444-4500