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PharmaMar Confirms Intention to Submit MAA to EMEA for YONDELIS(R) in Soft Tissue Sarcoma
Madrid (ots/PRNewswire) -
- 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 processes.
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).
@@start.t1@@ 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