Zeltia Group

Three New Key Studies at ASCO Highlight Antitumoral Activity of Yondelis(R)

Atlanta, Georgia (ots/PRNewswire) - - 86% Rate of Tumour Control in myxoid liposarcomas - Correlation Between DNA Repair Gene Expression and Response Rate in Sarcomas - 78% Rate of Tumour Control in Platinum Pretreated Ovarian Cancer Patients PharmaMar highlights the results of three important studies out of 10 presented on Yondelis(R) at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia (USA) on 3-4 June 2006. Yondelis(R) is being developed by PharmaMar in partnership with Johnson & Johnson Pharmaceutical Research & Development, L.C.C. (J&JPRD). The key points from each of the presentations are set out below. Yondelis - Soft Tissue Sarcomas Two pharmacogenomic studies were presented which demonstrate the activity of Yondelis in specific types of advanced sarcomas. Oral Presentation: Patterns of tumour response to Yondelis in myxoid liposarcomas - Dr F. Grosso et al Data was obtained from a compassionate use study of 44 patients with advanced myxoid liposarcomas, and was carried out by six investigators in referral centres specialising in the treatment of patients with soft tissue sarcoma (STS). The results indicate significant evidence of Yondelis' anti-tumoural activity in this specific patient population with long-lasting objective remissions and tumour control in 86% of patients. The median progression free survival (duration of tumour control) is 18 months and the median survival time is 28 months. The study also identified a clear correlation between the level of response and changes in the density of the patients' tumour tissue. This "tissue response" preceded dimensional regression (tumour shrinkage) in 62% of responders. Commenting on the study, Dr F Grosso, Investigator at Istituto Nazionale dei Tumori in Milan, Italy, said: "These remarkable results demonstrate that Yondelis, a drug known to provide benefit to patients with STS, may bring increased benefits to patients that suffer from this specific type of sarcoma. Myxoid liposarcomas are known to be linked to chromosomal abnormalities and ongoing studies are underway to identify the correlation between a given molecular signature and successful treatment outcome." Dr Jose Jimeno, Vice President of Scientific Development at PharmaMar, added: "Beyond the known clinically relevant impact of Yondelis in advanced pre-treated STS patients, the data presented in this population with dismal prognosis reinforces the value of Yondelis as an active anticancer agent. Yondelis has a clear role in myxoid liposarcomas and probably in other malignancies such as Ewing sarcomas that bear similar genetic abnormalities. The results generated warrant further studies in this tumour type as a first line treatment for metastatic disease as well as preoperative therapy." Poster: DNA repair functionality modulates the clinical outcome of patients with advanced sarcoma treated with Yondelis - Dr P. Schöffski et al Based upon the significant accumulated evidence that demonstrates the ability of Yondelis to induce long-lasting rates of prolonged responses (up to a number of years in several cases) and its correlation with DNA repair processes, this exploratory retrospective pharmacogenomic study was implemented to investigate whether there is a molecular signature that correlates with sensitivity or resistance to Yondelis. Data collected from analysis of tumour samples of sarcoma patients treated with Yondelis indicate the impact of the DNA repair mechanism on progression free survival and overall survival. This data shows that patients with an efficient TC-NER machinery (as demonstrated per high levels of ERCC1) have a better outcome to treatment with Yondelis, and that patients with a deficient homologous recombination repair machinery (demonstrated by low levels of expression of BRCA1) experience better progression-free survival and overall survival. Prof. Dr. P. Schöffski, Lead Investigator at the Universitaire Ziekenhuizen Leuven, Belgium, said: "This study provides powerful evidence of Yondelis' role in soft tissue sarcoma and also, more generally, of the future importance of pharmacogenomics in the treatment of cancer. The impact of deficient or mutant BRCA1 is well established in other tumour types such as breast and prostate cancers and development strategies for Yondelis for these highly prevalent cancers should be considered by the company." Dr José Jimeno, Vice President of Scientific Development at PharmaMar, said: "The data reinforces the notion of a targeted trans-tumoural oriented strategy and thus customised trials in other tumours, as breast, ovarian and prostate, known to be sensitive to Yondelis, should be implemented. Selective approach might be a good option for the clinical development of the compound in these important indications." Yondelis - Ovarian Cancer Poster: Phase II randomized open-label study of Yondelis given as two different dosing schedules in women with platinum-sensitive recurrent ovarian carcinoma - Dr JM del Campo et al This Phase II trial was designed to test the activity of two dosing schedules of Yondelis administered over 3-hour or 24-hour infusion every 3 weeks in patients with relapsed ovarian carcinoma. 107 patients were enrolled in the trial at 34 centres across Europe. The results demonstrate that both schedules are active, with 28.3% and 29.6% of objective response rates in the 3-hour 1.3 mg/m2 and the 24-hour 1.5 mg/m2 regimen respectively, with a median duration of response of 5.4 months. The activity of Yondelis appears to be independent of the number of previous platinum lines of therapy. Moreover, the rate of tumour control (Complete Responses + Partial Responses + Stable Disease) is 78% in the overall population. The safety results confirm the lack of cumulative toxicity, thus allowing multi-cycle therapies. A worldwide Phase III study in ovarian cancer (650 patients in 135 centres and 21 countries) is ongoing to compare the combination of Yondelis plus Doxil(r)(1)/Caelyx(r) (doxorubicin HCI liposome injection) to Doxil(r)/Caelyx(r) alone, in the second line treatment of ovarian cancer patients. (1) DOXIL(r) (doxorubicin HCI liposome injection) is marketed in the United States by Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market this medication as CAELYX(R) throughout the rest of the world, excluding Japan. Dr Miguel Angel Izquierdo, Director of Clinical Development at PharmaMar, commented: "Yondelis is amongst the most active agents in the treatment of patients with relapsed ovarian cancer and this randomized study adds further evidence of its activity. The response rates corroborate those of earlier studies and confirm the suitability of the 3-hour outpatient infusion regime being used in the Phase III pivotal trial that is now well underway." About Yondelis(R) 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. (J&JPRD) 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. In addition to a pivotal Phase II trial in soft tissue sarcoma, Yondelis also is being studied in a Phase III trial in ovarian cancer, and in Phase II in breast and prostate cancers. More than 3,400 patients have been treated to date with Yondelis. 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 believed to be 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. About PharmaMar 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(R) (co-developed with J&JPRD) in Phase III clinical trials; it was designated Orphan Drug status 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 (tel.: +34-91-846-6000) Investors: Catherine Moukheibir, 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: Zeltia Group Im Internet recherchierbar: http://www.presseportal.ch Contact: 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)

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