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Istanbul, Turkey (ots/PRNewswire) - PharmaMar, the biopharmaceutical company specialising in cancer therapy, announces today that it is to present new data from two of its clinical compounds, Kahalalide F and Aplidin(R), at the 31st European Society for Medical Oncology Congress (ESMO) being held in Istanbul, Turkey from 29 September to 3 October 2006.
Data will also be presented on PharmaMar's lead cancer compound, Yondelis(R), which demonstrate its potential in combination with carboplatin and expand its potential range of use.
The results of three Phase II trials to evaluate the anti-tumour activity of Kahalalide F will be presented. In all these trials Kahalalide F was administered to patients in a weekly one hour intravenous infusion at a dose of 650 microg/m2. The summary of the data is as follows:
The Phase II clinical trial of Kahalalide F as a second line therapy in patients with advanced non-small cell lung cancer (NSCLC) was a multi-centre, non-randomised study in 31 patients. One partial response was observed and stable disease was reported in eight patients, with the majority of the clinical benefit being seen in patients with squamous cell carcinoma.
The Phase II study of Kahalalide F as a first line therapy in patients with hepatocarcinoma (HC) was a non-randomised study in 22 patients with metastatic or irresectable HC. Stable disease was reported in ten patients (seven lasting more than three months and four lasting more than six months). A 50% decrease in the tumour marker alpha-fetoprotein, AFP (considered to be an indicator of improvement) was observed in two patients.
The Phase II study of Kahalalide F in patients with advanced malignant melanoma (AMM) enrolled 24 patients. Stable disease lasting more than three months was reported in five patients.
In all these trials Kahalalide F was very well tolerated with no serious adverse events reported, showing an excellent tolerability profile.
This exploratory Phase II trial of Aplidin(R) in patients with advanced renal or colorectal cancer was a multi-centre, open-label, randomised clinical and pharmacokinetic study of Aplidin(R), either alone or in combination with L-carnitine, in patients with advanced renal or colorectal cancer in objective progression. 81 patients were enrolled into two arms of the study, Arm A being administered Aplidin(R) at a dose of 5 mg/m2 and Arm B at a dose of 7 mg/m2 plus L-carnitine.
Anti-tumour activity was observed in patients with previously treated renal cancer (partial response 5.4% and 48.7% with stable disease). Stable disease lasting more than 12 weeks was seen in 32.4% of renal patients. In the colorectal patients, stable disease lasting more than 12 weeks was observed in 24.3% of patients. No difference in efficacy was observed between the two arms of the study.
The safety profile was similar to that seen in Aplidin(R) at the Phase I stage. The concomitant administration of L-carnitine allowed the administration of the higher 7 mg/m2 dose of Aplidin(R) but resulted in more severe incidence of side effects, as compared to the 5 mg/m2 dose. These data support the continuation of the clinical development of Aplidin(R) at a dose of 5 mg/m2 in renal cancer.
The results of a combination Phase I study of carboplatin and YONDELIS(R) (trabectedin) conducted in the UK and Spain in a total of 44 heavily pretreated ovarian patients will be presented. The data show that the combination was well tolerated and that the most common side effects observed were neutropenia and thrombocytopenia. Preliminary data on this study were presented at the ESMO congress in 2004.
Anti-tumour activity in ovarian cancer after failing other therapies was observed. Three partial responses (PR, 20%) and stable disease in 3 patients (SD, 20%) lasting longer than 3 months were observed, indicating that further study of the combination at the recommended dose is warranted.
This study shows that the combination of YONDELIS(R) and carboplatin is feasible and active at doses near the maximum for both agents. This combination expands the potential use of YONDELIS in a variety of tumour types in which platinum compounds are the main chemotherapy agents.
The results of a Phase II trial of YONDELIS(R) administered as a 3-hour intravenous infusion in sarcoma patients also will be presented. A total of 75 patients with Soft Tissue Sarcomas (STS), Osteosarcomas (OS), Rhabdomyosarcomas (RMS) or the Ewing's Family tumours (EFT) were enrolled and treated in several European countries, having progressed through standard therapy. Preliminary results were presented at ASCO in 2003.
The final results in STS demonstrated that YONDELIS(R) as a 3-hour infusion is a well-tolerated and active agent in this STS population. The data suggests the anti-tumour effect falls within the same range as the 24-hour continuous infusion, a regimen known to be active in STS (pivotal study STS-201 currently under registration). In addition, the longest response was observed in a patient with a myxoid liposarcoma, which has recently been shown to be sensitive to this agent. In EFT and RMS, some anti-tumour activity was observed, meriting further investigation.
Commenting on the ESMO presentations, Dr Miguel A. Izquierdo, PharmaMar's Director of Clinical Development, said:
"The Kahalalide F data confirm the excellent tolerability profile reported in previous studies and establish that this compound class warrants further clinical evaluation in combination to exploit its therapeutic index. The promising activity observed with Aplidin(R) in renal cancer and the fact that it is an inhibitor of the VEGF pathway, which is known to be relevant in renal cancer, makes the development of the compound in renal cancer a priority, particularly in combination with established anti-angiogenic drugs in this type of cancer. Aplidin remains in full development in solid and haematologic tumours and in pediatric cancer.
"The latest data on Yondelis confirm its anti-tumour activity in various sarcomas. They also demonstrate its potential as a combination therapy with carboplatin and its possible use in a variety of tumours where carboplatin is part of the standard chemotherapy treatment."
Notes to Editors
Kahalalide F is a depsipeptide derived from the sea slug Elysia rufescens. Kahalalide F alters the function of the lysosomal membranes inducing cell death by oncosis. Antitumour activity independent of MDR (Multi Drug Resistance) and p53 status and to correlate with basal ErbB3 expression.
Kahalalide F is currently in Phase II clinical trials in hepatocellular carcinoma, non-small cell lung cancer (NSCLC) and melanoma. It is also being evaluated for the treatment of severe psoriasis.
About Aplidin(R) (plitidepsin)
Aplidin(R) is a synthetic cyclodepsipeptide originally isolated from the marine tunicate Aplidium albicans. The mechanism of action of Aplidin(R) appears to involve oxidative mediated stress and is still under investigation. Aplidin(R) induces rapid apoptosis and also inhibits the VEGF (Vascular Entdothelial Growth Factor) autocrine loop, crucial in the vascularisation and growth of tumours. Human leukaemia and lymphoma tumour cell lines have been found to be particularly sensitive to Aplidin in models resistant to standard anticancer agents.
Phase II evaluation of Aplidin(R) in solid and haematological malignancies is currently undergoing in Europe, the US and Canada. It is also in Phase I in children with malignant solid tumours or leukemias.
Aplidin has Orphan Drug designation from the EC and the FDA for Acute Lymphoblastic Leukemia (ALL) and Multiple Myeloma (MM).
About Yondelis(R) (trabectedin)
Yondelis was originally isolated from the marine tunicate Ecteinascidia turbinata. Yondelis has a distinct mechanism of action. It is a unique antitumoural drug that binds into the minor groove of the DNA and interacts with DNA repair enzymes and transcription factors, interfering with cell cycle process. In July 2006, Yondelis(R) was submitted to the European Medicines Agency (EMEA) for regulatory approval for the treatment of soft tissue sarcomas (STS). In addition to STS, Yondelis(R) is being studied in a pivotal Phase III trial in ovarian cancer and in Phase II in prostate and breast cancers. It was designated Orphan Drug status for STS and ovarian cancer by the European Commission (E.C.) and the United States Food & Drug Administration (U.S. FDA.)
Yondelis(R) is being developed by PharmaMar together with Johnson & Johnson Pharmaceutical Research & Development, L.L.C. If key studies are successful and support marketing approval, the agreement between the parties provides that PharmaMar will market Yondelis(R) in Europe while J&J companies, Ortho Biotech Products, L.P. and Janssen-Cilag, will market the product in the U.S. and the rest of the world respectively.
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: PharmaMar
Im Internet recherchierbar: http://www.presseportal.ch
Media: Lola Casals, PharmaMar Communication (tel.: +34-91-846-6000);
Investors: Catherine Moukheibir, Zeltia Capital Markets Operations,