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17.02.2005 – 09:26

Zeltia Group

Aplidin(R) Commences Phase II Clinical Trials in Prostate and Bladder Cancers

    Madrid, Spain (ots/PRNewswire)

PharmaMar announces that its second most advanced marine-derived anti-tumour agent, Aplidin(R), has commenced Phase II clinical trials in both prostate and bladder cancers.

    Phase II trial in Prostate Cancer

    This is the first trial of Aplidin in solid tumours to be carried out in the United States (US). This study will focus on patients with androgen-independent prostate cancer, relapsing or progressing after a previous line of docetaxel-based chemotherapy. The objective of the study is to determine the anti-tumour activity of Aplidin. The schedule is 5 mg/m2 given as a 3 hour intravenous infusion every 2 weeks for up to 12 cycles. 46 patients are expected to be enrolled in the trial.

    Despite recent advances in disease management, no curative therapy currently exists for advanced prostate cancer. The available treatments, particularly in androgen-independent disease, are usually limited in terms of the duration of their efficacy. Consequently, median survival is less than 12 months after failure of initial androgen ablation for metastatic disease. Therefore, and particularly because of the high incidence of prostate cancer in the Western world, new therapeutic agents which would either improve tumour control or provide a cure are required.

    In 2005, over 230,000 new prostate cancer cases are projected in the US. With an estimated 29,900 deaths, prostate cancer is the second leading cause of cancer deaths in men in the US (2004, Cancer Facts and Figures, American Cancer Society). One in six American men will develop prostate cancer in the course of his lifetime (2004, Prostate Cancer Foundation). In the European Union, the incidence of new prostate cancer cases is around 198,000 each year (Globocan 2002, figures are for 25 EU countries).

    Phase II trial in Bladder Cancer

    This is a European multicentre study to evaluate the efficacy of Aplidin in patients with advanced or metastatic bladder cancer who have relapsed or progressed after first line chemotherapy. The primary end-point is objective tumour response. Based on the results from Phase I studies, Aplidin will be administered as a 3-hour infusion (5 mg/m2) every two weeks. The number of patients expected to be enrolled is 32.

    Bladder cancer is the most common cancer of the urinary tract. The American Cancer Society estimates that more than 60,000 people were diagnosed and 12,700 died of this disease in the United States during 2004 (ACS, 2004). Men are affected three times more frequently than women.

    In the EU approximately 111,000 patients are diagnosed with bladder cancer each year and 37,000 die from this disease (Globocan 2002, figures are for 25 EU countries). More than half of the patients with advanced bladder cancer experience recurrences.

    Dr M.A. Izquierdo, Director of Clinical Development at PharmaMar, commented: "We are continuing to progress the development of Aplidin in both solid tumours and haematological malignancies in line with our business plan."

    Notes to Editors

    About Aplidin(R)

    Aplidin is a cyclic peptide, originally isolated from the marine tunicate Aplidium albicans, currently obtained by total synthesis. It induces apoptosis rapidly and persistently, inhibits VEGF secretion and blocks cell-cycle.

    It is currently in therapeutic exploratory clinical evaluation (phase II) in solid and haematological malignancies, including paediatrics. The clinical program involves hospitals in Europe, Canada and the US. Approximately 400 patients have been treated. In preclinical development, human leukaemia, myeloma and lymphoma tumor cell lines were shown to be particularly sensitive to Aplidin. There is no evidence of cross-resistance with commonly used therapeutic agents for haematological malignancies.

    Aplidin shows no clinical evidence of relevant bone marrow toxicity. Its side effects are reversible and manageable (including muscular and liver biochemical alterations). Hair loss and oral ulcers are infrequent.

    Aplidin was granted Orphan Drug Designations for the treatment of Acute Lymphoblastic Leukaemia in the European Union in 2003 and in the US in 2004. The US FDA and the EC granted ODD also for the treatment of Multiple Myeloma in 2004.


    PharmaMar is the world leader biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived medicines. PharmaMar's clinical portfolio currently includes YondelisTM in phase III clinical trials (co-developed with Johnson & Johnson Pharmaceutical Research & Development), designated Orphan Drug for STS by the European Commission (E.C.) in 2001 and by the FDA in 2004, and Orphan Drug for ovarian cancer by the E.C. in 2003; Aplidin(R), in phase II, designated Orphan Drug for acute lymphoblastic leukaemia by the E.C. in 2003 and by the FDA in 2004, and for multiple myeloma by the FDA and the E.C. in 2004; Kahalalide F in phase II and ES-285 and Zalypsis(R) in phase I clinical trials.

    PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange, ZEL) PharmaMar's website is

ots Originaltext: Zeltia Group
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For more information, contact: Lola Casals, Communication Manager,
PharmaMar, Tel: +34-91-846-6000; David Yates & Deborah Scott,
Financial Dynamics, Tel: +44-(0)20-7831-3113