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
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
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
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
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
Im Internet recherchierbar: http://www.newsaktuell.ch
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