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Aplidin(R) Commences Combination Trials

Madrid (ots/PRNewswire)

- Further Steps in the Development of Aplidin(R) in Melanoma in
First Line Therapy
PharmaMar announces the initiation of a programme of combination
studies with Aplidin(R) (plitidepsin), PharmaMar's novel
marine-derived anti-tumour agent, originally isolated from the
tunicate Aplidium albicans.
Aplidin(R) in Combination with Dacarbazine (DTIC)
The first study is a Phase I/II trial of Aplidin in combination
with DTIC, the standard agent for the treatment of metastatic
malignant melanoma. This multicentre, randomised, open-label,
clinical and pharmacokinetic trial will determine the recommended
dose and assess efficacy of Aplidin(R) when administered alone or in
combination with DTIC as a first-line therapy.
The preliminary results of a Phase II study, which demonstrated
evidence of the anti-tumour activity of Aplidin(R) as a single agent
in previously treated patients with advanced or metastatic melanoma,
were presented at the ESMO Congress November 2004 in Vienna, Austria.
Aplidin in Combination with Carboplatin
The second of these combination studies will assess the safety and
tolerability of Aplidin when administered in combination with
carboplatin in patients with advanced solid and haematological
tumours. The Phase I multicentre, open-label, dose-escalating,
clinical and pharmacokinetic study will identify the maximum
tolerated dose and recommended dose of Aplidin administered in
combination with carboplatin to patients for whom there is no
standard therapy.
Dr M.A. Izquierdo, Director of Clinical Development at PharmaMar,
commented: "The previous observation of encouraging clinical activity
in a heavily pre-treated population of patients with malignant
melanoma warrants further investigation in first line therapy, both
as a single agent or in combination with DTIC. With the initiation of
these combination studies, we are seeking to broaden the therapeutic
potential of Aplidin in a number of different tumour types. Further
combination studies will be commenced in due course as we continue to
explore the opportunities for this compound."
About Aplidin
Aplidin is a cyclic peptide, originally isolated from the marine
tunicate Aplidium albicans, now manufactured synthetically. It
induces apoptosis rapidly and consistently, inhibits VEGF secretion
and blocks the cell-cycle.
It is currently being evaluated in Phase II trials in solid and
haematological malignancies, including paediatrics. The clinical
programme involves hospitals in Europe, Canada and the US.
Approximately 500 patients have been treated to date. In preclinical
development, human leukaemia, myeloma and lymphoma tumour 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(R) shows no clinical evidence of relevant bone marrow
toxicity. Its main side effects, muscular toxicity and liver
biochemical alterations, are reversible and manageable. Hair loss and
oral ulcers are infrequent.
About PharmaMar
PharmaMar is the world's leading biopharmaceutical companies 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 Johnson & Johnson
Pharmaceutical Research & Development) in Phase III clinical trials;
it is also designated Orphan Drug for Soft Tissue Sarcomas by the
European Commission (E.C.) in 2001 and by the Food & Drug
Administration (FDA) in 2004, and Orphan Drug for ovarian cancer by
the E.C. in 2003 and by the FDA in 2005. It also features 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 EC in 2004; as well as 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).
This press release is also available in the News section on
PharmaMar's web site: http://www.pharmamar.com/en/press
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

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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