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PharmaMar Highlights Aplidin(R) Results at AACR

Washington D.c. (ots/PRNewswire)

PharmaMar today announces the
presentation of five posters highlighting advances with three of its
compounds at the 97th Annual Meeting of the American Association for
Cancer Research (AACR), taking place in Washington from 1-5 April
2006. The posters include results from preclinical research on
Aplidin(R), Zalypsis(R) and PM02734.
PharmaMar's highlights from this year's AACR meeting are as
follows:
Aplidin(R)
Aplidin (plitidepsin) is a cyclic peptide, originally isolated
from the marine tunicate Aplidium albicans, now manufactured
synthetically. It is a potent inducer of apoptosis.
Aplidin is being evaluated in Phase II clinical trials in solid
and haematological malignancies, including paediatrics, in Europe,
USA and Canada. More than 500 patients have been treated to date. A
clinical programme of combination studies with Aplidin was initiated
in the fall of 2005. 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.
One of the studies presented at AACR shows that in specific tumour
xenografts, the combination of Aplidin with carboplatin demonstrated
potentiation of antitumour activity over either drug administered as
a monotherapy. Parenthetically, the combination of Aplidin and
carboplatin is currently being explored in a Phase I clinical trial
in patients with advanced solid and haematological tumours.
A second study analyzed Aplidin against a panel of human kidney
tumour cell lines both in vitro and in vivo. In cytototoxicity assays
in vitro, Aplidin demonstrated potency against human renal tumour
cell lines. In a separate, dose-ranging study, human kidney tumours
were implanted subcutaneously into athymic nude mice and were allowed
to grow in situ. Animals were then randomized and drug treatment
commenced. Aplidin, in combination with standard-of-care agents
including interferon and interleukin, was tested in these
pre-clinical models. Results of the study showed that Aplidin
moderately potentiates the antitumour effect of either agent given as
a monotherapy at the same dose in those renal tumour xenografts.
The third Aplidin study presented was aimed at characterizing the
molecular basis of the resistance to Aplidin, which is an area of
active investigation. Using a proteomic-based approach, 36 proteins
were identified as differentially expressed between wild-type and
Aplidin-resistant human cancer cells. The proteins detected, whose
levels are altered in Aplidin resistant cells, are associated with
regulation of cell survival, cellular transformation, redox state and
actin cytoskeleton-membrane linkage. These proteins represent
candidates to mediate the action or sensitivity of human cancer cells
to this drug. The study concluded that further studies on the
mechanism of action and sensitivity of human cancer cells to Aplidin
need to be performed to confirm their role.
Dr Glynn Faircloth, VP Preclinical R&D, PharmaMar USA, said:
"The results seen in the Aplidin studies provide the best
preclinical evidence yet for the drug's use in combination therapy.
By examining the effects of Aplidin in combination studies, we hope
to broaden its therapeutic potential in a number of different types
of cancer, and to guide clinical combination studies in the near
future. In addition, research at the molecular level provides
information on protein candidates for further study of the mechanism
of action of Aplidin and the sensitivity of human cancer cells to the
drug. Taken together, these additional data become valuable tools to
assist in the clinical development programme for this promising
compound."
Zalypsis(R)
Zalypsis(R) (PM00104) is a new synthetic alkaloid related to
Jorumycin and Renieramycins, currently in Phase I clinical trials.
The objectives of the present studies were to investigate the
influence of dose and dosing regimen on the toxicokinetics of
Zalypsis in animal models, which was part of the evaluation to
support Zalypsis multi-cycle toxicology studies. Preliminary insights
into the mechanism of action of Zalypsis are exploring cycle changes,
DNA binding properties, and transcriptional inhibition. Zalypsis has
demonstrated a significant in vitro activity against solid and
non-solid tumour cell lines as well as significant in vivo activity
in several xenografted human cell lines in mice, such as breast and
prostate.
PM02734
The novel investigational agent PM02734, a member of the
Kahalalide F family of compounds currently in Phase I clinical
trials, shows in vitro antitumour activity against breast, colon,
lung, neuroblastoma, prostate, sarcoma, and thyroid tumour cell
lines. Pharmacokinetic (PK) studies in vivo demonstrate that PM02734
presents PK parameters i.e., drug exposure that differ among separate
animal species. Follow up studies in breast and prostate tumours are
underway to incorporate this information to optimize drug exposure
for optimal activity.
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 Johnson & Johnson
Pharmaceutical Research & Development) in Phase III clinical trials;
it is designated Orphan Drug 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).
This press release is also available in the News section on
PharmaMar's web site: http://www.pharmamar.com/en/press/

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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