Madrid (ots/PRNewswire) - PharmaMar today announces the results of
the Aplidin(R) Phase II trial which were presented at the American
Society of Hematology 47th Annual Meeting in Atlanta, Georgia, USA,
on Sunday 11 December. Aplidin reached its objective of overall
response rate established in the first stage of the Phase II study in
patients with advanced multiple myeloma. Based on these positive
results, the second stage of this Phase II trial is already underway
in patients with this type of tumour.
The study is a Phase II multi-centre, open-label clinical and
pharmacokinetic trial in which Aplidin was administered as a three
hour infusion every two weeks in heavily pretreated patients (median
three prior chemotherapy lines) with relapsed or refractory multiple
myeloma. In 18 patients evaluated, Aplidin showed an acceptable
safety and toxicity profile, most notably a remarkable lack of
haematological toxicity. Out of 14 patients evaluable for efficacy, 1
showed a partial response and 5 showed stable disease.
Prof. Jesús San Miguel, MD, of the Hospital Clínico de Salamanca,
and trial investigator, commented: "Results of this first stage of
the Phase II trial with Aplidin demonstrate its antineoplasic
activity and confirm that it does not induce bone marrow toxicity, a
characteristic that lends itself to combination with other drugs.
Whilst it is early to determine the role of Aplidin in multiple
myeloma, the risk benefit profile is such that further investigation
with the drug is warranted."
Isabel Lozano, Chief Executive Officer of PharmaMar, said: "These
findings show interesting activity in Multiple Myeloma and confirm
the potential role of Aplidin as a single agent therapy in this
indication. We look forward to progressing the second stage of this
Phase II programme and we await with interest the results of our
other Phase II trials in progress which evaluate Aplidin in a number
of other tumour types, including melanoma, solid tumours and
Non-Hodgkin's Lymphoma, both as a single agent and in combination
with dacarbazine (DTIC) and carboplatin."
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 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.
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 6 products: 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 and for ovarian cancer by the European Commission (E.C.) and
by the Food & Drug Administration (FDA). It also features Aplidin(R),
in Phase II, designated Orphan Drug for acute lymphoblastic leukaemia
and for multiple myeloma; as well as 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, a leading European biotechnology and consumer chemical 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:
Zeltia Capital Markets Operations,
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,