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PharmaMar Reports Positive Phase II Results on Aplidin(R) in Patients With Advanced Multiple Myeloma at ASH
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/.
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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,