Aplidin(R) commences clinical trials
MADRID- 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 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.
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. The clinical programme involves hospitals in Europe, Canada and the US. Approximately 500 patients have been treated to date. In preclinical development, leukemia, 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: 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 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 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.
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. The clinical programme involves hospitals in Europe, Canada and the US. Approximately 500 patients have been treated to date. In preclinical development, leukemia, 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: 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.
posted by gwg at 9:35 AM
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