Vienna, Austria, November 2 (ots/PRNewswire) -
- Significant Advances in the Clinical Development of Yondelis(TM)
PharmaMar, the biopharmaceutical company specialising in cancer
therapy, presented new data from its two lead drugs, Yondelis(TM)
and Aplidin(R), at the 29th European Society for Medical Oncology
Congress (ESMO) held in Vienna, Austria from 29 October to 2
Data from two separate studies in patients with solid tumours
using Yondelis in combination with the chemotherapy drugs
Doxil(R)/Caelyx(R) and carboplatin were presented. The combination of
Yondelis with Doxil was shown to be safe and feasible. These trials
form the basis for the future development of Yondelis in ovarian
cancer as well as in other tumours.
New data was also presented from the preliminary results of a
Phase II study in Aplidin, which demonstrated evidence of Aplidin's
activity in patients with advanced or metastatic melanoma.
A summary of these presentations is as follows:
- Phase I study of Yondelis in combination with Doxil
(full poster presentation)
The trial indicates that the combination of Yondelis plus
Doxil/Caelyx is well tolerated and feasible, thus allowing the
delivery of therapeutic doses of both compounds. Partial responses
(reductions in tumour sizes) were observed in patients with ovarian
and head and neck cancers as well as in soft tissue sarcomas.
- Phase I combination study of Yondelis and carboplatin in
advanced solid tumours (poster presentation)
The goal of this study is to determine the recommended dose of
Yondelis in combination with carboplatin. Preliminary evidence of
antitumoural activity has been observed in this trial, although
additional clinical research is ongoing.
- Preliminary results of a Phase II study of Aplidin as a
second line therapy in patients with advanced or metastatic melanoma
This study concluded that Aplidin showed activity as a single
agent against melanoma in patients previously treated, with an
acceptable safety profile. Dr Timothy Eisen, study investigator,
concludes that further development of Aplidin in this disease is
In addition to these presentations of new data, previously
reported data were also presented at ESMO, including Yondelis
combinations with two other chemotherapy drugs, cisplatin and
paclitaxel, a compassionate use programme in Italy, and a
pharmacogenomics study on Yondelis.
A summary of these presentations follows:
- Phase I and pharmacokinetic study of Yondelis in combination
with cisplatin in advanced cancer patients resistant to cisplatin
(full poster presentation)
The combination of Yondelis and cisplatin was shown to be active
in patients with refractory ovarian cancer. Reversible, non-severe
toxicity was observed.
- Phase I and pharmacokinetic study of sequential paclitaxel
(Taxol) followed by Yondelis (poster presentation)
To date, four dose levels have been studied and no dose limiting
toxicity has been observed. Preliminary anti-tumor activity has been
observed in soft tissue sarcoma. At future dose levels, other tumor
types will be enrolled to evaluate the anti-tumor activity of this
combination. Prolonged disease stabilisation has been observed in
cancers resistant to chemotherapy such as sarcoma and melanoma.
- Yondelis in sarcomas given within a compassionate use
programme in Italy (poster presentation)
The investigator reports antitumour activity consistent with that
observed in formal clinical studies of Yondelis. The data
demonstrates that Yondelis is feasible in heavily pretreated patients
- Correlation of low expression of DNA repair gene, BRCA1 mRNA,
and survival of patients with advanced sarcoma treated with Yondelis
This study found that a low mRNA expression of the DNA repair
gene, BRCA1, may be associated with both better progression-free
survival and statistically significant longer survival after
treatment with Yondelis. Further evaluation of BRCA1 mRNA in patients
with sarcoma receiving Yondelis is warranted.
Commenting on the ESMO presentations, Jose Maria Fernandez,
Chairman of Zeltia, said:
"These new data on our two lead compounds, Yondelis and Aplidin,
give us further encouragement as to their safety and potential
activity in a number of different cancers and broaden the profile and
opportunity for both drugs. In particular, the combination trials of
Yondelis give us the platform to begin a Phase III trial in ovarian
cancer and possibly other solid tumours. "
YONDELIS is a novel marine-derived anti-tumour agent isolated from
the colonial tunicate Ecteinascidia turbinata. It is being
co-developed by PharmaMar and Johnson & Johnson Pharmaceutical
Research & Development, and is in Phase II clinical trials for soft
tissue sarcoma, ovarian, breast, endometrial, prostate and non-small
cell lung cancers. Yondelis has been granted Orphan Drug Designation
for Soft Tissue Sarcoma in Europe (in 2001) and in the US (in 2004);
and in ovarian cancer in Europe (in 2003).
Aplidin, a marine-derived peptide originally from Aplidium
albicans , is a multi-factorial apoptosis-inducing agent,
characterised by a low haematological toxicity and a high specificity
towards tumour cells. Currently in therapeutic evaluation studies
(phase II) in solid and haematological malignancies, including
Aplidin has also been granted Orphan Drug Designation for the
treatment of Acute Lymphoblastic Leukaemia in US & Europe and for
Multiple Myeloma in the US.
Yondelis(TM) is a PharmaMar trademark.
Aplidin(R) is a PharmaMar registered trademark.
PharmaMar is a biopharmaceutical company, advancing cancer care
through the discovery and development of innovative marine-derived
medicines. PharmaMar's clinical portfolio currently includes
Yondelis(TM) in phase II clinical trials (co-developed with Johnson &
Johnson Pharmaceutical Research & Development), designated Orphan
Drug for STS by the European Commission (E.C.) in 2001 and by the FDA
in 2004, and Orphan Drug for ovarian cancer by the E.C. in 2003;
Aplidin(R), in phase II, designated Orphan Drug for acute
lymphoblastic leukaemia by the E.C. in 2003 and by the FDA in 2004;
also designated Orphan Drug for multiple myeloma by the FDA in 2004;
Kahalalide F in phase II and ES-285 in phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia
Group (Spanish stock exchange: ZEL.MC; Bloomberg: ZEL SM; Reuters:
ZEL.MC). PharmaMar can be found on the Web at www.pharmamar.com
ots Originaltext: Zeltia Group
Im Internet recherchierbar: http://www.newsaktuell.ch
For more information, please contact: Lola Casals, PharmaMar, Tel:
+34-91-846-6000, David Yates & Deborah Scott; Financial Dynamics,
Tel: + 44-(0)20-7831-3113