PharmaMar presents new data of Zalypsis® and Irvalec® in pediatric, solid tumours and lymphoma at the 20th AACR-NCI-EORTC Symposium

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PharmaMar presents new data of Zalypsis® and Irvalec® in pediatric,
solid tumours and lymphoma at the 20th AACR-NCI-EORTC Symposium

23 October 2008

– Irvalec® and Zalypsis® are two compounds of marine origin, with a novel
mechanism of action, in phase I clinical development for the treatment of
various tumors
– A clinical study of 37 patients with solid tumors or lymphoma shows
Zalypsis has a good safety profile and is highly active. These findings
enable the continuation of Zalypsis clinical development
– Irvalec® shows significant antiproliferative activity in trials against
different tumor cell lines, at doses equivalent to the clinical
administration and higher to those obtained with five other antitumoral
compounds of ErbB pathway
– Two new preclinical studies made in collaboration with the European
Consortium for Innovative Therapies for Children with Cancer (ITCC) show
significant activity of the two compounds in pediatric tumors
– PharmaMar, a company of the Zeltia Group, is presenting data on four
trials during the 20th EORTC-NCI-AACR symposium, held in Geneva from 21- 24

Geneva, 23 October, 2008: PharmaMar, a biotechnology company of Zeltia
Group, has presented new data on two antitumoral compounds of marine origin,
Zalypsis® and Irvalec®, in Phase I trials in clinical development and in
vitro studies and with animal models.

Zalypsis® is a novel chemical entity related to the marine natural compounds
Jorumycin and the family of Renieramycins, obtained from molluscs and
sponges, respectively. Irvalec®, a new synthetic depsipeptide derived from
PharmaMar Development Program of marine origin compounds, is a new drug with
antiproliferative activity against a wide range of tumors, including breast,
colon, pancreas, lung and prostate.

PharmaMar has presented the results of 4 studies at the 20th annual
symposium of the European Organization for Research and Treatment of Cancer
(EORTC), the U.S. National Cancer Institute (NCI) and the American
Association for Cancer Research (AACR), taking place in Geneva (Switzerland)
from 21 to October 24.

In the first study, the safety of Zalypsis ® in 37 patients with solid
tumors or lymphoma was evaluated. The trial shows a good safety profile of
the drug, which enables the

continuation of its clinical development. The study was made in
collaboration with the Institut Gustave Roussy (Villejuif, France) and the
Northern Centre for Cancer Treatment (Newcastle, United Kingdom).

The second study presented at the Geneva meeting evaluated the activity of
Irvalec® in of colon cancer, breast, ovarian, lung, prostate, head and neck
and pancreas cell lines. Cytotoxicity data obtained with Irvalec® were
compared with five other compounds that inhibit the Erb-B/HER Pathway.

According to the results, Irvalec® shows a significant antiproliferative
activity at doses that may be achieved in the clinic, being a more potent
inhibitor of cell proliferation than other ErB inhibitors used in the
trials, and showing a differential activity profile. The study was made in
collaboration with the Beaujon University Hospital (Clichy, France).

In two other new studies presented at the meeting in Geneva, PharmaMar
evaluated the therapeutic potential of Irvalec® and Zalypsis® in pediatric

The preclinical evaluation of the first compound for the treatment of
pediatric cancer was made against six types of pediatric tumors cell lines
that represent 50% of treatment failures in this population: neuroblastoma,
Ewing's sarcoma, rhabdomyosarcoma, acute lymphoblastic leukemia,
medulloblastoma and osteosarcoma. Osteosarcoma and rhabdomyosarcoma cell
lines were the most sensitive to the drug.

The same methodology was followed for the evaluation of Zalypsis®. The most
significant results in in vitro tests were obtained in neuroblastoma and
rhabdomyosarcoma cell lines. The evaluation of the compound in animal models
also showed significant results, especially in the activity in

The trials were conducted by the R&D Department of PharmaMar in partnership
with the Emma Children's Hospital (Amsterdam, Netherlands), the University
Children's Hospital (Munster, Germany) and the Institut Gustave Roussy
(Villejuif, France), and members of the Innovative Therapies for Children
with Cancer (ITCC) which brings together 35 centres specializing in
pediatric oncology of six European countries.

The aim of the studies carried out in collaboration with ITCC is to
facilitate the identification of new compounds with significant potential in
the treatment of pediatric tumors.

Within PharmaMar Cancer Research Program and as part of the company’s
commitment with cancer patients, this biotech company of the Zeltia Group is
also evaluating the therapeutic potential of its marine origin compounds in
pediatric tumors.

About Zalypsis® (PM00104)
Zalypsis® (PM00104/50) is a new marine derived compound in Phase II
clinical trials for the treatment of solid tumours. Zalypsis® is a novel
chemical entity related to the marine natural compounds Jorumycin and the
family of Renieramycins, obtained from molluscs and sponges, respectively.
Zalypsis binds to DNA and is cytotoxic; however, it does not activate the
“DNA damage checkpoint” response. Thus, Zalypsis has cytotoxic effects
dependent on DNA binding that are not associated with DNA damage. In
pre-clinical trials, Zalypsis demonstrated strong in vitro and in vivo
antitumoural activity in a wide variety of solid and haematological tumour
cell lines and human transplantable breast, gastric, prostate and renal
xenografted tumours. Zalypsis also demonstrated a manageable and reversible
preclinical toxicology profile.

About Irvalec® (PM02734)
Irvalec® is a new depsipeptide from PharmaMar’s internal research
program for derivatives of the marine natural compounds. PM02734 is
manufactured synthetically by PharmaMar. Preliminary in vitro in-house
studies identified PM02734 as a new antiproliferative drug demonstrating
activity against a broad spectrum of tumor types: breast, colon, pancreas,
lung and prostate, among others. PM02734 has been selected for clinical
development based on its in vivo activity in xenografted human tumors, as
well as an acceptable non-clinical toxicology profile. PM02734 is in Phase I
clinical trials in patients with advanced malignant solid tumors.

PharmaMar is the world-leading biopharmaceutical company of the Zeltia
Group, and is committed to advancing the treatment of cancer through the
discovery and development of new marine-derived medicines. PharmaMar has
four novel compounds in clinical development. Yondelis® has received
Authorization for Commercialization from the European Commission for
treating advanced soft tissue sarcoma. Yondelis® is currently being marketed
in the European Union for the treatment of soft tissue sarcomas in adults
after failure of standard therapy. Aplidin®, Zalypsis®, and Irvalec® are
other marine-derived new agents in clinical development by PharmaMar, which
also has a rich pipeline of preclinical candidates, and a strong R&D

For further information:

Media Relations (Ph: +34 91 846 60 00)
Fernando Mugarza
Carlos Martínez de la Serna
Carolina Lanzas Otazu

Capital Markets (Ph: +34 91 444 45 00)
Alfonso Hurtado de Mendoza
Florencia Radizza

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