Irvalec and Zalypsis are two compounds of marine origin, with a novel mechanism of action, in phase-I clinical development for the treatment of different tumours A clinical study of 37 patients with solid tumours 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 tumour cell lines, at doses equivalent to the clinical administration and higher to those obtained with five other anti-tumoural 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 paediatric tumours 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 October 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 Programme of marine origin compounds, is a new drug with antiproliferative activity against a wide range of tumours, 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 US 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 paediatric tumours. The preclinical evaluation of the first compound for the treatment of paediatric cancer was
made against six types of paediatric tumours cell lines that represent 50 per cent 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 rhabdomyosarcoma.
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 Institute Gustave Roussy (Villejuif, France), and members of the Innovative Therapies for Children with Cancer (ITCC) which brings together 35 centres specializing in paediatric 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 paediatric tumours. Within PharmaMar Cancer Research Programme 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 paediatric tumours.
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.
Irvalec is a new depsipeptide from PharmaMar’s internal research program for derivatives of the marine natural compounds. PM02734 is manufactured synthetically by PharmaMar.
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.