PharmaMar Presents New Data Of Zalypsis(R) And Irvalec(R) In Pediatric, Solid Tumours And Lymphoma

Main Category: Lymphoma / Leukemia
Also Included In: Cancer / Oncology;  Blood / Hematology;  Clinical Trials / Drug Trials
Article Date: 23 Oct 2008 - 8:00 PDT

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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 tumors.

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 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 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

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 program.

PharmaMar