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CellAct Pharma Advances Phase I Clinical Trial of Topoisomerase Inhibitor in Cancer


10/16/2009 10:21:43 AM

Dortmund, Germany, October 16, 2009 – CellAct Pharma, which develops novel products to treat inflammation and cancer, announced today the continued enrollment of patients with advanced cancer into a Phase I clinical trial of CAP7.1. This follows a preliminary study in children with neuroblastoma. CAP7.1 is CellAct‘s lead small molecule candidate and is designed to target topoisomerase II in cancer cells and induce cell death.

The trial is an open-label, dose-escalation study evaluating the safety and pharmacokinetics of CAP7.1 in patients with solid tumors that are refractory to standard therapies. It will enroll 3 to 6 patients per cohort during the dose escalation phase of the study to a total of 30 patients.

The primary endpoint of the study will be safety, but patients also will be evaluated for anti-tumor activity as well as tolerance of the drug in order to determine the optimal schedule and level of dosing. The trial has been initiated in a specialized center for oncology in Germany. Data from the study is anticipated by mid 2010.

"CAP7.1 is a prodrug of Etoposide that has potential to treat multiple types of cancer, particularly lung and cancers with Multi Drug Resistance. The potential of CAP7.1 has been shown in a preliminary study in children with neuroblastoma, who tolerated the drug well and showed a preliminary therapeutic response,” stated Nalân Utku, M.D., Managing Director of CellAct. "The ability of CAP7.1 to inhibit growth of tumors in preclinical studies coupled with its bioavailability makes it an appealing product candidate to advance into human clinical trials."

CAP7.1 is designed as a prodrug of Etoposide, which inhibits topoisomerase II. In preclinical and clinical studies to date, CAP7.1 has demonstrated a unique mechanism of action independent of Etoposide effects, which is being further analyzed. CellAct has received a €0.7 million grant from the German ministry for education and science (Bmbf) to support this program.

About CellAct Pharma

CellAct Pharma is focused on the development of innovative therapeutics for the treatment of diseases with high unmet need, especially certain cancers and inflammatory diseases, such as rheumatoid arthritis and multiple sclerosis. CellAct's drug candidates target and modulate human molecules that have specific functions in tumour growth and immune response. A small molecule compound, CAP7.1 which targets topoisomerase II, is currently in a clinical Phase I study for the treatment of cancer. CellAct also develops antibodies against cell surface molecules in lymphocytes to treat cancer and inflammation. Fully human antibodies are generated in collaboration with Medarex, Inc. to be tested in clinical studies for the treatment of oncological and inflammatory diseases. For further information visit www.cellact.eu.


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