FDA approves clinical studies of novel anti-cancer drug developed by Italian researchers

Feb 10 2009

Nerviano Medical Sciences (NMS) has secured Food and Drug Administration (FDA) approval to conduct for the first time clinical trials of a novel antitumoral agent.

The drug blocks Cdc7, a protein that is responsible for the uncontrolled proliferation of cancer cells. The preclinical data, recently published on the prestigious journal Nature Chemical Biology (http://www.nature.com/nchembio/journal/v4/n6/full/nchembio.90.html), demonstrate that inhibition of Cdc7 induces tumor cell death and blocks the growth of various types of cancer in experimental animal models.

The FDA approval will allow to conduct clinical phase I trials in cancer patients. "The news that the FDA has approved the clinical experimentation of our Cdc7 inhibitor - explains Dr. Francesco Colotta, NMS Oncology VP - first of all represents an acknowledgment of the quality and innovation of Italian research in the field of oncology. The discovery of this new drug results exclusively from the efforts of our investigators at the NMS R&D Site in Nerviano; thanks to their competence and passion we will be the first in the world to explore this new antitumor mechanism".

About Nerviano Medical Sciences (NMS)

Nerviano Medical Sciences is the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe. Research activities in Nerviano generate on average two clinical candidate molecules per year. NMS takes advantage of strategic alliances with biotechnology as well as pharmaceutical companies to secure its long term business sustainability. The Company has already finalized partnerships with major companies such as Pfizer Inc., Bristol-Myers Squibb Co., Genentech Inc. as well as with several biotech companies and academic institutions.