Nerviano Medical Sciences Receives Approval From The FDA To Enter Phase I Clinical Trials For Their Polo Like Kinase (PLK) Inhibitor

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 14 May 2009 - 1:00 PDT

email to a friend   printer friendly   opinions  

The FDA has approved an Investigational New Drug (IND) application by Nerviano Medical Sciences to begin a phase I clinical study with its selective PLK-1 small molecule inhibitor for the treatment of cancer. PLK-1 is a mitotic kinase required for the proliferation of cancer cells. This new compound is orally bioavailable, highly efficient and well tolerated in preclinical models of cancer after repeated dosing. This unique inhibitor adds another promising candidate to the pipeline of innovative cell cycle targets with different mechanisms of action in clinical development which have been discovered and developed by NMS. These include inhibitors of CDK, Aurora and CDC-7. An IND for an inhibitor of CDC-7 was approved by the FDA in January this year and the first patients were treated with the compound in April. NMS CDK and Aurora inhibitors are in phase I and II clinical development, respectively, and are starting to show promising activity in specific patient populations.

The clinical development path foresees application of the NMS PLK-1 inhibitor in solid and hematological indications. "I am pleased to see the second IND approval this year and I highly appreciate the consistant delivery of high quality clinical candidates by the Nerviano site" comments Dr. Francesco Colotta, VP R&D at NMS.

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.

Source: Nerviano Medical Sciences

• Additional
• References
• Citations