Nerviano Medical Sciences, an Italian pharmaceutical R&D facility, has received FDA approval for its investigational new drug application to begin a Phase I clinical study with the company’s selective PLK-1 small molecule inhibitor for the treatment of cancer.
According to Nerviano, this new compound is orally bioavailable, highly efficient and well tolerated in preclinical models of cancer after repeated dosing. This inhibitor adds another promising candidate to the pipeline of cell cycle targets with different mechanisms of action in clinical development which have been discovered and developed by Nerviano Medical Sciences (NMS).
These include inhibitors of CDK, Aurora and CDC-7. An investigational new drug (IND) for an inhibitor of CDC-7 was approved by the FDA in January 2009 and the first patients were treated with the compound in April 2009.
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.
Francesco Colotta, vice president of R&D at NMS, said: I am pleased to see the second IND approval in 2009 and I highly appreciate the consistant delivery of high quality clinical candidates by the Nerviano site.