Nerviano Medical Sciences Receives Approval From the FDA to Enter Phase I Clinical Trials for Their Polo Like Kinase (PLK) Inhibitor

May 13, 2009

NERVIANO, Italy, May 13 /PRNewswire/ — 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.

    For information:

    Nerviano Medical Sciences
    Maria D'Acquino,
    tel +39-0331-581013,
    mob. +39-335-1863051,

SOURCE Nerviano Medical Sciences

Source: newswire

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