Onyx Pharmaceuticals Achieves Milestone in Cancer Program With Pfizer
21 September 2004 - 7:00AM
PR Newswire (US)
Onyx Pharmaceuticals Achieves Milestone in Cancer Program With
Pfizer PD332991 Enters Phase I Human Clinical Trials RICHMOND,
Calif., Sept. 20 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals,
Inc. (NASDAQ:ONXX) announced today that its collaborator, Pfizer
Inc, has initiated Phase I clinical trials for an anti-cancer
compound discovered during the two companies' research
collaboration. The initiation of human clinical trials triggers a
$500,000 milestone payment to Onyx. Pfizer is managing and funding
all clinical development and commercialization activities for this
compound, known as PD332991. In exchange, Onyx will receive a high
single-digit royalty if PD332991 is commercialized. Onyx will also
receive milestone payments associated with the achievement of
certain clinical and regulatory events. This novel compound is
intended to intervene in the misregulated cell cycle of tumor cells
by inhibiting a key enzyme, cyclin-dependent kinase 4 (cdk4). The
normal cell cycle consists of distinct phases during which the
cell's DNA is copied and the cell divides. Cdks are enzymes that
operate as switches to move the cell through these stages by
controlling protein phosphorylation. PD332991 is a cdk4 inhibitor
active in the initial stage (G1) of the cell cycle, a phase where
most human tumors have abnormal regulation. It is anticipated that
blocking cdk4 activity may provide an approach to inhibiting
proliferation of tumor cells at a key step in the cell cycle, one
where cancer cells become distinct from normal cells. Earlier this
year, at the annual meeting of the American Association for Cancer
Research (AACR), Pfizer researchers reported that PD332991 is a
highly selective and potent cdk4 inhibitor. It was shown to arrest
the cell in the G1 phase of the cell cycle, preventing it from
entering the S phase, the step where the cell's DNA is replicated.
Pfizer researchers demonstrated that oral administration of
PD332991 resulted in marked tumor regression in in vivo models.
Thus it appears that PD332991 has the potential to shrink tumors,
as well as to prevent tumor growth. Onyx Pharmaceuticals is engaged
in the development of novel cancer therapies that target the
molecular basis of cancer. With its collaborators, the company is
developing small molecule drugs, including BAY 43-9006 with Bayer
Pharmaceuticals Corporation. For more information about Onyx's
pipeline and activities, visit the company's website at
http://www.onyx-pharm.com/. This news release contains
forward-looking statements regarding expectations about the
development of a novel Cdk inhibitor, including further clinical
testing and the timing of such clinical trials; and the company's
expectations or beliefs of the compound's commercial potential.
These forward-looking statements involve a number of risks and
uncertainties that could cause actual events to differ from the
company's expectations. These risks are addressed in the company's
periodic reports filed with the Securities and Exchange Commission,
including but not limited to its Annual Report on Form 10-K filed
on March 15, 2004 and its Quarterly Reports on Form 10-Q.
DATASOURCE: Onyx Pharmaceuticals, Inc. CONTACT: Julie Wood of Onyx
Pharmaceuticals, Inc., +1-510-262-8757 Web site:
http://www.onyx-pharm.com/
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