FREMONT, Calif., Sept. 29 /PRNewswire-FirstCall/ -- Protein Design Labs,
Inc. (PDL) (Nasdaq: PDLI) today presented interim Phase I clinical data for
M200, its anti-alpha5beta1 integrin antibody for the treatment of refractory
solid tumors, at the 16th EORTC-NCI-AACR Symposium on Molecular Targets and
Cancer Therapeutics in Geneva, Switzerland. The data were reported in a
poster presentation by Dr. Eric Rowinsky, Clinical Professor of Medicine,
University of Texas Health Science Center and Senior Scientist, CTRC Institute
for Drug Development, San Antonio, Texas.
This ongoing study is a Phase I dose-escalation clinical trial. Sixteen
men and women between the ages of 29 and 81 (mean 58 years) with various solid
tumor types refractory to standard therapy have been enrolled in this study.
Tumor types included colorectal, melanoma, hepatic, pancreatic and non-small
cell lung cancers. Patients were enrolled into dose cohorts as follows: one
patient at 0.5 mg/kg, 2 patients at 1 mg/kg, 3 patients at 2.5 mg/kg,
3 patients at 5.0 mg/kg and 6 patients at 10 mg/kg. Each patient received
5 doses of M200 on study days 1, 15, 22, 29 and 36.
The study data showed that adverse events were generally mild to moderate
in intensity and included fatigue, nausea, constipation, headache and
anorexia. There were no severe or serious adverse events that were dose
limiting or considered by investigators to be related to M200. Three patients
in the two lowest dose cohorts tested positive for anti-M200 antibodies;
antibodies were not detected in patients who received the higher, Phase
II-relevant, dose cohorts.
Steven Benner, M.D., Senior Vice President and Chief Medical Officer, PDL,
said, "We are pleased that M200 was well tolerated with no dose-limiting
toxicities in this initial clinical study. Based on these results, we plan to
initiate over the next few quarters a series of open-label, Phase II trials in
renal, melanoma, pancreatic and non-small cell lung cancers."
Dr. Rowinsky noted that 10 of 15 evaluable patients had stable disease as
their best response, and that five of six patients treated at the highest dose
level, 10 mg/kg, achieved stable disease. Four patients with stable disease
after 5 doses of M200 in the Phase I study continued treatment with M200 in a
Phase I extension study. Three of these patients maintained stable disease
for greater than 16 weeks over the two studies.
Dr. Rowinsky added, "Stable disease in these patients with advanced
cancers may represent biological activity for M200 in this early phase trial."
About M200
M200 is a chimeric monoclonal antibody that may prevent tumor growth and
metastasis by blocking alpha5beta1 integrin. Alpha5beta1 integrin is a cell
adhesion molecule that is upregulated on activated endothelial cells and is
critical for survival and proliferation of endothelial cells during the
process of angiogenesis, or new blood vessel formation. M200 binds with high
affinity to alpha5beta1 integrin on activated endothelial cells causing
apoptosis and the inhibition of angiogenesis, regardless of the growth factor
(VEGF, bFGF, HGF and others) which stimulated angiogenic activity.
About Protein Design Labs
Protein Design Labs is a leader in the development of humanized antibodies
to prevent or treat various disease conditions. PDL currently has antibodies
under development for autoimmune and inflammatory conditions, asthma and
cancer. PDL holds fundamental patents for its antibody humanization
technology. Further information on PDL is available at http://www.pdl.com.
This press release contains certain forward-looking statements that
involve risks and uncertainties and PDL's actual results may differ materially
from those discussed above. Factors that may cause such differences are
discussed in the Company's Annual Report on Form 10-K for the year ended
December 31, 2003, and in its quarterly report on Form 10-Q for the period
ended June 30, 2004, and in other SEC filings. In particular, there can be no
assurance that the data from the Phase I study of M200 in solid tumors are
indicative of results which may be obtained in the planned Phase II studies,
nor can there be any assurance that the Phase II studies will be initiated
within the indicated timeframe.
NOTE: Protein Design Labs and the PDL logo are registered U.S. trademarks
of Protein Design Labs, Inc.
SOURCE Protein Design Labs, Inc.
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Related links:
http://www.pdl.com
CONTACT:
James R. Goff, Senior Director, Corporate
Communications of Protein Design Labs, Inc., +1-510-574-1421, or
jgoff@pdl.com
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