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Mersana Therapeutics Reports Phase I Results for XMT-1001 in
Patients with Solid Tumors at AACR-NCI-EORTC International
Conference
-- favorable pharmacokinetic and safety data
observed in first clinical trial of novel FleximerTM anticancer
agent --
Cambridge, MA
October 24, 2007
Mersana,
a cancer therapeutics company, announced interim results of a
Phase I study of its lead product candidate, XMT-1001, in patients
with
advanced solid tumors. The data was presented by Edward A. Sausville,
M.D., Ph.D, Professor of Medicine and Associate Director for Clinical
Research, University of Maryland Greenebaum Cancer Center in a
poster session on October 23 at the 2007 AACR-NCI-EORTC International
Conference
on Molecular Targets and Therapeutics taking place in San Francisco,
CA. Full text of the abstract #A146 “A Phase I Study of the
Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001
in Patients with Advanced Solid Tumors” can be viewed online
at the AACR website at www.aacr.org. XMT-1001 is a polymer-based
pro-drug of camptothecin (CPT), a well-characterized topoisomerase
I inhibitor with potent anti-tumor activity.
Commenting on the data,
Robert J. Fram, M.D. Chief Medical Officer at Mersana, stated: “The Phase I results show that, in humans,
camptothecin, the active agent in XMT-1001, is released gradually
from the Fleximer carrier as a pro-drug in a manner that will potentially
avoid common safety problems associated with drugs in this class.
To date, we’ve seen no evidence of drug-related serious adverse
events and the study is ongoing.”
Results were presented from
12 patients enrolled in an ongoing Phase I open-label, dose-escalation
trial designed to determine
the safety, tolerability and pharmacokinetic profile of XMT-1001.
To date, XMT-1001 has been well tolerated in patients and no serious
drug related adverse events have been reported. Preliminary results
demonstrate a favorable pharmacokinetic profile with low levels
of CPT, both total and free, recovered in urine. The maximum tolerated
dose (MTD) has not been reached and the study continues to accrue
patients.
“Our Fleximer nanotechnology platform is designed to create
proprietary new drugs from existing and novel pharmaceutical compounds,” said
Julie Olson, President and Chief Executive Officer of Mersana. “We
are pleased to note that in the Phase I study, our proprietary Fleximer-controlled
drug release system achieved results consistent with our objective
of extending the half-life of the camptothecin analog while avoiding
safety concerns. The favorable pharmacokinetic and safety data are
consistent with results from preclinical studies of XMT-1001,” she
concluded.
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