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PTC Therapeutics Presents Encouraging Phase 1 Results of its Novel VEGF Inhibitor, PTC299, at 30th Annual San Antonio Breast Cancer Symposium
Date:12/17/2007

PTC299 monotherapy significantly decreased human tumor and plasma VEGF levels, impeded tumor growth, and prolonged time to tumor progression in hormone- sensitive and -insensitive xenograft models. As assessed by dynamic contrast- enhanced magnetic resonance imaging (DCE-MRI), PTC299 also significantly reduced xenograft tumor volume and tumor perfusion, with effects beginning within one day of treatment initiation.

In the Phase 1 clinical studies, healthy volunteers received single doses or multiple doses through seven days of drug administration. PTC299 induced no serious, dose-limiting, or definitively drug-related adverse events. All clinical adverse events were mild (Grade 1) or moderate (Grade 2) in severity and did not require intervention. Consistent with preclinical findings which suggest that PTC299 selectively inhibits pathological tumor-associated VEGF production while sparing physiological VEGF expression, adverse events such as bleeding, hypertension, or proteinuria that have been associated with other VEGF inhibitors were not observed. Pharmacokinetic data indicated dose- proportional increases in plasma exposures with trough plasma concentrations exceeding those associated with activity in the preclinical models of breast cancer.

Together, these preclinical and Phase 1a clinical data have supported the recent initiation of a randomized, dose-ranging Phase 1b/2 clinical trial in patients with advanced breast cancer at New York University Medical Center. In addition to assessing longer-term safety and anti-tumor activity, the trial will evaluate tumor perfusion and metabolism and assess circulating VEGF and tumor markers. For additional information on the PTC299 clinical trial, please visit http://www.clinicialtrials.gov and search using the keyword, PTC299.

"The initiation of trials with PTC299 in patients with breast cancer provides further clinical validation of our prop
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SOURCE PTC Therapeutics, Inc.
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