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The new PTC299 clinical study is an open-label Phase II trial that will evaluate the efficacy, safety, and pharmacodynamics of PTC299 in up to 25 patients with neurofibromatosis type 2 (NF2) for up to 48 weeks.
The primary objective of the study is to assess how PTC299 affects tumor volume and changes in hearing and word recognition among patients with NF2. The trial will also assess the effects of PTC299 on tumor blood flow and vascular endothelial growth factor- related proteins. The study will be conducted at the Massachusetts General Hospital in Boston, Massachusetts.
The Phase II clinical trial of PTC299 is supported by a grant from the US Department of Defense neurofibromatosis research program.
According to PTC Therapeutics, PTC299 is a novel, orally administered investigational new drug that is designed to selectively block tumor-related vascular endothelial growth factor.
Langdon Miller, chief medical officer of PTC Therapeutics, said: "We are excited to rapidly advance the clinical development of PTC299 in NF2. We are hopeful that the novel mechanism of PTC299 will address unmet medical need for patients with NF2, building upon ongoing evaluations of the drug in patients with metastatic breast cancer, Kaposi's sarcoma, and other solid tumors."
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