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news.Biopharmaceutical company Tigris Pharmaceuticals has initiated a multi-center, phase II clinical trial of its drug candidate, A-007, in 250 patients with high-grade cervical intraepithelial neoplasia - a condition which can lead to cervical cancer.
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The primary objective of this phase II study is to determine the pathological response of A-007, a self-administered intravaginal gel, as compared to placebo in the treatment of high-grade CIN.
Secondary objectives are evaluation of safety, HPV eradication, and measurement of immunologic parameters. The trial is being conducted at 25 research centers in the US. Results from the trial are expected to be available in 2007.
Cervical intraepithelial neoplasia (CIN) is usually caused by the sexually transmitted human papillomavirus (HPV).
“Initiation of this large phase II trial is a significant step in the development of A-007 as a potential treatment for CIN and the eradication of high-risk HPV,” noted Dr Edmundo Muniz, CEO of Tigris. “There is a critical unmet medical need for non-surgical interventions to safely treat CIN and HPV and we are thrilled to have the top research centers for gynecologic oncology partnering with us in this trial.”