Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Neoprobe has received the FDA's approval to commence patient enrollment in a Phase III multi-center clinical study to evaluate the safety and efficacy of Lymphoseek, a lymphatic tissue targeting agent being developed by the company.
Subscribe to our email newsletter
Neoprobe intends to enroll approximately 200 patients at up to twenty-five cancer treatment centers in the US and Europe under the amended Phase III clinical protocol. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in patients with breast cancer, melanoma and other tumor types.
The company is also preparing for a second Phase III trial to involve less than 200 evaluable patients with head and neck squamous cell carcinoma. The second Phase III study is proposed to be conducted in patients undergoing full nodal dissection for the staging of head and neck squamous cell carcinoma and is intended to validate Lymphoseek as a lymph node targeting agent for use in Intraoperative Lymphatic Mapping procedures. The company hopes to commence this second Phase III rial around mid-2008.
David Bupp, Neoprobe’s president, said: “We expect to begin patient enrollment in the first Phase III clinical study shortly after the FDA-approved clinical protocol and associated materials receive final clearance from review committees of the investigational sites.”