FDA authorizes Neoprobe Corporation to commence patient enrolment in a phase 2 multi-centre clinical study to evaluate the safety and efficacy of Lymphoseek, a lymphatic tissue targeting agent being developed by the company.
According to the company release, the authorization to commence enrolment follows FDA's review of Neoprobe's responses to information requested by FDA in response to prior submissions by the company regarding the chemistry, manufacturing and control and non-clinical testing of Lymphoseek. Neoprobe intends to enrol up to eighty patients at five of the leading cancer treatment centres in the US under the amended phase 2 clinical protocol. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in breast and melanoma cancer patients.
Dr. Richard Orahood, Neoprobe's medical director, said, "To date, the clinical and preclinical results that have been completed demonstrate the benefits of Lymphoseek. We believe the safety and efficacy of Lymphoseek will be further supported by the completion of multi-centre studies. In preparation for the initiation of the phase 2 clinical study, Neoprobe met with the phase 2 investigators at the society of surgical oncology meeting in late March. We expect to begin patient enrolment in the phase 2 clinical study sometime in June after the FDA-approved clinical protocol and associated materials receive final clearance from review committees of the investigational sites."
Neoprobe currently markets the neo2000 line of gamma detection systems that are widely used by cancer surgeons for intraoperative lymphatic mapping and the Quantix line of blood flow measurement products that are designed to be used by cardiovascular surgeons, neurosurgeons and critical care physicians. In addition, Neoprobe holds significant interests in the development of related biomedical systems and agents including Lymphoseek and RIGScan. Lymphoseek is an investigational drug being developed as a lymphatic tracing agent. The RIGS system is an investigational technology that combines the company's gamma detection device technology with a proprietary disease-specific radiolabelled cancer targeting agent that is injected into a cancer patient prior to their surgery, and a patented surgical method to get real-time information to locate tumour deposits that may not be detectable by conventional methods.