|Shares of NeoProbe jump in post-trading|
|By Staff and Wire Reports|
|Thursday, 20 October 2011 06:47|
The NDA submission for Lymphoseek includes results from two Phase 3 studies of Lymphoseek, NEO3-05 and NEO3-09, performed in patients with either breast cancer or melanoma.. The firm seeks U.S. clearance to market Lymphoseek for use in Intraoperative Lymphatic Mapping (ILM), a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. According to the American Cancer Society, approximately 230,000 new cases of breast cancer and 70,000 new cases of melanoma are expected to be diagnosed in the United States in 2011.1 The Lymphoseek NDA has proposed use of the agent in anatomic delineation of lymphatic tissue.
“The acceptance of the Lymphoseek NDA filing marks a critical milestone for the clinical and regulatory development of this agent. Lymphoseek has undergone study in two prospective, well- controlled and designed Phase 3 clinical trials under the direction of nearly 30 investigators in more than 500 patients,” said Rodger A. Brown, Vice President, Regulatory Affairs and Quality Assurance, of Neoprobe. “We look forward to working in collaboration with the FDA to prepare for its pending review of the NDA.”
Neoprobe's investigational activities are focused on three particular developmental product initiatives: Lymphoseek(TM), RIGScan® CR and Activated Cellular Therapy (ACT). Its Lymphoseek is a proprietary radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure referred to as Intraoperative Lymphatic Mapping (ILM). Its RIGS system combines a hand-held gamma radiation detection probe, proprietary radiolabeled cancer-specific targeting agents, and patented surgical methods to provide surgeons with real-time information to locate tumor deposits not detectable by conventional methods, and to assist in more thorough removal of the cancer. The RIGScan® is designed to assist the surgeon in the more thorough removal of the cancer, thereby leading to improved surgical treatment of the patient. The targeting agents used in the RIGS process are monoclonal antibodies, labeled with a radioactive isotope that emits low energy gamma rays. It has also been collaborating in the development of an Activated Cellular Therapy (ACT) that uses the RIGS system to surgically locate specialized lymph node cells that can be grown and activated in a proprietary procedure.
Neoprobe's majority-owned subsidiary, Cira Biosciences, Inc., explore the development and commercialization of an activated cellular therapy technology that has shown promising early stage patient-specific treatment potential in oncology, viral (HIV/AIDS and hepatitis) and autoimmune diseases. The company markets its Gamma Detection Systems, detector probes and accessories worldwide for surgical procedures called Intraoperative Lymphatic Mapping (ILM) or sentinel lymph node biopsy, a minimally invasive technique for evaluating the potential spread of cancer to lymph node tissues and organs. It is also exploring other potential applications for the use of its gamma detection devices in cancer surgery. The company's Gamma Detection Systems has 1100/1101 Wireless Probes, 1102 Laparoscopic Probe, etc.