Business Wire
June 9, 2008
DUBLIN, Ohio -- Neoprobe Corporation, a diversified developer of innovative oncology and cardiovascular surgical and diagnostic products, today announced that a multicenter Phase 3 study of Lymphoseek(R) has been initiated in patients with either breast cancer or melanoma. The Phase 3 study will evaluate the efficacy of Lymphoseek to identify lymph nodes that may be predictive of determining whether a patient's cancer has spread into the lymphatic system. The Phase 3 study has been registered on the national clinical trials website www.clinicaltrials.gov.
David Bupp, Neoprobe's President and CEO, said, "Neoprobe is pleased to announce the initiation of its first Phase 3 study (NEO3-05) for Lymphoseek. At the present time, we have multiple sites initiated and by the end of this month, we expect to have more sites enrolling patients in the study than participated in the very successful Phase 2 clinical study of Lymphoseek. During July and August, additional sites will be initiated to commence patient enrollment including international sites, which will bring the total number of sites participating in the trial to approximately twenty. In addition, we are awaiting final regulatory clearance for a second Phase 3 study (NEO3-06) of Lymphoseek which will be conducted in patients with head and neck squamous cell carcinoma. Activities are underway to commence the second Phase 3 study when the appropriate regulatory clearances have been obtained. The two Phase 3 studies are designed to support the registration of Lymphoseek in the first half of next year. The initiation of the Phase 3 study is a key milestone for the development of Lymphoseek for Neoprobe and we expect the achievement of additional milestones in the coming months."
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neo2000(R) line of gamma detection systems that are widely used by cancer surgeons and is commercializing the Quantix(R) line of blood flow measurement products developed by its subsidiary, Cardiosonix Ltd. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek(R) and RIGScan(R) CR. Neoprobe's subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe's strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Copyright Business Wire 2008
