“The results of the Phase III trial, which have been reviewed with FDA, confirm our belief that if Lymphoseek is ultimately cleared for marketing it will provide meaningful improvement in the diagnosis and subsequent treatment of cancer patients.”
The TERACHEM Symposium approaches the multidisciplinary issues related to the development and production of new radiometal-labeled compounds through the determination of structures and biological properties, evaluation of pre-clinical experiments and clinical studies to validate clinical application in radiodiagnosis and radiotherapy. Dr. Cope’s presentation reviewed the chemical composition of Lymphoseek (Tilmanocept) and summarized Lymphoseek pre-clinical and clinical study results to date.
“We are pleased that the international radiopharmaceutical community has recognized Lymphoseek’s chemical novelty and importance as a revolutionary compound in the diagnosis of cancer patients. Our participation in this international gathering underscores the tremendous potential of our lead drug initiative,” said Dr. Cope. “The results of the Phase III trial, which have been reviewed with FDA, confirm our belief that if Lymphoseek is ultimately cleared for marketing it will provide meaningful improvement in the diagnosis and subsequent treatment of cancer patients.”
In March 2010, Neoprobe met with FDA to review the clinical outcomes of its Phase III trial in breast cancer and melanoma patients, NEO3-05. Since that time, the Company has held successful reviews of the pre-clinical and chemistry, manufacturing and control sections of the planned New Drug Application (NDA). The Company today also announced that FDA has confirmed a meeting for early October to review the pre-NDA submission. The Company expects to file the NDA within weeks of the anticipated successful outcome of the final pre-NDA meeting.
Source : Neoprobe