Lymphoseek UpdateOn October 30, 2012, Navidea resubmitted its Lymphoseek new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in response to the complete response letter (CRL) the Company received in September 2012.
- Completed the sublicense agreement with Alseres Pharmaceuticals, Inc. for a second promising neuroimaging candidate. NAV5001 is an Iodine-123 radiolabeled imaging agent being developed as an aid in the diagnosis of Parkinson’s disease and other movement disorders and a potential use as a diagnostic aid in dementia.
- Enrolled the first subject in a Phase 2 clinical trial of NAV4694, Navidea’s F-18 PET imaging agent being developed as an aid in diagnosing Alzheimer’s disease.
- Received a Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for development of our radioimmunoguided surgery (RIGS ®) agent aimed at detecting metastatic cancer, with potential funding of up to $1.5 million over three years if fully funded. The first-year Phase 1 funding of $315,000, which has already been approved, is expected to enable the Company to complete preclinical bridging activities using a RIGS tumor-antigen-targeted monoclonal antibody and prepare a standardized clinical trial protocol.
- Published the results of Lymphoseek Phase 3 clinical trials in melanoma in the online edition of the journal Annals of Surgical Oncology. The data indicated that Lymphoseek met the primary efficacy endpoint in the assessment of lymphatic mapping performance in patients with cutaneous melanoma. The study was titled, “Combined Analysis of Phase III Trials Evaluating [99mTc]Tilmanocept and Vital Blue Dye for Identification of Sentinel Lymph Nodes in Clinically Node-Negative Cutaneous Melanoma,” [DOI 10.1245/s10434-012-2612-z].
- Presented data on Lymphoseek at major scientific and medical conferences:
- Lymphoseek Phase 3 meta-analysis data on Lymphoseek and radiolabeled colloidal agents presented at the 32 nd Congress of the European Society of Surgical Oncology by Dr. Frederick Cope.
- Additional podium and poster presentations highlighting similar Lymphoseek Phase 3 results were made at: the American Association of Pharmaceutical Scientists , the European Association of Nuclear Medicine , and the American Society for Radiation Oncology.
- Cornelia Reininger, M.D., Ph.D., joined Navidea as Chief Medical Officer. Previously, Dr. Reininger had a central role in the development of diagnostic radiopharmaceuticals for Alzheimer’s and Parkinson’s diseases for Bayer Healthcare Pharmaceuticals and GE Healthcare and Amersham Health – Diagnostic Imaging.