Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has completed a pre-NDA assessment for Lymphoseek® with the U.S. Food and Drug Administration (FDA). As a result of the pre-NDA assessment, FDA has requested that data from both the completed NEO3-05 study and the NEO3-09 study currently in progress be included in the Company's primary New Drug Application (NDA) for Lymphoseek rather than submitting the NEO3-09 study data as a major amendment to the ongoing NDA review.
The previous plan to submit the NEO3-09 study data as a major amendment to the ongoing NDA review for Lymphoseek was the outcome of the successful March 2, 2010 meeting with FDA. The pre-NDA meeting held earlier this week with FDA was intended to review that plan for NDA submission with the safety and efficacy data from the NEO3-05 study and a pre-planned major amendment to submit the NEO3-09 study safety data as part of the ongoing NDA review.
NEO3-09 was originally intended as a supplement to the primary NDA for Lymphoseek for safety evaluation purposes and to support expanded product labeling claims. The pre-NDA assessment resulted in no modification to the NEO3-09 trial design or endpoints or to any of the other previously agreed-to clinical or regulatory components of the Lymphoseek NDA. As such, NEO3-09 will now be one of two adequate and well-controlled trials included in the primary NDA submission for first-cycle review.
NEO3-09 is currently enrolling patients at eight study sites across the U.S. Neoprobe expects this study to be completed in the first quarter of 2011 and to submit the primary NDA for Lymphoseek soon thereafter.
David Bupp, Neoprobe's President and CEO, said, "Neoprobe has agreed to FDA's request to include safety and efficacy data for Lymphoseek from both clinical trials to ensure that the Agency has the requested information to conduct a complete first-cycle review of the NDA for Lymphoseek. We believe the earlier than originally planned inclusion of the NEO3-09 study data will support stronger product labeling as an outcome of a first-cycle review of the Lymphoseek NDA and may also positively impact market adoption. The clinical and regulatory team at Neoprobe is working diligently on this process and looks forward to a complete and expeditious review of Lymphoseek."
Dr. George Mills, consultant to the Company and former FDA Division Director of Medical Imaging and Hematology Products, said, "The request for the total data package from two clinical trials is consistent with FDA's ongoing initiative to push for more complete primary submissions and to limit major amendments made to NDAs. This ongoing initiative to shorten drug review cycle times was re-emphasized by FDA's Office of New Drug Development in late 2009 and enables more successful first-cycle reviews which ultimately shortens overall drug approval timelines. The request for the inclusion of both clinical trials in the primary NDA review should be viewed as a positive indicator for Lymphoseek's approval prospects in the first-cycle review by the Agency."
Neoprobe will hold a conference call Thursday, October 7th at 9:00 AM ET to review the FDA request and provide an update following the pre-NDA meeting. Mr. Bupp will be joined on the conference call by Dr. Frederick Cope, Senior Vice President, Pharmaceutical Research and Clinical Development. The conference call can be accessed as follows:
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