Cancer diagnostics company Neoprobe (NYSE Amex:NEOP) is continuing to enroll patients in a phase 3 head and neck cancer clinical trial of its radiopharmaceutical Lymphoseek.
The trial is aimed at expanding Lymphoseek’s label to cover procedures known as sentinel lymph node biopsies, CEO Mark Pykett said in a conference call with investors. The sentinel lymph node is the first lymph node to which cancer is likely to spread from the primary tumor, according to the National Cancer Institute.
Neoprobe on Wednesday announced that it had filed a New Drug Application for Lymphoseek, but that filing sought labeling for a different clinical indication: intraoperative lymphatic mapping, which is a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified to determine if cancer has spread to the lymph nodes. That procedure is typically used for patients with breast cancer or melanoma.
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Neoprobe’s head and neck cancer clinical trial is expected to enroll 200 patients. The study’s estimated completion date is March 2013, according to information the company has filed with the National Institutes of Health.
In addition to expanding Lymphoseek’s label, Neoprobe is looking to strike deals with potential European and Asian distribution, and sales and marketing partners for the drug. Cardinal Health (NYSE: CAH) is handling U.S. distribution and sales and marketing of Lymphoseek. Lymphoseek has not been approved for sales anywhere in the world, but could obtain approval in the U.S. by the middle of next year.
Here’s how Pykett laid out his expected time line around the Lymphoseek NDA filing: First, the filing will go through a 45- to 60-day period in which the U.S. Food and Drug Administration decides whether it will accept the submission for review. If the agency accepts the submission, it would kick off a review period of the Lymphoseek NDA filing that could stretch out about 10 months. So it’s probably fair to say that Lymphoseek could be on the U.S. market sometime around the middle of next year if all goes well with the FDA’s review.
