DUBLIN, Ohio — Neoprobe Corp. has completed a Phase 3 clinical trial of its cancer-detection drug “with positive results” and plans next year to seek regulatory approval to sell the drug.
In the trial, the company’s Lymphoseek drug posted a 97 percent success rate in identifying cancerous lymph nodes in patients with breast cancer or melanoma, according to a statement from the company. The study’s goal was a 94 percent success rate.
Lymph nodes are small glands found throughout the body that act as part of the immune system and trap foreign bodies such as cancer cells. By correctly identifying cancerous lymph nodes, the drug decreases the number of lymph nodes doctors must remove and cuts down on drug side effects.
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“The filing of the end-of-Phase 3 report is an important milestone in the development process for Lymphoseek”, said David Bupp, Neoprobe’s chief executive.
Neoprobe has submitted an end-of-Phase 3 meeting request to the U.S. Food and Drug Administration to discuss the results of the clinical trial. That’s the company’s next step in seeking regulatory approval to sell Lymphoseek. Neoprobe expects to file an application for FDA approval next year, according to the statement.
Last month, Bupp told analysts that within two years of Lymphoseek’s release it would have more than half the market share — thanks to its agreement with Cardinal Health to distribute the drug once it’s ready.
When it released third-quarter financial results last month, Neoprobe said it would try to divest itself of Cardiosonix, a seven-year-old blood-flow device venture that has largely produced a trickle of losses. The company hopes to land an Israeli suitor for Cardiosonix, Chief Financial Officer Brent Larson said.
