A phase 3 clinical trial showed Neoprobe‘s (NYSE Amex:NEOP) radiopharmaceutical Lymphoseek to be superior to the current standard of care in identifying cancerous lymph nodes in patients with breast cancer or melanoma.
With the positive results of the trial in hand, Neoprobe CEO Mark Pykett reiterated the Dublin, Ohio’s company’s plans to file for regulatory approval of the drug in the third quarter, according to a statement from Neoprobe.
The news sent Neoprobe’s shares soaring, up 16 percent to $5.25 in early after-hours trading before dropping to $4.81 shortly thereafter.
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Neoprobe said the 150-patient study met all primary and secondary endpoints, and showed Lymphoseek to perform better than the current standard of care, vital blue dye, in identifying lymph nodes, a process known as intraoperative lymphatic mapping.
Lymphoseek showed no “clinically adverse events” in the trial, according to the statement.
“In clinical studies, Lymphoseek has been shown to be a safe and effective tool for superior detection of lymph nodes and offers an enhanced ability to accurately identify nodes with a high potential of tumor metastases,” Pykett said.
The company estimates Lymphoseek’s market value at (pdf) $450 million.