Neoprobe to file for FDA approval of Lymphoseek this summer

Neoprobe Corp. is looking to file for regulatory approval of its cancer-detection drug Lymphoseek this summer.

The company seems optimistic about Lymphoseek’s prospects after the “positive outcome” of a meeting with the U.S. Food and Drug Administration, Chief Executive David Bupp said in a statement announcing the company’s first-quarter financial results.

Receiving FDA approval for the drug, which could come several months after the company files its New Drug Application, would be a big deal for Neoprobe (OTCBB: NEOP). The company has yet to deliver any drugs to the market.

In phase 3 clinical trials last year, Lymphoseek posted a 97 percent success rate in identifying cancerous lymph nodes in patients with breast cancer or melanoma, the company said. The company has said 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.

For the first quarter, Neoprobe’s revenues were flat at $2.7 million compared to the prior year. Neoprobe generates its sales fromits GDS line of gamma detection devices used by cancer surgeons.

However, the company swung to a net loss of $2.6 million from a profit of $814,000 in last year’s first quarter. The company attributed the loss to an increase in expenses such aschemistry, manufacturing and development expenses associated with preparing to file the New Drug Application with the FDA.