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Neoprobe defends design of latest Lymphoseek clinical trial

Cancer diagnostics company Neoprobe (NYSE Amex:NEOP) shot back at critics of the company’s latest phase 3 clinical trial of its radiopharmaceutical Lymphoseek. “It’s clear this was the right study done the right way,” CEO Mark Pykett said during a conference call with investors and analysts to discuss the company’s first-quarter financial results. Pykett spent the […]

Cancer diagnostics company Neoprobe (NYSE Amex:NEOP) shot back at critics of the company’s latest phase 3 clinical trial of its radiopharmaceutical Lymphoseek.

“It’s clear this was the right study done the right way,” CEO Mark Pykett said during a conference call with investors and analysts to discuss the company’s first-quarter financial results.

Pykett spent the majority of his introductory prepared remarks detailing the rationale behind the design of the latest clinical trial of Lymphoseek, which is used to identify cancerous lymph nodes in patients with breast cancer or melanoma.

TheStreet.com columnist Adam Feuerstein last week raised what he viewed as several concerns about the study’s design. “Did the company make some crucial mistakes that call into question the legitimacy of Lymphoseek?” he asked.

Among those concerns were that the study compared Lymphoseek to a substance known as vital blue dye, the only U.S. Food and Drug Administration-approved agent for intraoperative lymphatic mapping (ILM). However, many doctors also use off-label generics for the procedure, so Feuerstein questioned whether the study should’ve included comparisons to the off-label drugs as well.

Pykett said such a study wouldn’t have carried much weight with the FDA since it never approved the generics in question for ILM in the first place.

Neoprobe said last week that the 150-patient clinical study met all primary and secondary endpoints, and showed Lymphoseek to perform better than vital blue dye in identifying lymph nodes. The study also showed vital blue dye was associated with more “false negatives” than Lymphoseek, meaning Lymphoseek also performed more accurately in detecting cancerous lymph nodes.

The company expects to file for FDA approval of Lymphoseek next quarter and hopes to begin commercializing the drug in the second half of 2012.

Regardless of arguments over whether the study was designed properly, the company and Feuerstein agree on one thing: the importance to Neoprobe of an American Society of Clinical Oncology (ASCO) meeting next month in which it’s scheduled to present full data from the clinical trial to doctors.

“The ASCO meeting will be a very important, early test for Neoprobe,” Feuerstein wrote. “Obviously, Neoprobe hopes oncologists who review the data there react favorably and endorse the company’s claims about Lymphoseek’s superiority.”

In Neoprobe’s first quarter, its loss widened to $4.4 million, or 5 cents per share, from $2.5 million, or 3 cents per share, in the year-ago quarter. The greater loss was attributed in part to costs associated with the separation agreement with former CEO David Bupp, who announced in March he’d step aside and let Pykett take on Neoprobe’s top spot.