Reiterating earlier reports from when the Dublin, Ohio-based company released top-line data on the trial, Neoprobe said in a statement that the study met all primary and secondary endpoints, and exhibited superior performance to the current standard of care for intraoperative lymphatic mapping.
Lymphoseek is used by surgeons to identify lymph nodes in patients with breast cancer or melanoma, and indicate whether cancer has spread to a particular lymph node. The company is expected to file a New Drug Application (NDA) for U.S. Food and Drug Administration approval of Lymphoseek in the coming months.
“Lymphoseek compared very favorably to the standard of care, vital blue dye, was well tolerated without side effects, and as noted by prior studies, continued to show superior performance characteristics,” said Dr. Anne Wallace, who presented the full data at the American Society of Clinical Oncology meeting in Chicago.
Neoprobe has received some criticism regarding the design of its Lymphoseek clinical studies. Last month, in a call to discuss the company’s first-quarter earnings, CEO Mark Pykett used most of his prepared remarks to defend the study from criticism by Adam Feuerstein, a columnist with TheStreet.com. “Did the company make some crucial mistakes that call into question the legitimacy of Lymphoseek?” Feuerstein wrote.
Then, last week, a blog post on Seeking Alpha by a hedge fund manager generated some online buzz around Neoprobe. The author, Martin Shkreli, argued that nearly all of Neoproble’s value is wrapped up in Lymphoseek, which he blasted as “close to worthless” and makes Neoprobe’s shares way overpriced.
Shkreli’s argument rested on concerns about the drug’s potential market size and pricing. He also predicted that Lymphoseek won’t obtain approval from the FDA and called the design of the clinical trials to test the radiopharmaceutical “bizarre.”
As long as the FDA doesn’t find fault with the study, Neoprobe executives won’t care what critics like Feuerstein and Shkreli say. An FDA decision on Neoprobe’s Lymphoseek application would likely come early next year, assuming the company files its NDA in this year’s third quarter, as it has predicted.