By Mary Welch
Phase III data released today on NeoTect, a scintigraphic imaging product for suspected malignant lung tumors developed by Diatide Inc., revealed that the test could identify a lung cancer nodule in nearly 97 percent of cases.
"Even although we already have an approvable letter from the FDA, we never disclosed any data to the public or scientific community about the pivotal trial," said Richard Dean, the company's president and CEO. "It shows that using peptides to target diseases is a valid technology."
NeoTect is a small synthetic peptide combined with technetium-99m. When injected into the patient, the peptide attaches itself to the somatostatin receptor on the tumor. After a two-hour wait, the patient is scanned with a gamma camera, which can pick up the gamma signal emitted by the technetium.
The multi-center pivotal trial involved 260 patients. One subset of 114 people had suspected solitary pulmonary nodules (SPNs); those in the other group had several tumors or a metastasis.
The trial showed that NeoTect identified a malignant tumor in 96.6 percent of all cases in the SPN group and had a specificity of 73 percent. The specificity means that of all the spots lighted up, 73 percent were cancer tumors. The others pointed to infections or other problems.
"It shows that in almost 97 percent of all cases, NeoTect identified a cancer tumor," Dean said. "When you're screening for cancer, you don't want to miss."
In the non-SPN group, statistically significant results were found, although the Londonderry, N.H., company still hasn't released the data.
Both subset results were compared to the accuracy rates of the standard treatments such as biopsy.
"They were comparable," Dean said, "but NeoTect is a noninvasive technology, which is a terrific advantage. In 15 percent of all lung biopsies, a lung is punctured, which is another complication as well as costly. Another alternative is to do open-chest surgery and take the nodule out and see [if it's malignant]."
In fact, Diatide did a study of the 114 patients with SPNs, conducted at the UCLA School of Medicine, comparing the costs of the four accepted diagnostic approaches. Life expectancies of the patients were calculated using an established model. The study found that using NeoTect could save from $68 to $1,800 per year of life per patient. The study disclosed that up to $50.4 million potentially could be saved annually when compared with CT-based detection approaches.
The FDA granted Diatide an approvable letter in December, with the final word expected by Aug. 8. The test could be available to hospitals and diagnostic clinics by September. Upon approval, the company would receive a milestone from its marketing partner, Nycomed Amersham plc, of London. The company estimated annual sales could reach $50 million per year. (See BioWorld Today, Dec. 18, 1998, p. 1.)
The data were expected to be presented today at the annual meeting of the Society of Nuclear Medicine in Los Angeles.
Diatide's stock (NASDAQ:DITI) closed unchanged Friday at $3.625.