A pharmaceutical now being considered for
approval by the FDA for the diagnosis of certain lung tumors may also
aid in the detection of primary and metastatic breast cancer tumors,
according to a preliminary clinical study presented at the annual
western regional meeting of The Society of Nuclear Medicine. The
study found that the drug, NeoTect (formerly known as P829), under
development by Diatide, Inc., was equivalent or superior to Miraluma,
an agent approved for use in the radiologic detection of primary and
metastatic breast cancer.
The data were presented by Hirsch Handmaker, MD, president of the
Healthcare Technology Group and a scientific advisor to the
Womens Cancer Prevention Research Initiative of the Arizona
Cancer Center in Phoenix. Dr. Handmaker is a scientific advisor to
Diatide and a member of the companys board of directors.
There is substantial need to develop new techniques that will
help clinicians to better identify malignant breast cancer tumors
before they widely metastasize, and to evaluate treatment
efficacy, said Dr. Handmaker. NeoTect is currently undergoing
priority review by the FDA for imaging malignant tumors in the lung.
The drug is based on a novel technology that combines a
small-molecule synthetic peptide with technetium-99m, a widely used
radioisotope. The peptide is designed to adhere to the somatostatin
receptor that is present in several types of cancer, while the
technetium-99m emits a gamma ray detectable by widely available gamma
Results of the Breast Cancer Study
The study involved 16 women whose mammograms or histologic studies
required additional evaluation for primary and metastatic breast
cancer. In 18 studies, the patients were imaged on separate occasions
with Miraluma and NeoTect. Comparisons of the images were obtained
following each evaluation with mammography, computed tomography, and
surgical pathology data, when available.
According to Dr. Handmakers report, evaluations determined that
NeoTect identified the primary and metastatic tumors that had been
detected with Miraluma, for an overall accuracy of 88.9%. Two
patients whose tumors yielded only faintly positive Miraluma images
had intense uptake of NeoTect. Use of both agents yielded
only one false-negative result in the series.
The receptors specifically targeted by NeoTect are known to he
concentrated in malignant tumors and may also be found in the
proliferating blood vessels that surround these tumors, said
Dr. Handmaker. These results support further clinical
evaluation of NeoTect as a possible noninvasive biological marker for
primary and metastatic breast cancer tumors, an application which may
have significant implications for improved therapy at both early and
late stages of the disease.