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(Drug information on somatostatin) receptor that is present in several types of cancer, while the technetium-99m emits a gamma ray detectable by widely available gamma camera systems.
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.