On October 31, 2018, ATOX signed joint research agreements with Hokkaido University and Sumitomo Heavy Industries, Ltd. aimed at regulatory approval of 68Ga-PSMA, a drug with the potential to deliver more effective diagnosis and treatment of prostate cancer.
Prostate cancer is known to be one of the most common cancers in Japan. Tests for prostate-specific antigens (PSAs), which are blood tumor markers, are used as a screening method for prostate cancer, but it is difficult to evaluate the spread of foci and to judge whether or not there is metastasis. To assess the spread of the primary lesion and determine the presence/absence of distant metastasis, CT, MRI, bone scans, and other techniques are used, but since none of them offers sufficient precision or accuracy, a more accurate diagnostic method has been desired. Furthermore, needle biopsy, the standard method used for definitive diagnosis, is accompanied by risks of post-test complications such as fever and inflammation.
In recent years, most of the R&D on 68Ga-PSMA PET has been done in Europe and the U.S. with a focus on developing a diagnostic imaging technique superior to other available prostate cancer detection methods. A number of clinical studies aimed at reducing the burden of testing by accurately determining the spread of the primary lesion have already been conducted. According to reports, such techniques can be useful in enabling precise treatment intervention through appropriate cancer staging, and they also show promise for improving the prognosis and QOL of patients.
Now that ATOX has acquired the exclusive Japanese sales rights for IRE ELiT’s 68Ge/68Ga generator "Galli Eo®," it will be handling quality testing of the product. For the purpose of realizing more effective prostate cancer diagnosis and treatment, ATOX will also help with preclinical research aimed at the adoption of 68Ga-PSMA PET diagnosis, physician-led clinical trials, and approval of 68Ga-PSMA synthesis devices using a 68Ge/68Ga generator.
*1: About 68Ga-PSMA
68Ga-PSMA is a radioactive label compound that binds to a prostate-specific membrane antigen (PSMA). Prostate cancer tissue is known to have a large number of PSMAs, so the administration of 68Ga-PSMA has the potential to non-invasively detect prostate cancer tissue and to verify the presence or absence of metastasis.
*2: PET diagnosis
This is a diagnostic imaging technique that works by injecting a diagnostic agent that emits positrons into the body. As the agent moves through the body, a “PET camera” from outside the body is used to capture images of diseases or internal organs. Selecting an appropriate diagnostic agent according to the purpose of the test makes it possible to diagnose brain or heart disease, cancer, and other disorders.
*3: 68Ge/68Ga generator
This is a compact device capable of producing 68Ga without the need to use a nuclear reactor or accelerator, thereby enabling simpler PET diagnosis.