1095 is a novel small molecule drug candidate being developed by Progenics Pharmaceuticals to specifically target prostate cancer cells. The compound is labeled with iodine-131, a radioactive form of iodine that emits radiation energy in the form of beta particles.
How 1095 works
It is designed to bind to a protein called prostate-specific membrane antigen, or PSMA, found on the surface of more than 95 percent of prostate cancer cells. When the compound is internalized by the cancer cells, iodine-131 delivers a dose of beta radiation directly to the tumor cells, killing them with minimal radiation to surrounding healthy tissues.
1095 in clinical trials
Preclinical studies have shown that is ably taken up by prostate cancer cells, and delivered lethal doses of radiation doses to those cells. Evidence of 1095 was recorded in the kidneys, suggesting a low level of radiation to healthy tissues.
In mouse models of prostate cancer, 1095 given in single or multiple dose schedules significantly reduced tumor burden for an extended period of time, improving the animals’ survival rates. No significant signs of toxicity were recorded.
It was also tested in a small study in 34 men with metastatic castration-resistant prostate cancer (mCRPC). Results showed that a first dose significantly reduced the tumor burden in most patients with minimal side effects. However, second and third doses of 1095 were less effective, and caused more frequent and more intense side effects, particularly anemia and dry mouth.
An open-label, dose-ascending Phase 1 trial (NCT03030885) is currently recruiting mCRPC patients at Memorial Sloan-Kettering Cancer Center (MSKCC) to evaluate the safety and tolerability of possibly five doses of 1095.
Progenics filed an investigational new drug application with the U.S. Food and Drug Administration (FDA) for 1095 in collaboration with Memorial Sloan-Kettering Cancer Center.
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