The FDA Approves the Investigational Drug EBTATE for Neuroendocrine Tumors

Molecular Targeting Technologies (MTTI), a radiopharmaceutical company, announced through Biospace that the FDA has given its approval for MTTI to move forward with a Phase 1 clinical trial to study the dosimetry and safety of EBTATE its proprietary product. Dosimetry is the measurement of the amount of radiation absorbed by a substance. It is measured by a device called a dosimeter.

EBTATE is used for targeted radionuclide therapy, a form of precision medicine. The treatment sends therapeutic amounts of radiation directly to malignant tumors. This process takes place by the administration of a radiolabeled molecule that seeks out specific cells. It sends radiation directly to malignant lesions such as bone metastases to cure or control cancer.

The therapy is an improvement over standard chemotherapy that is usually nonselective and damages rapidly dividing nontumor cells.

Evans Blue

A major factor of this technology is Evans Blue biological dye. It is a diagnostic agent used to estimate blood volume and detect lymph nodes.

Evans Blue binds to serum albumin and expands the time it takes to eliminate half of the radioactive substance it had absorbed. The end result is an improvement in the therapeutic outcome.

Following its FDA approval, the company has begun finalizing plans to conduct an open-label trial and dose-escalation study for patients who have neuroendocrine tumors (NET).

NET cancers start out as rare specialized cells that are called neuroendocrine cells. These cells are similar to cells that produce hormones. They also have traits much like those in nerve cells. Neuroendocrine cells may appear in any part of the body.

Molecular Targeting Technologies, a biotech company, focuses on rare cancers. The company develops targeted diagnostics and radiotherapeutics. MTTI holds a worldwide license to commercialize targeted radiopharmaceuticals.  MTTI plans to conduct a variety of clinical trials in 2021.