In a press release from early March 2021, radiopharmaceutical therapy company Molecular Targeting Technologies, Inc. (“MTTI”) shared that the FDA approved its Investigational New Drug (IND) application for EBTATE. The therapy is designed to treat patients with neuroendocrine tumors (NETs). Following this approval, MTTI is now able to begin a Phase 1 clinical trial to evaluate the safety, efficacy, tolerability, and dosimetry of the treatment.
EBTATE
MTTI uses a proprietary Evans blue (EB) technology platform to create specialized and targeted radiopharmaceutical products. The company licensed EBTATE from the National Institutes of Health (NIH). Altogether, the EB platform targets patients whose cancer over expresses somatostatin receptor type 2 (SSTR2). According to MTTI:
~80% of NETs overexpress somatostatin receptors. EBTATE was designed to extend in vivo half-life over Lutathera, increasing probability of binding to those receptors, enabling fewer, lower doses of the radiotherapeutic.
Thus far, preclinical studies have shown EBTATE to reduce tumor metastasis with negligible toxicity. Now, the IND approval will allow MTTI to continue performing research and potentially bring a new and beneficial therapy to market.
Neuroendocrine Tumors (NETs)
According to the Neuroendocrine Tumor Research Foundation (NETRF):
A neuroendocrine tumor (NET) is an uncommon cancer type that forms in neuroendocrine cells (Neuroendocrine Tumors may also be called islet cell tumors, carcinoid cancer, or carcinoid tumors). NETs can occur almost anywhere in the body, but neuroendocrine tumors most commonly form in the gastrointestinal tract, lung, and pancreas.
These tumors form in neuroendocrine cells, which receive messages from the nervous system and release certain hormones in response. These cells, and the resulting affect on the nervous and endocrine systems, play a role in blood sugar management, breathing, and heart rate, among others. However, neuroendocrine tumors can disrupt this. In some cases, NETs are considered non-functional, which means they do not release additional hormones. But functional NETs do release hormones and peptides, like gastrin or somatostatin receptors, which can cause health issues and a variety of symptoms.
Symptoms vary based on where the tumors are located and which part of the body is affected. For example, patients whose tumors appear in the gastrointestinal tract may experience symptoms such as:
- Jaundice (yellowing of the skin and eyes)
- Heartburn
- Unintended weight loss
- Extreme fatigue
- Bloody or off-color stool
- Nausea and vomiting
- Constipation or diarrhea
- Abdominal pain and cramping
Alternately, those whose neuroendocrine tumors are located in the pancreas may experience:
- Abdominal and back pain
- Indigestion
- Jaundice
- Diarrhea
- Abdominal lumps
- Unintended weight loss
- Blood clots
- High or low blood sugar
- Rapid heartbeat
- Stomach ulcers
- Rashes
- Dehydration
