In the past, imatinib has shown promise for treating patients with pulmonary arterial hypertension (PAH). But specialty pharmaceutical company Tenax Therapeutics, Inc. (“Tenax”) believed that it could create a specialty, novel imatinib formulation to improve treatment for patients. According to a news release from October 6, the FDA accepted the company’s Investigational New Drug (IND) application for this new treatment formulation. Now, Tenax hopes to begin a comparative pharmacokinetic study – and potentially a Phase 3 clinical trial – by the end of this year or early 2022.
According to Tenax, Imatinib is:
a tyrosine kinase inhibitor of PDGF, c-KIT, and BCR-ABL which are growth factors that regulate endothelial and vascular smooth muscle cell proliferation in PAH. These growth factors are highly expressed in patients with PAH and contribute to disease progression.
Imatinib mesylate was first FDA-approved for PAH in March 2020. Now, the company has developed a novel, delayed-release formulation of the treatment. This new version is also orally administered. Researchers believe that the delayed-release imatinib offers a more durable therapeutic response and helps reduce exercise intolerance. Perhaps more importantly, Tenax views imatinib as potentially disease-modifying. Unlike other existing therapies, imatinib shows the potential of preventing disease progression.
Pulmonary Arterial Hypertension (PAH)
Most commonly caused by BMPR2 gene mutations, pulmonary arterial hypertension (PAH) is a chronic, progressive type of high blood pressure within the lungs. As blood pressure remains high, the pulmonary arteries may thicken or harden over time, causing thin or blocked arteries, a weakened heart muscle, and a body that receives less oxygen-risk blood. Outside of BMPR2 gene mutations, PAH may also result from drug use, lung or liver diseases, HIV, congenital heart disease, or a variety of autoimmune diseases. PAH is 2x more common in females than males. Symptoms, which usually manifest between ages 30-60, include:
- Chest pain
- Swelling of the lower extremities
- Fainting or dizziness
- Shortness of breath which worsens during exertion
- Heart palpitations
- Cyanosis (a bluish discoloration to the lips and fingers)