Bellerophon Adds New Cardiopulmonary Indications for INOpulse System in New Licensing Agreement

Clinical stage biotherapeutics company Bellerophon Therapeutics recently took steps to expand its licensing agreement with INO Therapeutics LLC, a subsidiary of Mallinckrodt plc, which allows Bellerophon to advance INOpulse as a treatment for three other cardiopulmonary diseases: chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary hypertension associated with sarcoidosis and pulmonary hypertension associated with pulmonary edema from high altitude sickness.

The original scope of the license had only covered INOpulse’s indication for pulmonary arterial hypertension (PAH), pulmonary hypertension associated with COPD (PH-COPD) and pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF). The new, expanded agreement stipulates a 5 percent royalty on net sales for the added indications.

Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, said, “We are pleased to expand our agreement with INO Therapeutics. While nitric oxide is currently approved for use in the hospital setting to treat pulmonary hypertension in neonates, we believe that INOpulse, our portable nitric oxide delivery system, is well suited for use in a wide range of additional chronic conditions. This expanded license gives us the ability to broaden our targeted population of patients suffering from pulmonary hypertension. The three new indications will complement our ongoing clinical activities of INOpulse in PAH, which is entering Phase 3 with patient recruitment expected to start later this year, and in PH-COPD, which has completed a Phase 2a trial.”

INOpulse is a portable system that combines both a drug and delivery device, and helps address pulmonary hypertension. It works by delivering pulsed doses of nitric oxide, a vasodilator. The novel device is programmed to adjust drug dosage according to detected breathing patterns. It weighs only about 2.5 pounds and features a user-friendly interface, and 24-hour battery life.

In an earlier report on pulmonary hypertension, a team of Canadian researchers have published promising results of the first clinical trial in the world of a genetically enhanced stem cell therapy for pulmonary arterial hypertension (PAH). The study is entitled “Endothelial NO-Synthase Gene-Enhanced Progenitor Cell Therapy for Pulmonary Arterial Hypertension: the PHACeT Trial”.

Seven participant patients underwent a blood cell selection process (apheresis) to harvest a certain population of their white blood cells. These cells were grown in the laboratory under special conditions to select for stem-like cells called endothelial progenitor cells (EPCs) genetically engineered to produce greater amounts of nitric oxide, a natural substance that widens blood vessels and is essential for efficient vascular repair and regeneration. The genetically enhanced cells were then injected directly into the lung circulation of the same patient.

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