At the American College of Cardiology (ACC) meeting in Chicago this month, a researcher from the Montreal Heart Institute (MHI) in Canada presented the results of a Phase 2 clinical trial showing the safety of the PulmoBind biomarker and the ability of PulmoBind tomography scan to detect abnormal results in patients with pulmonary hypertension (PH).
The project, led by Dr. Jocelyn Dupuis, led to the development of the first safe, sensitive, and non-invasive molecular imaging agent designed for early diagnosis and monitoring of PH. PulmoBind is a peptide derived from human adrenomedullin, which is radio-labelled with metastable isotope 99 of technetium (99mTc, the most commonly used imaging isotope in clinical nuclear medicine).
The aim of the Phase 2 trial was the assessment of the safety and efficacy of PulmoBind in detecting pulmonary circulation anomalies associated with PH. Preliminary animal studies have shown that PulmoBind allows a rapid quantification of lung blood vessels through a standard nuclear medicine camera, and suggested that it could be employed as a marker of lung vascular disease.
At the ACC presentation, Dupuis demonstrated that PulmoBind could substitute for tests currently used in clinical trials to determine an early diagnosis and monitor treatment efficacy.
“This breakthrough brings great hope to patients with pulmonary hypertension because of the life-changing impact of benefiting from earlier treatment,” said Dupuis, the principal investigator, in a news release.
PulmoBind was jointly developed by Dr. François Harel from the MHI’s Nuclear Medicine Department and Alain Fournier, Ph.D., from the INRS–Institut Armand-Frappier.
“There is currently no equivalent to PulmoBind capable of performing a functional imaging of pulmonary circulation. We take pride in this product for which we carried out all stages of development, from the basic research to its human application. We were able to achieve this using the state-of-the-art equipment at the MHI’s Nuclear Medicine Department,” said Harel, a nuclear cardiology specialist.
“This discovery and the development of PulmoBind by Dr. Jocelyn Dupuis and Dr. Francois Harel could truly change the lives of patients with pulmonary hypertension by improving early diagnosis and personalized monitoring,” said Dr. Jean-Claude Tardif, director of the MHI Research Centre. “Once again, the Montreal Heart Institute has demonstrated its leadership position in cardiovascular precision medicine with this remarkable advancement.”
CQDM, a research consortium that financed the study, is satisfied with the results generated by the research project so far. “We are extremely proud to have supported this project from the very beginning,” said Diane Gosselin, CEO of CQDM. “We also salute the contribution of mentor Michael Klimas from Merck in the development of a positron emission tomography (PET) imaging version of PulmoBind. Results are very impressive and point to a bright future.”
Dupuis added, “I wish to express my gratitude to CQDM for believing in our project’s potential from the outset. Its clinical progress would not have been possible without their substantial financing of $2.8 million.”
The results obtained with PulmoBind will pave the way to a three-year Phase 3 trial with a total of 350 patients across 10 centers in North America.
Pulmonary hypertension, or elevation of the pressure in the pulmonary vessels, is caused by various clinical conditions. It may be idiopathic (of unknown origins) or associated with numerous diseases, including cardiovascular and lung disorders. Affected individuals suffer from progressive shortness of breath and, in its most severe forms, PH leads to a worse prognosis than many types of cancer.
There is no test currently available that can easily and non-invasively detect abnormalities of the pulmonary circulation. No cure currently exists for pulmonary hypertension, and substantial research efforts are dedicated to the development of new drugs to stop its progression or, better yet, reverse the disease pathology.
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