Since the company received orphan drug designation (ODD) from the FDA for its lead program CS1 in the rare cardiovascular disease pulmonary arterial hypertension (PAH) in March last year, Cereno Scientific paved the way for the next step in clinical development: a Phase II clinical trial in the indication expected to start in September following FDA approval of the company's Investigational new drug-application.
Read more about the regulatory benefits of ODD for Cereno Scientific here.
Partnership is the key to Phase II
One of the most important steps towards Phase II came earlier this year when Cereno Scientific began collaborating with the global CRO Worldwide Clinical Trials. Since then, the CRO has provided support and guidance in the final preparations for the Phase II study and will also conduct the clinical study. Worldwide is a recognized international CRO with more than 2 employees around the world with experience in successfully conducting clinical studies in a wide range of indication areas, including cardiovascular diseases such as PAH.
New collaboration with Abbott
Last week, Cereno Scientific announced that it had entered into a collaboration with another global company, AbbottThrough the agreement, the well-known pharmaceutical company will provide its CardioMEMS HF System to Cereno in the upcoming Phase II study. The CardioMEMS HF System is a system that monitors blood pressure in the pulmonary arteries and helps healthcare professionals proactively manage and treat heart failure, which is one of the consequences of PAH. At the same time, Abbott will have the opportunity to test its system in a new disease indication with the Phase II study.
By being able to monitor patients' pulmonary artery pressure during the study, Cereno will be able to use a smaller patient population, which means that the company will be able to reduce both time and costs for the phase II study.
Cereno CEO Sten R Sorensen expressed their satisfaction with the new collaboration in a press release:
»We are driven by innovation in cardiovascular disease treatments and are very pleased to now also be able to use a groundbreaking medical monitoring device like Abbott's. With their innovative CardioMEMS technology, we can continuously measure the pulmonary pressure of study participants, which will help us define the optimal dose range for the following clinical studies.«
Although Philip Adamson, MD, Chief Medical Officer of Abbott's Heart Failure business, commented in the press release on the collaboration and the opportunity to gather clinical evidence for the CardioMEMS System in a new indication:
»Patients with primary pulmonary hypertension –WHO group 1– are particularly difficult to manage medically, especially without information on pulmonary pressure. The collaboration with Cereno is very exciting with hopes of clarifying and improving treatment outcomes in PAH. By using CardioMEMS, this clinical study provides a unique opportunity to investigate the potential benefits of pulmonary pressure monitoring and possibly improve the medical care of this patient group.«
The study is led by a global opinion leader
The aim of the study is to demonstrate the safety, tolerability and efficacy of CS1 in patients with PAH. Cereno expects to be able to determine the dosage for subsequent studies using the CardioMEMS HF system, which has already been shown, when used by physicians, to significantly reduce the risk of hospitalizations for patients with myocardial infarction and improve the quality of life for patients living with NYHA (New York Heart Association) class III heart failure.
Cereno's CMO Björn Dahlöf expressed the benefits of what Abbott's CardioMEMS HF system will bring to the study:
»CardioMEMS provides a unique way of monitoring the PAH patient's condition through remote monitoring of pulmonary pressure, being the dominating disease manifestation. Furthermore, the access to the multitude of pulmonary pressure measurements in each individual gives the opportunity to determine dose and exploratory efficacy in a relatively small patient population.«
Dr Raymond Benza, who is an internationally recognized expert in cardiovascular diseases, with PAH as a primary clinical interest, and who is part of Cereno's scientific council, will be the principal investigator for the phase II clinical trial. The trial will be conducted at approximately six different US clinics and will include 30 patients. He comments on the collaboration to BioStock:
»Utilizing an innovative monitoring device as the CardioMEMS provides a secure way of receiving information about pulmonary pressure on a continuous basis from the patients in the study. I am, therefore, excited about the collaboration with Abbott and believe that CardioMEMS has great potential in improving the treatment management for PAH patients together with CS1 in the future. Having Abbott as a partner for the study also adds a layer of credibility to the study among participating physicians and clinical sites.«
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