This year's prestigious event will begin soon. Global CardioVascular Clinical Trialists (CVCT) and will be followed by four days of discussions on the latest clinical trials in the field of CVD. The virtual event brings together the global expertise in cardiovascular disease (CVD), including researchers, industry players, CROs, prestigious research institutions, regulatory representatives, patient organizations and many others.
Cereno Scientific collaborates with COPD in CVD
The Swedish biotechnology company Cereno Scientific, which develops drugs for a broad spectrum of CVDs, is one of the participants at this year's CVCT Forum. The company is represented by CMO Bjorn Dahlof who will be giving the presentation “The Evolving Landscape Of Pulmonary Arterial Hypertension Phase 3 Trials Part 2- Redefining Clinically Meaningful Endpoints.” Dr. Dahlöf will discuss the topic from an industry perspective together with representatives from global life science companies. Merck and Abbott, where the latter is one of Cereno's partners. See the full CVCT program here.
Through the company's Scientific Advisory Board (SAB), it has close collaboration with some of the most important Key Opinion Leaders (KOLs) in the CVD field, several of whom are involved in the CVCT Forum. Two of these are the forum's founder and chairman, Dr. Faiez Zannad and Dr. Bertram Pitt.
»I have been part of the CVCT community for several years in my capacity as Principal Investigator of major mortality and morbidity studies in cardiovascular disease prevention. Now, being CMO of Cereno Scientific brings another interesting dimension to cardiovascular trials and I also have the privilege to present our innovative phase II trial to the community. The gain [from the CVCT Forum] for me and the company will be the interaction and networking with leading thought leaders from all aspects of cardiovascular trials, gaining further knowledge and inspiration, and putting our phase II trial in context of the evolving field of PAH therapy and trials.« — Dr Björn Dahlöf, CMO Cereno Scientific
Another COPD participant at the CVCT Forum, and who is also a member of Cerenos SAB, is Dr. Raymond BenzaDr. Benza is particularly prominent in pulmonary arterial hypertension (PAH), which also happens to be Cereno's focus indication for the lead drug candidate. CS1In fact, Cereno, after the company's application for drug testing (Investigational New Drug, (IND) approved av FDA, recently initiated a phase II clinical trial in PAH with CS1.
The study evaluates a new treatment method for PAH that is based on epigenetic modulation through HDAC (Histone DeACytlase) inhibition, and Cereno's study design includes a number of experimental outcome measures. The study will also – through the aforementioned collaboration with Abbott – use CardioMEMS HF System, a device for monitoring pulmonary artery pressure. The CardioMEMS HF system has already been shown to significantly reduce the need for hospitalizations due to heart failure, and the FIAS II study with CS1 will be the first time the device is used in a PAH clinical trial.
Dr. Benza has been a key advisor to Cerenos during the design of the clinical components of the upcoming Phase II study, and he will also be the study's principal investigator. Read more about Cerenos SAB including a profile of Dr. Benza here.
KOLs help position Cereno in the industry
Having a close relationship with KOLs such as Zannad, Pitt and Benza gives Cereno Scientific credibility in the CVD space. This is a key value driver for the company, especially as it enters a new phase of clinical development with CS1, while expanding its development program with additional candidates with potential in more CVD indications. Read more here.
Experts share their insights
BioStock wanted to learn more about the importance of Cereno participating in the CVCT Forum and having such close collaboration with leading CVD KOLs, especially in view of the company's continued growth, both within the team and within its clinical development program. We therefore contacted the company's CMO, Dr. Björn Dahlöf, and CVCT Chairman and Co-Founder Dr. Zannad.
»The key purpose of the Global CVCT Forum is to bring together expert stakeholders from various backgrounds to discuss key recent and future clinical trials within cardiovascular, cardiorenal and cardiometabolic diseases in depth, both individually and in context. CVCT is the only global meeting that brings together the most authoritative stakeholders to discuss clinical trials in detail and I am very much looking forward to this year's edition. You can almost say that the CVCT Forum a gathering of "Who is Who" within cardiovascular diseases.« — Dr. Faiez Zannad, Member of Cereno Scientific's scientific council and co-chairman of the CVCT Forum
Dr. Dahlöf, Cereno is once again attending the CVCT Forum where CVD clinical trials come front and center. What will the company gain the most from attending this year?
- I have been part of the CVCT community for several years in my capacity as Principal Investigator of major mortality and morbidity studies in cardiovascular disease prevention. Now, being CMO of Cereno Scientific brings another interesting dimension to cardiovascular trials and I also have the privilege to present our innovative phase II trial to the community. The gain for me and the company will be the interaction and networking with leading thought leaders from all aspects of cardiovascular trials, gaining further knowledge and inspiration, and putting our phase II trial in the context of the evolving field of PAH therapy and trials.
You will be contributing at CVCT with a presentation alongside representatives from Merck and Abbott. What will this presentation focus on?
- My presentation will focus on the innovative and cost-effective design of our phase II trial in PAH, which is of utmost importance for future development of CS1 with Cereno being a small biotech company. Firstly, I will introduce the key features of the CS1 PAH program with a focus on the potential of epigenetic modulation in PAH, the smart formulation of CS1 and the unique combination of CS1's four efficacy pillars which are anti-proliferation/anti-fibrosis, anti-inflammation, pulmonary pressure reduction and anti-thrombosis. Secondly, I will highlight other key elements of the trial including remote monitoring of pulmonary pressure by the CardioMEMS technique in collaboration with Abbott and the long list of secondary exploratory objectives. In combination, we hope to have all we need for the next clinical trial, including safety and tolerability which is the primary objective of the phase II trial, the right dose(s), exploratory efficacy, and pharmacokinetics.
The company is currently searching for a Head of Clinical Development and a Head of Research and Preclinical Development. What are the overall implications of these additions?
- Yes, we have recently experienced rapid growth with an expanded pipeline and the initiation of our first phase II program. To support this, as well as the future growth of the company, we are continuously assessing the need to build out our organization. We have already strengthened our team with key roles within clinical trial execution and are currently looking for additional experts to lead our clinical research as well as preclinical development work. The new additions will enable us to successfully deliver on the ongoing development programs as they continue to progress, together with our collaboration partners.
Dr Zannad, as chair of CVCT, what is the main goal of the Forum?
- The key purpose of the Global CVCT Forum is to bring together expert stakeholders from various backgrounds to discuss key recent and future clinical trials within cardiovascular, cardiorenal and cardiometabolic diseases in depth, both individually and in context. CVCT is the only global meeting that brings together the most authoritative stakeholders to discuss clinical trials in detail and I am very much looking forward to this year's edition. You can almost say that the CVCT Forum is a gathering of "Who is Who" within CV.
And as a member of Cereno's SAB, how do you hope this year's Forum will contribute to the company's clinical development?
- I hope that Cereno will be able to both connect with, and take inspiration from, all the other stakeholders present at the CVCT and gain an expanded view on the different elements of clinical development. I am also looking forward to Cereno's contributions to the sessions focused on the evolving landscape of PAH trials. I think it will be interesting for the community to learn more about the innovative elements of their phase II trial.
Finally, what are your expectations for Cereno's phase II trial within PAH?
- It has been a pleasure to follow Cereno's journey so far, and I am impressed with the progress made by the team up to this point. CS1 is showing promising characteristics that fit very well with the pathogenesis of PAH, so I am excited to see the clinical evidence as it unfolds.