After receiving orphan drug designation from FDA - for CS1 for the treatment of pulmonary arterial hypertension (PAH) last spring, opened up new opportunities for Cereno Scientifics clinical strategy.
Since then, the company has focused on the rare disease with the ambition to conduct the best possible scientific and clinical preparations for the upcoming Phase II study of their epigenetic modulator in patients with PAH. The study will be conducted in the USA.
CRO has been hired for the phase II study
Proof of the company's commitment and determination to take the next step came last week, when Cereno Scientific announced that it had signed a letter of intent with Worldwide Clinical Trials. Worldwide is a recognized international contract research organization (CRO) with more than 2000 employees worldwide who have conducted successful studies in a number of therapeutic areas.
Through the collaboration, Worldwide will provide support and guidance for the final preparations for the Phase II study and will also conduct the study, which is expected to begin around mid-2021. In the meantime, Cereno Scientific has initiated the application process for an Investigational New Drug (IND) study following a successful pre-IND meeting with the FDA.
Dr. Benza elected to the Scientific Council
This week, Cereno Scientific took another step to strengthen its scientific and clinical capabilities when Scientific Advisor Dr. Raymond L. Benza has now joined the company's scientific board. Dr. Benza is an internationally recognized expert in cardiovascular disease (CVD) with PAH as one of his primary clinical interests. His current roles and past experience confirm his leadership position in the field.
He is Professor of Medicine at the Ohio State University Wexner Medical Center in Columbus, USA and Deputy Professor vid School of Biomedical Engineering vid Carnegie Mellon University in Pittsburgh, USA. He also holds Bob and Corinne Frick Endowed Chair in heart failure at the Ohio State University Wexner Medical Center where he also serves as Director of the Division for Cardiovascular Diseases.
Dr. Benza is also a member of AAmerican College of Physicians, American Heart Association Council on Clinical Cardiology, American College of Chest Physicians and American College of CardiologyHe represents American Board of Internal Medicine with certification in cardiovascular diseases, severe heart failure and transplantation.
Dr. Benza recently commented on the potential of CS1 in a press release:
»Cereno Scientific's CS1 has tremendous potential to be a game-changer for patients with PAH. I am pleased to have advised the company during 2020 and now look forward to joining the company's SAB. These patients do not have effective treatment options today, which is why I feel it important to support the development of high-potential clinical drug candidates such as CS1.«
Dr. Benza's previous clinical work in PAH, focusing on risk stratification, pharmacogenomics, and novel treatment approaches for the condition, has enabled Dr. Benza to be a researcher funded by National Institutes of Health (NIH) and American Heart Association (AHA). In addition, Dr. Benza served for four years as president Barack Obama's Advisory Committee on Organ Transplantation, ACOT, at Health Resources and Services Administration which falls under the U.S. Department of Health. In 2015, Dr. Benza was knighted by Vittorio Emanuele of Italy for his philanthropic work for patients with PAH.
Dr. Benza takes place in a high-profile team
Through his appointment to Cereno Scientific's scientific board, Dr. Benza joins the ranks of Dr. Deepak Bhatt, Ph.D Faiez Zannad, Ph.D Gunnar Olsson, Ph.D Gordon H Williams and then Bertram Pitt, who already brings world-leading clinical expertise and a strong global network to the company. Dr Benza's appointment was formally made when the Scientific Council met on Friday, with the aim of the renowned expert group presenting R&D updates and new research, as well as holding discussions. Read more about the Scientific Council members here and the network they contribute here.
Dr. Pitt, the chairman of the council, expressed his delight at having Dr. Benza on the council.
»I am pleased to welcome Dr. Benza to the Cereno Scientific Advisory Board. Dr. Benza is Head of Cardiology division at Ohio State University School of Medicine and is recognized as a leading expert in pulmonary hypertension. His expertise will broaden the board's perspective and help us move more efficiently to develop the potential of CS1 and other new opportunities.«
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