Sedan Cereno Scientific in March last year received orphan drug designation from FDA for their candidate CS1 In the rare disease pulmonary arterial hypertension (PAH), the company has prepared for a phase II clinical study within the indication.
Read more about ODD's regulatory benefits that Cereno Scientific can benefit from here.
Enhanced clinical expertise
Almost immediately after receiving orphan drug designation, Cereno Scientific acted to strengthen its clinical expertise by recruiting Dr. Raymond L. Benza to the role of scientific advisor. Dr. Benza is an internationally recognized expert in cardiovascular disease (CVD), with PAH as a primary clinical interest.
Cereno Scientific has found a CRO for the Phase II study
To ensure the best possible clinical conditions for a Phase II study with CS1, Cereno Scientific has been looking for a clinical research organization (CRO) to collaborate with, a CRO with high-quality expertise in cardiovascular clinical trials. Today, the news came that Cereno Scientific has found such a CRO and signed a letter of intent with Worldwide Clinical Trials, a well-established international CRO. Worldwide Clincal Trials has more than 2000 employees worldwide who have conducted successful studies in several therapeutic areas.
Cereno Scientific CEO Sten R. Sörensen is very excited about the opportunity to collaborate with Worldwide Clinical Trials:
»We feel confident that we have now found a competent partner for our Phase II study in the CRO Worldwide Clinical Trials. They have extensive experience in conducting studies in cardiovascular diseases and specifically in PAH. They also have the right network of clinicians and investigators, which gives us the best conditions for success. We are now receiving their input in the completion of the study protocol and regulatory study documentation to facilitate the further process in the best possible way and then be able to start the study. It is with anticipation that we start the new year and we look forward to the upcoming study milestones.«
Worldwide Clinical Trials will provide Cereno Scientific with valuable support and guidance through the final preparatory steps for the clinical trial, including providing input in determining the study protocol before eventually conducting the Phase II study with CS1 in PAH.
Application process started
The latest discussions with the FDA were successfully completed and during the latest advisory meeting, Cereno Scientific received confirmation that the company's development plan is acceptable in accordance with FDA standards. The meeting also meant that Cereno Scientific received important guidance regarding the implementation of the upcoming clinical study. At the same time, an investigational new drug (IND) application has been initiated with the FDA, which is necessary to conduct the study in the United States.
Overall, Cereno Scientific is well on track with its timeline and expects to initiate the Phase II study with CS1 in PAH in mid-2021, and BioStock looks forward to following Cereno Scientific's journey to Phase II.
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