Orcrist Bio Inc (ORC), a biotech company developing stem cell-mobilising pharmaceuticals, has filed with the European Competent Authority in Seville, Spain, a phase-I, open-label, single-ascending-dose, safety study of HYC750 in healthy male volunteers.
The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics (induction of haematopoiesis) of HYC750, a patent-protected formulation of hyaluronan. ORC utilized the regulatory expertise and experience of Kinesis Pharma BV (Breda, Netherlands) to develop the clinical trial submission. The planned study is to be conducted by InPEC BV (Breda, Netherlands) at their clinical trial site in Malaga, Spain.
Dr Thomas Ichim, chairman of ORC's Scientific Advisory Board commented, "HYC750 possesses a very favourable pharmacological and pharmaceutical profile and is an excellent candidate for aggressive and rapid clinical development."
"Filing the requisite regulatory documentation with the European authorities to initiate our phase-I clinical trial was a major accomplishment for our company and represents Orcrist's most important milestone thus far," said Dr Brett Schönekess, president and CEO of Orcrist. "We are thrilled with the expertise and professionalism provided by both Kinesis and InPEC, and are very excited to see the HYC750 clinical program move forward. Our clinical goal is to confirm the safety profile of HYC750 and to see a clear illustration of its stem cell mobilization properties, which would support its future development as a treatment for chemotherapy-related blood cell depletion."
"We are very honoured to be chosen by Orcrist to coordinate and perform their phase-I study with HYC750 and we look forward to the future initiation of the trial," commented Dr Ronald van der Geest, chief business officer of InPEC BV. "Orcrist, Kinesis, and InPEC have worked as a team on this project, and I believe a very strong clinical trial application has been submitted."
Orcrist Bio is a biotechnology company dedicated to developing and commercializing promising therapeutics for areas in which a clear market opportunity exists.
Kinesis Pharma BV is an independent, privately owned company based in The Netherlands. Kinesis aims to facilitate a fast and high quality drug development process in close collaboration with the preclinical and clinical R&D departments of pharmaceutical and biotech companies through consultancy and contract research services.
InPEC BV is a clinical CRO that focuses on the execution of Phase I and IIa clinical trials.