CALGARY, Canada, February 9 /PRNewswire/ -- Orcrist Bio Inc. (ORC) a biotech company developing stem cell-mobilizing pharmaceuticals, announced today that it 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 hematopoiesis) 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 honored 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.
About Orcrist Bio Inc.
Orcrist Bio Inc. is a biotechnology company dedicated to developing and commercializing promising therapeutics for areas in which a clear market opportunity exists. ORC's lead program revolves around HYC750, a novel stem cell mobilizer compound that promotes the egress of stem cells and other blood cells from the bone marrow into the blood, from which they can be harvested and applied toward treating chemotherapy-related white blood cell depletion. Orcrist is actively looking to add to its pipeline exploring the innate properties of HYC750 and its effects on stem cells, as well as through in-licensing opportunities of other products with clear market potential. ORC is located in Calgary, Alberta. The company is financed by its founders and by private investors.
About Kinesis Pharma BV
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 RD departments of pharmaceutical and biotech companies through consultancy and contract research services. Currently, Kinesis employs about 55 people, many of them with extensive industrial and/or regulatory experience.
About InPEC BV
InPEC BV is a clinical CRO that focuses on the execution of Phase I and IIa clinical trials. Its professional and experienced team, and state of the art facilities, embedded within the care of a private hospital with an ICU unit on the same floor, guarantee maximum safety for the full range of clinical pharmacology studies. Electronic data processing procedures are in place to enable high-quality and efficient data processing on-site. InPEC's head office is located in the Netherlands. Clinical facilities are located in Malaga, Spain.
For further information: on Orcrist Bio Inc., please see our website http://www.orcristbio.com. Contact information: Dr. Brett Schönekess, President and CEO, Phone: +1-403-984-3882 x 222, Email: brett@orcristbio.com
Contact information: Dr. Brett Schönekess, President and CEO, Phone: +1-403-984-3882 x 222, Email: brett@orcristbio.com
Comments