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
R&D 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.
Orcrist Bio Inc.