10 Feb 2009 09:00 AM
Chemotherapy-related White Blood Cell Depletion - Application For Phase I, Open-Label, Single-Ascending-Dose, Safety Study Of HYC750
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…
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…

