CellCyte Genetics Reaches Agreement for Production of Material in Support of CCG-TH30 IND Enabling Pharmacology Studies
News May 09, 2007
CellCyte Genetics Corp. has initiated an agreement for production of its lead compound CCG-TH30 used to deliver and retain stem cells in the heart.
This agreement comes after a comprehensive review by management to identify lead cGMP manufacturers and negotiate the contract terms for the Company's proprietary compound CCG-TH30.
The firm awarded the contract is in the process of producing sufficient quantities to be used by CellCyte in toxicology and preclinical studies. First delivery of the compound is expected within 7 days and additional quantities can be provided on an as-need basis.
The manufacturing company selected to produce this round of CCG-TH30 compound is a recognized leader and has a long history of manufacturing purified proteins from natural materials and blood sources under cGMP with similar characteristics to CellCyte Genetics' compound for major international pharmaceutical companies.
The firm is capable of producing the compound in large enough quantities to meet the requirements of the Company's proposed clinical trials. The selected manufacturer is also suited to the manufacture of CellCyte Genetics' compound because of specific economic and logistical within their current manufacturing process.
The data collected from this stage of toxicology and preclinical studies will be used in support of the CCG-TH30 Phase Ia clinical trials.
CellCyte Genetics Corp.'s management states that the Company has identified several GMP manufacturers for its CCG-TH30 compound and that discussions are underway for larger-scale production of CCG-TH30 compound for use in the clinical trials through Phase III and Phase IV.