CellPoint announced today that it has entered into an automated production agreement with KP Pharmaceutical Technology, Inc. to produce 1mg vials of its lead agent Oncardia®(ethylenedicysteine-glucosamine). CellPoint is currently completing Phase 2b and 3 nuclear imaging trials with 99mTc-Oncardia® in both cardiology and oncology imaging. The new formulation will simplify the steps that radio pharmacies will follow in the preparation of the radiopharmaceutical for use by medical personnel. If the radiopharmaceutical is approved by the U.S. FDA, the new formulation will be a better and more user-friendly cold kit preparation than the cold kits used in the clinical studies to date. CellPoint worked on the new formulation with Dr. Guy Bormans, the Department of Pharmaceutical and Pharmacological Sciences at K.U. Leuven University in Leuven, Belgium. The key to using this new formulation was to find a cGMP FDA approved automated kit manufacturer which could produce 1 mg vials. After an extensive review of manufacturers, KP Pharmaceutical was selected.
Oncardia® was developed to address the limitations of FDG-PET in cancer imaging while increasing access to cancer imaging to a significantly greater number of hospitals worldwide. CellPoint also referred to as Cell>Point is completing a Phase 3 trial for Oncardia® in lung cancer under a Letter of Agreement with the FDA pursuant to a Special Protocol Assessment, and a Phase 2b cardiovascular trial in patients with coronary artery disease. The focus in cardiology is to assess the patient’s ischemia in a rest only imaging procedure which will dramatically shorten the time required to complete the patient’s study and achieve noticeably greater diagnostic accuracy compared to the standard of care. “We are pleased to be working with KP Pharmaceutical to automate the kit production” according to Terry Colip, Managing Member of CellPoint.
ABOUT CELLPOINT, L.L.C.
CellPoint is a biopharmaceutical company focused on the development of universal molecular imaging compounds and molecular therapeutics for the diagnosis, staging, treatment and treatment monitoring of cancer, cardiovascular disease, and a range of ischemic diseases. CellPoint has exclusive licenses to five drug-development platforms, all from The University of Texas MD Anderson Cancer Center in Houston, a world leader in cancer research and care. Information on Cell>Point’s product candidates and licenses, recent press releases, and patents and patent filings can be obtained through its website at www.cellpointweb.com. The Company has offices in Centennial, Colorado and Houston, Texas.
ABOUT KP PHARMACEUTICAL TECHNOLOGY, INC.
KP Pharmaceutical Technology, Inc. (KPPT) is a leading Contract Research Organization (CRO) and a full-service cGMP manufacturer (CMO). KPPT is a privately held corporation started operations in 1997 in Bloomington, IN.KPPT has dedicated manufacturing areas with independent HEPA/HVAC air handling and dust containment systems. KPPT has a complete in-house, independent QC Laboratory fully equipped with modern analytical instrumentation required for raw material and finished product release testing and stability studies as per cGMP and ICH guidelines.
