EC Technology was the first technology platform licensed by Cell>Point from the University of Texas M.D. Anderson Cancer Center. Ethylenedicysteine N-acetylglucosamine (EC-G) is the first target specific compound developed from the EC Technology platform. The compound is comprised of a complex of a derivative of ethylenedicysteine (EC) and N-acetyl glucosamine (“EC-G”). EC functions as a chemical bridge linking tissue specific ligands (sugar analogues (e.g. glucosamine), proteins, peptides, steroids, etc.) or pharmaceutical compounds to radioactive or non-radioactive metal ions such as 99mTc, 68Ga, and Platinum (“Pt”) for diagnostic and therapeutic applications. This makes EC Technology an exceptionally flexible platform for developing products for both diagnostic imaging and therapy.Early in development, N-acetyl glucosamine was used because it was well known that hyper-active tumors function at a high metabolic level and have a high affinity for glucose. It was not known at the time how significant the combination of EC-G might become, not only for application in oncology, but also in cardiovascular and potentially other disease states.For decades, academic researchers and industry scientists had endeavored to create a stable 99mTc labeled sugar analogue for gamma (SPECT) cameras. This would be ideal because the thickness of the SPECT camera crystal is ideally designed for 99mTc. The historical problem that has prevented the reality of a 99mTc labeled sugar analogue has been the inability to create a stable effective compound that would keep the 99mTc intact with the targeting compound while in use. The current standard of care in molecular cancer imaging is FDG-PET which has been available for over 20 years; however, there have always been practical limitations that would be problematic if a worthy competitor became a reality. We believe that 99mTc-EC-G has the potential to be more than a worthy competitor. One of the issues with PET and PET/CT is the comparatively high capital cost of the cameras. Sales of new PET/CT cameras are growing at a declining rate. Approximately 5% of the U.S. hospitals have either PET or PET/CT cameras. Outside the U.S., the percentage of hospitals with either PET or PET/CT cameras is less than one-half of those in the U.S. SPECT and SPECT/CT cameras are found in over 95% of U.S. hospitals and in the majority of hospitals outside the U.S. In addition, it is the single isotope most familiar to radiologists around the world. The use of 99mTc offers certain advantages over other radioisotopes in radiological imaging such as prolonged half-life, lower radiation exposure, easier handling, availability 24/7, and on-site production if preferred.
99mTc-EC-G was originally developed as a cancer imaging agent for diagnosing and staging cancer. However, It was discovered during the Phase I oncology trial that 99mTc-EC-G had the potential to become a functional imaging agent for diagnosing the presence and extent of cardiovascular disease. Cell>Point is conducting a Phase 2 cardiology trial. 99mTc-EC-G is target specific for myocardial ischemia. It is not a myocardial perfusion imaging agent such as 99mTc-sestamibi which is widely used in traditional myocardial perfusion imaging. An objective of the Phase 2 study is to evaluate the capacity of 99mTc-EC-G to accurately diagnose the presence and extent of cardiac disease in patients who undergo “rest only” studies. If clinical study results confirm that 99mTc-EC-G given to the patient “at rest” provides at least equivalent diagnostic information as can be obtained from a full “stress/rest” myocardial perfusion imaging study, then 99mTc-EC-G will have the potential, if approved, to dramatically change nuclear cardiology imaging by, among other things, significantly reducing the time required to complete a nuclear cardiology imaging study. It is estimated that total study time could be reduced from 5-7 hours to 30-45 minutes.It should be noted that EC-G serves as the target specific backbone for the company’s therapeutic product compounds. The dexterity of EC-G comfortably fits the definition of a theranostic (diagnosis + therapy).
Beta Cell Technology
This technology is designed to target beta cell function in the pancreas. The first diagnostic agent developed from the Beta Cell platform is 99mTc-DTPA-Glipizide. The company is working to complete the GMP synthesis of DTPA-Glipizide. Once complete, preclinical small animal studies will be resumed to evaluate the therapeutic efficacy of diabetic drugs through pancreatic beta cell activity. In addition, 99mTc-DTPA- Glipizide will be evaluated in its ability to distinguish and evaluate Type I and Type II diabetes and to identify the presence of early stage pancreatic cancer.
In Situ Hydrogel
The third technology platform, In-Situ Hydrogel, is being developed as a site specific regional chemotherapy and radiotherapy delivery system. By comparison with other hydrogel technologies, In-Situ Hydrogel is unique in that it is capable of delivering a high yield dose of a therapeutic radionuclide, such as rhenium-188 (“188Re”), directly to the tumor site without collateral leakage into surrounding healthy tissue. In addition, In-Situ Hydrogel is capable of simultaneously delivering a therapeutic radionuclide and a chemotoxic drug to treat solid tumors and surgically unresectable tumors. The absence of post injection leakage should help reduce the side-effects experienced by patients who receive external beam radiation treatment. Pre-clinical studies have demonstrated the potential of In-Situ Hydrogel as an effective high yield delivery system. The hydrogel formulation traps the radionuclide and/or chemotherapeutic drug at the tumor site immediately following administration. The radionuclide remains trapped within the polysaccharide matrix while the chemotherapeutic drug slowly releases.
The fourth technology platform, N4 Technology, is a covalent lipophilic technology that is being used to develop agents for the treatment of Alzheimer’s, Parkinson’s, Huntington’s disease, depression and neuroendocrine tumors.
Dual Agent Technology
The fifth technology platform, Dual Agent Technology, is facilitating the development of dual use diagnostic agents. For example, a single agent will combine the radiopharmaceutical for SPECT imaging with the contrast marker for MRI or CT without interference or distortion between the radiopharmaceutical and contrast marker. The company plans to develop dual agents for use with SPECT/CT, SPECT/MRI, PET/CT and PET