Two innovative products that will enable users to generate and label PET radiotracers on-site at a significantly reduced cost will be developed by RadioMedix, Inc. with a $2.8 million grant from the Texas Emerging Technology Fund. According to Ebrahim S. Delpassand, MD, founder and CEO of RadioMedix, Inc., “these products – the GlucoMedixTM PET imaging agent and the SyntheMedixTM synthesizer unit – will make tumor profiling feasible, accessible, and cost effective.” Dr. Delpassand says the RadioMedix products will benefit carcinoid and neuroendocrine tumor patients because the PET (positron emission tomography) imaging studies with Gallium-68 Octreotide that will become widely available in the United States will be a state-of-the-art diagnostic tool and will significantly improve treatment monitoring.
At the present time, PET imaging using Fluorine-18 glucose is the technology used in diagnosis, staging, and monitoring response to therapy in the majority of cancer patients. However, these PET radiotracers require facilities that own a cyclotron, a highly complex and very costly machine; thus they are only located in large cities. The alternative that will be produced by RadioMedix is a small and relatively inexpensive generator using a Gallium-68 isotope that can be located on-site at medical imaging facilities or in research labs anywhere in the world.
Dr. Ebrahim Delpassand
While Gallium-68 Octreotide PET scans are conducted in other parts of the world, none have yet received Food and Drug Administration (FDA) approval for regular clinical use in the United States except for one clinical trial just starting, explains Dr. Delpassand. There is no standardized methodology that allows for the labeling of the imaging agent. The FDA requires pharmaceutical Good Manufacturing Practices (GMP) documentation in order to approve these agents. The new SyntheMedix synthesizer unit will automate the labeling process, currently done manually by highly trained technicians, resulting in a standardized labeling methodology.
Gallium-68 is a preferable radiopharmaceutical agent in PET imaging because it is a radioactive agent that does not require a cyclotron for production. The resolution produced by a Gallium-68 Octreotide PET scan is much higher than that of an indium Octreoscan, says Dr. Delpassand. Gallium, a metal, is also more flexible in the chemistry needed for labeling to detect cancer. The half-life of Gallium, the amount of time before the Gallium isotope is no longer viable, is only 68 minutes and having a machine that makes the Gallium immediately before the PET scan is another reason the new synthesizer unit is so important.
Gallium generator
The Texas Emerging Technology Fund was created by the Texas Legislature in 2005 at the urging of Governor Rick Perry to provide Texas with an unparalleled advantage in the research, development, and commercialization of emerging technologies. The grant to RadioMedix will help the company take its products from concept to development to ready for the marketplace. Dr. Delpassand envisions having the synthesizer unit and Gallium PET agent in the marketplace in 2012. He also hopes to have FDA-approved clinical trials for the Gallium PET agent begin in 2012.
In addition to founding RadioMedix, Dr. Delpassand is the founder and Chairman of the Board of Excel Diagnostics Imaging Clinics in Houston, Texas, the first research facility in the United States to receive FDA authorization to initiate a clinical trial for PRRT (peptide receptor radionuclide therapy) of Lutetieum-177 (LU-177) with Octreotate. This treatment is used for progressive neuroendocrine tumors that are resistant to octredotide/interferon treatment or chemotherapy. To read more about the clinical trial, CLICK HERE.
Dr. Delpassand is the former deputy chairman, associate professor and chief of clinical nuclear medicine at M.D. Anderson Cancer Center in Houston, Texas. He maintains voluntary appointments at the University of Texas Medical Branch and Baylor College of Medicine. He is also President of the Radioisotope Therapy of America (RITA) Foundation and a Fellow of the American College of Nuclear Medicine (FACNM). Dr. Delpassand’s established track record and extensive experience include the disciplines of therapeutic nuclear medicine, nuclear cardiology, monoclonal antibody imaging, and positron emission tomography (PET).
According to Richard R.P. Warner, MD, Medical Director of the Carcinoid Cancer Foundation, the new RadioMedix products will be very valuable for the carcinoid and neuroendocrine cancer community because “they advance the acuity of diagnostic ability and also the effectiveness of antitumor treatment by a gentle, noninvasive technique considerably beyond the current imaging modalities available in the United States.”
