Comparative oncology and clinical translation of glyco protein conjugated gold nano therapeutic agent (GA-198AuNP) [abstract]

Nanoscience Poster SessionAs part of our efforts toward clinical translation of GA-198AuNP, our studies are focused on therapeutic efficacy of nanoparticulate GA198AuNP agent in dogs with prostatic carcinoma. The overall goal is to gain clinical insights on therapeutic efficacy of GA198AuNP in a large animal model. We have performed a phase I clinical trial using GA-AuNP administered intravenously or intratumorally by injection or infusion. CT scans were performed prior to injection and 24 hours post injection in 3 of the 4 dogs. Following injections, dogs were allowed further treatment as recommended by the primary attending clinician. Four dogs have been treated to date. Complications related to GA-AuNP treatment were not observed, and all 4 dogs received adjunctive treatment with radiation therapy and/ or chemotherapy. These preliminary studies have clearly provided compelling evidence on the therapeutic potential of biocompatible GA-AuNP for their utility as novel therapeutic agents in treating various types of inoperable solid tumors. Intra-tumoral and intravenous administration of GA-AuNP is safe in dogs with spontaneously occurring tumors. As further therapeutic efficacy studies continue, the outcome of this clinical trial in a large animal model will generate therapeutic efficacy data which will be used for filing IND application for Phase I clinical trial studies. This clinical translation effort provides significant advances in terms of delivering optimum therapeutic payloads into prostate cancers with subsequent reduction in tumor volume, thus may effectively reduce/eliminate the need for surgical resection. This presentation will include details of clinical translation of GA198AuNP in prostate tumor bearing dogs

Experiences in Patenting, Licensing and Commercialization of Radiopharmaceuticals

Patent Issues Relative to Life Sciences R&D - Moving from Discovery in Academia to Commercialization PanelThis presentation will highlight successful efforts in working with the UM Office of Patents and Licensing to patent, license and commercialize radiopharmaceuticals for medical applications that emerged from collaborative research programs in which I was involved. Two FDA approved radiopharmaceuticals based on relevant patents have been commercialized and are in routine use in the U.S. and other countries. Ceretec™ is a diagnostic agent for imaging neurologic disorders and infectious processes in patients. Quadramet™ is a radiotherapeutic drug used for treatment of painful skeletal cancers. An exclusive license agreement with Amersham International was negotiated with UM for development and marketing of Ceretec™ while Quadramet™ resulted from a joint R&D program involving investigators at MU and Dow Chemical Company. A more recent patent was issued to protect the invention for use of radiolabeled bombesin peptides for diagnosis and treatment of human prostate, breast and other cancers. A license agreement was negotiated between the University and a venture capital company - Resolution Pharmaceuticals - for development of radiopharmaceuticals covered under the broad-scope US and European patents. Human clinical trials with a diagnostic agent and a therapeutic agent based on radiolabeled bombesin analogs have been performed and show promising results. It is important to recognize that the inventors of all three of these technologies worked closely with the UM Office of Patents and Licensing in identifying viable and desirable commercial partners and in negotiations of the licensing agreements. Flexibility was a key element in developing effective licensing agreements. The three examples highlighted in the presentation demonstrate three different approaches in developing corporate agreements that were successful in translating MU life sciences research into radiopharmaceuticals that are for use as diagnostic and therapeutic applications in human patients

Student Support-Radiochemistry Conference

The objectives of this program were to provide bursaries to assist students and post-doctoral fellows being trained in radiochemistry to actively participate in the 18th International Symposium in Radiopharmaceutical Sciences (ISRS-2009) held in Edmonton, Canada on July 12-19, 2009. The critical shortage of scientists in the U.S. trained radiochemistry and imaging scientists is well documented. Scientific meetings such as ISRS-2009 provide an outstanding opportunity to recruit active researchers and trainees in a venue that can inspire and mentor them to join the next generation of radiochemical scientists. The ISRS-2009 was particularly important in this meeting this objective since it is regarded as the premier international meeting that features investigators from across the globe involved in cutting-edge research to synthesize and characterize radiolabeled biomolecules for molecular imaging in living systems. For example, radiochemistry and radionuclide imaging scientists presented new approaches and technologies for synthesis of novel radiolabeled biomolecules with PET (including, 11C and 18F) and SPECT (including 99mTc and 111In). The radiochemical and radionuclide imaging research presented at the ISRS-2009 are directly related to and supportive of the biomolecular radioisotope, radiochemistry and imaging programs in the DOE, Office of Science (BER). There were a total of fifteen students or post-doctoral fellows from a variety of radiochemistry and radionuclide imaging research and educational institutions from across the country (Table 1). Announcements of the SRS/DOE bursary award program were made on the ISRS-2009 meeting web site (www.ISRS18.com), on the SRS website (www.srsweb.org), and via SRS email blasts (announcement Figure 1). The applications were reviewed and awardees selected by a committee composed of Dr. Ken Krohn, University of Washington, Seattle, WA, Dr. William Eckelman, Bethesda, MD,Dr. Michael Welch, Washington University, St. Louis, MO and Dr. Wynn Volkert, University of Missouri, Columbia, MO. The trainees presented results of their work via either an oral or a poster presentation. Abstracts of their papers presented at the ISRS-2009 meeting were published in the Journal of Labelled Compounds and Radiopharmaceuticals, Volume 52, Supplement 1, 2009 (www.interscience.wiley.com/journal/jier), the official Abstract Book for the ISRS-2009 meeting. A copy of the published abstracts presented by each of the fifteen trainees receiving the SRS/DOE Bursary Award is provided on the following pages. The list of the fifteen trainees receiving the 2009 Bursary awards funded by this DOE grant was published in the July 2010 issue of Nuclear Medicine and Biology (Volume 37(5), July 2010) and in the SRS website with appropriate acknowledgement to the U.S. Department [See Appendix 1 for copies of the 15 student/trainee abstracts]