Approaches in clinical trial


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Approaches in clinical trial

Nano Science & Technology Consortium

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Approaches in clinical trial

  1. 1. Approaches In Clinical Trial<br />
  2. 2. Clinical Trial At Nanosystems Biology Cancer Center (Caltech/UCLA CCNE)<br /> Drs. Caius Radu, Owen Witte and Michael Phelps at the Nanosystems Biology Cancer Center (Caltech/UCLA CCNE) have developed a series of positron emission tomography (PET) imaging agents. These agents are being tested for assigning patients for chemotherapy with drugs such as gemcitabine, cytarabine, fludarabine, and others used to treat cancers including metastatic breast, non-small cell lung, ovarian, and pancreatic, as well as leukemia and lymphomas. Tumors responsive to these drugs show up as bright images in PET scans when patients are first dosed with imaging agent. Biodistribution studies have been conducted in eight healthy volunteers. Clinical development is being conducted by Sofie Biosciences.<br />
  3. 3. Clinical Trial At Center of Nanotechnology <br />At the Center of Nanotechnology for Treatment, Understanding, and Monitoring of Cancer (NANO-TUMOR) (UCSD CCNE), Dr. Thomas Kipps developed a chemically engineered adenovirus nanoparticle to deliver a molecule that stimulates the immune system. Phase I clinical trials, being run jointly by Memgen and the Leukemia & Lymphoma Society, are underway in patients with chronic lymphocytic leukemia. An ongoing Phase I dose escalation study is evaluating patients who received direct intranodal injection of the chemically-engineered virus. Systemic clinical effects have been observed with a single injection with significant reductions in leukemia cell counts and reductions in the size of all lymph nodes and spleen. One patient went into complete remission. <br />
  4. 4. Clinical Trial At Calando Pharmaceuticals<br /> Calando Pharmaceuticals, founded by Dr. Mark Davis at the Caltech/UCLA CCNE, is conducting clinical trials with a cyclodextrin-based nanoparticle that safely encapsulates a small-interfering RNA (siRNA) agent that shuts down a key enzyme in cancer cells. This open-label, dose-escalating trial is testing the safety of this drug in patients who have become resistant to other chemotherapies. Calando is also conducting clinical trials cyclodextrin-based polymer conjugated to camptothecin. This trial is also an open-label, dose-escalation study of IT-101 administered in patients with solid tumor malignancies.<br />
  5. 5. Clinical Trial At Siteman Center of Cancer Nanotechnology Excellence (Washington University CCNE)<br /> At the Siteman Center of Cancer Nanotechnology Excellence (Washington University CCNE), Drs. Gregory Lanza and Samuel Wickline have developed a nanoparticle magnetic resonance imaging (MRI) contrast agent that binds to the αvβ3-intregrin found on the surface of the newly developing blood vessels associated with early tumor development. Kereos, which was founded by Alliance investigators, is conducting Phase I clinical trials with this agent to assess its utility in the early detection of cancer.<br />
  6. 6. Clinical Trial At Nanosphere<br /> Diagnostic company Nanosphere, founded by Dr. Chad Mirkin to commercialize technology developed at the Nanomaterials for Cancer Diagnostic and Therapeutics Center (Northwestern Univ. CCNE) has already received FDA approval for a nanosensor test for the drug Coumadin. This same technology can be easily adapted to detect important cancer biomarkers, such as prostate specific antigen (PSA) or to measure blood levels of anticancer agents. A joint project between Nanosphere, the Northwestern CCNE, and the Robert H. Lurie Comprehensive Cancer Center is conducting a clinical study using human tissue samples to monitor very low levels of PSA to determine if such measurements, which are well beyond the sensivity of conventional PSA assays, can provide early warnings of disease recurrence.<br />
  7. 7. Clinical Trial At Carolina Center of Cancer Nanotechnology Excellence (UNC)<br /> Clinical trials - scheduled to begin later this year on a new type of CT scanner, developed by Dr. Otto Zhou at the Carolina Center of Cancer Nanotechnology Excellence (UNC) uses carbon nanotubes as the x-ray source. This new scanner, developed through a joint venture with Xintek, founded by CCNE members, and Siemens, a leader in medical imaging, contains 52 nanotube x-ray sources and detectors arranged in a ring, that eliminates the need to move the x-ray source and increases precision and speed of CT scanning, could be preferred method for detecting small tumors.<br />
  8. 8. Clinical Trial At Center for Cancer Nanotechnology Excellence Focused on Therapy Response Stanford Univ.<br /> Discussions with the FDA to start clinical trials using carbon nanotubes to improve colorectal cancer imaging. Imaging agent being developed by Dr. Sanjiv Sam Gambhir from the Center for Cancer Nanotechnology Excellence Focused on Therapy Response Stanford Univ.<br />Clinical Trial At Univ. Washington Cancer Nanotechnology <br />A nanoparticle designed to cross the blood-brain barrier and specifically target glioblastomas is also nearing clinical trials. This nanoparticle agent can function as both an MRI contrast agent and a drug delivery device. Developed by Dr. Miqin Zhang - Univ. Washington Cancer Nanotechnology Platform Partnership for Pediatric Brain Cancer Imaging and Therapy.<br />
  9. 9. Clinical Trial At BIND Biosciences<br /> BIND Biosciences, founded by Drs. Robert Langer and Omid Farokhzad of the MIT-Harvard CCNE, anticipates having its lead compound in clinical trials in 2010. BIND’s targeted nanoparticles consist of a polymer matrix, therapeutic payloads, functional surface moieties, and targeting ligands which allow for particle optimization (i.e., accumulation in target tissue, avoidance of being cleared by immune system, and delivery of drug with desired release profile).<br />Clinical Trial At Liquidia Technologies <br />Liquidia Technologies founded by Univ. North Carolina CCNE Dr. Joseph DeSimone. Liquidia's proprietary PRINT (Pattern Replication In Non-wetting Templates) technology enables the design and manufacture of precisely engineered nanoparticles with respect to particle size, shape, modulus, chemical composition, and surface functionality.<br />
  10. 10. Clinical Trial At MIT-Harvard Center for Cancer Nanotechnology Excellence<br /> Dr. Ralph Weissleder, an investigator at the MIT-Harvard Center for Cancer Nanotechnology Excellence, is leading a clinical trial to determine if lymphotrophic superparamagnetic nanoparticles developed at the CCNE can be used to identify small and otherwise undetectable lymph node metastases.<br />The Integrated Blood Barcode (IBBC) chip, developed by Dr. James Heath at the Caltech/UCLA CCNE, is now undergoing validation tests to measure the levels of approximately 800 miRNAs from 21 melanoma patients before and after therapy. <br />
  11. 11. Thanks<br />