Originally Published MX November/December 2004
COVER STORY
Developing Clinical Support|
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Successfully commercializing a new medical technology frequently requires considerable support from clinicians in the field. Such end-users play a vital role in validating the clinical utility of a new technology, conducting clinical trials to support regulatory approvals, and performing ongoing research to demonstrate favorable outcomes.
At Proxima Therapeutics Inc. (Alpharetta, GA), early involvement of clinicians was never in doubt. The company's technology for postsurgical cancer irradiation was initially conceived by Jeff Williams, MD, a triple-board-certified physician at Johns Hopkins Medical Center (Baltimore). Following Dr. Williams's lead, Proxima moved early on to conduct clinical studies of its products.
Since these initial trials, Proxima has continued on a steady path of clinical research designed to support regulatory approval and encourage adoption of both the GliaSite and MammoSite products.
|
Date
|
Clinical
Milestone
|
| March 1999 | FDA approves clinical study of GliaSite radiation therapy system. |
| January 2000 | FDA
approves clinical study of MammoSite radiation therapy system. |
| April 2001 | FDA clears GliaSite. |
| May 2002 | FDA clears MammoSite. |
| August 2002 | Proxima initiates MammoSite patient registry. |
| January 2003 |
Study in International
Journal of Radiation |
| August 2003 | Study
in Journal of the National Cancer Institute finds partial-breast irradiation comparable to whole-breast radiation therapy over five years. Study in Journal of Neurosurgery finds that GliaSite safely delivers a therapeutic dose of radiation. |
| November 2003 | American
Society of Breast Surgeons becomes responsible for MammoSite patient registry. |
| February 2004 | FDA clears MammoSite elliptical balloon catheter. |
| May 2004 | Postmarket
studies of GliaSite and MammoSite presented at American Brachytherapy Society meeting. MammoSite receives new reimbursement coding. |
| July 2004 | American
Society of Breast Surgeons completes enrollment of MammoSite patient registry. |
| August 2004 | FDA clears next-generation MammoSite balloon catheter device. |
| October 2004 | American
Society for Therapeutic Radiology and Oncology presentations on GliaSite and MammoSite. Congress of Neurological Surgeons presentation on GliaSite. |
| Table I. Clinical milestones for Proxima Therapeutics have included a growing number of clinical studies as well as targeted publications and presentations to professional societies. | |
In August 2002, Proxima launched a patient registry to monitor the long-term outcomes of patients treated with MammoSite. In November 2003, this national prospective data-collection program was turned over to the American Society of Breast Surgeons, which recently reached its goal of enrolling 1500 patients, making the program the largest study of partial-breast irradiation in the world. Preliminary findings from the registry will be presented in December 2004 at the San Antonio Breast Cancer Symposium, a division of the Cancer Therapy & Research Center (San Antonio, TX).
Proxima's clinical research program has also enabled the company to respond to its customers' needs by attaining new reimbursement coding and developing product enhancements. Recent updates to the company's systems have included elliptical-shaped MammoSite balloon catheters that were cleared by FDA earlier this year and new features to make the MammoSite device easier to use. Building on its positive experience with the GliaSite and the MammoSite, Proxima recently received patents for the use of its technology platform with spinal metastases. The company is now involved in conducting early clinical work for this application.
Most recently, the first three-year data on MammoSite and postmarket data on GliaSite were presented at the annual meeting of the American Society for Therapeutic Radiology and Oncology.
Proxima president and CEO Timothy J. Patrick says that clinical studies will continue to play a major role in the company's future. "Continuing to develop a strong clinical portfolio for our products will help physicians and patients have a better understanding and access to these novel internal radiation treatments," he says.
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