I thought I'd toss up the latest PR from CLN. Another step in the journey to prominence:
Thursday November 9, 1:20 pm Eastern Time
Press Release
SOURCE: Celsion Corporation
Celsion Files FDA Application to Begin Pivotal Phase II Clinical Trials Of Its Breast Cancer Treatment System
COLUMBIA, Md., Nov. 9 /PRNewswire/ -- Celsion Corporation (Amex: CLN - news), headquartered in Columbia, Maryland, announced today that it has filed an application with the FDA to begin Phase II clinical trials of its breast cancer treatment system. The Company filed after its chief investigator, Dr. Robert Gardner, recommended moving forward to the Phase II level, based upon the completion of the Phase I trials.
Celsion's investigational breast cancer treatment system is based on technology developed at MIT for the Star Wars Initiative. It utilizes adaptive phased array technology to focus microwaves directly on cancerous cells in order to ``ablate'' (kill) the cells with targeted heat.
According to Dr. Augustine Cheung, Celsion Chairman and Chief Scientific Officer, ``Our breast cancer treatment system will seek to address two major groups of patients. Our goal is that patients normally expected to undergo mastectomy will, after Celsion's treatment, be able to undergo a lumpectomy instead. This is a far more conservative procedure that may enable the patient to preserve her breast.''
``In addition,'' Dr. Cheung said, ``we will also seek to use the treatment system on a second group of patients with smaller tumors who would be candidates for a lumpectomy. The goal with these patients will be to use the Celsion system to ablate these smaller tumors completely.''
Phase I studies are intended to demonstrate safety and feasibility of use. Phase II studies will test the treatment's safety and efficacy and must be successfully completed as part of the FDA review process for potential commercialization.
About Celsion: Celsion Corporation is a research and development company dedicated to commercializing medical treatment systems for cancer and other diseases using focused heat technology delivered by patented microwave technology. Celsion has research, license or commercialization agreements with leading institutions such as Duke University Medical Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center, the University of California at San Francisco, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center in New York and Duke University.
Forward-looking statements in this release are made pursuant to the ``safe harbor'' provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; possible changes in cost and timing of development and testing, capital structure, and other financial items; changes in approaches to medical treatment; introduction of new products by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. |
