CELN (CELSION CORP) UP $.33 TO $.59 ON 2.6 MILLION SHARES
FDA GRANTS CELSION IDE APPROVAL FOR ITS BREAST CANCER DEVICE
WHICH KILLS TUMORS WITH FOCUSED HEAT ALONE
Columbia, MD - January 28, 1999: Celsion Corp. (OTC BB: CELN) today announced that it received approval of its Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA) for its breast cancer treatment system which uses heat alone to ablate (destroy) breast tumors and viable cancer cells.
The IDE approval enables Celsion to proceed with phase one clinical studies for its non-surgical, minimally-invasive system which utilizes focused heat alone to kill cancerous tumors in the breast. Preclinical studies have indicated the possibility that the treatment will be non-toxic and side-effect-free.
The system's “Focused Heat Technology” was developed by Celsion using proprietary technologies licensed exclusively from several renowned engineering and medical research institutions, including the Massachusetts Institute of Technology (MIT).
BREAKTHROUGH IN BREAST TUMOR ABLATION (DESTRUCTION)
Until recently, the momentum of hyperthermia research was hampered by the industry's inability to target and focus heat exclusively on tumors and diseased areas. By utilizing “Star Wars” microwave missile targeting technology licensed from MIT, Celsion is now able to successfully target deep focused heat solely on affected areas without burning the body's healthy tissue and skin.
Preclinical studies at Massachusetts General Hospital (MGH), using breast tissue-equivalent phantoms and tumors in live animals, verified that Celsion's system is capable of selectively heating tumors at temperatures of up to 46 degrees Celsius without damage to surrounding healthy tissues in the human breast. Such high temperatures, maintained for 8-10 minutes, can cause complete tumor necrosis by eliminating all viable cancer cells within the tumor and its vicinity.
The results indicated that focused heat alone, delivered by Celsion's system, may be used clinically to not only ablate breast tumors but also eliminate all viable cancer cells in the tumor vicinity within the heated region. A parallel preclinical evaluation, performed in England, also confirmed the system's ability to focus deep heat within the body.
Celsion's focused heat cancer treatment system previously received FDA Premarket Approval (PMA) for commercialization as an adjunct to radiation therapy. The IDE enables the Company to begin a phase one clinical feasibility demonstration at MGH, which will be followed by multi-site phase two clinical trials, to obtain the efficacy data necessary to add a “tumor ablation” indication to the existing PMA denoting that the system alone effectively ablates cancerous tumors and viable cells within the human breast.
COMMERCIALIZATION
Since the breast cancer system has already obtained an FDA PMA, the Company has begun informal discussions to enter into strategic alliances with medical equipment manufacturers and oncology sales distributors worldwide. This will ensure that manufacturing, marketing, and distribution sales channels will be in place once the human clinical trials have been completed.
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ABOUT CELSION
In addition to its breast cancer system, Celsion is also conducting clinical studies towards the FDA approval of its non-surgical, side-effect-free treatment for the immediate symptomatic relief of benign prostatic hyperplasia (BPH). Phase one clinical trials of the Company's BPH system, which began in November 1998, are expected to completed in early 1999. Celsion then intends to commence multiple-site phase two clinicals of the system to collect the efficacy data necessary to apply for an FDA PMA for commercialization. The Company is also expanding its line of cancer treatment systems to include prostate cancer and deep-seated cancer systems.
Celsion Corporation is a research and development company dedicated to commercializing medical treatment systems for cancer and BPH using focused heat delivered by patented microwave technology. Clinicals and further development of the Company's treatment systems are being conducted by leading institutions such as the Massachusetts Institute of Technology, Massachusetts General Hospital, Montefiore Medical Center, and Duke University.
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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, possible changes in cost of materials, expense items, capital expenditures, capital structure, and other financial items; introduction of new products and possible acquisitions of 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.
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