To: Kimberly Lee who wrote (3433 ) 5/3/1999 12:09:00 PM From: Dave Gore Respond to of 108040
**CELN: NEWS JUST OUT. This one is worth checking out now. Two potential huge breakthroughs (Prostate and Breast Cancer) with exclusive technology licensed from MIT. Commercialization is not far off, since no Phase III is required. The News:Message 9284350 Why the news is important:Message 9285226 QUICK DD AND WHY I LIKE IT (ps-- this is the only biotech long term hold I own) 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.