Philips and Celsion Announce FDA Clearance to Commence Phase II Study of ThermoDox(R) and MR-Guided HIFU in Bone Cancer
A Non-Invasive Next Generation Approach With the Potential to Change the Oncology Paradigm
ANDOVER, MA and LAWRENCEVILLE, NJ -- (Marketwire) -- 08/07/12 --
Royal Philips Electronics (NYSE: PHG) (AEX: PHI) and Celsion Corporation (NASDAQ: CLSN) today announced that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate a clinical study supporting a joint development program for Celsion's ThermoDox® combined with Philips' Sonalleve MR-HIFU (MR-guided high intensity focused ultrasound) technology for the palliation of painful metastases to the bone caused by lung, prostate or breast cancers. The companies expect to initiate a Phase 2 study in this indication in the second half of 2012.
ThermoDox® combined with MR-HIFU will be investigated for pain palliation in patients with bone metastasis. Cancer progresses to the bone in a majority of patients with late-stage breast, prostate or lung cancer, with estimates of between 300,000 to 500,000 cases annually in the United States. Patients may experience excruciating and unrelenting pain, often treated with opiate drugs and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) with only modest benefit. External beam radiation therapy is effective in palliating painful bone metastasis, but is limited by accumulating toxic effects to normal organs.
Philips' MR-HIFU system has the potential to precisely and non-invasively target lesions with acoustic energy, creating sufficient heat to activate ThermoDox® and preferentially release high concentrations of doxorubicin in the targeted treatment area. Celsion is developing the combination of ThermoDox® and MR-HIFU through a joint research agreement with Philips Healthcare, a division of Royal Philips Electronics.
"The combination of Philips' MR-HIFU system, a high-precision, heat-based therapy, and ThermoDox®, a heat-triggered oncolytic agent, holds great potential in that it gives us the ability to combine non-invasive thermal treatment with local delivery of high concentrations of potent, well-characterized anti-cancer drugs directly in a target area," said Falko Busse, vice president and general manager, MR Therapy for Philips Healthcare. "This multi-modality approach could be transformative for the treatment of a number of cancers. We remain excited about our collaboration with Celsion, and look forward to beginning the clinical study as soon as possible."
"Celsion is excited to evaluate ThermoDox® in combination with MR-HIFU as a next generation, non-invasive treatment for a variety of cancers; a logical step to expand ThermoDox's great potential in oncology. FDA's clearance to clinically study the combination of ThermoDox® and MR-HIFU is a cornerstone of this joint Celsion/Philips effort," said Michael H. Tardugno, Celsion's president and chief executive officer. "As a recognized world leader in health care technology, Philips brings tremendous resources to this development pathway for ThermoDox®, optimizing its role in cutting edge medicine."
About ThermoDox® and Philips' Sonalleve MR-HIFU
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, being evaluated in multiple clinical trials. The lead program, known as the HEAT Study, a 700-patient Phase III clinical trial in patients with hepatocellular carcinoma, also known as primary liver cancer, is fully enrolled with data expected in the fourth quarter of 2012. Doxorubicin, ThermoDox's active agent, is an approved and frequently used oncology drug for the treatment of a wide range of cancers.
The Philips Sonalleve MR-HIFU system is currently commercially available in Europe and some other countries for the treatment of uterine fibroids, a prevalent condition in women of childbearing age and palliative treatments to relieve pain associated with bone metastasis. It is not available for sale in the USA.
For more information about Philips' Sonalleve MR-HIFU see: www.philips.com/sonalleve.
About Royal Philips Electronics
Royal Philips Electronics (NYSE: PHG) (AEX: PHI) is a diversified health and well-being company, focused on improving people's lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2011 sales of EUR 22.6 billion and employs approximately 122,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming, portable entertainment and oral healthcare. News from Philips is located at www.philips.com/newscenter.
About Celsion Corporation
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license, or commercialization agreements with leading institutions including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital and the University of Oxford.
For more information on Celsion, visit our website: http://www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers 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 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.
Celsion Investor Contact
Philips Media Contact
Tel: +1 (425) 487-7479
Source: Celsion Corporation
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