Intro: Celsion For New Investors
This compilation of product data is simply a cut a paste job from Celsion’s web site. It is basically a collection of the press releases categorized by product. It is not intended to replace that healthy DD that you usually do do. If anything appears to be taken out of context it was unintended. Suggestions welcome. I have numbered the products according to Celsions description on their home page.
VISION
By the year 2002, Celsion will be one of the foremost companies in the fight against cancer by giving patients hope that is warranted. That success will be the result of Celsion's ability to safely target and ablate (kill) tumors deep in the body. This will be accomplished by Celsion's unique patented technology from MIT that enables heat to be focused anywhere within the body. In addition we will bring a break-through technology for the treatment of benign prostatic hyperplasia (BPH) to market in the year 2002.
MISSION
Celsion's mission is to commercialize practical means of applying focused heat alone or in combination with chemotherapy and radiation therapy for cancer therapeutic purposes. These will be the most effective, highest quality medical treatment systems available. Our philosophy is to provide minimally or non-invasive, non-toxic treatments of maximum efficacy significantly exceeding those provided by competition. We will similarly treat BPH with a unique method of focused heat.
We intend that the cancer treatment systems consisting of Celsion's new proprietary equipment, based on deep focused heat, will ultimately enable all of the following:
the eradication of tumors when used alone or combined with radiation or chemotherapy targeted drug delivery via heat sensitive liposomes to deposit at least 50 times more chemotherapeutic drug at tumors than current treatments gene therapy to significantly improve the results of radiation and chemotherapy on tumors ultimately, the means of curing inflammatory, infectious and genetic diseases with targeted chemotherapy and gene therapy delivered by heat sensitive liposomes
STRATEGY
The Company's objective is to establish itself as an industry leader in the development and marketing of clinically effective, minimally invasive microwave thermotherapy systems for cancer, and other diseases. Hospitals, Clinics, HMOs and pharmaceutical companies employing Celsion's deep focused heat and targeted drug delivery systems will acquire Celsion's equipment at a minimal cost and will pay for utilizing Celsion's treatment services, disposable products or delivery systems - on a per use basis. Company revenues will come from sales of disposable products to the provider; from a sharing of medical treatment revenues with the provider; or from licensing fees charged to drug companies for targeted drug delivery and gene therapies. Celsion's deep focused heat technology positions the Company uniquely for large- scale, long-term growth.
(1) Deep cancer treatment and other product news that does not make references, by name, to BHP, and breast or prostrate cancer treatment
Celsion's deep cancer treatment system also uses the focused heating adaptive phased array method and is designed to safely eradicate tumors deep within the body without harming superficial tissues. The system is designed to target tumors in the liver, rectum, cervix, pancreas, lung, and other areas deep within the torso. The adaptive phased array deep cancer treatment system is designed to increase the effectiveness of radiation therapy and chemotherapy by about a factor of two without any added side effects. The Celsion deep cancer treatment system prototype is currently under development. Once the prototype machine is completed, clinical trials will begin at Duke and Northwestern Universities, the latter of which is currently conducting pre-clinical research on the adaptive phased array technology under a licensing agreement with the Massachusetts Institute of Technology (MIT).
Adaptive Phased Array Technology
Celsion's deep focused heat systems for the treatment of breast cancer, prostate cancer, and other deep-seated cancers of the body incorporate proprietary, patented, adaptive phased array (APA) technology which was originally developed by MIT for use in spaceborne radar surveillance systems for the Department of Defense's Star Wars project. Celsion holds an exclusive worldwide license agreement with MIT for the commercialization rights of the APA technology.
Time Line (press releases)
September 26, 1997 - receives premarket approval from the FDA's Center for Devices and Radiological Health for a design change to integrate a patented technology using adaptive phased array and nulling with the company's Microfocus 1000 hyperthermia cancer treatment system. celsion.com
June 17, 1998 - initiation of a sponsored research alliance with Duke University Medical Center to develop a new family of heat-activated targeted drug delivery, gene therapy, and anti-angiogenesis systems. Celsion holds the exclusive right to negotiate worldwide licenses of technologies developed through the alliance. celsion.com
November 18, 1998 - Massachusetts Institute of Technology has receives a U.S. patent for its thermodynamic adaptive phased array (APA) system which is designed to activate thermosensitive liposomes in order to achieve targeted drug and gene delivery for the treatment of localized diseases. The newly patented technology is exclusively licensed to Celsion. celsion.com
November 15, 1999 - signs an exclusive license agreement for the commercial rights to utilize Duke's proprietary heat- sensitive liposome technology (patent pending) for targeted delivery of drugs in the treatment of cancer and other diseases. If successfully developed and proven in human clinical trials, these second generation heat-sensitive liposomes may lead to significant improvement in effective delivery of chemotherapeutic drugs to fight cancer. The company said that Duke has agreed to accept shares of Celsion's Common Stock in lieu of cash for milestone payments under the terms of the agreement. celsion.com
May 23, 2000 - signs an exclusive world-wide agreement with Memorial Sloan-Kettering Cancer Center for the commercial rights to a heat activated gene therapy technology for treating cancers. celsion.com
January 31, 2001 - The National Institutes of Heath (NIH) intends to conduct pre-clinical evaluations for using Celsion's temperature sensitive liposomes in addition to radio frequency ablation hyperthermia for the local control of liver tumors. Celsion has signed a Material Transfer Agreement (MTA) to supply NIH with sufficient quantities of temperature-sensitive, drug-laden liposomes to conduct pre-clinical and clinical evaluations. Celsion also plans to supply NIH with a dedicated heating system for study of liver tumors in the near future. celsion.com
March 27, 2001 - announces it has been issued a key patent by the United States Patent Office, Patent No. 6,200,598, that supports its efforts to develop a highly promising drug delivery system. This drug delivery system potentially has application to prostate, liver, ovarian and other cancers. celsion.com
(2) Breast Cancer Treatment System
The Celsion breast cancer treatment system is designed to treat patients with small, medium, and large breast tumors. The system's ability to treat tumors of a range of sizes provides the potential to help a significant percentage of breast cancer patients. The treatment system uses minimally-invasive, adaptive microwave phased array technology to safely deliver controlled deep heating in tissue to eradicate breast tumors without harming superficial and surrounding healthy breast tissues.
Pre-Clinical Studies: Celsion recently completed pre-clinical trials of its prototype clinical breast cancer treatment system at the Massachusetts General Hospital (MGH), the research hospital of Harvard Medical School in Boston, Massachusetts.
Animal tests have verified that Celsion's APA deep-focused heat technology accurately focused heat, making it possible to ablate tumors with the Celsion system.
A second prototype clinical breast cancer treatment system at Oxford University in England was used to successfully conduct focusing tests on large animals.
Clinical Trials Status - Phase I and II: In January 1999, Celsion received Investigation Device Exemption (IDE) approval from the FDA for its breast cancer treatment system which uses heat alone to ablate breast tumors and viable cancer cells in the tumor vicinity.
The IDE approval enabled Celsion to proceed with Phase I clinical safety and feasibility studies in 1999, 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.
In October 1999, Celsion installed its breast cancer treatment system at a Columbia/HCA member hospital in West Palm Beach, Florida, which has recruited patients for Phase I clinical studies of Celsion's system.
Patients were also recruited for Phase I clinicals of Celsion's breast cancer treatment system at Harbor UCLA Medical Center in California. On August 1, 2000, Celsion announced that all 10 patients required to complete the Phase I clinical trial for its patented Breast Cancer Treatment System had been treated.
In December 2000, Celsion Corporation announced that the FDA approved Phase II clinical studies of its investigational breast cancer treatment system, which addresses both large and small breast cancers. In January 2001, Celsion Corporation announced that it had received medical device agency (MDA) approval to begin clinical studies of Celsion's breast cancer treatment system in England.
Time Line (press releases)
April 22, 1998 - shipped the first commercial version of its enhanced breast cancer treatment system to Massachusetts General Hospital (MGH).
celsion.com
May 12, 1998 - researchers from Hammersmith Hospital in London, England successfully conclude an initial study using Cheung's newly developed breast cancer treatment system. The in vivo study, which evaluated the system's ability to heat deep tissue in a large animal model, confirmed the system's safety and effectiveness.
celsion.com
January 29, 1999 - receives 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. celsion.com
February 3, 1999 - completes a $1 million private placement to be used by the Company, among other things, to conduct phase one clinicals of its breast cancer and benign prostatic hyperplasia (BPH) treatment systems. celsion.com
(Phase one clinicals of the Company's breast cancer treatment system are planned to commence at Massachusetts General Hospital (MGH) during the spring of 1999.
February 16, 1999 - Massachusetts General Hospital (MGH) files a patent application for a system designed to offer a minimally invasive alternative to mastectomy.
celsion.com
August 16, 1999 - receives approval from FDA to commence Phase I clinical studies at two new sites to evaluate the Company's focused heat breast cancer treatment system. celsion.com
October 12, 1999: In conjunction with Columbia/HCA Healthcare Corp., installs its breast cancer treatment system at a Columbia/HCA member hospital in West Palm Beach, Florida, which is now recruiting patients for Phase I clinical studies of Celsion's system. celsion.com
December 7, 1999 - Harbor UCLA Medical Center in California recruiting patients for Phase I clinical trials of Celsion's breast cancer treatment system. Additional Phase I testing began in October at a Columbia/HCA member hospital in Florida to expedite patient accrual and accelerate the trials. celsion.com
August 1, 2000 - announces all 10 patients required to complete Phase I Clinical Trials for its patented Breast Cancer Treatment System have been treated. Phase I Clinical Trials are designed to test the feasibility and safety of the treatment system.
The Company expects, within 45-60 days, to report results to the FDA and apply for permission to begin the final and pivotal Phase II multi-center trials necessary to obtain approval for commercialization. celsion.com
November 9, 2000 - announces that it has filed an application with the FDA to begin Phase II clinical trials of its breast cancer treatment system. celsion.com
December 11, 2000 - announces that the FDA has approved its application to proceed with Phase II clinical studies of its investigational breast cancer treatment system, which addresses both large and small breast cancers. celsion.com
January 11, 2001 - announces that the Medical Device Agency, a regulatory agency of the government of the United Kingdom, has granted the Company's investigational breast cancer treatment system medical device approval (MDA) to commence Phase II trials. Clinical trials will be conducted at Hammersmith Hospital in London, upon approval by the hospital's internal review board. This is a critical step toward CE labeling, a product approval necessary for use of Celsion's breast cancer treatment system in the European Community. celsion.com
(3) BPH System
Celsion's patented benign prostatic hyperplasia (BPH) system overcomes the problem of enlarged prostates in two ways. First, a unique microwave balloon catheter delivers transurethral microwave heating which shrinks the prostate and is anticipated to yield long term treatment benefits. Second, the balloon catheter is simultaneously expanded and compresses the urethra wall. The combination of microwave heat and balloon catheter compression created in animal tests a natural biological stent in the urethra, and is expected to provide immediate relief of urinary obstruction in clinical trials.
Clinical Trials Status - Phase I and II: The FDA approved Celsion's IDE in June 1998, and Phase I clinical feasibility human trials of its BPH system began at the Montefiore Medical Center in November 1998. This pilot study was completed in May 1999. The FDA granted an expanded Phase I study using a revised protocol in September 1999. In July 2000, the FDA approved Phase II multicenter clinical trials for its BPH treatment system. The Phase II trials commenced at the Montefiore Medical Center in New York City in October 2000 and other sites were added to the trials early in 2001.
Time Line (press releases)
March 26, 1997 - delivers newly developed BPH treatment system to the Montefiore Medical Center for preclinical evaluations. celsion.com
Feb. 11, 1998 - obtains the exclusive commercialization rights for two patents pertinent to radiometric temperature sensing technologies as part of its Benign Prostatic Hyperplasia (BPH) treatment system. celsion.com
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Feb. 18, 1998 - receives the results of preclinical evaluations of its patented Benign Prostatic Hyperplasia (BPH) treatment system. The experiments were conducted at the Montefiore Medical Center in New York City. celsion.com
April 27, 1998 - filed an Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA) in order to commence clinical studies of its benign hyperplasia (BPH) treatment system. celsion.com
June 1, 1998 - FDA approves the Company to commence phase one clinical trials of its patented benign prostatic hyperplasia (BPH) system. celsion.com
October 14, 1998 - receives the necessary funding and regulatory approval to commence phase one clinical studies in patients of its microwave heating and balloon compression system that offers non-surgical treatment of benign prostatic hyperplasia (BPH). celsion.com
February 3, 1999 - completes a $1 million private placement to be used by the Company, among other things, to conduct phase one clinicals of its breast cancer and benign prostatic hyperplasia (BPH) treatment systems.
celsion.com
May 3, 1999 - Montefiore Medical Center in Bronx, NY completes the Phase I clinical study of the Company's benign prostatic hyperplasia (BPH) treatment system.
celsion.com
September 10, 1999 - receives FDA approval for use of the Company's most recent benign prostatic hyperplasia (BPH) treatment protocol in an expanded Phase I BPH study of 20 patients based upon the results of the initial 10 patients treated. celsion.com
December 20, 1999 - initial patients treated in both the Phase I clinical studies for its breast cancer treatment system and its expanded Phase I clinical studies for its benign prostatic hyperplasia (BPH) system. Phase I clinical trials are designed to evaluate the feasibility and safety of these systems in patients. celsion.com
April 11, 2000 - completes an expanded Phase I Human Clinical Trial testing the safety of a 45-minute outpatient procedure designed to offer rapid relief to patients suffering from BPH - a prostate disease which impairs the ability to urinate of more than 50% of men over the age of 55. celsion.com
June 23, 2000 - applies to the FDA for approval to begin Phase II clinical trials of its BPH treatment system. celsion.com
July 24, 2000 - application approved. celsion.com
October 18, 2000 - announces that the pivotal Phase II multi-center trial for the Company's low heat/out-patient treatment system for Benign Prostatic Hyperplasia (BPH) has begun. celsion.com
May 18, 2001: Due to the high level of interest by urologists in participating in its Benign Prostatic Hyperplasia (BPH) pivotal Phase II clinical trials, the Company requests FDA approval to expand the number of test sites from six to ten.
celsion.com
(4) Prostate Cancer Treatment System
The Celsion prostate cancer treatment system operates in much the same way as the Celsion BPH treatment system. The system is minimally invasive and uses microwave applicators designed to safely eradicate prostate cancer without harming surrounding healthy tissues. The prostate cancer treatment system is designed to increase the effectiveness of radiation seed implant therapy by about a factor of two without any added side effects.
Preclinicals at UCSF
On December 1, 1999, Celsion initiated a sponsored research program with the University of California at San Francisco (UCSF) for preclinical evaluation of Celsion's focused heat prostate cancer treatment system.
UCSF scientists will conduct preclinical studies of Celsion's prostate cancer treatment system using focused heat in conjunction with radiation seed implant therapy. If the UCSF studies are successful, Celsion will apply to the FDA for approval to begin human clinical trials in order to obtain the safety and efficacy data necessary to apply for FDA Premarket Approval (PMA).
The PMA approval will enable Celsion to proceed with commercialization in the $6 billion prostate cancer treatment market in the U.S.
Time Line (press releases)
March 25, 1999 - acquires from MMTC, Inc., a Princeton, NJ-based developer of microwave technologies, the exclusive worldwide rights to commercialize MMTC's patented microwave heat and compression technology for prostate cancer treatment.
celsion.com
December 1, 1999 - initiates a sponsored research program with the University of California at San Francisco (UCSF) for preclinical evaluation of Celsion's focused heat prostate cancer treatment system. celsion.com
May 7, 2001 - National Cancer Institute (NCI) of the National Institutes of Health (NIH) agrees to support further development of technology licensed to Celsion for the treatment of prostate cancer. celsion.com |
