Duke Breast cancer trial

http://www.pratt.duke.edu/pratt_press/web.php?sid=441&iid=51

Good luck and God bless,

George

CELSION Provides Update on Status of Special Protocol Assessment (SPA) Submission
Columbia, MD - November 5, 2007: CELSION CORPORATION (AMEX: CLN) today is providing an update to its SPA application for Primary Liver Cancer.

Celsion Corporation has received comments this morning from the FDA regarding its September request for a special clinical protocol assessment for its study, "A Phase III, Randomized, Double-Blinded, Dummy-Controlled Study of the Efficacy and Safety of ThermoDox in Combination with Radiofrequency Ablation Compared to RFA-Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma." The comments from the FDA requested clarifications and recommendations to the study protocol and monitoring. On initial review, Celsion expects to satisfactorily address all of FDA comments and re-submit the protocol for formal special protocol assessment promptly.

"While we are disappointed that another review will be required", commented Michael H. Tardugno, president and chief executive officer of Celsion, "We recognize that the approval mechanism is iterative in nature. We believe the response made by FDA to our submission should not require any significant revisions to the study design. We will continue to work collaboratively with FDA with the intent of starting our study early next year."

The Company expects to discuss FDA's comments and its plans going forward during its third quarter conference call. The Company expects to announce the date and time of its conference call later today.

About Thermodox

ThermoDox is Celsion's proprietary heat-sensitive liposomal encapsulation of an approved and frequently used anti-cancer drug, doxorubicin which is used in the treatment of various cancers including breast cancer. Localized mild hyperthermia (39-42 degrees C) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

About Celsion:

Celsion is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems. Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, North Shore Long Island Jewish Health System. Additional information about Celsion Corporation can be found on the Celsion web site at 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.

Big News

Cytomedix Submits Cost Effectiveness Study For AutoloGel to CMS

What might have been!

BOSTON SCIENTIFIC PURCHASES ROCKY MOUNTAIN PROSTATE BUSINESS FROM HEALTHTRONICS, INC.
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Strategic acquisition of transurethral microwave therapy mobile provider

Natick, MA (October 2, 2007) -- Boston Scientific Corporation (NYSE: BSX) today announced that it has purchased the business of Rocky Mountain Prostate Center, a mobile provider for the treatment of benign prostatic hyperplasia (BPH, often referred to as enlarged prostate) from Healthtronics, Inc. Since 1997, Rocky Mountain Prostate Center has been providing mobile service support to the Urology community, utilizing the Prolieve Thermodilatation® System since 2005. The Prolieve System offers a dual-action technology using balloon dilatation to dilate the prostatic urethra and microwave heating to reduce the enlarged prostate tissue.
BPH affects many men over the age of 50 and can have a significant impact on quality of life, including a frequent need to urinate and pain or burning while urinating. Rocky Mountain Prostate Center provides the Urologist access to a mobile service to treat symptomatic BPH with the Prolieve System. Rocky Mountain Prostate brings the technology to the office and provides technical support during the procedure.
“The acquisition of Rocky Mountain Prostate allows Boston Scientific to reach and help more patients suffering from symptomatic BPH,” said Eric Goorno, President of Boston Scientific’s Urology/Gynecology business. “This purchase demonstrates Boston Scientific’s continued commitment to increasing the availability of microwave treatment for BPH throughout the United States.”

Celsion Bolsters Clinical Development Team
Thursday September 27, 9:43 am ET


COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX: CLN - News) today announced the appointment, effective October 1, 2007, of Nicholas Borys, M.D. to the position of Vice President and Chief Medical Officer. In this position Dr. Borys will manage the clinical development program for Celsion.
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Dr. Borys, who was most recently Chief Medical Officer at Molecular Insight Pharmaceuticals, Inc., has accumulated extensive experience in oncology and all phases of pharmaceutical development while holding increasingly senior positions at Taiho Pharma USA, Cytogen Corporation, Anthra Pharmaceuticals, Inc., Amersham Healthcare, Inc. and Hoffmann La-Roche Inc.

Dr. William Hahne, Celsion's Vice President, Clinical and Medical Affairs will collaborate with Dr. Borys on developing Celsion's clinical strategy for its current primary liver cancer and recurrent breast cancer at the chest wall pivotal programs. In addition, they will explore and identify additional indications for ThermoDox®, the company's proprietary heat activated liposomal formulation of doxorubicin, as well as other chemotherapeutic drugs, based on the company's unique heat activated liposome platform technology.

Michael H. Tardugno, Celsion's President and Chief Executive Officer commented, "We are delighted that Dr. Borys has joined our team. Dr. Borys has a wealth of clinical development experience with a strong focus on oncology, and will be very valuable to the company as it initiates its primary liver cancer pivotal study, and develops plans to advance the recurrent breast cancer at the chest wall program to a pivotal study."

Mr. Tardugno added, "Dr. Borys' addition is in line with our focus of building an organization with the clinical and scientific competencies to execute our strategy. Both Dr. Hahne and Dr. Borys have extensive experience in the oncology arena. The product of their collective strength and experience should prove to be a very valuable asset for Celsion."

12:30PM Celsion announces Acceleration Plans for Its Breast Cancer Phase I Study (CLN) 5.71 +0.06 : Co announces that it has reached agreement with investigators at Duke University to supplement the Phase I dose escalation study for recurrent breast cancer at the chest wall, currently being performed under an investigator I.N.D at Duke University, through the filing of a Company I.N.D using the same clinical protocol. Celsion plans to add up to three additional sites in the study.

Good news. Buyt remember that the proceeds to CLN wil;l be reduced by repayment of the $15M loan plus accrued interest. Even with this the news is very good.

BSX BUYING PROLIEVE

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070418:MTFH85733_2...

CLN +14% to 5.00 on news - CLN spiking on news - 9:24 AM EDT April 18, 2007
CELSION CORPORATION (AMEX:CLN) today announced that it has entered into an Asset Purchase Agreement under which Boston Scientific Corporation (NYSE:BSX) will purchase the Company's Prolieve assets for $60 million, subject to reduction under certain circumstances. The Asset Purchase Agreement contains customary terms and conditions, including approval by Celsion's stockholders.

Super new news

http://biz.yahoo.com/bw/070323/20070323005636.html?.v=1

CLN traded at $4.80 during After Hours. This moved up more than 5%. .

Very Nice Chart below: Scroll Down

CLN has had a nice steady rise to $4 the last couple of weeks. Management is buying which helps encourage price appreciation. Ask now at 4.15. Maybe it can get to $5 or $6 in the next few months. Jim

Feb 1, 2007
Urology Times E-News







A course of the investigational drug silodosin, 8 mg once daily for 12 weeks, was superior to placebo for the relief of both obstructive and irritative symptoms in men with BPH, two phase III studies showed. Secondary endpoints included improvement in maximum urine flow. Very rapid and statistically significant improvements were seen in both endpoints, researchers reported.

The agent preferentially binds to the alpha (1A) receptors in the prostate and bladder neck relative to cardiovascular-associated receptors, maximizing target organ activity and minimizing potential effects on blood pressure.

Silodosin was well tolerated in both studies, according to its manfucturer, Watson Pharmaceuticals. Incidences of cardiovascular- and blood pressure-related side effects, including dizziness and orthostasis, were low in both trials. As expected in highly uroselective (1A)-adrenoceptor antagonists, ejaculations with little or no semen were the most commonly reported side effect reported in the trials. The vast majority of these side effects were mild to moderate in intensity, and patient withdrawal from the trial was low.

looking like we have a large buyer buying every day

Celsion Reports on ThermoDox(TM) at American Society of Clinical Oncology Gastrointestinal Symposium
Monday January 22, 9:04 am ET
Researchers Report That 22 Patients Have Been Treated in a Phase I Study Using ThermoDox in Combination with Radiofrequency Ablation to Treat Patients with Unresectable Hepatic Malignancies with No Unexpected Toxicity


COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX:CLN - News) today reported that Dr. Bradford J. Wood, Chief, Interventional Radiology Research at the National Institutes of Health's National Cancer Institute presented the progress of a Phase I dose escalation study, using ThermoDox, to treat unresectable liver cancer. ThermoDox, a heat activated liposomal formulation of doxorubicin, in conjunction with Radiofrequency Ablation (RFA) was used with limited and manageable toxicity to treat 22 patients, 8 with primary hepatocellular carcinoma and 14 with metastatic liver cancer, at doses of up to 60 mg/m2. The study is being performed at the National Cancer Institute (NCI) as part of a Cooperative Research and Development Agreement (CRADA), under the leadership of Dr. Wood and Dr. Steven K. Libutti, Senior Investigator, Head, Tumor Angiogenesis Section, Surgery Branch, CCR, NCI; and at Queen Mary Hospital in Hong Kong under the leadership of Dr. Ronnie T.P. Poon, MD, Professor of Surgery, Faculty of Medicine at Queen Mary Hospital, University of Hong Kong. Dr. Wood presented the abstract and poster at the ASCO-GI meeting in Orlando, Florida.
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In the study, patients with up to 4 lesions ranging from 3 to 7 centimeters are eligible to receive ThermoDox at doses ranging from 20 to 70 mg/m2. The effect of the treatment on the diameter of the lesions is followed using MRI, PET and contrast enhanced CT scans taken pre-treatment and at one and three months post-treatment. Lesion diameters will be compared to those of other patients treated with RFA alone. This study, being carried out by Celsion and the NCI continues to enroll patients into the 60 mg/m2 treatment cohort.

Celsion has licensed the global rights to the temperature-sensitive liposome technology from Duke University where ThermoDox is also being used in this Phase I clinical study of patients with recurrent chest wall breast cancer under the care of Dr. Kim Blackwell, the principal investigator.

Dr. William Hahne, Celsion's Vice President of Research and Development, commented "We are pleased that dose in this study continues to escalate safely as clinical evidence suggests that a higher dose should result in increased efficacy. We are continuing to work with the FDA to finalize endpoints for a Phase III study in primary liver cancer, to be conducted by Celsion, in which we expect to initiate enrollment in 2007. This work will be used to refine tumor targeting and ultimately to improve the efficacy of drugs using our heat activated delivery system."

CLN: Awards Options to Michael Tardugno
Celsion Corporation (CLN) reported the grant of a stock option award to Mr. Michael Tardugno, who commenced employment with Celsion as its President and Chief Executive Officer today. As previously disclosed, the Board of Directors of Celsion approved the option grant to Mr. Tardugno effective as of January 3, 2007, to purchase 430,000 shares of common stock at a per share exercise price equal to the closing price of the common stock on The American Stock Exchange on January 3, 2007. The closing price on such date was $2.42.



The stock option granted to Mr. Tardugno vests in four equal annual installments commencing on the first anniversary of the grant date and is subject to forfeiture in the event of resignation or termination for cause prior to vesting.

bizjournals.com
Celsion stock up after study results
Wednesday January 3, 2:08 pm ET


Stock in biotechnology company Celsion rose as much as 13 percent after the company reported on experiments using its heat sensitive cancer treatment.
Columbia-based Celsion says scientists at Duke University used temperature-sensitive liposomes developed by Celsion in lab experiments with rodents, and found that heat, and the time at which heat was used, showed evidence of controlling the delivery of tumor killing drugs and their effectiveness.

It says the results were published Wednesday in the Journal of the National Cancer Institute.

Celsion has global licensing rights to the heat activated liposome technology. It is currently in Phase I clinical trials as a potential treatment for liver cancer and recurring breast cancer.

Celsion (AMEX: CLN - News) had $4.1 million in revenue last quarter, up 29 percent. The company cut its loses in half to $990,000, largely from resumed shipments of its prostate cancer treatment, Prolieve. The catheter kit was taken off the market for several months last year because of manufacturing defects.

News is doing the job. Now +24% to 2.36. Jim

bizjournals.com
Celsion stock up after study results
Wednesday January 3, 2:08 pm ET


Stock in biotechnology company Celsion rose as much as 13 percent after the company reported on experiments using its heat sensitive cancer treatment.
Columbia-based Celsion says scientists at Duke University used temperature-sensitive liposomes developed by Celsion in lab experiments with rodents, and found that heat, and the time at which heat was used, showed evidence of controlling the delivery of tumor killing drugs and their effectivenes

It says the results were published Wednesday in the Journal of the National Cancer Institute.

Celsion has global licensing rights to the heat activated liposome technology. It is currently in Phase I clinical trials as a potential treatment for liver cancer and recurring breast cancer.

Celsion (AMEX: CLN - News) had $4.1 million in revenue last quarter, up 29 percent. The company cut its loses in half to $990,000, largely from resumed shipments of its prostate cancer treatment, Prolieve. The catheter kit was taken off the market for several months last year because of manufacturing defects.

Published January 3, 2007 by the Washington Business Journal

its the value of the contract minus some debt divided by the total shares. so what is the story with this stock first is the pipe line some drugs moving forward nicely. Second is the stock is in the cell block with the AMEX for non compliance because the share price is to low. This will be fixed if we get FDA aproval, or win the las suit vs AMS, if we win the suit vs AMS BSX will exicute its option in my opinion. So the 2 catlist are the law suit and the new drugs.

Would appreciater an explanation of your $4.17 figure.

AP
SEC Charges Hedge Fund Over Shorting
Tuesday December 12, 3:19 pm ET
By Judith Burns, Dow Jones Newswires
SEC Charges Hedge Fund With Naked Short-Selling


WASHINGTON (AP) -- Federal regulators sued a Dallas-based hedge-fund manager Tuesday, alleging he pulled in more than $6.5 million of gains through illegal trading involving "naked" short sales of dozens of companies.
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Edwin Buchanan Lyon IV, the managing partner and chief investment officer of Gryphon Partners LP, was charged by the Securities and Exchange Commission on Tuesday, along with Gryphon and six other related firms based in Texas and Bermuda.

According to the SEC's complaint, filed in federal district court in Manhattan, from 2001 to 2004, Gryphon would engage in "naked" short sales, typically through Canada, after agreeing to invest in PIPE deals, or private investments in public equity.

The SEC also charged Gryphon with trading on inside information on at least four PIPE deals, involving Celsion Corp., Gentner Communications Corp., Manufacturers Service Ltd. and PhotoMedex Inc., by selling their shares short ahead of public announcement of the stock offerings. Lawyers advised Lyon not to engage in trading in advance of the deals, but he did it anyway, according to the SEC.

Short selling, which involves sales of borrowed shares in hopes of replacing them later at a lower price, is legal. So-called "naked" short selling occurs when the short seller doesn't borrow shares before selling them, a practice that was legal in Canada at the time.

The SEC claimed Lyon and Gryphon engaged in deceptive sales involving at least 35 companies that sought PIPE financing, after telling those firms that the hedge fund wouldn't sell or transfer the shares it acquired through the PIPE deals. The companies included Guilford Pharmaceuticals Inc., IntelliData Technologies Inc. and Heartland Oil & Gas Corp.

The SEC is seeking to have Lyon and Gryphon return their allegedly ill-gotten gains, with interest, and pay civil penalties.

"Insider trading and fraud by hedge funds continues to be a high priority for the commission," said Robert Kaplan, an assistant director in the SEC's enforcement division in Washington. He added that the agency will seek "substantial" penalties from the defendants.

The case isn't the SEC's first to target alleged manipulation involving PIPE deals and hedge funds, which are lightly regulated investment vehicles meant for the ultra-wealthy. Hedge fund manager Jeffrey Thorp and three hedge funds paid $15.8 million in March to settle SEC allegations of insider trading and illegal sales of shares involved in PIPE transactions.

Lyon isn't the first Gryphon manager to run afoul of the law, either. Former manager Jonathan Daws pleaded guilty in 2005 to charges of manipulating the price of penny stocks using information obtained from U.S. government sources. Daws was charged in a scheme that included former Federal Bureau of Investigation agent Jeffrey Royer; Royer's former girlfriend, Lynn Wingate; and former short-seller and Web site operator Anthony Elgindy.

Kaplan said the conduct alleged against Lyon and Gryphon was unrelated to the charges against Daws.

Ralph Ferrara, an attorney who represents Lyon and Gryphon, was traveling and couldn't be reached immediately for comment.

the value is in the BSX contract add another 4.17 to the stock price giving you aroung $7

Glad you started a board for this one. Im pretty confused about it. The conferance call was one of the worst ive heard in a long while. Only one question about meeting the conditions of its listing and they wouldnt answer how they plan on doing it.
The only ray of sunshine came a day after the CC when they announced they were back in business and shipping product again. How much is that worth to the stock price?

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AP
Celsion Launches Prolieve on FDA OK
Friday August 11, 11:21 am ET
Celsion Launches Prolieve Enlarged Prostate Treatment System on FDA Approval


COLUMBIA, Md. (AP) -- Medical device maker Celsion Corp. said Friday it started shipping a modified version of its enlarged prostate treatment system after the Food and Drug Administration approved a supplemental marketing application.
The Prolieve Thermodilation system uses microwaves to treat benign prostatic hyperplasia, a non-cancerous enlargement of the prostate. In late July, the agency accepted the marketing application.

At the end of the first quarter, the company switched manufacturers to reduce costs and because of a scaling up problem and had to reapply with the FDA.

Celsion will begin shipments to distributor Boston Scientific Corp.

Celsion shares rose 41 cents, or 19 percent, to $2.56 in morning trading on the American Stock Exchange. Shares have traded between $1.50 and $6.60 over the past 52 weeks. Boston Scientific shares added 58 cents, or 3.7 percent, to $16.28 on the New York Stock Exchange.