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GelStat Corporation Completes Patient Enrollment in Clinical Trial of GelStat Migraine in Triptan Users

Posted on: Thursday, 2 December 2004, 09:00 CST

MINNEAPOLIS, Dec. 2 /PRNewswire-FirstCall/ -- GelStat Corporation (OTC Bulletin Board: GSAC) today announced that it has completed patient enrollment in a clinical trial of GelStat(TM) Migraine. Patients enrolled were those who routinely use a triptan for the treatment of their migraine headaches.

The multi-center, open-label clinical trial is designed to evaluate the efficacy and cost effectiveness of GelStat Migraine in a triptan reliant population. After a one month baseline evaluation during which triptan use and clinical outcomes are recorded, patients use GelStat Migraine for two months as an early intervention, first line therapy, recording clinical outcomes and employing triptans only as needed.

Approximately half the enrolled patients have now completed the protocol, with the remainder expected to complete the study in less than three months. It is expected that 60 patients at four centers will treat nearly 250 migraine headaches with GelStat Migraine during the course of the trial.

"We are pleased to have completed yet another important milestone in our clinical program for GelStat Migraine," said Stephen Roberts, M.D., chairman and chief executive officer of GelStat. "We are confident that GelStat Migraine performs well, even among this most difficult patient population."

Americans spend approximately $3 billion each year on prescription medications for the treatment of migraine headaches, primarily on triptans such as sumatriptan (Imitrex(R)), presently considered the "gold standard" in migraine therapy.

An effective OTC treatment that substantially reduces the need for prescription medications should be welcomed by patients, health care providers and employers, as the cost of present medications creates a tremendous burden on each of these groups. In addition, concerns over side effects cause approximately two-thirds to delay or avoid prescription use and result in nearly 8 of 10 patients actively seeking a novel product with similar efficacy but fewer such adverse side effects.

"Our confidence in the performance of GelStat Migraine as well as our commitment to providing solid clinical data should be apparent from this trial comparing GelStat Migraine with the "gold standard" of migraine therapy," said Dr. Roberts. "We believe GelStat Migraine offers a number of unique advantages over other presently available medications, and that while no single medication presents all the answers, GelStat Migraine can be an important part of treatment for a large majority of those with migraine. We intend to continue building the scientific and clinical case for GelStat Migraine until it achieves broad acceptance in both the medical and patient communities."

About GelStat Migraine

GelStat Migraine is a new, patent pending OTC medication for acute relief from the pain and associated symptoms of migraine and migraine-like headaches. Over 90 percent of 30 million Americans with migraine employ OTC medications as part of their treatment arsenal and nearly 60 percent rely exclusively on OTC medications. In general, older OTC headache medications are based on aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) with these agents reported to exhibit an effect in approximately 25 percent of those with moderate to severe migraine. Americans spent an estimated $2.6 billion last year on over 600 million units of OTC headache medication.

The initial clinical trial of GelStat Migraine showed it to be effective for 83 percent of those with moderate to severe migraine. Migraine pain was completely eliminated in 48 percent of patients and was arrested at the mild pain phase in 35 percent. Though all of the patients enrolled in that study were those whose migraine consistently progressed to moderate or severe headache pain, after treatment with GelStat Migraine at the mild pain phase only 17 percent went on to develop moderate pain and 0 percent (none) developed severe pain. In addition, GelStat Migraine effectively relieved the associated symptoms of migraine such as nausea, photophobia and phonophobia. Side effects were reported as mild and infrequent, primarily that users did not like the taste of the medication. Further details regarding this initial clinical trial are available on the Company's website (http://www.gelstat.com/)

About GelStat Corporation

GelStat Corporation is a consumer healthcare company dedicated to the cost-effective development and marketing of advanced OTC health care products. Development efforts are focused on very large markets where GelStat products can offer improved efficacy, safety, and/or convenience over existing OTCs.

The Company has announced plans to introduce "GelStat(TM) Sinus", "GelStat(TM) Arthritis" and "GelStat(TM) Sleep", and believes that each of these products performs well and is effective for its intended use. The National Institute of Allergy and Infectious Disease estimates that 37 million Americans are affected by sinusitis every year. Between 40 and 70 million Americans have some form of arthritis according to the National Institutes of Health. Approximately 70 million Americans are reported to be "problem sleepers".

The Company has also recently announced the formation of a wholly owned subsidiary, "GS Pharma, Inc." to pursue various pharmaceutical (prescription drug) opportunities that are believed to exist relative to the Company's intellectual property and now ongoing research and development work. The direct commercialization and development of these opportunities is believed to be beyond the scope of activity reasonably possible for GelStat Corporation in the foreseeable future. Therefore, in the interest of maximizing shareholder value, the Company is at present investigating several potential opportunities with regard to this subsidiary and what it believes to be prescription pharmaceutical opportunities.

For more information on GelStat Corporation, please visit http://www.gelstat.com/

Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statement other than a statement of historical fact should be considered a forward- looking statement. Such forward-looking statements are based on the Company's current expectations and involve known and unknown risks, uncertainties, or other factors which may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Risks, uncertainties and assumptions include, but are not limited to, the possibility that clinical trial results may be other than as expected, or entirely unfavorable, and that the market for the sale of certain products, or all products, may not develop as expected, or at all. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation and does not intend to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect unanticipated events or developments.

Contact:

Media Inquiries:

Tony Carideo

The Carideo Group, Inc.

612-317-2880

Investor Relations:

Brock Malky Insight Capital

724-453-1800

GelStat Corporation

CONTACT: Tony Carideo, Media Contact of The Carideo Group, Inc., +1-612-317-2880; or Brock Malky, Investor Relations Contact of Insight Capital,+1-724-453-1800, both for GelStat Corporation

Web site: http://www.gelstat.com/

Source: PRNewswire-FirstCall

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