DUSA Pharmaceuticals reports completion of Phase III Levulan PDT patient enrollment/treatment.TORONTO--(BUSINESS WIRE)--May 22, 1997--DUSA Pharmaceuticals, Inc. (NASDAQ/NMS:DUSA DUSA Deputy Under Secretary of the Army DUSA Deakin University Student Association DUSA Dundee University Students' Association (Scotland) DUSA Designated Unclassified Subject Area ) announced today that patient enrollment is now complete for its pivotal Phase III clinical trials using Levulan(TM) Photodynamic Therapy photodynamic therapy n. A type of phototherapy in which a nontoxic light-sensitive compound that has been injected into a patient is exposed selectively to light, whereupon it becomes toxic to targeted malignant and other diseased cells. (PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT ) for pre-cancerous actinic actinic /ac·tin·ic/ (ak-tin´ik) producing chemical action; said of rays of light beyond the violet end of the spectrum. ac·tin·ic adj. keratoses (AKs) of the skin. Investigators conducting the two identical AK phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials at 16 sites across the U.S. have now enrolled and treated a total of more than 200 patients, each with 4 to 15 AKs, for a total of between 800 and 3,000 AKs. Each patient is followed after treatment for 3 months to determine safety and efficacy, including a re-treatment if necessary after 8 weeks. Once all patients have completed follow-up, the data will be collected and analyzed for incorporation into DUSA's first planned filing of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) to the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ), expected to occur by late '97/early '98(1). In Phase II studies, DUSA has previously reported up to 90 to 100% complete clinical clearance of AKs with Levulan PDT, using one or two treatments respectively. Although these and other Phase II trials do not guarantee similar results in Phase III, the Company is optimistic about the outcome of the current trials(1). DUSA Pharmaceuticals, Inc. is a development stage pharmaceutical company engaged primarily in the development of light-activated Levulan PDT and PD for multiple therapeutic or diagnostic medical indications. DUSA is a world leader in topically or locally applied PDT and PD. The Company is incorporated in New Jersey, with executive offices in Toronto, Ontario, and R&D administration in Tarrytown, New York Tarrytown is a village in Westchester County, New York, United States. The population was 11,090 at the 2000 census. The Village of Tarrytown is located in the northwest part of the Town of Greenburgh, New York. . Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties, which may cause actual results to differ materially from the statements made. Such factors include, but are not limited to, changing market conditions, the progress of clinical trials and the results obtained, the establishment of new corporate alliances, the impact of competitive products and pricing, the timely development of light devices for several indications, FDA approval and market acceptance of the Company's products, and other risks detailed from time to time in the Company's United States Securities and Exchange Commission (SEC) filings. These statements are marked by "(1)." CONTACT: DUSA Pharmaceuticals, Inc. D. Geoffrey Shulman, MD, 416/363-5059 Fax: 416/363-6602 or Sunrise Financial Group Derek Caldwell, 212/421-1616 Fax: 212/421-5944 |
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