DUSA BEGINS PHASE III ACTINIC KERATOSIS CLINICAL TRIAL; FOLLOWS END OF PHASE II FDA MEETING.TORONTO, Ontario--(BUSINESS WIRE)--Dec. 4, 1996--DUSA Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on NMS See NetWare Management System. : DUSA) reported today the initiation of the Company's first Phase III clinical pivotal trials, using DUSA'S ALA Photodynamic Therapy for the treatment of multiple 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). The start of the trials follows a recent end of Phase ll meeting with the 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. . The two multi-center trials are being conducted at 13 leading US dermatology research centers. Each investigator-blinded, vehicle-controlled trial will include 100 patients, with each patient having 4 to 15 AKs of the face or scalp. Patients will be treated with 20% ALA topical solution from a unique unit-dose applicator ap·pli·ca·tor n. An instrument for applying something, such as a medication. applicator, n a device for applying medication; usually a slender rod of glass or wood, used with a pledget of cotton on the end. and a fixed dose of non-laser blue light using DUSA's proprietary light source. In the Company's completed Phase II trials, this combination resulted in 90% complete clearing of the lesions with one treatment, and 100% with two treatments. Dr. Geoffrey Shulman, DUSA's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , stated "We are delighted to be entering the last phase of clinical trials for AK, the Company's first indication, keeping DUSA on track for its first 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 filing targeted for late '97. The Company is also continuing its active development programs in bladder cancer diagnosis, hair removal, acne and endometrial ablation." DUSA Pharmaceuticals, Inc. is a development stage New Jersey pharmaceutical company engaged primarily in the development of ALA Photodynamic Therapy ("PDT") and Photodiagnosis ("PD") for multiple medical indications. PDT and PD utilize light-activated compounds such as ALA to induce a therapeutic or diagnostic effect. DUSA is a leader in topically or locally applied PDT and PD. - Please note that DUSA Pharmaceuticals has relocated its Executive Offices to 181 University Avenue, Suite 1208, Toronto, Ontario M5H 3M7. Phone number: 416.363.5059; Fax 416.363.6602. 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, 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. CONTACT: DUSA Pharmaceuticals, Inc. D. Geoffrey Shulman, MD, FRCPC FRCPC Fellow of the Royal College of Physicians and Surgeons of Canada , 416/363-5059 or Sunrise Financial Group Derek Caldwell, 212/421-1616 |
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