DUSA Pharmaceuticals, Inc. initiates Phase IIb clinical trial on acting keratosis.MISSISSAUGA, Ontario--(BUSINESS WIRE)--July 17, 1995--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 DUSA Deputy Under Secretary of the Army DUSA Deakin University Student Association DUSA Dundee University Students' Association (Scotland) DUSA Designated Unclassified Subject Area ; TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). ; DSP) - reported today that it has initiated a Phase IIb clinical study at the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). Irvine (UCI) using the company's ALA Photodynamic Therapy (PDT) in 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 (AK), a common pre-cancerous skin condition, resulting in over 3 million physician visits per year in the United States. AK primarily affects adults who are susceptible to sun damage, and who have had significant sun exposure over the years. In completed Phase I/IIa studies directed by Dr. Gerald Weinstein, head of the Department of Dermatology at UCI, a total of 230 individual AK lesions were treated on 39 patients. In 31 lesions treated at the highest drug dosage, over 90% achieved complete or partial clearing after only one treatment. This new Phase IIb trial, uses a standardized concentration of ALA solution, and exposure to a new proprietary, non-laser blue light source, with 1 or 2 treatment sessions. Additional centers in Florida and Chicago are set to start in the near future. This study is expected to lead to Phase III trials starting early in 1996, followed by DUSA's 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 ), planned for the end of 1996. Dr. Geoffrey Shulman, president of DUSA and a board certified dermatologist, stated, "For the treatment of multiple AKs, we believe ALA PDT will provide a significant advance in therapy for both patients and dermatologists compared to current topical alternatives, which have to be used for a number of weeks, and tend to be highly irritating." DUSA Pharmaceuticals, Inc. is a development stage New Jersey company, with worldwide rights to ALA PDT, an experimental treatment for skin cancers, pre-cancers psoriasis and other skin and internal disorders. This treatment combines the use of a pharmaceutical compound with exposure to light to induce a therapeutic effect. DUSA's clinical trial program has made it a leader in the field of dermatological PDT. CONTACT: DUSA Pharmaceuticals, Inc., Mississauga D. Geoffrey Shulman, MD 905/677-4554 905/677-5494 (fax) or Sunrise Financial Group, New York Derek Caldwell 212/421-1616 212/421-5944 (fax) |
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