DUSA Pharmaceuticals reports 90 - 100% efficacy in Phase II clinical trial results.MISSISSAUGA, Ontario--(HealthWire)--May 14, 1996--DUSA Pharmaceuticals Inc. (NASDQAQ 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 (1) (Digital Signal Processor) A special-purpose CPU used for digital signal processing applications (see definition #2 below). It provides ultra-fast instruction sequences, such as shift and add, and multiply and add, which are commonly used in math-intensive ) reported positive Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II results today of its topical ALA Photodynamic Therapy (ALA PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT ) for precancerous, 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) of the face and scalp. This study represents the first use of the DUSA non-laser blue light source, which can treat an entire face or scalp at once. With data available on 36 patients, at the optimal light dosage, approximately 90% of treated AKs cleared completely after a single treatment. The few remaining lesions cleared after a second treatment, leading to an overall complete response rate of 100% at that dosage. The overall placebo response rate was 26%. In the study, thirty six patients had four discrete lesions of the face or scalp randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to receive 20% ALA solution or placebo. The patients then were randomized to receive a specified light dose to all four lesions simultaneously, using DUSA's proprietary light source. An investigator who was unaware of the patients' treatment, then made objective measurements of the lesions at weeks 1, 4, and 8. If lesions remained at week 8, they were treated again, and re-examined at weeks 12 and 16. Following ALA PDT, AK lesions turned red and became slightly swollen. Over the next week, the lesions developed a light scale which flaked away, leaving the site smooth, with an excellent cosmetic result. As expected, during PDT, when the drug was activated by light, patients reported mild to moderate discomfort, described as a "burning or stinging" sensation at the lesion sites. The discomfort was self limiting in its duration, required no intervention and did not cause any of the patients to interrupt therapy. No additional side effects were reported. The optimum light dose defined from this study is being used to treat patients in a new Phase IIb study at seven clinical sites in the United States. 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. CONTACT: DUSA Pharmaceuticals Inc. D. Geoffrey Shulman, 905/677-4554 or Sunrise Financial Group Derek Caldwell, 212/421-1616 |
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