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Biotech / Medical : Pharmacyclics (PCYC) -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (491)	8/25/1999 10:54:00 PM
From: squetch	Read Replies (1) \| Respond to of 717

ex2.excerptamedica.com Antrin photoangioplasty: results of a phase I trial of a novel therapeutic modality in patients with lower extremity arterial atherosclerosis P. Kramer, S. Rockson1, M. Razavi1, D. Adelman2 MidAmerica Heart Institute, Kansas City MO1Stanford University Medical Center, Stanford, CA 2Pharmacyclics, Inc., Sunnyvale CA, United States Lutetium Texaphyrin (Antrin) is a photesensitizing expanded porphyrin that is avidly taken up by atheromatous plaque. The safety, tolerability, and preliminary efficacy of Antrin photoangioplasty (PA) was assessed in a Phase I dose-ranging clinical trial in patients with claudication due to atherosclerotic stenosis of the iliac or superficial femoral arteries. Antrin was given IV over 5 min at doses of 1, 2, 3, 4, or 5 mg/kg. Photoillumination with laser-generated far-red light at 732 nm was performed using an optical fiber with a 3 cm diffusion tip centered over the target lesion at fluence rates of 425, 531, 664, or 830 mW/cm. Pharmacokinetics were assessed with timed plasma sampling. Quantitative angiography and intravascular ultrasound (IVUS) of the target lesions were performed at baseline and 28 days after treatment. Doses of drug and light were escalated in cohorts of 3 pts. In the absence of dose-limiting toxicity, drug or light doses were increased in subsequent cohorts. To date, 34 pts have been enrolled, and follow-up angiography and IVUS have been completed and analyzed in 23. In 15 (65%) of these 23 pts, there was >10% improvement in MLD or cross-sectional area by quantitative angiography and IVUS, respectively. There have been no major symptomatic, angiographic, or biochemical adverse effects of Antrin PA. Conclusions: These preliminary results strongly suggest that Antrin photoangioplasty is a novel, safe, well-tolerated, nontraumatic, and effective treatment for atherosclerotic obstruction of the iliac and superficial femoral arteries. The results of the completed trial will be presented.