Pharmacyclics, Inc.
Sep 27, 1999
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Pharmacyclics Announces Antrin® Photoangioplasty Phase II Clinical Trial Patient Treated During Live Case Demonstration at TCT

Washington (PRNewswire)

September 27, 1999

Clinical Data Also Presented at Annual Meeting of Interventional Cardiologists

Pharmacyclics , Inc. (Nasdaq: PCYC), announced that a patient from its ongoing Phase II clinical trial of Antrin® (motexafin lutetium) photoangioplasty was treated during a live case demonstration at the 11th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium. Investigators also presented pre-clinical and clinical data indicating the potential benefits of Antrin photoangioplasty for the treatment of peripheral artery disease (PAD, i.e., blockages of the arteries in the lower extremities). More than 8,000 interventional cardiologists, radiologists and other related medical professionals attended the TCT Symposium this year.

The live case demonstration was performed by one of the Phase II clinical study investigators, Thomas M. Shimshak, M.D., associate director, Peripheral Vascular Division, The Carl and Edyth Lindner Center for Clinical Cardiovascular Research at the Ohio Health Center in Cincinnati, Ohio. Paul H. Kramer, M.D., clinical associate professor of medicine at the University of Missouri School of Medicine, the study's national principal investigator, also participated in the case. The patient was an elderly male with severe symptomatic PAD, who, according to the Phase II study protocol, will have a follow-up evaluation at 180 days.

"We demonstrated to this large audience that Antrin photoangioplasty is an innovative procedure that is easy to perform," said Shimshak. "We also highlighted its potential role in treating peripheral and coronary artery disease."

The Phase II clinical trial is a multi-center, randomized controlled study in 375 patients being conducted in the United States. It is designed to evaluate Antrin photoangioplasty as both a primary treatment for PAD and for the prevention of restenosis following balloon angioplasty. Patients will be randomized into one of three arms: two treatment arms and a control arm. The two treatment arms will evaluate different dosing regimens. The endpoints of the study will be measurable improvement at 180 days in angiography, ankle-brachial index (ABI), treadmill tests, intravascular ultrasound (IVUS) and Rutherford-Becker classification scores of clinical outcomes.

Investigators also presented laboratory and clinical data on Antrin photoangioplasty during the TCT Symposium. Daniel I. Simon, M.D., associate director of interventional cardiology at Brigham & Women's Hospital and assistant professor of medicine at Harvard Medical School in Boston, presented pre-clinical data regarding Antrin's mechanism of action. The data indicated that the combination of far red light (i.e., 732nm) and Antrin induces apoptosis of macrophages and impairs growth and proliferation of both macrophages and smooth muscle cells.

"This mechanism represents a novel, non-traumatic treatment approach to atherosclerosis," said Simon. "We are continuing these studies and plan to present the data in more detail at the American Heart Association meeting in November."

Results of the Phase I clinical study were also presented by Dean J. Kereiakes, M.D., medical director of the Lindner Center and professor of clinical medicine at the University of Cincinnati College of Medicine. The results indicated that Antrin photoangioplasty was safe, well-tolerated and showed evidence of clinical activity in patients with symptomatic PAD. These findings were presented for the first time last month at the 21st Congress of the European Society of Cardiology. Kereiakes reported that no adverse vascular responses were seen at 28 days following treatment with Antrin photoangioplasty. There was no evidence of vascular damage, thrombus, hemorrhage or dissection. No deleterious effects on normal vessel wall were observed. He also reported that Antrin photoangioplasty demonstrated clinical activity as measured by angiography, IVUS, ABI and Rutherford-Becker clinical outcome scores.

"We are excited about the potential applicability of this new therapy for the treatment of atherosclerotic diseases," said Kereiakes. "The ability of this agent to localize in atherosclerotic plaque may allow us to target specific areas of arterial blockage. We will learn much more about its potential benefits from the Phase II trial."

Antrin Injection is a water-soluble photosensitizing agent that accumulates selectively in vascular plaque and is cleared readily from the rest of the body. Traditionally, vascular plaque is treated with mechanical devices that physically reduce the plaque or maintain the blood vessel opening. Antrin is designed to reduce or eliminate vascular plaque using a non-mechanical technique called photoangioplasty. In photoangioplasty, Antrin is injected into the bloodstream, accumulating in the diseased portions of blood vessels. These targeted areas are then exposed to light, which is delivered by an optical fiber inserted into the vessel using standard catheterization techniques. When activated by the light, Antrin generates a chemical reaction that reduces or destroys the plaque.

Pharmacyclics is a pharmaceutical company developing products to improve upon current therapeutic approaches to cancer, atherosclerosis and retinal disease. The company's products are ring-shaped small molecules, called texaphyrins. These patented agents are derived from Pharmacyclics' versatile technology platform for designing and synthesizing energy-potentiating drugs. The texaphyrins localize in cancer cells, atherosclerotic plaque and neovasculature, where they can be activated by various forms of energy, including X-rays, light and chemotherapeutics, to eliminate diseased tissue.

NOTE: The statements made in this press release may contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from the company's expectations. The results obtained from the Phase I study are not necessarily predictive of those that will be obtained in later studies, including the Phase II study. In addition to the matters described in this release, future actions by the U.S. Food and Drug Administration and other domestic and foreign regulatory agencies, the initiation, timing and results of pending or future clinical trials, as well as risk factors listed from time to time in the company's reports as filed with the U.S. Securities and Exchange Commission, including but not limited to, its reports on Forms 10-Q and 10-K, may affect the actual results achieved by the company. Pharmacyclics®, the "pentadentate" logo® and ANTRIN® are trademarks of Pharmacyclics, Inc.