Wednesday October 17, 7:30 am Eastern Time
Press Release
SOURCE: Pharmacyclics, Inc.
Pharmacyclics Regains Rights to Optrin From Alcon
Company Will Continue Development, Seek Other Partners Based on Promising Phase II Data
SUNNYVALE, Calif., Oct. 17 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC - news) announced today that it has regained worldwide rights to develop and market Optrin(TM) (motexafin lutetium) Injection for the potential photodynamic treatment of age-related macular degeneration (ARMD) and other retinal diseases from Alcon. Pharmacyclics will continue to develop Optrin based on its analysis of preliminary data from a 75-patient Phase II dose-ranging clinical trial recently completed by Alcon.
``We are very encouraged by the visual acuity data from this trial, especially given that most patients received only one treatment over the course of the study, and currently available photodynamic therapy regimens require multiple treatments,'' said Richard A. Miller, M.D., Pharmacyclics' president and chief executive officer. ``Based on these data, we will continue development of this product and seek other corporate collaborations or partnerships to help us realize its clinical and commercial potential.''
Pharmacyclics and Alcon entered into an evaluation and license agreement in December 1997 for the commercialization of Optrin for ophthalmology indications, including ARMD. Under the terms of the agreement, Alcon conducted and bore all costs for worldwide development and drug registration for ophthalmology indications of Optrin.
Alcon was responsible for conducting the multicenter phase II trial that was designed to evaluate safety and closure of diseased vessels (i.e., choroidal neovascularization, CNV) using various drug and light treatment regimens, and to monitor visual acuity and other clinical parameters. An abstract will be submitted to present the details of the data at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in May, 2002 in Fort Lauderdale, Fla.
Seventy-five patients were treated with various doses of drug and light in this Phase II study. All patients received a single intravenous injection of Optrin, followed by light delivered to the retina. Twenty-nine patients received a second course of treatment either three or six months after the first treatment. Fluorescein angiograms were performed to evaluate safety.
Photodynamic therapy with Optrin was generally well tolerated at drug doses of 2.0 mg/kg and light doses of 50, 65 or 95 Joules/cm squared. The most common side effect was mild paresthesias (i.e., tingling in the fingertips). Some patients experienced rash, and four patients had transient retinal damage, three of whom were treated with the highest doses of drug and light (i.e., 2mg/kg and 125 Joules/cm squared). CNV closure, which may be a potential indicator of biological activity, was infrequently observed.
Clinical activity was assessed by serial measurements of visual acuity. A Kaplan-Meier analysis of the data demonstrated that visual acuity improved or remained stable at six months and one-year follow-up in 70 percent and 60 percent, respectively, of the 68 patients who received 2mg/kg of drug and less than 125 Joules/cm squared of light.
ARMD is a disorder resulting from abnormal CNV, a proliferation of blood vessels that leak fluid and cause progressive damage to the retina, which often progresses to blindness. There are about 200,000 new cases of ARMD per year in the United States. Without treatment, only about 40 percent of patients would be expected to remain stable or improve their visual acuity within a year of diagnosis according to the literature.
Optrin selectively accumulates in certain types of diseased tissue where it can then be activated to destroy diseased cells by 732nm light, a wavelength that effectively penetrates body tissues. Optrin is water-soluble and clears relatively quickly from the bloodstream.
Pharmacyclics is a pharmaceutical company developing products to improve upon current therapeutic approaches to cancer, atherosclerosis and retinal disease. The company's products are rationally designed, ring-shaped small molecules called texaphyrins that disrupt the bioenergetic processes of diseased cells, such as cancer and atherosclerotic plaque. When activated by various forms of energy, including X-ray and light, these texaphyrins can help to reduce or eliminate the diseased tissue. More information about the company, its technology, and products can be found on its web site at www.pcyc.com.
NOTE: The statements made in this press release about the progress and reports of the results of clinical trials, product development activities, and success of potential products, other than statements of historical fact, are forward-looking statements. The forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements, including risks associated with the initiation, timing, and results of clinical trials, the progress of research and development programs, the regulatory approval process in the United States and other countries, competitive products, future capital requirements, and patent protection. For further information about risks that may affect the actual results achieved by Pharmacyclics, please see the company's reports as filed with the U.S. Securities and Exchange Commission from time to time, including but not limited to, its reports on Form 10-Q and 10-K. Pharmacyclics® and the ``pentadentate'' logo® are registered trademarks of Pharmacyclics, Inc. Optrin is a trademark of Pharmacyclics, Inc.
SOURCE: Pharmacyclics, Inc. |
