Good news finally from the ophthalmology front. There's been total silence for well over a year on this program, and I was starting to get concerned. Although this program is behind that of QLTIF, and probably also that of MRVT, I wouldn't be surprised if it ends up as the superior product.
Incidentally, the PCYC web site now shows 20 sites open for enrollment in the Gd-Tex Phase III.
Peter
Headline: Pharmacyclics Receives Payment From Alcon to Continue Development of
Lutetium Texaphyrin for Ophthalmology
======================================================================
SUNNYVALE, Calif., April 23 /PRNewswire/ -- Pharmacyclics, Inc.
(NASDAQ:PCYC) today announced that Alcon Pharmaceuticals, Ltd. (an affiliate
of Alcon Laboratories, Inc.) has committed to further evaluation and clinical
development of lutetium texaphyrin ("Lu-Tex"/OPTRIN(TM)) in the field of
ophthalmology.
Pharmacyclics and Alcon entered into an evaluation and license agreement
in December 1997 for the use of Lu-Tex for ophthalmology indications including
age-related macular degeneration (ARMD), the leading cause of blindness in
adults in the U.S. Under the terms of the agreement, Alcon conducts and bears
all costs for the worldwide development and drug registration for
ophthalmology indications of Lu-Tex. Alcon has been conducting preclinical
and clinical development of Lu-Tex.
Pharmacyclics has received an additional payment from Alcon and may
receive further payments based upon successful completion of milestones, as
well as a royalty on product sales. The payment received by Pharmacyclics
comes as a result of Alcon's ongoing phase I/II clinical study evaluating
safety, optimum drug and light dosing, and efficacy. Additional clinical
trials are expected to begin later this year.
"We are very pleased by the progress made by Alcon and its commitment to
further development of Lu-Tex," stated Marc L. Steuer, senior vice president
of business development for Pharmacyclics.
"We are excited about the potential of Lu-Tex in treating eye disorders,
such as age-related macular degeneration. We believe this drug's unique
properties may provide important advantages for treatment of ARMD," stated
Gerald D. Cagle, Ph.D., Alcon's senior vice president, research and
development.
ARMD is a disorder resulting from abnormal neovascularization, 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 U.S. To date, there is no approved treatment to
reverse or prevent the damage caused by ARMD.
Lu-Tex is one of a group of patented synthetic molecules called
texaphyrins. Lu-Tex 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. Lu-Tex is
water-soluble and clears relatively quickly from the body. Preclinical
studies have shown that, following activation by light, Lu-Tex can selectively
destroy retinal neovascularization.
The Alcon group is the global leader in the research, development,
manufacture and marketing of ophthalmic products, including surgical
instruments and accessory products, intraocular lenses, prescription drugs and
contact lens care solutions. The Alcon group is wholly owned by Nestle S.A.
Pharmacyclics is a pharmaceutical company developing energy-potentiating
drugs to improve radiation therapy and chemotherapy of cancer, and to enable
or improve the photodynamic therapy of certain cancers, atherosclerotic
cardiovascular disease and diseases of the retina. The company's products are
ring-shaped small molecules, called "texaphyrins," which are patented agents
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.
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. 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.
NOTE: Pharmacyclics(R), the "pentadentate" logo(R) and OPTRIN(TM) are
trademarks of Pharmacyclics, Inc.
SOURCE Pharmacyclics, Inc.
-0- 04/23/99
/CONTACT: Leiv Lea of Pharmacyclics, Inc., 408-774-0330; or
Angela M. Bitting of Russell-Welsh, Inc., 650-312-0700, ext. 15, for
Pharmacyclics, Inc./
/Company News On-Call: prnewswire.com or fax,
800-758-5804, ext. 110031/
/Web site: pcyc.com;
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