Should be the first of many such announcements:
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SUNNYVALE, Calif., Aug. 20 /PRNewswire/ -- Pharmacyclics, Inc.
(NASDAQ:PCYC) today announced the initiation of two phase I clinical trials
of its gadolinium texaphyrin (Gd-Tex) radiation sensitizer for the treatment
of primary brain tumors at the University of California, Los Angeles (UCLA)
Jonsson Comprehensive Cancer Center in Los Angeles, CA. These studies are two
of several clinical trials being sponsored by the National Cancer Institute
(NCI) to be conducted under a Cooperative Research And Development Agreement
(CRADA) with the NCI.
Gd-Tex is a radiation sensitizer that has completed phase II testing for
the treatment of brain metastases. Gd-Tex localizes into tumors and has been
shown to increase the potency of radiation treatment. In March, 1997, the
Decision Network of the NCI voted to sponsor additional clinical trials at
leading institutions across the country using Gd-Tex as a radiation sensitizer
to treat a variety of cancers including brain, head and neck, lung, pancreas
and prostate.
The UCLA trials, the first of the NCI-sponsored trials to open, will
enroll patients with newly-diagnosed glioblastoma multiforme, who will receive
radiation therapy to the brain following intravenous administration of Gd-Tex.
Also participating in this study are University of Southern California/Norris
Comprehensive Cancer Center in Los Angeles, CA and Cooper House Systems/Robert
Wood Johnson Medical School, Camden, NJ. Primary brain tumors
(non-metastatic), such as glioblastoma multiforme, are usually fatal due to
tumor progression. Radiation therapy is used for tumor control but is not
curative. Patient enrollment has begun in the first trial, which is designed
to evaluate various dosing regimens of Gd-Tex with a standard dose of
radiation. In a second trial, Gd-Tex will be administered prior to surgery,
and localization of the drug will be measured from the resected tumors.
Patients will then receive a treatment course of Gd-Tex and radiation.
Additional NCI-sponsored trials are expected to start over the next several
months.
"We are very excited about the potential use of Gd-Tex in primary brain
tumors," said Judith Ford, M.D., Ph.D., assistant professor of radiation
oncology at UCLA and principal investigator on the study.
"The NCI-sponsored trials provide an opportunity to examine Gd-Tex in a
broad range of potential indications," said Richard A. Miller, M.D., president
and chief executive officer of Pharmacyclics. "We are delighted that these
trials are underway in parallel with our clinical development of Gd-Tex for
brain metastases."
Animal studies have indicated that Gd-Tex increases the efficacy of
external beam radiation therapy. The company recently presented phase Ib/II
clinical data for treatment of brain metastases at the meeting of the
American Society of Clinical Oncology (ASCO) where a 73% response rate was
reported. In a case-matched historical control analysis, a favorable effect
on survival was shown for patients treated with Gd-Tex and radiation compared
to patients receiving radiation alone. Based on the phase Ib/II results the
company expects to initiate a pivotal multi-center phase III trial.
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 and atherosclerotic
cardiovascular disease. The company's products are small ring-shaped
molecules, called "texaphyrins," which are patented agents derived from
Pharmacyclics' versatile technology platform for designing and synthesizing
energy-potentiating drugs. These texaphyrins localize in cancer cells and
atherosclerotic plaque, where they can be activated by forms of energy,
including X-ray, chemical and light, 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.
SOURCE Pharmacyclics, Inc.
-0- 08/20/98
/CONTACT: Leiv Lea of Pharmacyclics, Inc., 408-774-0330; or
Angela 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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