[MOL] Fwd: Pharmacyclics Announces Start of Phase III Gd-Tex Trial... [02835] Medicine On Line

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[MOL] Fwd: Pharmacyclics Announces Start of Phase III Gd-Tex Trial...

Dear Carla and all
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Pharmacyclics Announces Start of Phase III Gd-Tex Trial for Brain Metastases

SUNNYVALE, Calif., Sept. 25 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC)
today announced the initiation of a pivotal phase III trial with its Gd-Tex
radiation sensitizer for the treatment of patients with brain metastases. The
multi-center trial will be conducted at numerous leading academic and
community-based medical centers and will include about 30 sites in the United
States, Canada and Europe.

The prospectively randomized trial is planned to enroll approximately 425
patients with brain metastases. Patients will be randomly assigned to
treatment with either standard whole-brain radiation therapy or treatment with
Gd-Tex plus standard whole-brain radiation therapy. The Gd-Tex treated group
will receive ten intravenous injections of Gd-Tex, each prior to ten daily
fractions of radiation therapy. It is anticipated that all patients will be
followed for a minimum of 6 months after completion of treatment or until
death. The primary end point of the study is survival. Secondary end points
also include tumor response, time to neurologic progression and neurocognitive
function. The study will be monitored by an outside, independent Data Safety
Monitoring Board who will review and analyze interim data two-thirds into the
study for possible early termination of the trial in the event of significant
efficacy or unacceptable toxicity.

The median survival of patients with brain metastases treated with radiation
therapy is approximately 3-4 months and depends on various prognostic features
such as tumor type, performance status, age and presence of systemic,
extracranial disease. Although most patients with brain metastases die from
disease progression in the brain, many patients will die due to progression of
their disease in other locations in the body. The trial's patient eligibility
requirements are designed to enroll those patients most likely to succumb to
tumor growth in the brain. Improved local control of tumor growth from
radiation therapy in Gd-Tex treated patients could result in prolonged
survival compared to radiation therapy alone.

The FDA has agreed that the proposed Phase III trial qualifies for "fast
track" review, should efficacy end points be met. A single pivotal trial is
adequate for approval, since survival, rather than a surrogate end point, is
the primary end point of the study.

Patients with brain metastases may also suffer devastating non-fatal
complications related to uncontrolled progression of the tumor in the brain,
which include headaches, seizures, paralysis, blindness and neurocognitive
deterioration. The study's secondary end points are intended to quantitate
improvement in neurologic and neurocognitive function and quality of life.

"Survival has been selected as the primary end point because, unfortunately,
death occurs relatively quickly in patients with brain metastases and survival
is a convincing and easily measurable end point," stated Markus Renschler,
M.D., senior director of clinical research at Pharmacyclics and an oncologist.
"We believe that better local control of tumor growth in the brain by
treatment with Gd-Tex and radiation could prolong survival or result in
improved neurologic or neurocognitive function, which are secondary end points
of the clinical trial."

Neurocognitive testing measures a patient's cognitive and fine motor
capabilities. Although existing published neurocognitive testing procedures
will be used, the initial 25 patients entered into the trial will receive Gd-
Tex and radiation therapy to confirm the reliability of the neurocognitive
testing methods and allow for modifications to the procedures before
randomization of patients entered into the trial begins.

"We continue to make progress in the development of Gd-Tex, which now enters
advanced clinical testing," said Richard A. Miller, M.D., president and CEO of
Pharmacyclics. "With the initiation of the phase III clinical trial, we
continue to build a foundation towards oncology product development."

Gd-Tex is a radiation sensitizer that has been shown to accumulate selectively
in cancer. In previously reported phase I and Ib/II clinical trials involving
over 100 patients, the company established that Gd-Tex is well tolerated with
a dose limiting toxicity of reversible elevation of liver enzymes following
repeated injections of the drug. Preliminary results of the company's phase
Ib/II trial in patients with brain metastases were reported at the meeting of
the American Society of Clinical Oncology in May 1998. Although not a
prospectively randomized trial, a comparison to a historical control data base
was performed. Gd-Tex treated patients were compared to the historical
controls using a case-matching technique, which was done to improve the
comparability between groups with respect to known clinical prognostic
features. Gd-Tex treated patients were found to have a statistically
significant better response rate and prolonged survival compared to the case-
matched controls. In a separate multivariate analysis, receiving Gd-Tex
treatment was found to be one of the most important prognostic features
predictive of survival.

Additional clinical studies with Gd-Tex are being sponsored by the National
Cancer Institute (NCI) for a variety of clinical indications including adult
and pediatric brain tumors, and cancers involving the lung, head and neck,
pancreas and prostate.

Gd-Tex, one of a group of patented synthetic molecules called texaphyrins,
captures and focuses medically useful forms of energy, such as X-rays, which
are used in the radiation therapy of cancer. In preclinical and clinical
trials, Gd-Tex was shown to selectively accumulate in cancer cells, and, when
activated by X-ray energy (radiation therapy), Gd-Tex appears to increase the
damage to cancer cells, without increasing the damage to normal cells.

Metastases to the brain are one of the most devastating consequences of
cancer, affecting up to 20% of all cancer patients. Lung cancer and breast
cancer are the most common causes of brain metastases. Brain metastases occur
when cancer cells become dislodged from their primary site and migrate to the
brain where they take up residence and grow. In the United States, about
170,000 patients receive radiation therapy each year for treatment of brain

Radiation therapy is used to treat 700,000 cancer patients per year in the
United States. Like many cancer treatments, radiation is indiscriminate, and
is cytotoxic to the tumors and surrounding tissues. A major limitation of
radiation therapy is related to the damage it causes to surrounding organs. By
harnessing X-ray energy, Gd-Tex is designed to enhance the efficacy of cancer
radiation therapy.

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 ring-shaped, small
molecules, called "texaphyrins," which are patented agents derived from
Pharmacyclics' versatile technology platform for designing and synthesizing
energy-potentiating drugs. These texaphyrins have been shown to 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.

NOTE:  Pharmacyclics(R) and the Pentadentate Logo are registered trademarks of
Pharmacyclics, Inc.

SOURCE  Pharmacyclics, Inc.

CO:  Pharmacyclics, Inc.

ST:  California



09/25/98 07:30 EDT http://www.prnewswire.com

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