SUNNYVALE, Calif., Jan. 8 /PRNewswire/ --
Pharmacyclics, Inc. (Nasdaq: PCYC) will provide additional results from its
Phase III clinical trial of lead product, Xcytrin(R) (motexafin gadolinium)
Injection, indicating its potential utility in lung cancer patients with brain
metastases (i.e., lung cancer that has spread to the brain) at the 20th Annual
JPMorgan H&Q Healthcare Conference in San Francisco.
The company will also announce preliminary results of a Phase II clinical
trial of Xcytrin in glioblastoma multiforme (GBM, i.e., primary brain tumor)
that will lead to initiation of a pivotal Phase III trial in GBM in the first
half of 2002.
"Results from the ongoing analysis of the data from the Phase III trial
appear to indicate that Xcytrin improves local tumor control and neurologic
function in lung cancer patients with brain metastases, which makes up to
60 percent of the total market for this disease," said Richard A. Miller,
M.D., Pharmacyclics' president and chief executive officer. "We will complete
our data analyses and meet with the FDA as soon as possible. We also plan to
prepare a New Drug Application to submit as soon as possible based on the
outcome of that meeting. We will continue to study Xcytrin in other tumor
types, including a Phase III trial in primary brain tumors and ongoing studies
with the National Cancer Institute in brain tumors, non-small cell lung cancer
and pancreatic cancer. We are in a strong financial position with
$142 million in cash as of the most recently reported quarter."
The company's randomized controlled trial was conducted at more than
50 leading cancer centers in the United States, Canada and Europe and enrolled
401 patients; 251 with lung cancer, 75 with breast cancer and 75 with other
tumor types. It was designed to compare the safety and efficacy of standard
whole brain radiation therapy (WBRT) to standard WBRT plus Xcytrin. The
prognosis and response to therapy of patients with brain metastases is
dependent on tumor type and extent of tumor spread within the body.
Therefore, the study had co-primary efficacy endpoints of survival and time to
neurologic progression and the pre-specified statistical analysis plan called
for stratification and data analysis based on tumor type: lung, breast or
others and extent of disease, i.e., RPA class. As previously reported, there
was not a statistically significant difference observed in overall survival or
time to neurologic progression for all patients.
There was significant improvement in time to neurologic progression in
lung cancer patients receiving Xcytrin. In these patients, median time to
neurologic progression was 7.4 months for the control group and exceeded
12 months for the Xcytrin-treated group (unadjusted p=0.048). For RPA
Class II lung cancer patients (n=214), also a pre-specified strata, the median
time to neurologic progression was 6.3 months for the control group and again
exceeded 12 months for the Xcytrin-treated group (unadjusted p=0.013). A
further analysis of this data shows that progression-free survival at one year
was 18.6 percent in Xcytrin-treated patients compared to 10.5 percent in the
control group. An independent Events Review Committee that was blinded to the
treatment assignment determined neurologic progression based on several
objective and quantitative clinical assessments.
Newly available secondary endpoint data on neurocognitive function confirm
Xcytrin's apparent ability to control tumor progression in lung cancer
patients. This is the first trial of its kind to comprehensively and
objectively evaluate brain function using a battery of six different
standardized neurocognitive tests including memory and executive function
(i.e., the ability to reason and make decisions). There was a significant
improvement in time to neurocognitive progression across all of these tests in
favor of the Xcytrin-treated lung cancer patients versus control (p=0.046).
The relative risk of a neurocognitive progression was 81 percent greater for
the control patients than for the Xcytrin-treated patients (i.e., hazard ratio
of 1.81; 95 percent confidence interval of 1.01-3.25).
The Phase III trial also showed Xcytrin to be well tolerated. The most
commonly reported side effects were transient skin discoloration, nausea and
mild diarrhea.
The company is still in the process of evaluating all the data from the
trial and plans to report the findings at the Annual Meeting of the American
Society of Clinical Oncology next May.
Xcytrin in Primary Brain Tumors
Updated results of a Phase I dose-escalation trial to assess the safety
and tolerability of Xcytrin for the potential treatment of primary brain
tumors (i.e., glioblastoma multiforme, GBM) were presented last month at the
Annual Meeting of the American Society of Therapeutic Radiation Oncology. In
this trial, Xcytrin was well tolerated and median survival for the first
28 patients is 16.8 months, which compares favorably to a median survival rate
of about 10-11 months reported in the literature for a similar patient
population. Among the limited number of side effects observed were non-dose
related rash and finger blisters.
Pharmacyclics recently completed enrollment in a 25-patient Phase II study
in GBM. A preliminary analysis of this data so far confirms the results
observed in the Phase I trial. As a result, the company plans to initiate a
pivotal Phase III trial in GBM by the end of the first half of this year.
Other studies now underway with Xcytrin include those being performed
under a cooperative research and development agreement with Pharmacyclics and
the National Cancer Institute for the treatment of non small-cell lung cancer,
glioblastoma multiforme, childhood gliomas (life-threatening brain tumors in
children) and pancreatic cancer. Several other trials in other cancer
types are in the planning stages. The company also will initiate a Phase I
trial to investigate Xcytrin's potential to enhance the effects of
chemotherapy, specifically doxorubicin in the first quarter of 2002.
Webcast Details
Dr. Miller will present at the 20th Annual JPMorgan H&Q Healthcare
Conference in San Francisco today at 11:00 a.m. PST in the Elizabethan A&B
Room. The presentation will be webcast live and archived for 60 days and can
be accessed at http://www.eventsdigital.com/events/jpmhq/healthcare2002 or by logging
onto the investor section of the company's web site at http://www.pcyc.com.
About Xcytrin
Xcytrin, the first of a new class of drugs called texaphyrins, selectively
accumulates in cancer cells and disrupts cellular metabolism by a unique
mechanism of action. By interfering with the flow of energy in cancer cells,
Xcytrin prevents cancer cells from repairing damage caused by the effects of
radiation and chemotherapy without increasing damage to normal tissue.
About Brain Metastases and Primary Brain Tumors
Brain metastases is one of the most common conditions treated with
radiation therapy. There are about 150,000 to 170,000 cases per year and the
incidence is increasing. The most common cause of brain metastases is lung
cancer, affecting up to 90,000 patients. Brain metastases occur when cancer
cells spread to the brain and grow, causing major neurologic complications.
Patients with brain metastases usually suffer serious deterioration of
neurologic and neurocognitive function such as loss of short-term memory,
compromised verbal skills and fine motor coordination, and reduction in
cognitive performance. Most patients with brain metastases have multiple
lesions and are not candidates for surgical resection or radiosurgery. The
goal of whole brain radiation therapy is to reverse or prevent neurological
deterioration and prevent death due to tumor progression in the brain. There
are about 17,000 new cases of primary brain and nervous system tumors each
year in the U.S. and more than 13,000 deaths occur from these types of
malignancies.
About Pharmacyclics
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 used in
combination with 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 http://www.pcyc.com.
NOTE: The statements made in this press release about the financial
position of the company, the initiation of clinical trials, progress and
reports of clinical trial results, product development activities and
potential filing of a marketing application with the U.S. Food and Drug
Administration, 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 U.S. and
other countries, and future capital requirements. 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. The company does not intend to update
forward-looking statements. Pharmacyclics(R), Xcytrin(R), and the
"pentadentate" logo are registered trademarks of Pharmacyclics, Inc.
SOURCE Pharmacyclics, Inc.
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Related links:
http://www.pcyc.com
CONTACT:
Jim Weiss, or Leiv Lea, both of
Pharmacyclics, Inc., +1-408-774-0330, or cell, +1-415-203-0328
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