Pharmacyclics Announces Start of Xcytrin Phase II Clinical Trial in Primary Brain Tumors

Apr 10, 2001, 01:00 ET from Pharmacyclics, Inc.

    SUNNYVALE, Calif., April 10 /PRNewswire/ --
 Pharmacyclics, Inc. (Nasdaq:   PCYC) today announced the initiation of a
 Phase II clinical trial to evaluate the company's investigational lead
 product, Xcytrin(R) (motexafin gadolinium) Injection, for treatment of
 glioblastoma multiforme (GBM, i.e., primary brain tumor), the most common
 primary central nervous system (CNS) tumor in adults.
     The main objectives of this multi-center, single-arm study are to evaluate
 the safety and pharmacokinetics of a six-week treatment course of Xcytrin
 combined with a standard six-week course of radiation therapy in
 20 newly-diagnosed GBM patients.  Eight leading cancer centers in the
 United States are now enrolling patients, and the company expects to complete
 enrollment and analysis of the safety data by the fourth quarter of this year.
 If safety results are adequate, the company plans to initiate a pivotal
 Phase III trial in this indication by the end of this year.
     "GBM is the most aggressive and devastating type of CNS tumor," said the
 study's co-chair W.K. Alfred Yung, M.D., Professor and Chairman, Department of
 Clinical Neuro-Oncology, MD Anderson Cancer Center, Houston.  "While radiation
 therapy has improved survival, we have not been able to intensify it further
 due to the damage it causes normal brain tissue.  Adding a tumor-selective
 agent like Xcytrin to standard radiation may enhance local tumor control and
 prolong survival."
     Promising preliminary results from the Phase I study in this indication
 were presented at the 42nd Annual Meeting of the American Society for
 Therapeutic Radiology and Oncology (ASTRO) last October.  Updated
 Phase I study results will be presented at the American Society of
 Clinical Oncology (ASCO) annual meeting in May in San Francisco.
     The American Cancer Society estimates that there are about 17,000 new
 cases of brain and nervous system tumors and that more than 13,000 deaths
 occur from these types of malignancies in the United States each year.  Nearly
 12,000 new cases of GBM are diagnosed in the United States each year and the
 incidence has been increasing over the past decade.  The peak incidence of GBM
 occurs after the age of 40.
     After surgical resection of all or part of the tumor, radiation therapy
 remains the most effective treatment for patients with newly diagnosed GBM.
 Median survival time for surgery followed by standard courses of radiation is
 36 weeks, compared with 14 weeks for surgery alone.  Though radiation prolongs
 survival, most patients eventually experience recurrences that ultimately lead
 to death.  Increasing doses of conventional radiation therapy beyond the
 standard amount is limited by potential toxicity to the normal brain, and has
 not resulted in improved survival.
     Patient enrollment was recently completed in a pivotal Phase III study of
 Xcytrin for the treatment of brain metastases, i.e., advanced stage cancer
 that has spread from another part of the body to the brain.  Top-line results
 of that trial are expected by the end of this year.
     "We now have studies completed or ongoing in at least five cancer tumor
 types designed to test Xcytrin's potential versatility in treating different
 types of cancer," said Markus Renschler, M.D., senior director of clinical
 development for Pharmacyclics.  "The primary goal of this study is to confirm
 the appropriate dose so we can initiate a pivotal Phase III trial in this
 important indication as soon as possible."
     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 makes the tumor potentially more responsive to the effects of
 radiation and chemotherapy without increasing damage to normal tissue.
     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(R), Xcytrin(R), and the "pentadentate" logo(R) are
 registered trademarks of Pharmacyclics, Inc.
 
 

SOURCE Pharmacyclics, Inc.
    SUNNYVALE, Calif., April 10 /PRNewswire/ --
 Pharmacyclics, Inc. (Nasdaq:   PCYC) today announced the initiation of a
 Phase II clinical trial to evaluate the company's investigational lead
 product, Xcytrin(R) (motexafin gadolinium) Injection, for treatment of
 glioblastoma multiforme (GBM, i.e., primary brain tumor), the most common
 primary central nervous system (CNS) tumor in adults.
     The main objectives of this multi-center, single-arm study are to evaluate
 the safety and pharmacokinetics of a six-week treatment course of Xcytrin
 combined with a standard six-week course of radiation therapy in
 20 newly-diagnosed GBM patients.  Eight leading cancer centers in the
 United States are now enrolling patients, and the company expects to complete
 enrollment and analysis of the safety data by the fourth quarter of this year.
 If safety results are adequate, the company plans to initiate a pivotal
 Phase III trial in this indication by the end of this year.
     "GBM is the most aggressive and devastating type of CNS tumor," said the
 study's co-chair W.K. Alfred Yung, M.D., Professor and Chairman, Department of
 Clinical Neuro-Oncology, MD Anderson Cancer Center, Houston.  "While radiation
 therapy has improved survival, we have not been able to intensify it further
 due to the damage it causes normal brain tissue.  Adding a tumor-selective
 agent like Xcytrin to standard radiation may enhance local tumor control and
 prolong survival."
     Promising preliminary results from the Phase I study in this indication
 were presented at the 42nd Annual Meeting of the American Society for
 Therapeutic Radiology and Oncology (ASTRO) last October.  Updated
 Phase I study results will be presented at the American Society of
 Clinical Oncology (ASCO) annual meeting in May in San Francisco.
     The American Cancer Society estimates that there are about 17,000 new
 cases of brain and nervous system tumors and that more than 13,000 deaths
 occur from these types of malignancies in the United States each year.  Nearly
 12,000 new cases of GBM are diagnosed in the United States each year and the
 incidence has been increasing over the past decade.  The peak incidence of GBM
 occurs after the age of 40.
     After surgical resection of all or part of the tumor, radiation therapy
 remains the most effective treatment for patients with newly diagnosed GBM.
 Median survival time for surgery followed by standard courses of radiation is
 36 weeks, compared with 14 weeks for surgery alone.  Though radiation prolongs
 survival, most patients eventually experience recurrences that ultimately lead
 to death.  Increasing doses of conventional radiation therapy beyond the
 standard amount is limited by potential toxicity to the normal brain, and has
 not resulted in improved survival.
     Patient enrollment was recently completed in a pivotal Phase III study of
 Xcytrin for the treatment of brain metastases, i.e., advanced stage cancer
 that has spread from another part of the body to the brain.  Top-line results
 of that trial are expected by the end of this year.
     "We now have studies completed or ongoing in at least five cancer tumor
 types designed to test Xcytrin's potential versatility in treating different
 types of cancer," said Markus Renschler, M.D., senior director of clinical
 development for Pharmacyclics.  "The primary goal of this study is to confirm
 the appropriate dose so we can initiate a pivotal Phase III trial in this
 important indication as soon as possible."
     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 makes the tumor potentially more responsive to the effects of
 radiation and chemotherapy without increasing damage to normal tissue.
     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(R), Xcytrin(R), and the "pentadentate" logo(R) are
 registered trademarks of Pharmacyclics, Inc.
 
 SOURCE  Pharmacyclics, Inc.

RELATED LINKS

http://www.pcyc.com