MGI PHARMA Initiates Additional Phase 2 Trial of Irofulven In Hormone-Refractory Prostate Cancer

Phase 2 Trial to Evaluate Every-Other-Week Dosing Schedule



Apr 12, 2001, 01:00 ET from MGI PHARMA, INC.

    MINNEAPOLIS, April 12 /PRNewswire/ -- MGI PHARMA, INC. (Nasdaq: MOGN)
 today announced that it has initiated an additional Phase 2 clinical trial of
 irofulven, its novel anti-cancer compound, using an intermittent dosing
 schedule to treat hormone-refractory prostate cancer patients.  This
 randomized, multi-center Phase 2 trial conducted in Europe will evaluate the
 anti-tumor activity, safety, and clinical benefit of irofulven as a single
 agent and in combination with prednisone.  Up to 54 patients will be treated
 with irofulven on an every-other-week dosing schedule.  Results from this
 Phase 2 trial will be used to develop recommendations for an anticipated Phase
 3 trial with irofulven in prostate cancer.  Decrease in PSA (prostate-specific
 antigen) is the primary endpoint, along with objective tumor response in
 patients with measurable disease.  Time to disease progression, duration of
 response, overall survival and clinical benefit will also be assessed.  The
 patient enrollment period for this Phase 2 trial is expected to last
 approximately 18 months.
     The anti-tumor activity of irofulven in hormone-refractory prostate cancer
 patients has already been evaluated in a prior Phase 2 trial where irofulven
 was dosed daily for five days every 28 days.  All of the 32 patients who were
 evaluable for PSA response had stable or decreasing PSA levels and four of
 those patients had partial PSA responses (defined as a decrease of at least
 50 percent for at least one month).  In addition, one of the nine patients who
 had measurable disease had an objective partial response.
     Improved tolerance and an ability to deliver more drug over multiple
 courses of treatment has been observed in an ongoing dose-optimization trial
 using an every-other-week dosing schedule, which will be assessed in this new
 trial.  "This new multi-center Phase 2 trial of irofulven, in patients with
 hormone-refractory prostate cancer, used alone or in combination with
 prednisone, will provide us with valuable additional insight about irofulven's
 role in treating this type of cancer," said Professor Stephane Culine, head of
 the medical oncology department of Val d'Aurelle-Paul Lamarque Anticancer
 Center at Montpellier in France, and the lead investigator for the trial.
 "Considering the anti-tumor activity shown in a previous Phase 2 trial and a
 new dosing schedule that is better tolerated, we hope to demonstrate further
 evidence of irofulven's efficacy in this disease."
     Dr. John MacDonald, senior vice president of research and development at
 MGI PHARMA, commented, "Our continued research in this area demonstrates MGI's
 commitment to addressing the unmet needs of cancer patients, and
 hormone-refractory prostate cancer is clearly an area where we hope irofulven
 will make a difference in patients' lives."
 
     About Hormone-Refractory Prostate Cancer
     In men, carcinoma of the prostate is the second highest cause of
 cancer-related death after lung cancer, with an estimated 198,100 new cases to
 be diagnosed and 31,500 anticipated deaths in the United States in 2001,
 according to the American Cancer Society.  Worldwide, the incidence of
 microscopic prostate malignancy increases from 30 percent in men over 50 years
 in age, to more than 50 percent in men in their eighties.  The standard
 treatment for local disease is either radical prostatectomy or pelvic
 irradiation.  Approximately 20 to 30 percent of men with prostate cancer have
 distant metastases at the time of diagnosis.
     Hormone therapy is the first therapy to show efficacy in reducing tumor
 growth, but the duration of the response averages only 12 to 18 months.  Among
 patients with disseminated disease, 70 to 80 percent experience subjective
 symptomatic relief, and approximately 40 to 60 percent achieve objective
 remission.  Second-line hormonal therapy provides clinical improvement in only
 10 to 20 percent of such patients, has a duration of less than six months, and
 does not significantly improve survival, indicating that a large number of
 patients become hormone-refractory after first-line treatment.  Chemotherapy
 has been of limited value in the management of patients who have become
 refractory to hormone therapy.  Despite many years of effort to develop
 effective chemotherapy administered before, during, or after hormone therapy,
 few effective drugs have been identified.
     Advanced clinical trials are needed to compare the current standard
 treatment of mitoxantrone in combination with prednisone to other drug
 combinations to identify the best combination for improving quality of life
 and positively affecting survival.
 
     About Irofulven
     Irofulven (also known as MGI 114, hydroxymethylacylfulvene, or HMAF) is
 the first product candidate being developed by MGI PHARMA from its family of
 proprietary anti-cancer compounds called acylfulvenes.  Irofulven is currently
 being tested in a series of clinical trials for the treatment of solid tumors,
 across a variety of cancers.  Irofulven has demonstrated promising anti-tumor
 activity as a single agent in clinical testing against pancreatic, ovarian and
 prostate cancers.  In February 2001, MGI PHARMA initiated a pivotal Phase 3
 trial of irofulven in advanced-stage, gemcitabine-refractory pancreatic cancer
 patients.  Side effects from irofulven are comparable to those seen with
 marketed chemotherapies and include bone marrow suppression (decreases in
 platelets or white blood cell counts), nausea, vomiting and fatigue.  Patients
 and health care providers seeking information on the various irofulven
 clinical trials may call MGI PHARMA's Medical Communications Help Line at
 800-562-5580 or the National Cancer Institute's Cancer Information Service at
 800-4-CANCER (TTY 800-332-8615).
 
     About MGI PHARMA
     MGI PHARMA, INC. is an oncology-focused pharmaceutical company that
 acquires, develops and commercializes proprietary products that meet patient
 needs and build shareholder value.  MGI focuses its sales efforts solely in
 the United States and collaborates with other pharmaceutical or biotechnology
 companies for its products in international markets.  For more information
 about MGI, please visit the Company's web site at http://www.mgipharma.com
 
     This news release contains forward-looking statements that may include
 statements regarding intent, belief or current expectations of the Company and
 its management.  These forward-looking statements are not guarantees of future
 performance and involve a number of risks and uncertainties that may cause the
 Company's actual results to differ materially from the results discussed in
 these statements.  Factors that might affect MGI PHARMA's results include, but
 are not limited to the ability of MGI PHARMA's product candidates including
 irofulven to be proven safe and effective in humans and to ultimately compete
 successfully with other therapies, continued sales of MGI PHARMA's marketed
 products, development or acquisition of additional products, reliance on
 contract manufacturing, changes in strategic alliances, and other risks and
 uncertainties detailed from time to time in the Company's filings with the
 Securities and Exchange Commission.  MGI PHARMA does not intend to update any
 of the forward-looking statements after the date of this news release to
 conform them to actual results.
 
 

SOURCE MGI PHARMA, INC.
    MINNEAPOLIS, April 12 /PRNewswire/ -- MGI PHARMA, INC. (Nasdaq: MOGN)
 today announced that it has initiated an additional Phase 2 clinical trial of
 irofulven, its novel anti-cancer compound, using an intermittent dosing
 schedule to treat hormone-refractory prostate cancer patients.  This
 randomized, multi-center Phase 2 trial conducted in Europe will evaluate the
 anti-tumor activity, safety, and clinical benefit of irofulven as a single
 agent and in combination with prednisone.  Up to 54 patients will be treated
 with irofulven on an every-other-week dosing schedule.  Results from this
 Phase 2 trial will be used to develop recommendations for an anticipated Phase
 3 trial with irofulven in prostate cancer.  Decrease in PSA (prostate-specific
 antigen) is the primary endpoint, along with objective tumor response in
 patients with measurable disease.  Time to disease progression, duration of
 response, overall survival and clinical benefit will also be assessed.  The
 patient enrollment period for this Phase 2 trial is expected to last
 approximately 18 months.
     The anti-tumor activity of irofulven in hormone-refractory prostate cancer
 patients has already been evaluated in a prior Phase 2 trial where irofulven
 was dosed daily for five days every 28 days.  All of the 32 patients who were
 evaluable for PSA response had stable or decreasing PSA levels and four of
 those patients had partial PSA responses (defined as a decrease of at least
 50 percent for at least one month).  In addition, one of the nine patients who
 had measurable disease had an objective partial response.
     Improved tolerance and an ability to deliver more drug over multiple
 courses of treatment has been observed in an ongoing dose-optimization trial
 using an every-other-week dosing schedule, which will be assessed in this new
 trial.  "This new multi-center Phase 2 trial of irofulven, in patients with
 hormone-refractory prostate cancer, used alone or in combination with
 prednisone, will provide us with valuable additional insight about irofulven's
 role in treating this type of cancer," said Professor Stephane Culine, head of
 the medical oncology department of Val d'Aurelle-Paul Lamarque Anticancer
 Center at Montpellier in France, and the lead investigator for the trial.
 "Considering the anti-tumor activity shown in a previous Phase 2 trial and a
 new dosing schedule that is better tolerated, we hope to demonstrate further
 evidence of irofulven's efficacy in this disease."
     Dr. John MacDonald, senior vice president of research and development at
 MGI PHARMA, commented, "Our continued research in this area demonstrates MGI's
 commitment to addressing the unmet needs of cancer patients, and
 hormone-refractory prostate cancer is clearly an area where we hope irofulven
 will make a difference in patients' lives."
 
     About Hormone-Refractory Prostate Cancer
     In men, carcinoma of the prostate is the second highest cause of
 cancer-related death after lung cancer, with an estimated 198,100 new cases to
 be diagnosed and 31,500 anticipated deaths in the United States in 2001,
 according to the American Cancer Society.  Worldwide, the incidence of
 microscopic prostate malignancy increases from 30 percent in men over 50 years
 in age, to more than 50 percent in men in their eighties.  The standard
 treatment for local disease is either radical prostatectomy or pelvic
 irradiation.  Approximately 20 to 30 percent of men with prostate cancer have
 distant metastases at the time of diagnosis.
     Hormone therapy is the first therapy to show efficacy in reducing tumor
 growth, but the duration of the response averages only 12 to 18 months.  Among
 patients with disseminated disease, 70 to 80 percent experience subjective
 symptomatic relief, and approximately 40 to 60 percent achieve objective
 remission.  Second-line hormonal therapy provides clinical improvement in only
 10 to 20 percent of such patients, has a duration of less than six months, and
 does not significantly improve survival, indicating that a large number of
 patients become hormone-refractory after first-line treatment.  Chemotherapy
 has been of limited value in the management of patients who have become
 refractory to hormone therapy.  Despite many years of effort to develop
 effective chemotherapy administered before, during, or after hormone therapy,
 few effective drugs have been identified.
     Advanced clinical trials are needed to compare the current standard
 treatment of mitoxantrone in combination with prednisone to other drug
 combinations to identify the best combination for improving quality of life
 and positively affecting survival.
 
     About Irofulven
     Irofulven (also known as MGI 114, hydroxymethylacylfulvene, or HMAF) is
 the first product candidate being developed by MGI PHARMA from its family of
 proprietary anti-cancer compounds called acylfulvenes.  Irofulven is currently
 being tested in a series of clinical trials for the treatment of solid tumors,
 across a variety of cancers.  Irofulven has demonstrated promising anti-tumor
 activity as a single agent in clinical testing against pancreatic, ovarian and
 prostate cancers.  In February 2001, MGI PHARMA initiated a pivotal Phase 3
 trial of irofulven in advanced-stage, gemcitabine-refractory pancreatic cancer
 patients.  Side effects from irofulven are comparable to those seen with
 marketed chemotherapies and include bone marrow suppression (decreases in
 platelets or white blood cell counts), nausea, vomiting and fatigue.  Patients
 and health care providers seeking information on the various irofulven
 clinical trials may call MGI PHARMA's Medical Communications Help Line at
 800-562-5580 or the National Cancer Institute's Cancer Information Service at
 800-4-CANCER (TTY 800-332-8615).
 
     About MGI PHARMA
     MGI PHARMA, INC. is an oncology-focused pharmaceutical company that
 acquires, develops and commercializes proprietary products that meet patient
 needs and build shareholder value.  MGI focuses its sales efforts solely in
 the United States and collaborates with other pharmaceutical or biotechnology
 companies for its products in international markets.  For more information
 about MGI, please visit the Company's web site at http://www.mgipharma.com
 
     This news release contains forward-looking statements that may include
 statements regarding intent, belief or current expectations of the Company and
 its management.  These forward-looking statements are not guarantees of future
 performance and involve a number of risks and uncertainties that may cause the
 Company's actual results to differ materially from the results discussed in
 these statements.  Factors that might affect MGI PHARMA's results include, but
 are not limited to the ability of MGI PHARMA's product candidates including
 irofulven to be proven safe and effective in humans and to ultimately compete
 successfully with other therapies, continued sales of MGI PHARMA's marketed
 products, development or acquisition of additional products, reliance on
 contract manufacturing, changes in strategic alliances, and other risks and
 uncertainties detailed from time to time in the Company's filings with the
 Securities and Exchange Commission.  MGI PHARMA does not intend to update any
 of the forward-looking statements after the date of this news release to
 conform them to actual results.
 
 SOURCE  MGI PHARMA, INC.