Studies Show New Long-Acting Form of Erythropoietin Boosts Blood Hemoglobin Levels in Anemic Cancer Patients During Chemotherapy

Investigational Drug Offers Potential for More Convenient, Less Frequent

Dosing Than Erythropoietin for Patients Undergoing Chemotherapy



Apr 24, 2001, 01:00 ET from University of Vienna Medical School, Division of Oncology

    BERLIN, April 24 /PRNewswire Interactive News Release/ -- New data shows
 that the investigational drug ARANESP(TM) (darbepoietin alfa) increases
 hemoglobin levels in cancer patients with anemia due to chemotherapy, reducing
 the need for blood transfusions and correcting anemia.  ARANESP is a
 long-acting form of rHuEPO (recombinant human erythropoietin), the current
 therapy for chemotherapy-induced anemia.  When dosed once weekly during
 chemotherapy, ARANESP worked as well or better than rHuEPO given three times
 per week, the standard dosing schedule.
     The data on this investigational injected drug were presented here by
 Robert Pirker, M.D. from the University of Vienna Medical School, Division of
 Oncology in the Department of Internal Medicine Oncology, at the 2nd annual
 meeting of the Network for the Advancement of Transfusion Alternatives (NATA).
 The two-day NATA meeting includes anesthesiologists, intensive care
 specialists, surgeons, transfusion medicine specialists, and other medical
 professionals interested in transfusion medicine and alternatives.  These
 medical professionals use erythropoietic agents such as ARANESP and rHuEPO, to
 decrease the need for transfusions in various settings.  Conservation of blood
 has increasingly become an issue worldwide making alternatives to blood
 transfusions desirable.  Additionally, risks such as transmission of
 blood-borne viruses are furthering studies in transfusion alternatives.
     "Anemia is a common side effect of chemotherapy, and may require the delay
 or reduction of treatment, potentially compromising its long-term
 effectiveness, and may also require blood transfusions," said Dr. Pirker.  He
 said that rHuEPO is very effective in managing chemotherapy-induced anemia,
 but injections three times per week can be inconvenient for many patients and
 physicians.  "A single dose of ARANESP just once a week or once every three
 weeks, as suggested in these studies, would provide flexibility for both
 patients and physicians, and could facilitate delivery of planned doses of
 chemotherapy on time and reduce the need for transfusions," he said.
     ARANESP, also known as novel erythropoiesis stimulating protein, is a new
 erythropoietic protein (a protein that stimulates production of
 oxygen-carrying red blood cells) with a longer half-life than the currently
 available erythropoeitic class rHuEPO -- more than 40 hours in patients with
 cancer receiving chemotherapy -- which significantly increases its biological
 activity.  Also made through recombinant DNA technology like rHuEPO, ARANESP
 is not yet licensed and is currently undergoing phase 3 clinical trials.
 
     Studies and Findings
     Dr. Pirker presented findings from two phase 1/2 multi-center studies of
 ARANESP in anemic patients with solid tumors receiving multicycle
 chemotherapy.  Both studies used an open-label, randomized design.  In the
 first study, 218 patients being treated with chemotherapy for solid tumors and
 who were anemic (hemoglobin 11.0g/dL or less) received either a
 once-weekly subcutaneous dose of ARANESP (doses ranged from 0.5 to 4.5 ug/kg
 body weight) or rHuEPO three times per week (150U/kg body weight) for
 12 weeks, beginning on the first day of their chemotherapy cycle.
     In this study, ARANESP was shown to be as or more effective than rHuEPO in
 treating anemia.  For example, 22 percent of patients receiving rHuEPO still
 needed red blood cell transfusions, compared to 15 percent and 7 percent of
 those receiving 0.5 ug/kg and 4.5 ug/kg ARANESP, respectively.  The response
 to ARANESP was also dose dependent.  For example, 24 percent of patients
 receiving 0.5 ug/kg ARANESP had a hemoglobin response -- an increase of 2g/dL
 or more -- compared to 50 percent of patients receiving 2.25 ug/kg and
 70 percent of patients receiving 4.5 ug/kg.  As hemoglobin increased with
 treatment with ARANESP or rHuEPO, patient-reported fatigue levels, an
 indicator of quality of life, decreased.
     "These findings underscore the importance of treating anemia with agents
 like ARANESP or rHuEPO," Dr. Pirker said.  "We're not just increasing red
 blood cell volume -- we're improving the quality of life of patients," he
 said.
     In the second study, 162 patients received either a placebo or ARANESP
 (doses ranged from 4.5 ug/kg to 13.5 ug/kg) once every three weeks.
 Forty-four percent of placebo patients required red blood cell transfusions
 compared to 22 percent to 25 percent of patients receiving the various doses
 of ARANESP.  The hemoglobin response to ARANESP was again found to be dose
 dependent, and patients given higher doses responded more rapidly.
     "In these studies, our findings showed that ARANESP, when administered
 once per week or once every three weeks, is as safe and effective as rHuEPO in
 treating anemia in patients receiving chemotherapy for solid tumors," Dr.
 Pirker said.  "It reduced the need for allogenic blood transfusion and its
 associated risks, and the increased hemoglobin levels are associated with
 reduced fatigue and improved quality of life.  It offers both patients and
 physicians the potential of greater convenience compared to rHuEPO," he said.
 He added that due to the longer dose duration and more rapid, dose dependent
 response, ARANESP shows potential in blood loss management applications in
 surgery and the ICU as well.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X51451222
 
 

SOURCE University of Vienna Medical School, Division of Oncology
    BERLIN, April 24 /PRNewswire Interactive News Release/ -- New data shows
 that the investigational drug ARANESP(TM) (darbepoietin alfa) increases
 hemoglobin levels in cancer patients with anemia due to chemotherapy, reducing
 the need for blood transfusions and correcting anemia.  ARANESP is a
 long-acting form of rHuEPO (recombinant human erythropoietin), the current
 therapy for chemotherapy-induced anemia.  When dosed once weekly during
 chemotherapy, ARANESP worked as well or better than rHuEPO given three times
 per week, the standard dosing schedule.
     The data on this investigational injected drug were presented here by
 Robert Pirker, M.D. from the University of Vienna Medical School, Division of
 Oncology in the Department of Internal Medicine Oncology, at the 2nd annual
 meeting of the Network for the Advancement of Transfusion Alternatives (NATA).
 The two-day NATA meeting includes anesthesiologists, intensive care
 specialists, surgeons, transfusion medicine specialists, and other medical
 professionals interested in transfusion medicine and alternatives.  These
 medical professionals use erythropoietic agents such as ARANESP and rHuEPO, to
 decrease the need for transfusions in various settings.  Conservation of blood
 has increasingly become an issue worldwide making alternatives to blood
 transfusions desirable.  Additionally, risks such as transmission of
 blood-borne viruses are furthering studies in transfusion alternatives.
     "Anemia is a common side effect of chemotherapy, and may require the delay
 or reduction of treatment, potentially compromising its long-term
 effectiveness, and may also require blood transfusions," said Dr. Pirker.  He
 said that rHuEPO is very effective in managing chemotherapy-induced anemia,
 but injections three times per week can be inconvenient for many patients and
 physicians.  "A single dose of ARANESP just once a week or once every three
 weeks, as suggested in these studies, would provide flexibility for both
 patients and physicians, and could facilitate delivery of planned doses of
 chemotherapy on time and reduce the need for transfusions," he said.
     ARANESP, also known as novel erythropoiesis stimulating protein, is a new
 erythropoietic protein (a protein that stimulates production of
 oxygen-carrying red blood cells) with a longer half-life than the currently
 available erythropoeitic class rHuEPO -- more than 40 hours in patients with
 cancer receiving chemotherapy -- which significantly increases its biological
 activity.  Also made through recombinant DNA technology like rHuEPO, ARANESP
 is not yet licensed and is currently undergoing phase 3 clinical trials.
 
     Studies and Findings
     Dr. Pirker presented findings from two phase 1/2 multi-center studies of
 ARANESP in anemic patients with solid tumors receiving multicycle
 chemotherapy.  Both studies used an open-label, randomized design.  In the
 first study, 218 patients being treated with chemotherapy for solid tumors and
 who were anemic (hemoglobin 11.0g/dL or less) received either a
 once-weekly subcutaneous dose of ARANESP (doses ranged from 0.5 to 4.5 ug/kg
 body weight) or rHuEPO three times per week (150U/kg body weight) for
 12 weeks, beginning on the first day of their chemotherapy cycle.
     In this study, ARANESP was shown to be as or more effective than rHuEPO in
 treating anemia.  For example, 22 percent of patients receiving rHuEPO still
 needed red blood cell transfusions, compared to 15 percent and 7 percent of
 those receiving 0.5 ug/kg and 4.5 ug/kg ARANESP, respectively.  The response
 to ARANESP was also dose dependent.  For example, 24 percent of patients
 receiving 0.5 ug/kg ARANESP had a hemoglobin response -- an increase of 2g/dL
 or more -- compared to 50 percent of patients receiving 2.25 ug/kg and
 70 percent of patients receiving 4.5 ug/kg.  As hemoglobin increased with
 treatment with ARANESP or rHuEPO, patient-reported fatigue levels, an
 indicator of quality of life, decreased.
     "These findings underscore the importance of treating anemia with agents
 like ARANESP or rHuEPO," Dr. Pirker said.  "We're not just increasing red
 blood cell volume -- we're improving the quality of life of patients," he
 said.
     In the second study, 162 patients received either a placebo or ARANESP
 (doses ranged from 4.5 ug/kg to 13.5 ug/kg) once every three weeks.
 Forty-four percent of placebo patients required red blood cell transfusions
 compared to 22 percent to 25 percent of patients receiving the various doses
 of ARANESP.  The hemoglobin response to ARANESP was again found to be dose
 dependent, and patients given higher doses responded more rapidly.
     "In these studies, our findings showed that ARANESP, when administered
 once per week or once every three weeks, is as safe and effective as rHuEPO in
 treating anemia in patients receiving chemotherapy for solid tumors," Dr.
 Pirker said.  "It reduced the need for allogenic blood transfusion and its
 associated risks, and the increased hemoglobin levels are associated with
 reduced fatigue and improved quality of life.  It offers both patients and
 physicians the potential of greater convenience compared to rHuEPO," he said.
 He added that due to the longer dose duration and more rapid, dose dependent
 response, ARANESP shows potential in blood loss management applications in
 surgery and the ICU as well.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X51451222
 
 SOURCE  University of Vienna Medical School, Division of Oncology