A Phase 1, Multicenter, Open-Label Dose Escalation Study Evaluating the Safety and Tolerability of Multiple Hematide Injections in Subjects With Refractory Non-Small Cell Lung Cancer, Breast Cancer, or Prostate Cancer Who Are Anemic and Receiving Cytotoxic Chemotherapy

Inclusion Criteria:

- Females of childbearing potential who are sexually active must agree to use adequate
contraception, and can neither be pregnant nor lactating from Screening throughout
the duration of the study.

- Individuals with one of the following histologically confirmed tumors:

- stage IIIB/IV non-small-cell lung cancer

- metastatic breast cancer

- androgen insensitive prostate cancer and are scheduled to receive at least 4
weeks of chemotherapy, including a taxane.

- Has progression or relapse after treatment with at least one regimen of chemotherapy
or hormone therapy.

- Has a hemoglobin value of greater than or equal to 8 and less than 10.5 g/dL within 1
week prior to administration of study drug.

- Has an Eastern Cooperative Oncology Group Performance Status of 0-2.

- Has one ferritin level greater than or equal to 100 ng/mL within 4 weeks prior to
study drug administration.

- Has one serum or red cell folate level above the lower limit of normal within 4 weeks
prior to study drug administration.

- Has one vitamin B12 level above the lower limit of normal within 4 weeks prior to
study drug administration.

- Has one absolute neutrophil count greater than or equal to 1.5 x 109/L within 1 week
prior to administration of study drug.

- The subject has a serum creatinine less than or equal to 1.5 mg/dL or a measured
creatinine clearance greater than 60 mL/min.

- The subject has one platelet count greater than or equal to 100 x 109/L within 1 week
prior to administration of study drug.

- The subject has a Life expectancy greater than 4 months.

- The subject has a body mass index between 18 and 30 kg/m2, inclusive, prior to study
drug administration.

- The subject has a negative test result for hepatitis B surface antigen, and hepatitis
C virus antibody at Screening.

Exclusion Criteria:

- Has a history of failure to respond to erythropoiesis-stimulating agent treatment.

- Has had treatment with any erythropoiesis-stimulating agent in the past 4 weeks.

- Is known to have antibodies to other erythropoiesis-stimulating agents or history of
Pure Red Cell Aplasia.

- Has received Peginesatide in a previous clinical study or as a therapeutic agent.

- Has a history of hypersensitivity or allergies to Peginesatide, other
erythropoiesis-stimulating agents or related compounds.

- Has had red blood cell transfusion within 4 weeks prior to study drug administration.

- Has known hemoglobinopathy (eg, homozygous sickle-cell disease, thalassemia of all
types, etc).

- Has known hemolytic condition.

- Has known blood loss as a cause of anemia, iron deficiency anemia, or anemia caused
by gastrointestinal bleeding.

- Has any previous or planned radiotherapy to more than 30% of active bone marrow.

- Has donated more than 400 mL of blood within the 90 days preceding the beginning of
the study.

- Has known intolerance to parenteral iron supplementation.

- Has received IV iron within 1 week of study drug administration.

- Has history of bone marrow or peripheral blood cell transplantation.

- Has central nervous system metastases.

- Has a history of deep venous thrombosis, pulmonary embolism or other thrombotic event
(eg, stroke, myocardial infarction, etc.) in the previous 6 months or known history
of hypercoagulable disorder.

- Has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis,
systemic lupus erythematosus, etc).

- Has poorly controlled hypertension per the investigator's judgment within 4 weeks
prior to study drug administration (eg, systolic greater than or equal to 170 mm Hg
or diastolic greater than or equal to 100 mm Hg on repeat readings).

- Has had a seizure in the 6 months prior to study drug administration.

- Has advanced chronic congestive heart failure - New York Heart Association Class III
or IV.

- Has a history or presence of an abnormal electrocardiogram at Screening that, in the
investigator's opinion, is clinically significant.

- Has a known history of human immunodeficiency virus.

- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
abuse (defined as consumption of more than 4 alcoholic drinks per day) within 1 year
prior to Baseline.

- Has aspartate aminotransferase or alanine aminotransferase greater than 2.5 times the
upper limit of normal (aspartate aminotransferase or alanine aminotransferase greater
than 5 times the upper limit of normal if liver metastases are present), active liver
disease or jaundice.

- Is currently taking or anticipated to require anticoagulants other than aspirin (eg,
coumadin, ticlopidine, etc.).

- Has a bilirubin greater than the upper limit of normal.

- Has pyrexia/fever greater than or equal to 39°C within 48 hours prior to study drug
administration.

- Has high likelihood of early withdrawal or interruption of the study (eg, myocardial
infarction within the past 3 months, severe or unstable coronary artery disease,
stroke, respiratory, autoimmune, neuropsychiatric or neurological abnormalities, or
any other clinically significant medical diseases or conditions within the prior 6
months that may, in the investigator's opinion, interfere with assessment or
follow-up of the subject).

- Has anticipated elective surgery during the study period.

- Has exposure to any investigational agent within 1 month prior to administration of
study drug or planned receipt during the study period.