Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer

1. Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy (unless dose has been stable for 1 month prior to Baseline and remains stable during the trial), immunosuppressive therapy, corticosteroids \> 20 mg/day prednisone or equivalent (unless administered to prevent contrast material reactions during radiographic procedures), or growth factor treatment (eg, erythropoietin) within 14 days prior to initiation of study drug.

2. Presence of an acute toxicity of prior chemotherapy, with the exception of alopecia or peripheral neuropathy, that has not resolved to ≤ Grade 1, as determined by NCI CTCAE v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).

3. Receipt of \>3 prior regimens of cytotoxic chemotherapy, including any use in the neo-adjuvant, adjuvant, and/or metastatic settings ,Unless more than 1 year elapsed since the Neo-adjuvant treatment was completed

4. Receipt of Blood Transfusion during 2 weeks prior to Baseline

5. Life expectancy \<12 weeks.

6. Major surgery or radiation therapy within 28 days prior to initiation of study drug,

7. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness.

8. Patients with history of brain metastasis

9. Known active hepatitis B or C or other active liver disease (other than malignancy).

10. Severe liver dysfunction (Child-Pugh Class B or C) and

11. Patients with a history of esophageal bleeding have varices that have been sclerosed or banded and no bleeding episodes have occurred during the prior 6 months.

12. Active infection requiring systemic therapy.

13. Insulin-requiring diabetes mellitus will not be included if, according to the investigator, not stable, during the last 6 months.

14. History of any of the following within 12 months prior to initiation of study drug:

Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), unstable angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism (within the last 6 months). Left Ventricular Ejection Fraction \<50% .

15. Uncontrolled arterial hypertension, or anti-hypertensive drugs whose type or dose has been changed within 1 months prior to screening or whose dose is anticipated to change within cycle 1.

16. Risk of syncope, in the judgment of the Principal Investigator, according to the patient's history of syncope.

17. History of ongoing cardiac dysrhythmias requiring drug treatment

18. Malignancies can be a reason for exclusion only if active during the last year or requiring any anti-tumor treatment. Skin non-melanomatous tumors and thyroid carcinomas - can be included. as well as, Previously treated malignancy within the past 2 years that the Principal Investigator deems to be at low risk for recurrence during the course of this trial.

19. Use of any investigational agents within a minimum of 4 weeks or 5 half-lives of initiation of study drug.

20. Pregnant or lactating female.

21. Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Principal Investigator, are effective and adequate for that patient's circumstances while on study drug and for 3 months afterward.

22. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.

23. Any known multiple allergy, or acute allergic reaction within the subject's medical History or General Practitioner's records.

What this study is about