Exhibit 99.1
![LOGO](https://capedge.com/proxy/8-K/0001193125-19-255304/g803680g0926035727504.jpg)
FibroGen Announces Initiation of Phase 2 Clinical Trial of Roxadustat for the Treatment
of Anemia in Cancer Patients Receiving Chemotherapy
SAN FRANCISCO, CA September 26, 2019 — FibroGen, Inc. (NASDAQ: FGEN) today announced first patient dosed in the company’s Phase 2 clinical study of roxadustat, afirst-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI), for the treatment of chemotherapy-induced anemia (CIA) in cancer patients receiving chemotherapy.
“There is a significant unmet need among cancer patients experiencing anemia,” said John Glaspy, M.D., M.P.H., professor of medicine andco-chair of the Division of Hematology/Oncology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). “Investigation of roxadustat as a potential therapy that may be able to overcome the shortcomings of current treatments and alleviate the challenges faced by cancer patients undergoing chemotherapy is welcome.”
“Chemotherapy-induced anemia is a devastating side effect of chemotherapy that can interfere withquality-of-life, exposes patients to risks associated with red blood cell transfusion, and may even set limitations on the dose of chemotherapeutic agents that can be used; yet, it is undertreated,” said Nashat Gabrail, M.D., Gabrail Cancer Center, Canton, Ohio.
Chemotherapeutic agents are known suppressors of red cell production by the bone marrow, and 30% to 90% of patients treated with myelosuppressive chemotherapy develop anemia, resulting in decreased functional capacity, and impaired quality of life. In contrast to other common side effects experienced by patients undergoing treatment for cancer, CIA is often a “silent” side effect with insidious symptoms. CIA can be one of the most common underlying etiologies of the fatigue in cancer patients, and is associated with cognitive dysfunction, dyspnea, and depression. As a result of such reduced quality of life, some patients choose to discontinue or delay chemotherapeutic treatment, increasing the potential for suboptimal outcomes.
“Roxadustat has been studied in anemia associated with chronic kidney disease in global Phase 3 studies enrolling over 9,000 patients, and is approved for treatment of anemia in CKD patients on dialysis and not on dialysis in China, and in CKD patients on dialysis in Japan, with preparation of the U.S. NDA submission and the European MAA submission underway,” said K. Peony Yu, M.D., Chief Medical Officer of FibroGen. “We and our partners, AstraZeneca and Astellas, are committed to investigating roxadustat’s potential in the treatment of anemia that currently affects a majority of cancer patients undergoing chemotherapy.”
This16-week Phase 2 study is designed to evaluate the efficacy and safety of roxadustat in anemic subjects undergoing chemotherapy treatments when the anticipated outcome isnon-curative. The trial will enroll up to 100 anemic cancer patients withnon-myeloid malignancy (solid tumor) having a hemoglobin level at or below 10 g/dL, while undergoing myelosuppressive chemotherapy and continuing such chemotherapy for at least another 8 weeks. Patients are to receive oral roxadustat three times a week for
Page 1 of 3