On July 26, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Eisai Inc. has dosed the first patient in a collaborative phase 1b/2 clinical trial to assess whether Eisai’s eribulin mesylate (HALAVEN) in combination with Halozyme’s investigational drug PEGPH20 (PEGylated recombinant human hyaluronidase) can improve overall response rate (ORR) – the proportion of women that have a predefined reduction in tumor burden – as compared with eribulin alone as a therapy in women with advanced or metastatic, High-Hyaluronan (HA) HER2-negative breast cancer (Press release, Halozyme, JUL 26, 2016, View Source [SID:1234514042]). Schedule your 30 min Free 1stOncology Demo! "Initiation of this study is not only a major milestone in our collaboration with Eisai, it underscores our combined focus on advancing the treatment of metastatic breast cancer—one of the most common cancers in women worldwide," said Dr. Helen Torley, president and chief executive officer.
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PEGPH20 is an investigational drug administered intravenously that targets the degradation of HA, a glycosaminoglycan – or chain of natural sugars throughout the body – that can accumulate around cancer cells to inhibit other therapies. Eribulin, a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai, is a microtubule dynamics inhibitor with a distinct binding profile that has been shown in in vitro studies to lead to apoptotic cell death after prolonged and irreversible mitotic blockage. In HA-high triple-negative breast preclinical animal models, the addition of PEGPH20 to eribulin showed a significant increase in tumor growth inhibition and overall tumor regression when compared to eribulin alone.
The collaborative study will seek to determine whether or not the combination therapy of eribulin and PEGPH20 can improve the overall response rate in patients with metastatic breast cancer with high levels of HA. The study protocol includes metastatic HER2-negative patients with HA-high breast cancer that were previously untreated and those that received one prior line of therapy.
About Advanced Breast Cancer
Advanced or metastatic breast cancer is a very difficult condition to treat and only 26.3 percent of women will survive beyond five years. (SEER 2016)
About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan.
FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.
About Eribulin Mesylate Injection (Available as HALAVEN)
Halaven (eribulin mesylate) is a microtubule dynamics inhibitor indicated for the treatment of patients with:
Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First and only in the halichondrin class, eribulin is a microtubule dynamics inhibitor with a distinct binding profile. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells.