Date: 2015-07-31
Type of information: Clinical research agreement
Compound: PEGPH20 and eribulin (Halaven®)
Company: Eisai (Japan) Halozyme Therapeutics (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: enzyme. PEGPH20 is an investigational PEGylated form of Halozyme\'s proprietary recombinant human hyaluronidase under development for the 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 designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer. mitotic inhibitor/tubulin binder. Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane. Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Disease: first line HER2-negative metastatic breast cancer
Details: * On July 31, 2015, Eisai and Halozyme Therapeutics have signed a clinical collaboration agreement to evaluate Eisai\'s agent eribulin mesylate (Halaven®) in combination with Halozyme\'s investigational drug PEGPH20 (PEGylated recombinant human hyaluronidase) in first line HER2-negative metastatic breast cancer. The companies will jointly share the costs of a phase 1b/2 clinical trial to assess whether or not eribulin, in combination with PEGPH20, 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 breast cancer. 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 high levels of hyaluronan. In hyaluronan-rich triple-negative breast preclinical animal models, the addition of PEGPH20 to eribulin showed a significantly higher tumor growth inhibition and overall tumor regression when compared to eribulin alone.
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