Date: 2015-08-06
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Halozyme Therapeutics (USA - CA) Pancreas Center at the University of California, San Francisco (UCSF) (USA - CA)
Product: PEGPH20
Action
mechanism: enzyme. PEGPH20 (PEGylated recombinant human hyaluronidase) targets the degradation of hyaluronan (HA), a chain of natural sugars that can accumulate around cancer cells, inhibiting other therapies. By degrading HA, PEGPH20 may increase the access of co-administered chemotherapeutic and immunotherapeutic agents. 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.
Disease: pancreatic cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On August 6, 2015, Halozyme Therapeutics announced the Pancreas Center at the University of California, San Francisco (UCSF) has initiated a clinical research study of Halozyme's investigational new drug, PEGPH20 in pancreatic cancer patients who are candidates for potentially curative surgery. The trial will be conducted within the UCSF Helen Diller Family Comprehensive Cancer Center. The Phase 2 study will investigate PEGPH20 in combination with gemcitabine and nab-paclitaxel (Abraxane®) in patients with borderline resectable Pancreatic Ductal Adenocarcinoma (PDAC). The study will track the progress of up to 36 patients through chemotherapy and surgical treatment. At the American Society of Clinical Oncology annual meeting this year, interim results of the randomized Phase 2 Study 202 clinical study of PEGPH20 with Abraxane® and gemcitabine showed a doubling of progression-free survival and an improvement trend in overall survival in high HA metastatic pancreatic cancer patients. In addition, the potential risk profile, including the rate of thromboembolic events, were also presented.
