US-based biopharmaceutical firm Halozyme Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for its PEGylated recombinant human hyaluronidase (PEGPH20) to treat pancreatic cancer.
The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products that show promise for the diagnosis and/or treatment of rare diseases or conditions.
Currently, the company is investigating PEGPH20 in a Phase II trial in combination with gemcitabine and nab-paclitaxel (ABRAXANE) in patients with metastatic pancreatic cancer.
Halozyme Therapeutics president and chief executive officer Dr Helen Torley said the orphan drug designation follows the fast track designation and allows the company to collaborate more closely with the FDA to facilitate development of PEGPH20 and is part of its core strategy to bring this therapy to patients as rapidly as possible.
"Receiving Orphan Drug designation is an important milestone for this clinical development program," Torley said.
PEGPH20 is an investigational PEGylated form of the company’s recombinant human hyaluronidase being developed for the systemic treatment of tumors that accumulate hyaluronan.