Halozyme Therapeutics Inc (HALO)

[rod5247]

Pancreatic cancer treatment advancing in clinical trials

Results from an early-phase study in pancreatic cancer show that an enzyme called PEGPH20 is safe when used in combination with chemotherapy to attack tumors. The enzyme is designed to lower the extraordinarily high pressure within many pancreatic cancers, allowing chemotherapy to penetrate to attack tumor cells.

“We learned first that we could administer this drug safely with chemotherapy,” said Dr. Sunil Hingorani of Fred Hutch’s Clinical Research Division, the study’s principal investigator. The Phase 1 study results also suggest that PEGPH20 “is behaving in patients as predicted in mouse models and that the inability to get chemotherapy into the tumor may be a primary mechanism of disease resistance,” he said.

Randomized Phase 2 studies of the new combination treatment are nearing completion, and an international Phase 3 trial will begin within the next few months, Hingorani said. Although all of the study sites have not yet been finalized, the trial will be available at Seattle Cancer Care Alliance, Fred Hutch’s patient-care arm. Pancreatic cancer patients elsewhere who may be interested in participating in the upcoming phase 3 trial should contact trial sponsor Halozyme Therapeutics, he said, or talk to their oncologist about the availability of the trial in their area.

The Phase 1b trial enrolled 28 patients with untreated stage 4 metastatic pancreatic cancer. Its results, published last week in Clinical Cancer Research, “further substantiate that this strategy should be pursued” in further trials, Hingorani said. The study also provided some insights into additional measures of enzyme activity in tumors that the team is considering incorporating into the new trial, he said.

Halozyme’s PEGPH20 program in pancreatic cancer was granted fast-track status by the U.S. Food and Drug Administration in 2014 to speed the development and review of the drug for this malignancy, which is notoriously difficult to treat. Since then, clinical trials have proceeded swiftly.

“The train’s moving very rapidly, and in many respects, more rapidly than I would have anticipated,” Hingorani said.

PEGPH20 is a version of a naturally occurring enzyme called hyaluronidase. Hyaluronidase breaks down a substance called hyaluronic acid, or HA, which absorbs the shock of everyday activity in the knees and other joints. But some tumors, including many pancreatic cancers, produce it in high amounts, and high HA correlates with a poor prognosis. The water-loving HA inside tumors draws in and binds the moisture from surrounding tissues, which results in such high pressures that blood carrying anticancer drugs cannot readily get in.

— By Susan Keown / Fred Hutch News Service

http://www.fredhutch.org/en/news/center-news/2016/02/good-news-mielcarek-bleakley-meshinchi-hingorani-schiffer-gralow-anderson-correnti.html