San Diego-based Halozyme Therapeutics announced on Wednesday that the FDA has lifted a hold on a clinical trial of its pancreatic cancer drug, PEGPH20.
The hold on patient enrollment and dosing was put in place this April when the company, based on recommendations from an independent data monitoring committee, decided to evaluate a possible increase in the rate of thromboembolism, or blood clots, in patients treated with PEGPH20.
After reviewing data, the committee recommended last month that the trial (Study 202) be resumed under revised protocols. Patients considered to be at a high risk of thromboembolic events will be excluded from the study, and others will be given low molecular-weight heparin to help prevent blood clots.
PEGPH20 was developed through research conducted by Dr. Gregory Frost while he was at the University of California, San Francisco. While studying the extracellular matrix he discovered that tumors use hyaluronan to create a protective layer around them. Based on his findings, he went on to develop the enzyme PEGPH20, which breaks down the hyaluronan matrix.
In an article in Medscape Medical News in 2013, Dr. Frost stated:
“Nobody else is taking this approach to the cancer. When we first started, people thought we were crazy, thought we would make the tumor spread and explode. Now we are somewhere between people thinking this is crazy and thinking this is the obvious solution.” (Click here to read the article.)
He went on to say that pancreatic cancers with a high level of hyaluronan had a poorer prognosis than those that did not. When PEGPH20 is given intravenously, the hyaluronan is broken down and subsequently “liberates fluid from the tumor, pressure normalizes, reperfusion occurs, and tumor metabolism changes.”
PEGPH20 is used in combination with gemcitabine, a drug that has proven to be effective in pancreatic cancer. Gemcitabine is also used in combination with Celgene’s pancreatic cancer drug Abraxane, which I wrote about in December of last year. Click here to read the Celgene article on the BioSurplus blog.
According to Halozyme CEO, Dr. Helen Torley:
“We are committed to the development of PEGPH20 in pancreatic cancer. Halozyme worked diligently with the FDA and the DMC to develop the plan to allow the study to restart. We are pleased to be able to continue enrolling patients in this clinical program as there remains a significant need for new treatment options for pancreatic cancer patients.”