Halozyme Therapeutics acknowledged today that the FDA placed a formal clinical hold on its troubled Study 202 assessing its experimental drug PEGPH20 in patients with pancreatic cancer—less than a week after the company temporarily halted enrolling and dosing patients in the ongoing Phase II trial.
The agency told Halozyme it placed the clinical hold following the company’s pause in study activity. The trial’s independent data monitoring committee is evaluating data from the trial to learn why patients treated with PEGPH20 as well as nab-paclitaxel and gemcitabine saw a higher rate of blood clots and other thromboembolic events compared with patients treated with nab-paclitaxel and gemcitabine alone.
“We will be providing this information to the data monitoring committee and the FDA in parallel so they can complete their respective assessments," Helen Torley, M.B. Ch.B., M.R.C.P., Halozyme’s president and CEO, said in a statement.
“Pancreatic cancer has one of the lowest survival rates of any cancer. We remain committed to evaluating PEGPH20 as a possible therapy to address this devastating disease," Dr. Torley added.
As with Halozyme’s statement last week, the company’s latest remarks did not indicate when Halozyme expects to resume enrolling and dosing patients in Study 202, or how many patients had been enrolled and dosed when the temporary halt occurred.
The trial was envisioned as having 124 subjects, divided evenly between a treatment arm of PEGPH20 and nab-paclitaxel, and a gemcitabine arm, preceded by eight subject “run-in” phase assessing safety and tolerability, according to Study 202’s page on ClinicalTrials.gov (NCT01839487), last updated on January 27.
The study is one of two Phase II trials for PEGPH20; the other, SWOG, also aims to assess the drug for pancreatic cancer.
PEGPH20 is an investigational PEGylated form of Halozyme’s FDA-approved recombinant human hyaluronidase rHuPH20 (marketed as Hylenex®), designed to dramatically increases the half-life of the compound in the blood and allow for intravenous administration.
The temporary halt for Study 202 came two months after Halozyme publicly cited “potential acceleration of the PEGPH20 program” among several R&D programs for which it raised funds through a public offering of common stock that closed in February and generated approximately $107.8 million in net proceeds.
Dr. Torley identified two milestones related to PEGPH20 among “key development and commercialization events over the next twelve months” in a January 13 statement based on Halozyme’s presentation at the JPMorgan 32nd Annual Healthcare Conference: “For PEGPH20, these include completion of enrollment of the Phase [II] pancreatic cancer study (Study 202) and initiation of a study to evaluate PEGPH20 in an additional tumor setting.” That setting was not disclosed.
Just a day before its April 4 announcement of the temporary halt, Halozyme quietly filed a notice with the SEC that its vp and chief commercial officer, James P. Shaffer, resigned effective March 31. He will continue as a consultant through September 30, but “will receive no additional compensation for his services,” the company stated in an 8-K filing.
No reason for his resignation was stated in the filing, which noted that he will receive the equivalent of 26 weeks’ base salary and the continuation of health benefits through September 30. Shaffer’s 2013 base salary was $366,670, part of his total compensation last year of $1,100,512, according to a company proxy statement filed April 7.