Human Genome Sciences is in the process of beginning an independent audit of its clinical trials amid "a renewed climate of concern" nationally over the testing of gene-based drugs in people, Chief Executive Officer William Haseltine told shareholders yesterday at the company's annual meeting.
Haseltine made the comments after shareholders asked about several events this year, including HGS' hiring of a new vice president of regulatory affairs and the U.S. Food and Drug Administration's hold on clinical trials involving VEGF-2, a gene-therapy drug manufactured by HGS.
Haseltine did not elaborate on the audit plans of the Rockville-based and left shortly after the shareholders meeting for a board meeting.
Dr. David Stump, the company's senior vice president of drug development, declined to comment further, as did company spokeswoman Kate De Santis. Haseltine was traveling and couldn't be reached following the board meeting.
Such an audit, however, wouldn't necessarily mean there is anything wrong with any of HGS' seven clinical trials. Any such review by outside consultants may simply be a preventive measure sparked by high-profile problems in gene-based drug trials in several quarters, as well as the FDA's vigilance.
Last fall, for example, an Arizona teenager died after receiving a gene-based therapy overseen by a group of University of Pennsylvania researchers. An FDA-ordered hold on those trials and hearings by the National Institutes of Health and Congress followed.
The Clinton administration said Tuesday that it would seek the ability to levy fines of up to $250,000 on scientists who violate federal rules for human research and $1 million on universities employing them.
Yesterday, Haseltine didn't comment specifically on the Clinton administration proposal but told shareholders, "we welcome the moves by the FDA to tighten up clinical trials." He also said sharpened oversight would ensure public confidence in clinical trial results.
The experimental drug VEGF-2, a protein injected directly into the heart, was designed to stimulate the growth of new blood vessels in patients with heart or circulation problems. Human testing of the drug was suspended in February in response to questions raised by the FDA, Human Genome Sciences said in a regulatory filing.
In April, the FDA sent a warning letter to Dr. Jeffrey M. Isner, chief of vascular medicine at St. Elizabeth's Medical Center in Boston and a principal investigator in the trial, saying that he had violated regulations and potentially endangered patients in the trial.
Among other violations, the FDA said, the trials had improperly enrolled a patient who had lung cancer - potentially leading VEGF to build blood vessels that fed the growth of his tumor - and failed to report in a timely manner the death of a patient who had a heart attack while enrolled in the trial.
The trials were handled through Vascular Genetics Inc., a North Carolina-based company in which Human Genome Sciences has a 19.9-percent stake and warrants to purchase an additional 5.1-percent stake, according to an HGS filing with the government. St. Elizabeth's and Isner also have stakes in Vascular Genetics.
Isner has since responded to the FDA's letter, and St. Elizabeth's Medical Center spokeswoman Sonya Hagopian yesterday said that the hospital is hopeful trials will be allowed to resume. "We're definitely eager to work with the FDA to get the trials back on track," she said. "We answered the FDA's concerns on the larger issues, and we felt like we put together a thorough response."
Haseltine said Human Genome Sciences isn't confident that the trials will resume. But, he said, "we still have great faith in this drug. It has been active in animal models and preliminary evidence indicates it works in human."
Wire services contributed to this article.