ImClone Plans More Erbitux Clinical Tests
ImClone Systems Inc. and Bristol-Myers Squibb Inc. are beginning a new round of clinical tests of Erbitux, a promising drug to treat colon cancer.
A 250-patient trial now underway is expected to satisfy the Food and Drug Administration for approval, the companies said last week. Larger trials are scheduled to begin next year.
On Friday, shares of ImClone jumped 7% on the news to close at $7.77 on the Nasdaq Stock Market. The stock has lost 87% this year. Bristol-Myers shares fell 6% to $21.76 on the New York Stock Exchange.
The companies’ application for approval to market the drug, which has shown promise in treating colon cancer without the side effects of chemotherapy, was rejected by regulators in December because of scientific flaws in the clinical studies.
Since then, ImClone and Bristol--which committed $2 billion to ImClone to share in Erbitux profits--have been caught up in the controversy surrounding insider trading charges leveled at ImClone’s former Chief Executive Samuel Waksal and his friend, Martha Stewart, chief executive of Martha Stewart Living Omnimedia Inc.
Waksal and Stewart, who has not been charged in the case, have maintained their innocence.
On Thursday, the House Energy and Commerce Committee will hold its second ImClone hearing. Committee Chairman Rep. W.J. “Billy” Tauzin (R-La.) has said his panel will focus on what went wrong with Erbitux and on ways to improve the FDA’s review process.
The Justice Department and the Securities and Exchange Commission also are investigating New York-based ImClone.
Desperately ill patients and their advocates have complained that the insider trading scandal surrounding ImClone is needlessly costing lives.
The companies said Friday that they may have a plan in place by the end of the year to provide the drug to some of the nation’s most ill patients.
Usually, patients needing unapproved treatments are enrolled in clinical trials meant to gather data for FDA approval. Needy patients not involved in the trials can still obtain experimental drugs through “compassionate use” and “expanded access” programs allowed by the agency.
Patient advocates have been negotiating with ImClone for at least 13 months to start an expanded-access program.
“I’m still disappointed we don’t have an expanded-access program,” said Frank Burroughs, who founded the Abigail Alliance for Greater Access to Developmental Drugs after his 21-year-old daughter died while trying in vain to obtain Erbitux.
Waksal was forced to step down as chief executive and has been indicted on insider trading and a host of related charges.
He also is accused of tipping off family members and Stewart to sell their ImClone stock in the days before the FDA publicly announced its rebuff of the Erbitux application, sending the stock plummeting.
