Cissi Jackson, whose tumors vanished during an experimental cancer drug trial at the Medical College of Ohio last year, starts the next chapter of what she calls her “magical'' treatment next week.
Sarah Lyons, protocol coordinator for the Medical College of Ohio's Cancer Institute, yesterday said, if all goes as planned, the 62-year-old Pemberville woman will receive her 101st dose of an antibody known as H11 on Monday afternoon.
Mrs. Lyons contacted Mrs. Jackson and her husband, Dave, late yesterday afternoon with news that the U.S. Food & Drug Administration had given the green light for continued treatment. The FDA had until mid-March to rule on the issue.
“It's fantastic,'' Mrs. Jackson said.
The rapid retreat of Mrs. Jackson's advanced breast cancer was documented in a five-part series in The Blade, “Working on a Cure: Cancer on Trial,'' published Feb. 10-14, which followed five cancer patients through a trial testing the safety of H11.
“I think it's just great,'' said Mr. Jackson. “But we knew, with everybody fighting for us, we could do it.”
H11 maker Viventia Biotech, Inc., of Toronto will supply the drug free to Mrs. Jackson. MCO will cover all other treatment costs.
At 6 p.m. yesterday, the last institutional requirement fell into place when the board that watches out for the interests of all MCO human research subjects - the Institutional Review Board - approved Mrs. Jackson's treatment.
Board members asked, however, that payment for treatment be clarified in any paperwork Mrs. Jackson receives. In addition, its members said her treatment is not continuing research, but compassionate use of a drug that, thus far, has worked in only one of 12 patients who tried it.
The drug is still very early in the research review process. Although the Phase I study at MCO identified a safe dose of the drug, H11 must be tested in far larger groups of patients before it can meet FDA approval.
A Phase II trial is expected to take place later this year.