Biotech Values

[DewDiligence]

ABT Tests ABT-888 in Phase-0 Trial

[Notwithstanding the quote from an official at NCI, this is actually not the first-ever phase-0 trial; I know of at least one other and there may have been several.]

http://www.reuters.com/article/marketsNews/idINN1329907420090413

›Mon Apr 13, 2009 4:00pm EDT

WASHINGTON, April 13 (Reuters) - A new type of cancer trial can quickly show whether a drug is safe and worth testing in a large group of patients, researchers said on Monday.

They said the first-ever Phase 0 trial, of an Abbott Laboratories Inc cancer pill, showed it was safe and showed some signs of working against a range of advanced cancers.

"Most importantly, this trial showed that it is possible to enroll a small number of patients, treat them with a low dose of a new drug, identify whether the desired target of the drug was affected, and obtain all of this critical information relatively quickly," the National Cancer Institute, which conducted the study, said in a statement.

Writing in the Journal of Clinical Oncology, the NCI researchers said they tested ABT-888, an experimental pill that interferes with an enzyme that helps repair damaged DNA.

Given alongside conventional chemotherapy drugs, ABT-888 is designed to make them more effective in killing tumors.

The usual first step in testing a drug in people is a phase I clinical trial, which explores both drug safety and tolerance. The next stage is a larger, phase II trial.

The new phase 0 approach focuses on whether patients can tolerate the drug and looks for indications that it has done what it is supposed to do.

"For the past several decades there has been a low success rate of new therapies for the treatment of cancer," Dr. Shivaani Kummar, who led the study, said in a statement.

"This has necessitated re-evaluation of the standard anticancer drug development paradigm, of which phase 0 trials will be a key part of a new approach."

Because the drugs are given in very small doses for very short times to just a few people, drug makers need less animal data to get started than they would need for a traditional phase I trial.‹