The Food and Drug Administration has slammed the breaks on clinical trials for RegeneRx Biopharmaceuticals Inc.’s injectable heart attack drug.
Regulators put mid-stage trials on an indefinite hold due to
non-compliance by one of its contractors with Good Manufacturing
Practice standards, a set of quality and safety regulations governing
pharmaceutical manufacture.
The Rockville biotech firm planned to begin enrolling patients for
the Phase 2 trial of the compound, RGN-352, within weeks. Phase 1 trials
of the drug had yielded positive results.
The FDA’s hold is related to problems at a contract site and does not
pertain to the overall safety of its drug candidate, the company said
in a news release. As a “virtual company,” RegeneRx relies heavily on
outsourcing to bring its products through the clinic.
The setback represents the latest difficulty for the biotech, which was delisted from the New York Stock Exchange in December.
The company last year won a $3 million National Institutes of Health grant to fund research for the heart attack drug.
