SPECT-ulating on efficacy

Collateral Therapeutics Inc. has announced that its Generx adenoviral-delivered FGF-4 therapy tended to reduce the size of perfusion defects in a Phase II trial. But the results give no hint of what to expect from its ongoing Phase IIb/III registration trials.

The imaging method used to evaluate the exertional angina patients in the Phase II trial has not been proven to correlate with clinical improvements, and the company is not evaluating the same endpoint in its Phase IIb/III trials. So while the Phase II trial provides proof-of-principle for Generx's angiogenic mechanism of action, it does not provide information on clinical benefit...