Drug Development

FDA lifts a hold on a Novartis hearing loss drug, and tiny GenVec gets a lift

Back in early January, the struggling penny stock biotech GenVec $GNVC posted a notice with the SEC that its partner Novartis had paused their study on a partnered hearing loss drug so the pharma giant could review safety data.

This morning we found out that there was a clinical hold on the early-stage program, which has now been lifted by the FDA. But there’s no explanation for what triggered the hold.

The drug is CGF166, which constitutes GenVec’s lifeline. It’s a gene therapy, using a benign virus to deliver an atonal gene (Atoh1) key to embryonic development which is supposed to induce the differentiation of sensory cells in the inner ear, restoring hearing. A little more than two years ago Novartis handed over a $2 million payment to GenVec following its IND approval. That was part of a $213 million package that was signed in 2010.

GenVec also experienced a catastrophic trial failure of its lead drug in 2010, which eventually persuaded the company to announce plans to shut down. But company exec Douglas J. Swirsky came up with a new plan, built on the ongoing commitment from Novartis and a plan to capitalize somehow on its viral delivery vectors for gene therapies. The company ended 2015 with less than $9 million in cash and its stock closed Friday at 60 cents.

“We appreciate the FDA’s review and the diligent efforts of our collaborator, Novartis, that have enabled the continuation of the CGF166 trial,” said Swirsky, president and CEO of GenVec, in a statement. “We look forward to the near-term enrollment of new patients and believe that the trial will be completed sometime in 2017 as previously expected.”

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