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GenVec awaits guidance from Novartis after study pause

GenVec says Novartis will continue to collect safety data on the nine patients currently enrolled in the study before determining whether to proceed with incremental patients.
GenVec awaits guidance from Novartis after study pause
GenVec ended 2015 with $8.7 mln in cash and investments.

GenVec (NASDAQ:GNVC), a clinical-stage gene delivery company, said it is awaiting further guidance from Novartis (NYSE:NVS), its partner on the CGF166 study, which the Swiss company paused earlier this month.

CGF166 is GenVec's lead product candidate for hearing loss.

Novartis will continue to collect safety and efficacy data on the nine patients currently enrolled in the study before determining whether to proceed with incremental patients, Gaithersburg, Maryland-based GenVec said in a statement on Wednesday.

GenVec said it is awaiting further guidance from its partner on the CGF166 study and is committed to updating shareholders when it gains greater clarity.

On January 8, GenVec was notified by its partner Novartis that enrollment was paused in that clinical study.

This pause was based on a review of data by the trial's Data Safety Monitoring Board in accordance with criteria in the trial protocol.

"While we are disappointed with the pause, as with any first-in-man study, it is important to proceed with care to gain a broad understanding of a product's therapeutic profile," GenVec CEO Douglas Swirsky said in the statement..

"While there is no certainty the trial will continue and timing is also uncertain, we hope enrollment can resume in the coming months and that the trial will be completed sometime in 2017, as previously expected."

Beyond CGF166, GenVec is studying the potential versatility of GenVec's AdenoVerse platform technology across a wide range of areas including therapeutic gene delivery, vaccines, regenerative medicine, cell therapy, oncolytics, gene editing, nucleic acid therapeutics and immunotherapy.

On the IP front, GenVec has also recently strengthened its patent portfolio for claims covering its proprietary adenovectors isolated from mountain gorillas and monkeys.

The company ended 2015 with $8.7 mln (unaudited) in cash and investments. The company believes that existing resources are sufficient to fund its operations into the second quarter of 2017.

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Genvec Timeline

Newswire
September 25 2012

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