As recently as April, InVivo therapeutics was sounding buoyant about the prospect of its first in man study happening pretty quickly. Now the spinal cord injuries technologist has been forced to issue an update on the clinical timeline for its biopolymer scaffolding to treat acute SCI. It seems the FDA wants the patients in its IDE trial to be staggered rather than simultaneous as the company had planned.
When the FDA granted InVivo therapeutics an Investigational Device Exemption (IDE) under which it could perform designated clinical studies, the company clearly wasn’t expecting the agency to demand that the five-person pilot trial would be staggered such that each patient will be followed for three months prior to requesting approval to enroll the next patient. InVivo now says that because it needs to obtain FDA approval to enroll each subsequent patient, the Company anticipates that from the date of the first enrolled patient, it will take at least 21 months to complete enrollment. Consistent with FDA guidance, the Company then expects to conduct a pivotal study with a control group to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.
According to its press release on the subject, InVivo now expects that, based on the judgment of new management, it will enroll the first patient during the first quarter of 2014.
Further, management has undertaken a comprehensive project and timeline review of its hydrogel technologies platform, as well as its application to pain treatment, dural sealants, dural replacements, nerve conduits and fibrosis treatment, and will provide an update as to the status of those programs as data is available.
Notably, Fierce Medical Devices has reported that the delay may put off a potential pivotal study and hoped-for commercialization indefinitely. It also noted that the share price had fallen 40% on the news.
Michael Astrue, Interim Chief Executive Officer of InVivo, said, “We remain fully committed to beginning this study as soon as possible. While the study will take additional time, we look forward to bringing this important therapy into the clinic.”
Source: InVivo Therapeutics Corporation