InVivo Therapeutics has sent the revised protocol and related study documents to the US Food and Drug Administration (FDA) for conducting a clinical trial designed to measure the safety of its investigational scaffold device for spinal cord repair.
It now includes all changes that were conditions of approval by the FDA. The revised protocol and related study documents will be sent to six US sites by the company so that it can now begin institutional review board submissions and finalise clinical study contracts with InVivo.
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InVivo Therapeutics expects to be enrolling subjects at the first clinical study site in the first two weeks of March. The in-house manufacturing process remains on track to provide scaffolds in mid-February.
The company has also announced the completion of a strategic review of its Hydrogel programme. Rather than diluting its limited resources with multiple projects, the company will focus its efforts on accelerating one programme.
On funding of the Hydrogel programme, the company is likely to decide in the second quarter whether the programme will be partnership-funded or self-generated. The company is currently in discussions with a company that owns a proprietary protein for the funding.
Meanwhile, the company is producing more safety data on its Hydrogel platform so that products being developed will be more ready for licensing and clinical trials.
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By GlobalDataInVivo Therapeutics interim CEO Michael Astrue said: "Our incoming chief executive officer, Mark Perrin, will inherit dedicated employees and a realistic strategic plan that can generate enormous value for shareholders. I am confident in Mark’s ability to take this company to the next level."
