InVivo in 2016: Looking Ahead ? December 17, 2015
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InVivo in 2016: Looking Ahead ? December 17, 2015
This year was one of tremendous progress for InVivo. In 2015, we uplisted to a major stock exchange, completed enrollment of the pilot stage of the pivotal probable benefit INSPIRE study, communicated encouraging early clinical data, and engineered an accelerated regulatory plan to bring the Neuro-Spinal Scaffold? that much closer to commercialization. However, as we are on a mission ?to redefine the life of the spinal cord injury (SCI) patient? ? and realizing the ultimate goal is still in front of us ? I?d like to outline what lies ahead for 2016 and how we plan to continue to create fundamental value for our most important partners: shareholders and patients.
Propelling through the INSPIRE study
We have continued to foster a collaborative and fruitful relationship with the Food and Drug Administration (FDA) that has allowed us to dramatically shorten traditional clinical development timelines. In December 2015, we unveiled our plan for the INSPIRE study, including the conversion of our pilot study into a pivotal probable benefit study. Having laid the critical groundwork for INSPIRE, in 2016 we will set out to:
Announce an Objective Performance Criterion (OPC) for INSPIRE
Expand the INSPIRE study to the full 20 patients
Announce at least 10 new INSPIRE sites, with 7 coming on board in the first half of the year
Approach full enrollment of INSPIRE by the end of the year
Announce results from the INSPIRE study as appropriate
Obtaining marketing approval for the Neuro-Spinal Scaffold is inherently different from obtaining marketing approval for many devices because of the accelerated regulatory pathway we have chosen ? Humanitarian Device Exemption (HDE). Unlike a Premarket Approval (PMA), for which a sponsor usually has to power and conduct a pivotal study that demonstrates the investigational product is statistically superior to a control, an HDE only requires the demonstration of safety and probable benefit, which is a lower regulatory hurdle. In order to assess probable benefit, HDE sponsors can establish an Objective Performance Criterion (OPC) to prospectively define success in an uncontrolled study. We are in late-stage discussions with the FDA regarding the definition of the OPC, using historical benchmarks from large, well-established natural history databases as a guide. Once the OPC is agreed upon, we should have a clear view of the likely path to commercialization. Of course, the OPC is not the only variable that the FDA evaluates when reviewing an HDE application. Approval is not guaranteed if the OPC is met, and even if the OPC is not met, the FDA may approve a therapy if safety and probable benefit is supported by a comprehensive review of all clinical endpoints and preclinical results.
In parallel to the OPC discussions with FDA, we will continue to enroll patients, and we expect the FDA will authorize us to expand the number of patients to the full 20 in 2016. We hope to be approaching full enrollment by the end of the year, which will hinge upon a steady ramp-up of clinical sites. We are targeting as many as 10 new sites by year-end, with 7 coming on board in the first half of the year. In addition to several more sites in the U.S., we plan to open our first ex-U.S. sites in Canada and the United Kingdom.
It is extraordinary to think that just over a year after enrolling the first patient in our study, we are now running a pivotal trial with planned international expansion and the potential to file an application for HDE approval in just two years.
Value Beyond INSPIRE ? Cervical SCI and Bioengineered Neural Trails?
In addition to all of the exciting progress with the INSPIRE study in which we are investigating the Neuro-Spinal Scaffold in patients with acute, neurologically complete thoracic SCI, we also expect to make significant progress in 2016 with our programs dedicated to cervical and chronic SCI. To that end, we recently announced our plans to initiate in mid-2016 a study for acute, neurologically complete cervical SCI. The importance of moving higher in the spinal cord cannot be overemphasized, as cervical SCI represents a higher-risk/higher-reward condition than thoracic SCI. In general, gaining or losing a single neurological level in patients with thoracic injuries may have minimal impact on the patient?s overall function and quality of life. However, in the cervical cord, a single level often makes a dramatic difference. We are highly encouraged by the safety profile of the Neuro-Spinal Scaffold in the INSPIRE study to date, and we look forward to testing the Neuro-Spinal Scaffold in injuries where small changes in neuronal preservation or regrowth may have substantial impact on function. I?ll devote an entire CEO?s Perspective on the importance of pursuing a treatment for cervical SCI when we officially launch the program (mid-2016).
We are also devoting significant resources to advancing our Bioengineered Neural Trails program for the 276,000 patients in the U.S. currently living with chronic SCI. Recently, we announced the acquisition and filing of foundational intellectual property for this exciting new approach to stem cell therapy for chronic SCI. We?ll continue to update the public with our progress in this area and are targeting a pre-IND (Investigational New Drug) meeting with the FDA by the end of 2016, which will help inform our development and clinical plans for the program.
This has been a fantastic year of progress for InVivo, but I believe that 2016 will be even more exciting as we continue to move closer to our goal of redefining the life of the spinal cord injury patient.
Mark Perrin, CEO and Chairman
December 17, 2015
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Originally Posted by lunasicc42
