Restoring Spinal Health: New Biotherapeutics to Address Disorders and Injuries

Biologics

biotherapeutics for spinal health
There are currently no FDA-approved therapies for spinal-related injuries and disorders. What can biotherapeutics companies do to take advantage of this opportunity?
Image source: Flickr CC user Michael Dorausch

More than 12,000 people sustain a spinal cord injury (SCI) every year. In addition to this figure, the number of spinal disorders is also increasing. Factor in the demand for minimally invasive surgeries to treat spine conditions, and we’re currently witnessing a push to develop new treatments and devices in this area. In fact, the global spinal biotherapeutics market was worth $1.9 billion in 2014, with the largest share belonging to the North American region.1

Lack of FDA-Approved Biotherapeutics Suggests an Opportunity for Companies

While we’ve previously discussed how disorders can negatively impact the central nervous system, the fact of the matter is that an SCI can have lifelong repercussions upon a person’s quality of life. Imagine losing sensory or motor function in your body, and most especially your limbs. Sustaining such an injury can significantly alter a person’s lifestyle in the blink of an eye. But with as much innovative technology as we currently have at our disposal, it should be possible to help these patients.

Unfortunately, the reality paints a different picture. To date, there are no FDA-approved therapies or medical devices that can restore motor or sensory function to a patient with an SCI. Part of the reason for this lack of treatment stems from the complex pathologies that can be found at the site of a spinal injury. Among the adverse effects we can observe at an SCI are demyelinated axons and cavitation of the injury site. Focusing on one issue may ultimately have no effect due to the existence of the others.

One company specializing in regenerative medicine, however, may have found the answer. Last summer, Asterias Biotherapeutics launched a clinical trial testing their new therapy targeting patients with newly sustained complete SCIs. These patients have lost all sensation and motor ability below the injury site, complete with paralysis of both sets of limbs. By using oligodendrocyte progenitor cells obtained from embryonic stem cells, the potential treatment could ultimately lead to the survival and regrowth of axons at the injury site. In preclinical animal testing, the therapy was shown to improve locomotor function in both hind- and forelimbs, a positive result that researchers are hoping will carry over to human subjects.2 After all, even minor improvement in sensory and motor function can lead to a large change in quality of life for a patient with an SCI.

Thus far, the outlook for Asterias’s new biotherapeutic remains optimistic. Safety data from the first round of clinical trials proved excellent, so researchers began dosage escalation last fall.3 If clinical trials continue on this positive trajectory, perhaps we might even see our first FDA-approved therapy for an SCI within the next decade. It might even lead to more advances in the treatment of other spinal injuries and disorders.

Biotherapeutics Can Lead to Advances in Regenerative Medicine

Because of the lack in approved therapies, companies have plenty of opportunities they can pursue to meet the increasing demand in this area. Just because Asterias’s treatment specifically targets patients with newly sustained complete SCIs, that doesn’t mean theirs must as well. Due to the complex pathologies involved in spinal injuries, they can instead develop biotherapeutics focused on different aspects. They can choose to concentrate on improving axon health or perhaps they prefer to work on restoring motor function in patients with older spinal injuries. On the other hand, who’s to say they can’t work on a treatment that combines both?

If Asterias’s clinical trials prove successful, other forms of stem cell-based biotherapeutics can be created to address various spinal-related disorders. The involvement of stem cells opens the door to cell regeneration and even disease reversion. We might even be able to see a biologic therapy for an inherited spinal disorder someday. On the other hand, the complexities involved in restoring spinal health might also similarly require complex biologic therapies. For example, combination therapies might be required to treat certain spinal injuries. We’ve previously seen how effective such therapies can be in the management of conditions where traditional treatment methods may have adverse effects as a result of long-term usage. When used in conjunction with traditional therapies, they often boost efficacy, which can mean that a lower concentration treatment can be administered to the patient. As a result, concerns about safety and cumulative toxicity can be reduced. Combination therapies have also shown to be particularly effective in treating patients who prove unresponsive to only one type of treatment. In the case of spinal injuries and disorders, a combination treatment that makes use of biologics may ultimately be the answer to improving these patients’ lives.

Whether it’s a treatment meant to target SCIs or one that addresses inherited spinal disorders, life sciences companies will need the appropriate tools to support their research and development from the initial discovery phases to the final manufacturing stages. The BIOVIA Biologics Solution is a comprehensive suite tailored to carry organizations throughout their efforts to develop new and innovative biotherapeutics. Its ability to manage high volumes of data, whether related to cell lines or experimental assays, can aid researchers as they work to gain crucial insights and determine developability early in the process. The solution even comes with systems built to aid regulatory compliance—necessary in the quest for FDA approval. If your life sciences firm is interested in a solution that can streamline your R&D efforts to meet the demanding pace of innovation in the biotherapeutics field, then please contact us today to learn more about the BIOVIA Biologics Solution.

  1. “The Global Spine Biologics Market Was Valued at $1.9 Billion in 2014,” December 2, 2015, http://www.prnewswire.com/news-releases/the-global-spine-biologics-market-was-valued-at-19-billion-in-2014-559869211.html
  2. “Asterias Biotherapeutics Announces First Patient Treated in Phase 1/2a Dose-Escalation Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury,” June 8, 2015, http://asteriasbiotherapeutics.com/asterias-biotherapeutics-announces-first-patient-treated-in-phase-12a-dose-escalation-clinical-trial-of-ast-opc1-for-complete-cervical-spinal-cord-injury/
  3. “Asterias Biotherapeutics to Begin Dose Escalation in the SCiStar Phase 1/2a Clinical Trial of AST-OPC1 for Complete Cervical Spinal Cord Injury,” October 20, 2015, http://asteriasbiotherapeutics.com/asterias-biotherapeutics-to-begin-dose-escalation-in-the-scistar-phase-12a-clinical-trial-of-ast-opc1-for-complete-cervical-spinal-cord-injury/

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