Millions of people worldwide suffer from traumatic injuries or health conditions that cause damage to soft tissues including nerves, muscles, and blood vessels. The body can heal some of that damage, but more serious cases like the severing of a nerve or sustained oxygen deprivation can lead to permanent loss of movement or sensation in a limb, or even require amputation.
Vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) are naturally occurring biomolecules in the body that are known to help enhance tissue regrowth after injury or chronic disease. However, delivering these growth factors via traditional oral or infusion methods has posed numerous challenges including low efficacy, a very short duration of action, and toxicity. As a result, these promising molecules have not been successfully developed into therapies. Alternatives such as muscle transplantation procedures exist, but they often have poor re-innervation results, and a better option is needed.
The promise of growth factors like VEGF and IGF-1 has been largely unrealized due to their systemic toxicity and poor duration of action with bolus injection. The fact that we can now deliver an effective, non-toxic dose of these molecules directly to target sites could finally break the logjam and allow the creation of truly revolutionary regenerative medicines.
This video describes how an alginate hydrogel can be used to trigger the formation of new blood vessels at an ischemic site in the body. Credit: Wyss Institute at Harvard University.
Our Solution
A technology created at the Wyss Institute solves this problem by loading both VEGF and IGF-1 into a biocompatible hydrogel “scaffold” that is injected under the skin at the site of injury or disease. The scaffold allows for a sustained, local release of these growth factors at much lower doses, resulting in impressive repair of injured tissues.
Product Journey
The hydrogel scaffold was developed in the lab of Wyss Core Faculty member Dave Mooney, Ph.D., and has been successfully used for several applications including wound healing, vaccines, and single-cell encapsulation. The hydrogel’s tunable properties allow it to be customized for a variety of cargoes and purposes, and Mooney’s team decided to explore its capacity to “rescue” drugs that showed promise in the lab but had historically languished due to difficulties with delivering them to the target site. In multiple preclinical studies conducted at the Wyss Institute, the co-delivery of growth factors VEGF and IGF-1 using this method demonstrated a sustained ability to restore muscular function and reverse nerve damage. Blood perfusion recovered by 80-90% while muscle strength recovered to pre-injury levels after a few weeks.
Based on these encouraging results, the Wyss Institute began searching for a commercial partner who would be able to bring this medical innovation to the market. Alkem Laboratories Limited, a leading pharmaceutical manufacturer in India, recognized that the technology had the potential to address many health issues at a much lower cost than most drugs due to the fact that VEGF and IGF-1 are generic molecules, and seized the opportunity to bring this impactful treatment to global populations that have limited access to medical care.
Impact
Alkem licensed this technology in late 2021, and plans to develop it into a therapeutic that can treat multiple vascular conditions including diabetic neuropathy, foot ulcers, peripheral arterial disease, and ischemic injury.