The lifetime prevalence of hip fracture in the U.S. is 10% for men and 20% for women. Incidence is expected to continue to rise, driven by an increasing elderly population. Even with today’s surgical repair techniques and post-operative care, at 6 months postinjury, only half of patients can perform their pre-fracture daily living activities. At 1 year after hip fracture, older adults are five times more likely to be institutionalized than age-matched controls without hip fracture, and mmortality rates resulting from hip fracture range from 12% to 37% within the first year. In parallel, the cost to the U.S. healthcare system is also staggering, and amounts to between $10 and $15 billion annually.
Pluristem Therapeutics (NASDAQ: PSTI), a leading innovator in cell therapy, expects to start a Phase III trial that will evaluate the efficacy of its PLX-PAD cell therapy in reducing recovery time and improving outcomes following surgery for femoral neck fracture, the most comment form of hip fracture. The PLX-PAD cells are targeting more rapid and better muscle regeneration after the trauma of the fracture and repair procedure. Better muscle recovery may be able to speed up patient recovery, reduce mortality rates, and reduce both the total cost of treatment and loss in productivity for the growing number of patients.
If we assume about 20% of the $10 to $15 billion in annual costs for hip fracture in the U.S. are from post-op services, then accelerating recovery and reducing the need for these post-op services could add up to a billion in cost savings and healthier, happier patients.
In a Phase II trial of PLX-PAD cells in hip replacement surgery, which also involves trauma to an important hip muscle, an impressive 500% improvement in gluteus medius muscle strength 6 months following total hip replacement surgery were reported for patients treated with Pluristem’s PLX-PAD cells, as compared to placebo. Muscle volume similarly improved by 300% in the treated group versus placebo at month 6. Interestingly, the same study showed a 4000% improvement in muscle strength in the non-operated gluteus medius muscle for PLX-PAD treated patients as compared to placebo. This may indicate that PLX-PAD potentially has systemic benefits that accelerate full body recovery following surgery.
This phase II trial showing regeneration of muscle after hip surgery forms the basis of the protocol designed for a pivotal Phase III trial for recovery after surgery from hip fracture.
PLX-PAD cells are placental derived, allogeneic cells that are available off-the-shelf. The trial protocol for the planned Phase III study is now pending approval by the U.S. Food and Drug Administration and the European Medicines Agency (EMA). It may qualify for the Breakthrough Therapy designation and benefit from the 21st Century Cures Act in the U.S., as well as being eligible for the EMA’s Adaptive Pathways pilot project, which can accelerate the timeline to marketing approval in Europe. Pluristem expects to commence the trial in the second half of 2017.