completed a study in rabbits that suggests it can spark a similar bone healing effect with its SMC-103 product candidate as scientists saw with a BMP-2 injection. Rabbits are an important experimental model for bone healing, Crockett says, but SMC’s next step is to show it can confirm the results in weight-bearing bones from a higher species like a sheep.
If those results can be replicated, the manufacturing for SMC should be relatively straightforward, and much cheaper than it would be to make an engineered protein, Crockett says. The carbohydrates are also quite rugged molecules, meaning they can withstand extremes in temperature and acidity, unlike relatively fragile protein molecules that need to handled with care. The durability of the carbohydrates raise the possibility that they can be delivered in a variety of ways, beyond the original collagen sponge, Crockett says.
Over the past year, Crockett says SMC’s plans have come into much clearer focus, in terms of timelines, budgets, and the regulatory requirements it will need to meet to advance this product candidate. He was brimming with can-do attitude when we spoke earlier this week, confident that he has found the people with money and expertise that will be needed to get SMC’s first clinical trials underway in 2014.
And while a million things can go wrong in any trial, he’s betting that SMC has hit upon a lower-risk approach to regenerative medicine than some of the better-known approaches with stem cells or engineered proteins.
“Instead of injecting growth factors or stem cells in the body, we’re using what’s already there,” Crockett says. “We’re just enhancing the body’s natural process, enhancing bone healing. We’re not accelerating the natural process, which can probably cause something harmful.”
