By Ray Blanco
This post Off-the-Radar Biotechs About to Break Out appeared first on Daily Reckoning.
Some big scientific breakthroughs are set to take place this year.
And fortunes could be made with a few off-the-radar biotech pioneers.
What I am talking about are the handful of small biotech companies applying regenerative medicine platforms to degenerative diseases and ailments like paralysis.
These degenerative diseases have always been tough to treat, and few therapies are available. That’s not surprising, since we’ve lacked — until recently — the ability to create healthy and functioning human cells to replace ones lost in the body to injury and disease.
Now, though, a handful of breakthrough companies are aiming to correct that lack with new pluripotent stem cell technology.
Stem cells have the ability to reproduce and change into functional cells and tissues. And pluripotent stem cells are the most potent. They can turn into any cell type in the human body. Furthermore, they can divide and reproduce without end.
This makes them an ideal starting point for manufacturing cell-based therapies.
One Step Ahead of the Rest
One company using this platform to help heal spinal cord injuries and paralysis is already heaving great success in FDA trials with a new cell line.
Their recent FDA Phase 1 trial data shows that patients treated with a new cell line are seeing a significant return of nerve function thanks to these grafts.
And last month, this same company announced nine-month follow-up data for patients that were given a 10 million cell dose to their injury. Even though this is only half of what researchers believe will be a full dose, at least 50% of patients have already shown signs of recovery.
This includes two levels of improvement in motor function, as well as improvements in arm, hand and finger function.
The nine-month data confirms what the company reported at three and six months, too.
Showing us that the new cell therapy has great durability. The introduced cells help heal the injury, and the result is more than temporary.
Under the accumulating evidence, the FDA has also decided to approve an expansion to this trial to include patients with spinal cord injury at the C4 location — which is in the middle of the neck.
This is a very significant development.
The C4 spinal location is one of the most common locations for a spinal cord injury, and it often results in paralysis from the neck down.
And now the FDA is allowing the company to expand its treatment window from 14–30 days after injury to 21–42 days.
Small Companies, Big Market Share
All these data bode very nicely for the future.
And not only for the developers of this specific cell therapy, but for other small biotech companies also trying to carve out market share in the pluripotent stem cell therapy space.
According to the National Spinal Cord Injury Statistical Center, there are some 17,000 new spinal cord injuries per year. This represents a large potential market for any company that masters this new technology and provides viable treatments for degenerative injuries.
Even more promising is that this …read more
Source:: Daily Reckoning feed
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