Last weekend, CNN came out with an exhilarating piece on the story of Bobby Ghassemi, comatose for two years after a devastating car accident that severely damaged his brain. He was not expected to survive, and in fact was given the same comatose rating as a plank of wood.
Bobby's father, Peter Ghassemi, heard the story of a West Virginia miner named Randal McCloy, a comatose patient with brain damage similar to Bobby's, who was treated with massive doses of omega-3 rich fish oil via a feeding tube back in 2006, and three weeks later came out of his coma. Peter began to fight with Bobby's doctors to do the same with his son.
"It was a fight," Peter Ghassemi said. "They didn't believe, and they said, 'Fine, the West Virginia miner was one case. Bring me 999 more cases, a thousand more cases ... before I can give it to your son.' "
Such resistance is absolutely baffling, being that fish oil isn't some experimental drug with unknown side effects. It's just food, and the kid was comatose. Thank God, they eventually conceded and "allowed" Bobby to have the fish oil. Two weeks later, he started emerging from his coma. He has since recovered.
There have been no extensive studies on the effects of fish oil on brain repair in comatose patients, but what the evidence seems to suggest is that fish oil contains the very same molecular building blocks that the brain uses for everyday maintenance and repair. When the brain is damaged, it needs a massive infusion of these brain building blocks. Fish oil provides the bricks to repair the hardware.
Most drugs designed to treat neurological disorders are not designed for hardware repair, or to actually fix malfunctioning tissue in the brain or nervous system. They are rather designed to improve or alter the functioning of the existing tissue. Sometimes it works, but the brain is not actually fixed with these medications.
One famous example is Eli Lilly's (LLY) Prozac®, which is a serotonin reuptake inhibitor for depression. Viibryd® is an enhanced version developed by the private company Clinical Data, later acquired by Forest Labs (FRX) for $1.2B, also an SRI designed to treat major depressive disorder. It was worth $1.2B on the bet that it would probably work better than Prozac®. It was expected to sell $500MM a year, but last quarter took on just over $37 million.
Consider a paradigm shift along the lines of fish oil. For a revolution in brain treatment, we need to actually repair hardware, not just alter brain function. Neuralstem, Inc. (CUR) is trying to do that on many different fronts with stem cell therapies for different diseases at various levels of clinical approval. It just got FDA approval for a Phase 1b trial of NSI-189, designed to stimulate neuron growth in the hippocampus and cure depression by actually fixing the brain.
Another more recent example is Ampyra, developed by Acorda Therapeutics, Inc. (ACOR), which helps MS patients walk by easing signal transmission within damaged nerves. It does not actually fix the nerves. Acorda is also looking for half a billion dollars in Ampyra sales. As of 2011, sales clocked in at $210MM, nicely on track, but not there yet.
Neuralstem is battling the problem, again, from a hardware perspective. A Phase I trial was just recently completed for treatment of Lou Gherig's disease (ALS) by injection of stem cells directly into the spine. ALS and MS are not the same - ALS is spontaneous motor neuron death and MS is an autoimmune disease - but the concept of rebuilding the actual hardware is.
Neuralstem has been taking the fish oil approach at this since 1996, burning over $100MM in 16 years of product development. Only now are things just starting to move. It is these FDA-mandated clinical trials that drain these revolutionary companies of their resources, but this little piece of news about FDA easing its policies for potential life-saving experimental drugs may lighten that burden for Neuralstem - or at least it is an encouraging sign.
Watch out for share dilutions as Neuralstem has used those in the past to raise capital, but if you believe in the fish oil approach as the future of neurological treatments, keep your eye on Neuralstem's clinical trials.