Neurotrope's Approach To Alzheimer's Disease: 'Our Improvement Data Is The Best Anyone Has'
Dr. Daniel Alkon, the chief scientific officer at Neurotrope Inc (NASDAQ: NTRP), discussed the fight against Alzheimer's disease in an interview with Benzinga.
Benzinga: What is bryostatin, and how is it used for the treatment in patients with moderate to severe Alzheimer's disease? Can you comment a bit more on the drug?
Alkon: Bryostatin is a chemical that was found in the sea and is manufactured by bacteria, that live on bryozoan, which are similar to algae.
Roughly 20 to 30 years ago, a chemist from the University of Arizona went diving to find a chemical that has anti-tumorigenic properties. He identified this compound, and the National Cancer Institute has sponsored this ever since, with over 63 trials in roughly 1,500 patients.
Originally the algae were used to try and stop cancer. It did not prevent it, but it laid down a profile for safety, so we [knew] what dosing levels were safe.
With around $250 million dedicated to preclinical research, our studies identified this compound as potentially having multi-modal efficacy for Alzheimer's disease.
The NCI has been our sponsor for the last 10 years, providing this compound for free.
Benzinga: I heard that bryostatin does not just treat the symptoms, but treats the disease itself. Is that statement accurate?
Alkon: When we look at the data very carefully, it helped patients have better and improved memory. For the time in 100 years of research a compound has shown that it [made] patients better [and] not just slowed down the process of decline.
The improvement is measured with the Severe Impairment Battery, which has about 12 different measuring factors, including memory and hallucination. Each gives us a composite measurement.
Our data showed that the patients were getting better. They not only improved during the treatment but after the procedure. They continued to improve for many weeks after the treatment.
The underlying mechanism is the regeneration of the wiring in the brain. That's what happens to Alzheimer's patients: they lose their wiring. To our knowledge, we have the only therapeutic to help treat this disease.
Benzinga: What do you think makes your drug different from others, or what improvements has Neurotrope made to help with the treatment of moderate to severe Alzheimer's disease? Is it the wiring?
Alkon: To our knowledge, no other drug shows real potential to regrow the wiring. That is why we ventured to treat advanced patients that already have lost most of their wiring and memory. That's probably the most distinguishing feature in restoring the memory.
When we get to an advanced patient, it's not only the wiring that is gone, but the neurons are even dying. This drug also prevents the death of the neurons. We hope to confirm this in our latest trial and our continuing trials.
The number of Alzheimer's disease patients is growing. They are facing a steady decline, which is costing the U.S. roughly $300 million a year. It is projected to reach $1 trillion by 2050. It's a huge concern. Not only does it rob families of their loved ones but, it affects the caregiver enormously, along with the patient.
Benzinga: Neurotrope presented at the Alzheimer Solutions Conference at the University of the Sciences in Philadelphia. Can you comment on how you feel that the conference went? Moreover, what was an important takeaway from the conference for Neurotrope or yourself?
Alkon: I think that our presentation was very well-received. Currently, our improvement data is the best anyone has. In a few months, we are going to report our next trial.
When organizations get together in a meeting to go after innovative solutions, we must think about these solutions [and] not in a standard way.
One way Neurotrope has gone about this is that we decided to start with memory itself. Alzheimer's disease is the only form of dementia that can begin with just recent memory loss.
The death of neurons and the restructuring of the wire are all a part of the bigger picture. Ask yourself this: why are humans the only species on earth that get Alzheimer's? No other species get it; even the mouse models are not natural. We have to put human genes to make the symptoms appear.
Benzinga: In a press release it was said that the company is expecting to release results from a confirmatory Phase 2 clinical trial for bryostatin in the second half of 2019. Is Neurotrope still on track to release the Phase 2 confirmatory results in the upcoming months?
Alkon: Absolutely. We have finished giving and measuring the drug by monitoring and processing the data. We expect to have the data by late August or early September and announce the first results.
Our last trial in relation to the confirmatory trial was like a road map for us. It guided us on what was safe for the patients and what dose would give restoration in curing and getting back their memory.
We found something we had not expected. We had programmed in our analysis the standard of care. Then, we would check to see what would happen if we divided up the patients that got NMDA and the ones that didn't.
When we looked at the results, it was remarkable: the patients that got NMDA had no benefit. However, patients that did not receive NMDA had a unique advantage.
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