BCLI - ALS Parkinson's Potential CureRight now we are waiting for Tuesday April 21, 2015 results of the trial Phase 2a study. Here is what was covered in their January 2nd conference call.
The stock spiked pre-call but for some reason the market didn’t care after the call, probably because the phase 2 trials will not begin until mid 2015.
Key points from the conference call:
1. Due to the patients response rates it was deemed unethical to stop the treatment from moving forward. Phase 2a study is only preformed to make sure the treatment is safe.
2. The company is currently in talks with the health administration in Israel to provide treatment for all ALS patients in that country. That might be announced in the next few months, or might not happen until later?
3. Their clean room can only currently support 20 patients per month, in converting the stem cells. They have been working on capacity and scalability. They can freeze the cells so they only need to process a patient one time.
4. Embryonic stem cells are not clearing the phase 2a studies (this is not the BCLI method, but stem cells from embryos are currently not safe) – 2a trials are the safety study before going to the next step clinical phase 2. Their process has no side effects because they are converting adult bone marrow cells. So basically they are getting such strong results in phase 2a study that they are clinically meaningful, as this is just the safety check with a small group. They are not supposed to be getting results from this.
5. ALSFR Scores this is how they measure a person with ALS (mobility test compared with breathing) – 40 would be someone that can walk with minimal disability 30 would be someone that can walk with trouble 15 would be someone confined to a wheelchair. So baseline case over three months without the drug the person goes from a 40 to a 31, with the drug they go from a 40 to a 36 but when they give the person the second does the person bounces back up. So in theory you can keep the person at a pretty high level if they are responding to the drug. For what period of time unknown.
6. One person out of the 12 in the phase 2a study improved, 1 person had no results. The person that improved on the ALSFR Score from a 30 to a 32. So only 2 points but still statistically relevant as this has never happened with an ALS patient before I think ever. Itis all downhill.
7. The dosage in the phase 2a study group had 3 groups – group 1 at 24million cells per treatment group 2 at 36 million cells group 3 at 48 million cells – the dosage for phase 2 is 125 million cells per treatment. So this is more than 2x the treatment give to the strongest group. Does more equate to a more positive reaction… I guess that would be a questions.
8. They started with ALS to get the ophan drug status. ALS is much harder to treat than parkinsons which is a much larger group. Spending on Parkinsons treatments is $25 Billion per year in the US. So if it works on ALS it should work on Parkinsons - as that was the original goal and it would be logical at least in my mind that the treatement would be better with Parkinsons.
So if the results in the phase 2 and phase 3 studies follow the phase 2a study this stock can go up in a big way.