Asterias Biotherapeutics Inc (NYSEAMERICAN: AST) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced a six month data readout from a clinical study that proved to be positive. Of course, the news excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The data;
- what we’re seeing from the stock as a result; and
- what we’ll be watching for ahead.
AST Flies On Clinical Update
As mentioned above, Asterias Biotherapeutics is having an incredibly strong start to the trading session today after announcing a clinical update. in a press release issued early this morning, the company announced additional data from its ongoing Phase 1/2a SciStar study. In the study, the company is evaluating the safety and potential efficacy of AST-OPC1 in the treatment of severe cervical spinal cord injury.
In the release, AST reminded investors that the SCiStar study included 25 subjects with subacute motore complete cervical spinal cord injury. As a result of their injuries, the individuals have lost essentially all movement below their injury site and experience severe paralysis of the upper and lower limbs. In the release, the company said that all patients in the study have completed their six month follow-up and provided updated results.
To date, AST said that there have been no serious adverse events related to the AST-OPC1 cells. Not only were there no adverse events, encouraging data showed evidence that these cells have engrafted at the injury site and helped to prevent cavitation.
The company also announced that 100% of Cohort 5 subjects have recovered at least one motor level on at least one side through six months, with two subjects having recovered one motor level bilaterally. 86% of Cohort 2-5 subjects recovered at least one motor level on at least one side and 18% of the subjects recovered two or more motor levels on at least one side. In a statement, Ed Wirth, CMO at AST, had the following to offer:
The results from the SCiStar study remain encouraging as the six-month follow-up data continued to demonstrate a positive safety profile and show that the AST-OPC1 cells are successfully engrafting in patients… We are pleased that 19 of the 22 subjects dosed in Cohorts 2 through 5 have recovered at least one motor level on at least one side through six months of follow-up and four of these subjects have recovered two motor levels during this same period. We expect to release the top-line 12-month data for the study in the first quarter of 2019 and are actively evaluating the design of a randomized controlled study for OPC1.
The above statement was followed up by Michael Mulroy, CEO at the company. Here’s what he had to offer:
The results are in-line with the data we reported earlier in the year for cohorts 3 and 4 and the overall body of evidence to date supports the primary safety objective for the study… There remain no serious or unexpected adverse events related to OPC1 and we believe the durable engraftment of the OPC1 cells, as evidenced in the earlier results as well, is an important prerequisite to seeing sustained clinical benefits. We expect to report the 12 month data on cohorts 3 and 4 later this quarter and the full trial results in early 2019 and begin to have more formalized discussions with FDA in the fourth quarter of 2018 on the next clinical study design for OPC1. We are also in early discussions with the California Institute for Regenerative Medicine (CIRM) regarding a possible grant to partially fund the next clinical study.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of Asterias Biotherapeutics, the news proved to be overwhelmingly positive. After all, their proprietary cells are leading to a strong recovery in patients included in the SCiStar clinical study. So, it’s no surprise that excited investors are sending the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:16), AST is trading at $1.80 per share after a gain of $0.15 per share or 9.09% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on AST. In particular, we’re interested in following the story surrounding the company’s AST-OPC1 cells as the treatment seems to be showing incredible promise. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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