Bio-Path Holdings Inc (NASDAQ: BPTH) is rocketing early on in the trading session this morning, and for good reason. The company announced a positive clinical update from its Phase 2 clinical trial of BP1001.
As you would imagine, the news proved to excite investors who are pushing the stock on a run for the top. Today, we’ll talk about:
- The clinical update;
- what we’re seeing from BPTH stock as a result; and
- what we’ll be watching for ahead.
BPTH Announcse Clinical Update
As mentioned above, Bio-Path Holdings is having an incredibly strong start to the trading session this morning after announcing a positive clinical update. The update, provided via press release, was centered around the company’s asset under development, BP1001.
In the release, BPTH announced an update to the previously reported interim analysis from an interim analysis from its Phase 2 trial. During the trial, the company is assessing the treatment as an option for acute myeloid leukemia (AML).
The primary endpoint on the study was to determine whether the combination of preigebersen and LDAC provides greater efficacy than would be expected from LDAC alone in a de novo patient population.
In a second cohort, the company evaluated the efficacy and safety of prexigebersen in conjunction with Decitabine for the treatment of AML.
The interim analysis, completed in April of 2018, proved to be promising. 47% of patients responded and four out of seventeen patients achieved complete response.
Recently however, the results were updated, showing an improved efficacy profile of 65%. Five patients to date have achieved a complete response and one patient has achieved a morphologic leukemia free state. The company also said that six stable disease responses were observed, two of these patients saw a greater than 50% reduction in bone marrow blasts.
The company also said that the safety and tolerability data from the trial remains positive. In a statement, Peter Nielsen, President and CEO at BPTH, had the following to offer:
These updated interim data from Stage 1 of our Phase 2 study of prexigebersen in de novo AML patients give strong evidence of the safety and efficacy profile of our lead compound and underscore its potential to provide meaningful treatment improvement in this difficult-to-treat patient population. We were particularly pleased with these results, especially when you consider that the large percentage of these patients are secondary AML patients. The CR/CRp/CRi rate for LDAC treatment alone for the class of patients in this study was benchmarked at 7-13%1, whereas prexigebersen treatment with LDAC is currently showing a 29% CR/CRi/MLFS rate, with a highly favorable safety profile.
Prexigebersen with its efficacy and safety profile, is an ideal combination candidate with frontline therapy. Our aim is to match prexigebersen with the leading frontline therapies to improve treatment options for patients. Consequently, we maintain an in-depth knowledge of all new therapies and therapies in development. As the treatment landscape evolves, we continue to nimbly respond to those advances and the plans for our registration-directed clinical development program for prexigebersen as a treatment for AML reflects these changes.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Bio-Path Holdings, the news proved to be incredibly positive.
After all, AML is an incredibly difficult to treat cancer. With positive efficacy, safety and tolerability data, the company is making clear progress toward the potential submission of an NDA for BP1001.
So, it’s not surprising to see that investors are excited, 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 (9:53), BPTH is trading at $7.68 per share after a gain of $3.06 per share or 66.41% 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 BPTH. In particular, we’re interested in following the continued development of BP1001 as the data surrounding the treatment is proving to be overwhelmingly positive. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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