Moleculin Biotech Inc (NASDAQ: MBRX) is having a great day in the market today, and for good reason. The company announced positive data, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The newly announced data;
- what we’re seeing from MBRX stock as a result; and
- what we’ll be watching for ahead.
MBRX Announces Data
As mentioned above, Moleculin Biotech is having a strong day in the market today after the company announced positive data surrounding Annamycin. The announcement came by way of press release early this morning.
The data came from the company’s ongoing open label, single arm Phase 1/2 clinical study of Annamycin in Poland. The company said that after receiving a single dose of the treatment in the first cohort 2 out of 3 patients treated responded sufficiently to qualify for a potentially curative bone marrow transplant.
MBRX also said that all 3 patients were reviewed by the Safety Review Committee, which determined that no drug-related adverse events were observed that would prevent advancing the trial to the next higher dose level.
The company also said that in the European trial, one patient experienced grade 2 mucositis and no other adverse events related to treatment have been reported to date.
In a statement, Walter Klemp, Chairman and CEO at MBRX, had the following to offer:
The progress in Europe, specifically Poland, continues to be encouraging. In just a few months, we have completed the first cohort and we’ve seen a partial response from 2 out of 3 patients sufficient to qualify them for a potentially curative bone marrow transplant. It’s important to remember that these are relapsed or refractory patients for whom the standard of care failed.
So, to see this kind of response at the starting dose level in the dose-ranging phase, we believe is quite remarkable. And, although this data is still preliminary and may not be indicative of the ultimate outcome of the trial, the improvement in activity at 120 mg/m2 in Poland as compared with the 100 mg/m2 cohort in the US is consistent with our expectations for Annamycin.
Recognizing that cardiotoxicity is a significant limitation of existing therapies, we are pleased that we continue to see no evidence of cardiotoxicity in any of the patients treated thus far. Specifically, there was no observed reduction in left ventricle ejection fraction, which is the standard metric for acute cardiotoxicity, nor any change in biomarkers that would indicate the potential for long-term cardiovascular impairment. This is an important step in the ongoing clinical study of Annamycin and toward our goal of ultimately demonstrating the drug’s safety and effectiveness to support regulatory approval in both the US and European Union.
What We’re Seeing From The Stock
One of the first lessons that we lern when we start to work in the market is that the news leads to moves. When it comes to Moleculin Biotech, the news proved to be incredibly positive.
After all, positive clinical data means that the company is one step further down the development path. Moreover, the positive safety profile means that the company can move forward with higher doses that will likely improve efficacy.
So, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:03), MBRX is trading at $1.47 per share after a gain of $0.15 per share or 11.39% 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 MBRX. In particular, we’re interested in following the story surrounding the company’s continued work to develop Annamycin as well as the rest of its pipeline. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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