TrovaGene Inc (NASDAQ: TROV) is having a great day in the market today, and for good reason. The company announced new data from a Phase 1b/2 clinical study, exciting investors and sending the stock screaming for the top. Today, we’ll talk about:
- The data;
- what we’re seeing from TROV stock as a result; and
- what we’ll be watching for ahead.
TROV Announces New Data
As mentioned above, Trovagene is having an incredibly strong day in the market today, and for good reason. The comapny announced new, positive clinical data. The data came from the ongoing Phase 1b/2 clinical study of Onvansertib in combination with standard-of-care chemotherapy for the treatment of Acute Myeloid Leukemia (AML).
This was overwhelmingly positive news as Onvansertib is the company’s lead candidate. The drug is a first-in-class, 3rd generation, highly-selective oral Polo-like Kinase 1 (PLK1) Inhibitor. At the moment, TROV has two ongoing open-label clinical trials surrounding Onvansertib. The first is the Phase 1b/2 trial in AML. The second of these trials is a Phase 2 trial in metastatic castration-resistant prostate cancer (mCRPC).
The data that was released today was featured in a poster presentation at the 60th American Society of Hematology Annual Meeting. The data demonstrate that when combined with LDAC or decitabine, Onvansertib is benefiting patients who have relapsed or refractory AML. The data also suggest that the treatment is safe and well-tolerated with no serious adverse events reported to date.
In a statement, Dr. Amer Zeidan, lead investigator on the trial, had the following to offer:
AML patients with relapsed/refractory disease have very limited, if any, treatment options… While we are still early in the trial where patients are being treated in the dose escalation phase, we are encouraged by the safety profile of onvansertib. Importantly, there are signs of preliminary efficacy we are already seeing in the dose escalation phase of the trial of onvansertib in combination with decitabine or low dose cytarabine. One patient has achieved an ongoing partial response; showing a significant reduction in blast count and hematologic count improvement, while 9 patients so far have stable disease. AML, especially when relapsed or refractory, is a biologically aggressive cancer, so prolonged periods of stable disease are considered clinically meaningful. We anticipate as we continue in the trial and reach the recommended Phase 2 dose that we will see additional evidence of clinical efficacy.
The above statement was followed up by Dr. Mark Erlander, CSO at TROV. Here’s what he had to offer:
A key component of our Onvansertib clinical development program is the integration of a predicative biomarker strategy to help identify patients who are more likely to respond to treatment… Thus far we have observed a rapid and durable inhibition of the PLK1 enzyme by Onvansertib in a subset of patients, which is also associated with a higher response to treatment, as measured by decreases in circulating and bone marrow leukemic blast cells. We believe this will provide a significant advantage as we advance our clinical trial in AML, and other cancers, and will enable us to select sub-populations of patients who will benefit most from treatment with Onvansertib.
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. In the case of Trovagene, the news proved to be overwhelmingly positive. After all, the positive clinical data means that the company’s work with Onvansertib is paying off and that the treatment is heading in the right direction down the development path. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top in the market today. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (11:33), TROV is trading at $0.74 per share after a gain of $0.047 per share or 6.73% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on TROV. In particular, we’re interested in following the continued development of Onvansertib as the treatment is yielding strong results. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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