SELLAS Life Sciences Group Inc (NASDAQ: SLS) is climbing in the market this morning, trading on gains around 20%. The gains come after the company announced positive data from a Phase 1/2 clinical trial. Here’s what’s happening:
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SLS Stock Jumps On Positive Data From AML Trial
In the press release, SELLAS Life Sciences provided data from a Phase 1/2 study of GPS in patients with AML in second complete remission. The data proved to be overwhelmingly positive with an extended overall survival rate.
In fact, in patients receiving GPS, an overall survival was clocked in at 21.0 months at a median follow-up of 30.8 months. Patients treated with the best standard of care experienced an overall survival rate of just 5.4 months.
Importantly, SLS said that the final analysis of the data showed that GPS therapy continues to be well-tolerated throughout the study. In a statement, Angelos Stergiou, MD, ScD h.c., President and CEO at SLS, had the following to offer:
We’re extremely pleased with this follow-up data, which show that GPS may have potential as a longer-term therapy for AML patients in CR2, an aggressive disease where the majority of patients typically relapse and have a survival rate of approximately 5 months with best standard therapy. The 21-month survival data observed further increases our confidence in the potential of GPS as a maintenance treatment for AML patients in CR2, the same patient population as our pivotal Phase 3 study, known as REGAL.
In the release, SLS also said that it is currently enrolling patients in its ongoing Phase 3 REGAL study. This study compares GPS monotherapy in the maintenance setting to investigators’ choice best available treatment in AML patients.
All patients in the study have achieved hematologic complete remission, with or without thrombocytopenia. This has taken place after second-line antileukemic therapy. Moreover, these patients are deemed ineligible for or are unable to undergo allogenic stem-cell transplant.
Why This Is Important
First and foremost, the data released today was great. GPS treatment has extended overall survival four fold when compared to best standard of care. Moreover, the treatment has proven to be well-tolerated. The truth is that results don’t get much better than that.
This opens the door to potentially overwhelmingly positive results from the Phase 3 study. Of course, if these results are positive, the company will likely push for potential FDA approval and commercialization.
If SELLAS Life Sciences were to break into the AML market, it would be a massive deal. Think about it, SLS stock trades with a market cap of just $13 million. However, this treatment may allow it to break into a market that’s expected to be worth more than $2.7 billion by the year 2025. Considering this, the company doesn’t need to tap into the entire market as a fraction of this market would be a big deal for the company.
All in all, investors have quite a bit to look forward to here.
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