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Mesoblast Heart Failure Trial Delivers Positive Interim Results

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Mesoblast Ltd., an Australia-based regenerative medicine company currently in a Phase 3 clinical trial in chronic heart failure, has received successful interim data, which prompted the Maxim Group to comment favorably on the study's design and progress.

On April 10, Mesoblast Ltd. (MESO:NASDAQ; MSB:ASX) issued a press release announcing its "allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in patients with moderate to advanced chronic heart failure (CHF) was successful in the pre-specified interim futility analysis of the efficacy endpoint in the trial's first 270 patients." The company plans to enroll about 600 patients.

The press release states that, "after notifying the Company of the interim analysis results, the trial's Independent Data Monitoring Committee (IDMC) additionally stated that they had no safety concerns relating to MPC-150-IM and formally recommended that the trial should continue as planned."

The primary endpoint of the interim analysis was "a comparison of recurrent heart failure related major adverse cardiovascular events (HF-MACE) between patients treated with MPC-150 and a control group," according to an April 10 Maxim research report.

The Maxim analysts observed that Mesoblast's trial design, which includes statistical analysis using the "Joint Frailty Model," is a significant factor in determining the efficacy of the company's stem cell treatment for heart failure.

“Smart statistical design represents one of multiple factors. It is more than a nuance, indicating an evolution of our understanding of clinical science, stem cells' mechanism of action, and an improved understanding of heart failure itself," the report states. "We believe that the therapy, delivery, time of delivery, dose, patient entry criteria, endpoints, and timing of this study all represent an evolution in our understanding."

Maxim also believes that "the probabilities of success for Mesoblast's [heart failure] trial are substantially greater than is represented by the company's current valuation."

Maxim has a 12-month target price of $14 on Mesoblast; its shares are currently trading at around $11.75.

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