Mesoblast prepares for a critical trial of their cell therapy with end-stage heart failure patients, as it announced it had completed the enrolment of patients.
On Thursday (September 28) Mesoblast Limited (NASDAQ:MESO; ASX:MSB) completed the enrolment for its phase 2b cell therapy trial of its allogeneic mesenchymal precursor cell (MPC) therapy treating end-stage heart failure.
According to the release, Mesoblast will determine success in this trial if over a six-month period MPC-150-IM can “strengthen native heart muscle” enough to maintain “circulation in end-stage heart failure patients once they have been weaned from left ventricular assist devices (LVADs).”
The chief executive officer of Mesoblast, Dr. Silviu Itescu told the Investing News Network (INN) the work his company is doing has been a focus of the cardiovascular community. Itescu said the company is testing a way to improve the current treatment used for these patients.
Mesoblast alleges of the 50,000 patients facing end-stage heart failure, less than 5,000 are treated with LVADs due to high risks of “increased morbidity, recurrent hospitalizations,” and other medical complications.
Pilot trial showed Mesoblast the potential of MPC-150-IM
“We believe that MPC-150-IM could substantially impact outcomes of patients with end-stage heart failure by reducing LVAD-related morbidity, reducing hospital re-admission rates, and improving survival,” Itescu said in the company’s announcement.
The company previously conducted a pilot study with a smaller dose of 25 million cells, which showed improvement in the patients. Now with 150 million cells, Mesoblast hopes the results will continue the positive trend.
The data collected in this new trial, as Itescu told INN, will complement the one collected for a phase 3 study of MPC-150-IM in patients with moderate to advanced chronic heart failure (CHF).
This phase 3 trial for the company’s allogeneic mesenchymal precursor cell, was able to meet a pre-specified interim futility analysis of the efficacy endpoint for the first 270 enrolled patients.
At the market close on Thursday, Mesoblast’s share price declined 1.27 percent on the NASDAQ. Still, on a year-to-date basis, Mesoblat’s shares have increased slightly by 1.68 percent.
Analyst firms Oppenheimer and Cantor Fitzgerald began covering Mesoblast this year. Dr. Mark Breidenbach and Matthew Biegler, analysts at Oppenheimer, gave Mesoblast’s NASDAQ stock a price target of $16. At the close on Thursday, the company’s NASDAQ listing was valued at $5.44.
Oppenheimer warned against several situations in their downside scenario where the company could see a downturn if it’s top line results are “negative or ambiguous.” The investing firm also cautioned investors if Mesoblast doesn’t attract partnerships to offset the development and commercialization costs of their development pipeline.
“While we think MSCs (mesenchymal stem cell therapies) have been dragged through the mud in recent years… Mesoblast’s products have demonstrated clinical efficacy across multiple indications in randomized trials,” Breidenbach and Biegler wrote on their research note, published on August 30.
The co-authors of the Cantor Fitzgerald note, Dr. Elemer Piros and Justin Kim, wrote the see Mesoblast well positioned to get “multi-billion royalties” amounting to $6 billion.
“Mesoblast has generated a platform of clinical data validating the mechanism of action of the underlying cells to restore and control active disease states of acute GVHD, chronic heart failure (CHF), chronic lower back pain (CLBP), and rheumatoid arthritis (RA),” Cantor Fitzgerald,’s June 7 report indicated.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.