Loss of tissue/organ during injury or during surgery indicates the need of innovative therapies that can regenerate tissues restoring their normal function. In this regard, an interdisciplinary field “Regenerative medicine” comes into picture, which while applying engineering and life science principles can stimulate regeneration, at the same time can possibly repair or heal diseased and damaged tissues and whole organs. Thus, regenerative medicine can be described as the process that restores or regenerate human tissues, cells, or organs to resume normal functioning. Many regenerative medicine therapies/products have been approved by Food and Drug Administration (FDA) and are now commercially available including cell-based immunotherapy products, gene therapy products, cell-therapy products, tissue engineered products.
One such regenerative medicine company is Mesoblast Limited (ASX: MSB). Let’s take a glimpse of the company which has been under the spotlight recently.
Mesoblast Limited (ASX: MSB) is a dual listed regenerative medicine company with its offices located in locations such as Melbourne, New York, Singapore and Texas. Mesoblast is engaged into development and commercialisation of novel allogenic cellular medicines for treating severe, debilitating inflammatory diseases with significant unmet need. Mesoblast’s patented manufacturing process is based on its innovative its mesenchymal lineage cell platform technology that generates industrial-scale, off-the-shelf, frozen, cellular medicines.
Mesoblast’s Broad Product Portfolio
The company has established wide-ranging product portfolio leveraging its innovative and patented cell therapy technology platform including Mesenchymal Precursor Cells (MPCs) and Mesenchymal Stem Cells (MSCs) with a well-defined multimodal mechanism of action.
Mesoblast has a robust portfolio of regulatory approved commercial products as well as late-stage pipeline products comprising:
- TEMCELL® HS Inj: For the treatment of Acute Graft Versus Host Disease, 1st allogenic regenerative medicine approved in Japan.
- Alofisel®: For the treatment of Perianal Fistula, 1st allogenic regenerative medicine approved in Europe.
- Remestemcel-L: For Acute Graft Versus Host Disease (aGVHD). Its rolling BLA (Biologics Licence Application) submission to FDA seeking approval has been initiated after accomplishing success in its Phase 3 trial.
- Revascor: Used in advanced heart failure and end-stage heart failure, with phase-3
trial of advanced heart failure near completion and for end-stage heart failure is expected to commence before the CY2019 end.
- MPC-06-ID: For chronic lower back pain with phase 3 trial currently in pipeline.
- MPC-300-IV: For Rheumatoid Arthritis and Diabetic Nephropathy with its Phase 2 trials already completed.
Update on Phase 3 trial of Revascor
Recently on 18 December 2019, Mesoblast unveiled the completion of final scheduled review of Revascor in Advanced Chronic Heart Failure Phase 3 trial. The phase 3 trial was overseen by an independent data monitoring committee, which during its tenth and final scheduled meeting has recommended that the trial would continue as per the schedule.
Prior to this in an announcement dated 17 December 2019, the company informed that the number of primary endpoint events that are required for completion of trial has been exceeded for Mesoblast’s Phase 3 trial of Revascor in Advanced Chronic Heart Failure. Th final study visits for all the patients who have survived this cardiovascular outcomes trail has now initiated, targeting the last visit in January 2020 end which would be followed by collection of final data and entry processes and finally locking the database, with the results expected in mid-2020. These results would be crucial to underpin the regulatory approval in the U.S., and China via the Tasly collaboration.
Revascor Phase 3 Trial
It is a double-blind, randomized, sham procedure-controlled trial with around 566 patients with advanced chronic heart failure and reduced ejection fraction enrolled. In this study Revascor is being investigated as an add-on treatment to current standard-of-care for reduction of recurrent major adverse cardiac events (HF-MACE) and terminal cardiac events (TCEs) related to non-fatal heart failure-related major adverse cardiac events (HF-MACE) and terminal cardiac events (TCEs).
Given the treatment benefits observed with Mesoblast’s Revascor in earlier Phase 2 trial results together with the projected rates of HF-MACE in comparably advanced populations of heart failure patients, the trial was designed to accumulate over 531 total primary endpoint events (HF-MACE).
It was further reported that pre-specified interim futility analysis of the primary efficacy endpoint was successful in the 1st two hundred and seventy patients enrolled in Phase 3 trial.
Operational Highlights for Q1 FY2020
Key Milestones to achieve
- Filing of the completed Biologic License Application (BLA) submission to the US FDA which would be followed by the anticipated launch of the given drug in US next year.
- Data Read outs for Phase 3 trial of Revascor planned in H1 CY20. Expecting pivotal results underpinning the regulatory approval in countries like US, China via collaboration with Tasly.
- Confirmatory Phase 3 trial of Revascor- to reduce mucosal bleeding in end-stage heart failure patients who have been imbedded with an LVAD, is also expected to commence.
- Expecting a combined outcome of pain and function at twelve and twenty-four months. 24 months follow up schedules in H1CY20 for last patient last visit.
- Expecting pivotal results to underpin regulatory approval in the U.S., as well as Europe via Grünenthal collaboration.
Stock Performance: MSB's shares are trading at $1.990 as on 19 December 2019, at AEDT 03:53 PM). The market cap of the company stands at $1.04 billion with nearly 536.68 million outstanding shares. The 52 weeks high and low of the stock was noted at $2.230 and $1.015, respectively.
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