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20-F
MESOBLAST LTD filed this Form 20-F on 08/31/2018
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April

Phase 3 trial of product candidate MPC-150-IM in patients with moderate to advanced chronic heart failure was successful in the pre-specified interim futility analysis of the efficacy endpoint in the trial's first 270 patients. The trial’s Independent Data Monitoring Committee formally recommended that the trial should continue as planned

Received A$3.7 million from the Australian Government for Research & Development activities conducted during the 2016 fiscal year.

FDA cleared the commencement of a 24-patient trial sponsored and funded by the Boston Children’s Hospital and combining Mesoblast's mesenchymal precursor cells (MPCs) with corrective heart surgery in children under the age of 5 with hypoplastic left heart syndrome.

March

Successfully completed a fully underwritten institutional placement of 26.25 million new shares for gross proceeds of approximately $40.0 million.

Results from the Phase 2 trial in patients with chronic low back pain due to intervertebral disc degeneration showed that a single intra-discal injection of 6 million MPCs resulted in meaningful improvements in both pain and function that were durable for at least 36 months.

FDA granted a Fast Track designation for the use of MSC-100-IV to achieve improved overall response rate in children with steroid refractory acute graft versus host disease.

February

39-week data from the Phase 2 trial in patients with RA resistant to anti-Tumor Necrosis Factor agents showed that a single intravenous infusion of the product candidate MPC-300-IV was well tolerated and demonstrated a durable improvement in clinical symptoms, physical function, and disease activity relative to placebo over this period of follow-up.

Results of a new study published in the peer-reviewed journal Stem Cell Research & Therapy showed that a single intravenous infusion of 150 million of the Company’s proprietary allogeneic “off-the-shelf” STRO-3 immunoselected MPCs significantly improved clinical disease severity, reduced joint cartilage erosions, and improved synovial inflammation and histopathology in a large animal model of early RA.

December

Entered into an equity purchase agreement with Mallinckrodt Pharmaceuticals to exclusively negotiate a commercial and development partnership for MPC-06-ID in the treatment or prevention of moderate/severe chronic low back pain due to disc degeneration and MSC-100-IV in the treatment of aGVHD. As consideration, Mallinckrodt purchased approximately 20.04 million of Mesoblast’s ordinary shares for gross proceeds of approximately A$29.6 million.

MD Anderson Cancer Center and the United States National Institutes of Health (NIH) agreed to fund a clinical trial combining MPC-based expansion and ex-vivo fucosylation of hematopoietic stem cells for cord blood transplantation in cancer patients.

November

Phase 3 trial of product candidate MSC-100-IV used as front-line therapy in children with steroid-resistant aGVHD was successful in a pre-specified interim futility analysis.

October

Received the Frost & Sullivan Asia Pacific 2016 Cell Therapy Company of the Year Award.

Results from the Phase 2 trial of product candidate, MPC-300-IV, in patients with diabetic kidney disease published in the peer-reviewed journal EBioMedicine.

September

Mr William (Bill) A. Burns, former Chief Executive Officer (CEO) of Roche Pharmaceuticals, appointed Vice Chairman of Mesoblast.

August

Intellectual property portfolio covering the use of its MPCs in the treatment of rheumatic diseases, including RA, strengthened by the granting of a key patent by the United States Patent and Trademark Office.

Results from Phase 2 trial in biologic refractory RA showed that a single intravenous infusion of product candidate, MPC-300-IV, was well tolerated and demonstrated a dose-related improvement in clinical symptoms, physical function and disease activity relative to placebo through the 12 week primary endpoint.

24 month results from phase 2 trial of chronic low back pain product candidate MPC-06-ID presented at the 24th Annual Scientific Meeting of the Spine Intervention Society and received the 2016 Best Basic Science Abstract award.

July

Announced plans for an early interim analysis on its Phase 3 chronic heart failure trial, projections for annualized cash burn and the establishment of an equity facility to provide up to A$120.0 million funding at the Company’s discretion for up to three years.

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